10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from to
Commission file number 1-9860
BARR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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42-1612474 |
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(State or Other Jurisdiction of
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(I.R.S. Employer |
Incorporation or Organization)
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Identification No.) |
400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677-7668
(Address of principal executive offices)
201-930-3300
(Registrants telephone number)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or
a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer þ Accelerated filer o Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of October 26, 2007 the registrant had 107,750,550 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 thousands, except share amounts)
(unaudited)
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September 30, |
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December 31, |
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2007 |
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2006 |
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Assets |
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|
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Current assets: |
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|
|
|
|
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Cash and cash equivalents |
|
$ |
212,329 |
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$ |
231,975 |
|
Marketable securities |
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|
269,659 |
|
|
|
673,746 |
|
Accounts receivable, net of reserves of $268,175 and $236,577,
respectively |
|
|
473,261 |
|
|
|
511,136 |
|
Other receivables, net |
|
|
69,215 |
|
|
|
67,461 |
|
Inventories |
|
|
501,045 |
|
|
|
426,272 |
|
Deferred income taxes |
|
|
79,076 |
|
|
|
82,597 |
|
Prepaid expenses and other current assets |
|
|
30,225 |
|
|
|
35,926 |
|
Current assets held for sale |
|
|
46,407 |
|
|
|
58,886 |
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|
|
|
|
|
|
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Total current assets |
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|
1,681,217 |
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|
2,087,999 |
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|
|
|
|
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|
|
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Property, plant and equipment, net of accumulated depreciation of $360,699
and $196,709, respectively |
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|
1,078,026 |
|
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|
1,004,418 |
|
Deferred income taxes |
|
|
38,183 |
|
|
|
37,872 |
|
Marketable securities |
|
|
20,905 |
|
|
|
8,946 |
|
Other intangible assets, net |
|
|
1,487,151 |
|
|
|
1,471,493 |
|
Goodwill |
|
|
276,301 |
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|
276,449 |
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Long-term assets held for sale |
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|
15,050 |
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|
10,945 |
|
Other assets |
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|
73,149 |
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|
63,740 |
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|
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Total assets |
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$ |
4,669,982 |
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$ |
4,961,862 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
139,593 |
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$ |
137,362 |
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Accrued liabilities |
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258,753 |
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|
271,407 |
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Current portion of long-term debt and capital lease obligations |
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|
344,969 |
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|
742,192 |
|
Income taxes payable |
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|
9,116 |
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|
21,359 |
|
Deferred tax liabilities |
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|
855 |
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|
8,266 |
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Current liabilities held for sale |
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10,834 |
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31,307 |
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Total current liabilities |
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764,120 |
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1,211,893 |
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Long-term debt and capital lease obligations |
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1,804,795 |
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1,935,477 |
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Deferred tax liabilities |
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209,422 |
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|
221,259 |
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Long-term liabilities held for sale |
|
|
2,288 |
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|
2,580 |
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Other liabilities |
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|
100,598 |
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|
84,327 |
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Commitments & Contingencies (Note 15) |
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Minority interest |
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36,283 |
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|
41,098 |
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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, $.01 par value per share; authorized 200,000,000;
issued 110,481,923 and 109,536,481,
respectively |
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1,105 |
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|
1,095 |
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Additional paid-in capital |
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|
665,821 |
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|
610,232 |
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Retained earnings |
|
|
973,833 |
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877,991 |
|
Accumulated other comprehensive income |
|
|
212,407 |
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|
76,600 |
|
Treasury stock at cost: 2,972,997 shares |
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(100,690 |
) |
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(100,690 |
) |
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Total shareholders equity |
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1,752,476 |
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1,465,228 |
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Total liabilities and shareholders equity |
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$ |
4,669,982 |
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$ |
4,961,862 |
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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 thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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|
2007 |
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2006 |
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Revenues: |
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Product sales |
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$ |
558,868 |
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$ |
300,881 |
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$ |
1,705,773 |
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$ |
914,021 |
|
Alliance and development revenue |
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|
31,996 |
|
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|
31,489 |
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|
93,540 |
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|
96,858 |
|
Other revenue |
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|
10,521 |
|
|
|
|
|
|
|
32,576 |
|
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|
|
|
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|
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|
|
|
|
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Total revenues |
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|
601,385 |
|
|
|
332,370 |
|
|
|
1,831,889 |
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|
1,010,879 |
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|
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Costs and expenses: |
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Cost of sales |
|
|
267,331 |
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|
89,578 |
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|
844,664 |
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|
295,413 |
|
Selling, general and administrative |
|
|
190,332 |
|
|
|
88,695 |
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|
557,185 |
|
|
|
271,155 |
|
Research and development |
|
|
60,361 |
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|
|
39,969 |
|
|
|
186,804 |
|
|
|
114,121 |
|
Write-off of in-process research and development |
|
|
243 |
|
|
|
|
|
|
|
4,601 |
|
|
|
|
|
|
|
|
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|
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|
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Earnings from operations |
|
|
83,118 |
|
|
|
114,128 |
|
|
|
238,635 |
|
|
|
330,190 |
|
|
|
|
|
|
|
|
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|
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|
|
|
|
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Interest income |
|
|
8,462 |
|
|
|
6,782 |
|
|
|
27,201 |
|
|
|
16,729 |
|
Interest expense |
|
|
38,914 |
|
|
|
1,090 |
|
|
|
122,481 |
|
|
|
1,546 |
|
Other income (expense), net |
|
|
6,487 |
|
|
|
(42,865 |
) |
|
|
11,677 |
|
|
|
(25,104 |
) |
|
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|
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|
|
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|
Earnings before income taxes and minority interest |
|
|
59,153 |
|
|
|
76,955 |
|
|
|
155,032 |
|
|
|
320,269 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Income tax expense |
|
|
14,451 |
|
|
|
24,194 |
|
|
|
49,696 |
|
|
|
109,158 |
|
Minority interest |
|
|
249 |
|
|
|
|
|
|
|
(1,662 |
) |
|
|
|
|
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|
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|
|
|
|
|
|
Net earnings from continuing operations |
|
|
44,951 |
|
|
|
52,761 |
|
|
|
103,674 |
|
|
|
211,111 |
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|
|
|
|
|
|
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|
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|
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|
|
|
|
Discontinued operations |
|
|
|
|
|
|
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|
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|
|
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|
Loss from discontinued operations, net of taxes |
|
|
(5,990 |
) |
|
|
|
|
|
|
(7,796 |
) |
|
|
|
|
Loss on disposal of discontinued operations, net of taxes |
|
|
(36 |
) |
|
|
|
|
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from discontinued operations, net of tax |
|
|
(6,026 |
) |
|
|
|
|
|
|
(7,832 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
38,925 |
|
|
$ |
52,761 |
|
|
$ |
95,842 |
|
|
$ |
211,111 |
|
|
|
|
|
|
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Basic: |
|
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|
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|
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|
|
|
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|
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|
Earnings per common share continuing operations |
|
$ |
0.42 |
|
|
$ |
0.50 |
|
|
$ |
0.97 |
|
|
$ |
1.99 |
|
Loss per common share discontinued operations |
|
|
(0.05 |
) |
|
|
|
|
|
|
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings per common share basic |
|
$ |
0.37 |
|
|
$ |
0.50 |
|
|
$ |
0.90 |
|
|
$ |
1.99 |
|
|
|
|
|
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|
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Diluted: |
|
|
|
|
|
|
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|
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|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.41 |
|
|
$ |
0.49 |
|
|
$ |
0.95 |
|
|
$ |
1.95 |
|
Loss per common share discontinued operations |
|
|
(0.05 |
) |
|
|
|
|
|
|
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings per common share diluted |
|
$ |
0.36 |
|
|
$ |
0.49 |
|
|
$ |
0.88 |
|
|
$ |
1.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares basic |
|
|
107,298 |
|
|
|
106,311 |
|
|
|
107,008 |
|
|
|
106,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
108,852 |
|
|
|
108,061 |
|
|
|
108,584 |
|
|
|
108,187 |
|
|
|
|
|
|
|
|
|
|
|
|
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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 thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
95,842 |
|
|
$ |
211,111 |
|
Adjustments to reconcile net earnings to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
221,404 |
|
|
|
53,531 |
|
Deferred revenue |
|
|
(5,037 |
) |
|
|
(2,223 |
) |
Minority interest |
|
|
1,510 |
|
|
|
|
|
Stock-based compensation expense |
|
|
23,379 |
|
|
|
20,322 |
|
Deferred income tax benefit |
|
|
(49,129 |
) |
|
|
(12,723 |
) |
Loss on derivative instruments, net |
|
|
8,591 |
|
|
|
32,089 |
|
Write-off of acquired in-process research and development |
|
|
4,601 |
|
|
|
|
|
Other |
|
|
(641 |
) |
|
|
(8,736 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
(Increase) decrease in: |
|
|
|
|
|
|
|
|
Accounts receivable and other receivables, net |
|
|
65,644 |
|
|
|
43,729 |
|
Inventories |
|
|
(41,927 |
) |
|
|
(6,686 |
) |
Prepaid expenses |
|
|
8,990 |
|
|
|
(7,426 |
) |
Other assets |
|
|
(1,899 |
) |
|
|
(7,173 |
) |
Increase (decrease) in: |
|
|
|
|
|
|
|
|
Accounts payable, accrued liabilities and other liabilities |
|
|
(66,825 |
) |
|
|
71,389 |
|
Income taxes payable |
|
|
(7,238 |
) |
|
|
40,822 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
257,265 |
|
|
|
428,026 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(80,235 |
) |
|
|
(36,297 |
) |
Proceeds from sale of property, plant and equipment |
|
|
811 |
|
|
|
109 |
|
Purchases of marketable securities |
|
|
(1,634,643 |
) |
|
|
(2,481,570 |
) |
Sales of marketable securities |
|
|
2,032,365 |
|
|
|
2,409,399 |
|
Purchases of derivative instruments |
|
|
|
|
|
|
(48,900 |
) |
Settlement of derivative instruments |
|
|
(2,586 |
) |
|
|
1,517 |
|
Acquisitions, net of cash acquired |
|
|
(86,822 |
) |
|
|
(63,302 |
) |
Investment in debt securities |
|
|
(2,041 |
) |
|
|
|
|
Investment in venture funds and other |
|
|
(482 |
) |
|
|
(3,627 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
226,367 |
|
|
|
(222,671 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Principal payments on long-term debt and capital leases |
|
|
(616,830 |
) |
|
|
(1,115 |
) |
Proceeds from long-term debt and capital leases |
|
|
70,890 |
|
|
|
|
|
Tax benefit of stock incentives |
|
|
8,245 |
|
|
|
12,748 |
|
Proceeds from exercise of stock options and employee stock purchases |
|
|
26,581 |
|
|
|
26,256 |
|
Other |
|
|
871 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(510,243 |
) |
|
|
37,889 |
|
|
|
|
|
|
|
|
Effect of exchange-rate changes on cash and cash equivalents |
|
|
6,965 |
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and cash equivalents |
|
|
(19,646 |
) |
|
|
243,244 |
|
Cash and cash equivalents at beginning of period |
|
|
231,975 |
|
|
|
30,010 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
212,329 |
|
|
$ |
273,254 |
|
|
|
|
|
|
|
|
SEE ACCOMPANYING NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
5
BARR PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except for share and per share amounts)
(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 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 Transition Report on Form 10-K/T (the Transition
Report) for the six-month period ended
December 31, 2006 (the Transition Period). 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 financial statements reflect all adjustments (including those
that are normal and recurring) that are necessary in the judgment of management for a fair
presentation of such statements in conformity with GAAP.
The consolidated financial statements include all companies which Barr directly or indirectly
controls (meaning it has more than 50% of the voting rights in those companies). Investments in
companies where Barr holds between 20% and 50% of a companys voting rights are accounted for by
using the equity method, with Barr recording its proportionate share of that companys net income
and shareholders equity. The 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 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. All information, data and figures provided in this
report for the three and nine months ended September 30, 2006 relate solely to Barrs financial
results and do not include PLIVAs results.
Certain amounts in the Companys prior-period financial statements have been reclassified to
conform to the presentation for the three and nine months ended September 30, 2007. Such amounts
include the Companys reclassification of amortization expense from selling, general and
administrative expense to cost of sales. See Note 9 below.
2. Recent Accounting Pronouncements
In
September 2006, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting Standard (SFAS) No.
157, Fair Value Measurements, which defines fair value, establishes a framework for measuring fair
value under GAAP and expands disclosure about fair value measurements. The statement is effective
for fiscal years beginning after November 15, 2007. The Company is currently evaluating the impact
that adopting this statement will have on its consolidated financial statements.
In February 2007, the FASB issued SFAS No. 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
6
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 is currently evaluating the impact that adopting this statement will have on its
consolidated financial statements.
In June 2007, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue
No. 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 Company is currently evaluating the impact
that adopting this EITF will have on its consolidated financial statements.
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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
(table in thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for basic and diluted earnings (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings from continuing operations |
|
$ |
44,951 |
|
|
$ |
52,761 |
|
|
$ |
103,674 |
|
|
$ |
211,111 |
|
Net loss from discontinued operations |
|
|
(6,026 |
) |
|
|
|
|
|
|
(7,832 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
38,925 |
|
|
$ |
52,761 |
|
|
$ |
95,842 |
|
|
$ |
211,111 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: Weighted average shares basic |
|
|
107,298 |
|
|
|
106,311 |
|
|
|
107,008 |
|
|
|
106,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.42 |
|
|
$ |
0.50 |
|
|
$ |
0.97 |
|
|
$ |
1.99 |
|
Loss per common share discontinued operations |
|
|
(0.05 |
) |
|
|
|
|
|
|
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share basic |
|
$ |
0.37 |
|
|
$ |
0.50 |
|
|
$ |
0.90 |
|
|
$ |
1.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: Weighted average shares diluted |
|
|
108,852 |
|
|
|
108,061 |
|
|
|
108,584 |
|
|
|
108,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.41 |
|
|
$ |
0.49 |
|
|
$ |
0.95 |
|
|
$ |
1.95 |
|
Loss per common share discontinued operations |
|
|
(0.05 |
) |
|
|
|
|
|
|
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share diluted |
|
$ |
0.36 |
|
|
$ |
0.49 |
|
|
$ |
0.88 |
|
|
$ |
1.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calculation of weighted average common shares diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares basic |
|
|
107,298 |
|
|
|
106,311 |
|
|
|
107,008 |
|
|
|
106,089 |
|
Effect of dilutive options |
|
|
1,554 |
|
|
|
1,750 |
|
|
|
1,576 |
|
|
|
2,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
108,852 |
|
|
|
108,061 |
|
|
|
108,584 |
|
|
|
108,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Not included in the calculation of diluted earnings
per-share because their impact is antidilutive: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options outstanding |
|
|
928 |
|
|
|
146 |
|
|
|
1,912 |
|
|
|
58 |
|
7
4. Acquisitions and Business Combinations
PLIVA d.d.
On October 24, 2006, the Companys wholly owned subsidiary, Barr Laboratories Europe B.V.
(Barr Europe), completed the acquisition of PLIVA, headquartered in Zagreb, Croatia. Under the
terms of the cash tender offer, Barr Europe made a payment of $2,377,773 based on an offer price of
HRK 820 (Croatian Kuna (HRK)) per share for all shares tendered during the offer period. The
transaction closed with 96.4% of PLIVAs total outstanding share capital being tendered to Barr
Europe (17,056,977 of 17,697,419 outstanding shares at the date of the acquisition). Subsequent to
the close of the cash tender offer, Barr Europe purchased an additional 390,809 shares on the
Croatian stock market for $58,309, including 53,128 shares totaling $8,432 purchased during the
three months ended September 30, 2007 and 240,856 shares totaling $36,372 during the nine months
ended September 30, 2007. As the acquisition was structured as a purchase of equity, the
amortization of purchase price assigned to assets in excess of PLIVAs historic tax basis will not
be deductible for income tax purposes. With the addition of the treasury shares held by PLIVA, Barr
Europe owned or controlled 98.12% of PLIVAs voting share capital as of September 30, 2007
(17,447,786 of 17,781,524 outstanding shares).
The purchase price of $36,372 for the 240,856 shares acquired during the nine months ended
September 30, 2007 has been allocated to the estimated fair values using the same valuation
methodology as employed with shares acquired on October 24, 2006. The fair values attributed to
in-process research and development (IPR&D) that was expensed during the three months ended
September 30, 2007 was $243, and such amount was $4,601 for the nine months ended September 30,
2007. The share purchases in the nine months ended September 30, 2007 resulted in an increase in
goodwill of $6,880.
By
October 24, 2007, the Company had finalized the valuation and completed the purchase price
allocation for the PLIVA acquisition.
Refer to Note 9 below for the factors impacting the PLIVA goodwill adjustments.
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, 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 was $38,060 and includes
cash paid of $28,568, accrued amounts of $2,993 for a working capital
adjustment and minimum future payments of $6,176 due in
2008 and 2009, and $323 of transaction fees. The Company may also be
required to pay up to an additional
$11,509 based on the achievement of defined performance milestones for 2007 and 2008. The operating
results of ORCA are included in the consolidated financial statements subsequent to the September
5, 2007 acquisition date. As part of the preliminary purchase price allocation the Company has assigned fair
values as follows:
|
|
|
|
|
Inventory |
|
$ |
3,442 |
|
Products acquired |
|
|
29,327 |
|
Goodwill |
|
|
3,514 |
|
Other assets |
|
|
5,880 |
|
Liabilities |
|
|
(4,103 |
) |
|
|
|
|
Total |
|
$ |
38,060 |
|
|
|
|
|
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.
8
5. Discontinued Operations
Since its acquisition of PLIVA on October 24, 2006, the Company has been evaluating PLIVAs
operations and has decided to divest or exit certain non-core operations including its operations
in Spain and Italy, and its animal health and veterinary business operated by Veterina d.d.
(Veterina). As a result, as of September 30, 2007, the assets and liabilities relating to Spain
and Veterina met the held for sale criteria of FAS 144, Accounting for the Impairment or Disposal
of Long Lived Assets.
On September 28, 2007, the Company sold 100% of the outstanding shares in Pliva Pharma,
S.p.A., its Italian subsidiary, for $4,001. This resulted in a loss on the sale of $36.
In connection with the planned divestiture of Veterina, the Company announced on October 5,
2007 that its PLIVA subsidiary had sold 100% of the ordinary shares in Veterina through a public
offering in Croatia. The Veterina business has been segregated from continuing operations and is
included in assets held for sale and discontinued operations, net of taxes. See Note 17 below for
further details.
The Companys operations in Spain and Italy are part of the generic pharmaceuticals segment.
The Companys Veterina business is a separate operating segment which does not meet the
quantitative thresholds for separate disclosure and, as such, is included in other in Note 16
below.
The
following combined amounts of the Companys operations in Spain
and Italy and the Veterina
business have been segregated from continuing operations and included in discontinued operations,
net of taxes, and loss on sale of discontinued operations in the condensed consolidated statement
of operations, as shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
September 30, 2007 |
|
|
|
|
|
|
September 30, 2007 |
|
|
|
|
|
|
Italy |
|
|
Spain |
|
|
Veterina |
|
|
Total |
|
|
Italy |
|
|
Spain |
|
|
Veterina |
|
|
Total |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generics |
|
$ |
2,478 |
|
|
$ |
4,190 |
|
|
$ |
|
|
|
$ |
6,668 |
|
|
$ |
8,302 |
|
|
$ |
18,620 |
|
|
$ |
|
|
|
$ |
26,922 |
|
Other |
|
|
|
|
|
|
|
|
|
|
7,386 |
|
|
|
7,386 |
|
|
|
|
|
|
|
|
|
|
|
23,826 |
|
|
|
23,826 |
|
|
|
|
|
|
Total net revenues of discontinued operations |
|
$ |
2,478 |
|
|
$ |
4,190 |
|
|
$ |
7,386 |
|
|
$ |
14,054 |
|
|
$ |
8,302 |
|
|
$ |
18,620 |
|
|
$ |
23,826 |
|
|
$ |
50,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes and minority interest |
|
$ |
(518 |
) |
|
$ |
(2,777 |
) |
|
$ |
(2,843 |
) |
|
$ |
(6,138 |
) |
|
$ |
(1,427 |
) |
|
$ |
(4,001 |
) |
|
$ |
(2,285 |
) |
|
$ |
(7,713 |
) |
Loss on sale of discontinued operations |
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
(36 |
) |
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
(36 |
) |
Income tax benefit (expense) |
|
|
|
|
|
|
|
|
|
|
148 |
|
|
|
148 |
|
|
|
|
|
|
|
|
|
|
|
(83 |
) |
|
|
(83 |
) |
Minority interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations-net of tax |
|
$ |
(554 |
) |
|
$ |
(2,777 |
) |
|
$ |
(2,695 |
) |
|
$ |
(6,026 |
) |
|
$ |
(1,463 |
) |
|
$ |
(4,001 |
) |
|
$ |
(2,368 |
) |
|
$ |
(7,832 |
) |
|
|
|
|
|
The following combined amounts of assets and liabilities related to the Spain and Veterina
businesses have been segregated and included in assets held for sale and liabilities held for sale
on the Companys condensed consolidated balance sheet as of September 30, 2007 and December 31,
2006. Assets and liabilities relating to the Italian operations were divested prior to September
30, 2007, however such assets and liabilities are included in assets held for sale at December 31,
2006 in the combined table below:
9
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Accounts receivable, net |
|
$ |
24,743 |
|
|
$ |
21,929 |
|
Inventories |
|
|
19,618 |
|
|
|
26,139 |
|
Prepaid expenses and other current assets |
|
|
2,046 |
|
|
|
10,818 |
|
|
|
|
|
|
|
|
Current assets held for sale |
|
|
46,407 |
|
|
|
58,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
11,368 |
|
|
|
5,781 |
|
Deferred income taxes |
|
|
1,267 |
|
|
|
2,378 |
|
Other intangible assets, net |
|
|
2,297 |
|
|
|
2,677 |
|
Other assets |
|
|
118 |
|
|
|
109 |
|
|
|
|
|
|
|
|
Long-term assets held for sale |
|
|
15,050 |
|
|
|
10,945 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets held for sale |
|
$ |
61,457 |
|
|
$ |
69,831 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
7,065 |
|
|
$ |
18,761 |
|
Accrued liabilities |
|
|
3,480 |
|
|
|
12,293 |
|
Current portion of long-term debt and capital lease obligations |
|
|
289 |
|
|
|
253 |
|
|
|
|
|
|
|
|
Current liabilities held for sale |
|
|
10,834 |
|
|
|
31,307 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt and capital lease obligations |
|
|
1,711 |
|
|
|
1,738 |
|
Deferred tax liabilities |
|
|
457 |
|
|
|
636 |
|
Other liabilities |
|
|
120 |
|
|
|
206 |
|
|
|
|
|
|
|
|
Long-term liabilities held for sale |
|
|
2,288 |
|
|
|
2,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities held for sale |
|
$ |
13,122 |
|
|
$ |
33,887 |
|
|
|
|
|
|
|
|
6. Investments in Marketable Securities
Investments in Marketable Securities and Debt
Trading Securities
The fair value of marketable securities classified as trading at September 30, 2007 and
December 31, 2006 was $3,581 and $3,718, respectively, which is included as a component of current
marketable securities. Net gains (losses) for the nine-month period ended September 30, 2007 and
for the six-month period ended December 31, 2006 were $999 and $(572), respectively. These amounts
are included as a component of other income. Of such amount, losses
in the amount of $16 are
unrealized and relate to securities still held at September 30, 2007.
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 $11,259 and $10,293 at September 30, 2007
and December 31, 2006, respectively.
Available-for-sale debt securities at September 30, 2007 include $243,442 in commercial paper
and market auction debt securities and $30,370 in municipal and corporate bonds and federal agency
issues. The commercial paper and market auction debt securities are readily convertible into cash
at par value with interest rate reset or underlying maturity dates ranging from October 1, 2007 to
December 11, 2008. The municipal and corporate bonds and federal agency issues have maturity dates
ranging from October 15, 2007 to February 1, 2010.
Available-for-sale debt securities at December 31, 2006 included $617,286 in commercial paper
and market auction debt securities and $50,419 in municipal and corporate bonds and federal agency
issues. The commercial paper and market auction debt securities were readily convertible into cash
at par value with interest rate reset or
10
underlying maturity dates that ranged from January 1, 2007
to February 11, 2008. The municipal and corporate bonds and federal agency issues had maturity
dates that ranged from January 1, 2007 to April 1, 2009.
The unrealized gains (losses) on available-for-sale investments at September 30, 2007 and
December 31, 2006 were $875 and $(466), respectively.
7. 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 $800,000 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, as amended.
Derivative financial instruments are measured at fair value and are recognized as assets or
liabilities on the 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 $4,540 and $0 for the three months ended
September 30, 2007 and 2006, respectively, and $4,975 and $0 for the nine months ended
September 30, 2007 and 2006, respectively.
The terms of the interest rate swap agreements that are still in effect as of September 30,
2007 are shown in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notional |
|
|
|
|
|
|
|
|
|
|
Principal Amount |
|
|
|
Start Date |
|
Maturity Date |
|
Receive Variable Rate |
|
Pay Fixed Rate |
$ |
175,000 |
|
|
|
|
March-30-07 |
|
Jun-30-08 |
|
90 day LIBOR |
|
|
5.253 |
% |
$ |
125,000 |
|
|
|
|
Jun-30-07 |
|
Jun-30-10 |
|
90 day LIBOR |
|
|
5.4735 |
% |
$ |
100,000 |
|
|
|
|
Jun-30-07 |
|
Jun-30-10 |
|
90 day LIBOR |
|
|
5.3225 |
% |
$ |
100,000 |
|
|
|
|
Sept-30-07 |
|
Sept-30-10 |
|
90 day LIBOR |
|
|
4.985 |
% |
$ |
100,000 |
|
|
|
|
Sept-30-07 |
|
Sept-30-09 |
|
90 day LIBOR |
|
|
4.92875 |
% |
$ |
100,000 |
|
|
|
|
Sept-30-07 |
|
Mar-31-09 |
|
90 day LIBOR |
|
|
4.755 |
% |
$ |
100,000 |
|
|
|
|
Sept-30-07 |
|
Sept-30-09 |
|
90 day LIBOR |
|
|
4.83 |
% |
During the nine-month period ended September 30, 2007, the Company unwound a treasury lock on
a ten-year U.S. Treasury security used to lock-in the current benchmark interest rate. The
treasury lock was previously designated as a cash flow hedge of the Companys forecasted floating
rate interest payments on an anticipated transaction. As of June 30, 2007, this hedging
relationship no longer qualified for hedge accounting. Consequently, the unwinding of this
treasury lock resulted in a $3,515 net gain reclassified from accumulated other comprehensive
income and recorded in other income in the three months ended June 30, 2007.
11
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 forecasted foreign currency transactions occurring at various dates through 2007. At
September 30, 2007, none of the Companys remaining foreign exchange derivatives were eligible for
hedge accounting, resulting in their changes in fair value being reported in other (expense)
income. The gains or losses realized on these instruments at maturity are intended to offset the
losses or gains of the transactions they are hedging.
The table below summarizes the respective fair values of the derivative instruments described
above at September 30, 2007 and December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
|
|
Balance Sheet |
|
|
Balance Sheet |
|
|
|
Assets |
|
|
Liabilities |
|
|
Assets |
|
|
Liabilities |
|
Interest rate swap |
|
$ |
20 |
|
|
$ |
(7,997 |
) |
|
$ |
1,267 |
|
|
$ |
(443 |
) |
Forward rate agreements |
|
|
245 |
|
|
|
(85 |
) |
|
|
997 |
|
|
|
(163 |
) |
Foreign exchange forward contracts |
|
|
820 |
|
|
|
(4,932 |
) |
|
|
383 |
|
|
|
(106 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,085 |
|
|
$ |
(13,014 |
) |
|
$ |
2,647 |
|
|
$ |
(712 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials and supplies |
|
$ |
177,749 |
|
|
$ |
160,345 |
|
Work-in-process |
|
|
99,895 |
|
|
|
67,798 |
|
Finished goods |
|
|
223,401 |
|
|
|
198,129 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
501,045 |
|
|
$ |
426,272 |
|
|
|
|
|
|
|
|
9. Goodwill and Other Intangible Assets
Goodwill at December 31, 2006 and September 30, 2007 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic |
|
|
Proprietary |
|
|
|
|
|
|
Pharmaceuticals |
|
|
Pharmaceuticals |
|
|
Total |
|
Goodwill balance at December 31, 2006 |
|
$ |
228,529 |
|
|
$ |
47,920 |
|
|
$ |
276,449 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional acquisition of PLIVA shares |
|
|
6,880 |
|
|
|
|
|
|
|
6,880 |
|
PLIVA goodwill adjustments |
|
|
(27,648 |
) |
|
|
|
|
|
|
(27,648 |
) |
Currency translation effect |
|
|
16,959 |
|
|
|
|
|
|
|
16,959 |
|
Goodwill on acquisition of ORCA |
|
|
3,661 |
|
|
|
|
|
|
|
3,661 |
|
|
|
|
|
|
|
|
|
|
|
Goodwill balance at September 30, 2007 |
|
$ |
228,381 |
|
|
$ |
47,920 |
|
|
$ |
276,301 |
|
|
|
|
|
|
|
|
|
|
|
12
PLIVA goodwill adjustments for the nine months ended September 30, 2007 include the following
purchase price allocation and valuation revisions made based on additional information available to
modify the Companys initial estimates for certain assets and liabilities.
|
|
|
|
|
Current assets (excluding cash) |
|
$ |
(6,686 |
) |
Property, plant & equipment |
|
|
(40,122 |
) |
Other non-current assets |
|
|
291 |
|
Current
liabilities(1) |
|
|
4,812 |
|
Deferred tax liabilities |
|
|
6,320 |
|
Other liabilities |
|
|
7,737 |
|
|
|
|
|
Total PLIVA goodwill adjustments |
|
$ |
(27,648 |
) |
|
|
|
|
(1) The initial PLIVA opening balance sheet reflected an accrued liability of $1,500 relating
to a potential obligation owing by PLIVA to certain former employees in connection with their
allegations of invention rights relating to the process for manufacturing Azithromycin. Upon a
Croatian courts entry of a judgment in favor of the former
employees in June 2007, the Company
allocated an additional $12,500 as an accrued liability relating to this matter. PLIVA is
appealing the decision, and believes it has strong grounds for full or partial reversal on appeal.
PLIVAs obligation to pay any amount to the former employees will not arise unless and until the
decision in favor of the former employees is affirmed on appeal.
Intangible assets at September 30, 2007 and December 31, 2006 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
|
Gross |
|
|
|
|
|
|
Net |
|
|
Gross |
|
|
|
|
|
|
Net |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
Finite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product licenses |
|
$ |
45,350 |
|
|
$ |
18,876 |
|
|
$ |
26,474 |
|
|
$ |
45,350 |
|
|
$ |
15,624 |
|
|
$ |
29,726 |
|
Product rights |
|
|
1,429,606 |
|
|
|
179,163 |
|
|
|
1,250,443 |
|
|
|
1,301,939 |
|
|
|
64,788 |
|
|
|
1,237,151 |
|
Land use rights |
|
|
97,341 |
|
|
|
1,105 |
|
|
|
96,236 |
|
|
|
88,053 |
|
|
|
166 |
|
|
|
87,887 |
|
Other |
|
|
28,829 |
|
|
|
470 |
|
|
|
28,359 |
|
|
|
38,626 |
|
|
|
94 |
|
|
|
38,532 |
|
|
|
|
|
|
|
Total amortized finite-lived intangible assets |
|
|
1,601,126 |
|
|
|
199,614 |
|
|
|
1,401,512 |
|
|
|
1,473,968 |
|
|
|
80,672 |
|
|
|
1,393,296 |
|
|
|
|
|
|
|
Indefinite-lived intangible assets tradenames: |
|
|
85,639 |
|
|
|
|
|
|
|
85,639 |
|
|
|
78,197 |
|
|
|
|
|
|
|
78,197 |
|
|
|
|
|
|
Total identifiable intangible assets |
|
$ |
1,686,765 |
|
|
$ |
199,614 |
|
|
$ |
1,487,151 |
|
|
$ |
1,552,165 |
|
|
$ |
80,672 |
|
|
$ |
1,471,493 |
|
|
|
|
|
|
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 $40,213 and
$7,894 for the three months ended September 30, 2007 and 2006, respectively, and $120,262 and
$25,406 for the nine months ended September 30, 2007 and 2006, respectively. During the Transition
Period (six months ended December 31, 2006), the Company revised the presentation of amortization
expense to include this item within cost of sales instead of selling, general and administrative
expense. The presentation for the three and nine months ended September 30, 2006 was reclassified
to conform to that of the three and nine months ended September 30, 2007.
The Company reviews the carrying value of its long-lived 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
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:
13
|
|
|
|
|
Years Ending December 31, |
2008 |
|
|
$ |
168,084 |
2009 |
|
|
$ |
154,639 |
2010 |
|
|
$ |
146,238 |
2011 |
|
|
$ |
136,047 |
2012 |
|
|
$ |
126,892 |
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 September 30,
2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Gross |
|
|
|
|
|
|
Net |
|
|
Average |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Amortization |
|
Product Rights by Therapeutic Category |
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Period |
|
|
|
|
Contraception |
|
$ |
383,412 |
|
|
$ |
56,098 |
|
|
$ |
327,314 |
|
|
|
18 |
|
Antibiotics, antiviral & anti-infectives |
|
|
227,375 |
|
|
|
30,864 |
|
|
|
196,511 |
|
|
|
10 |
|
Cardiovascular |
|
|
211,704 |
|
|
|
26,950 |
|
|
|
184,754 |
|
|
|
10 |
|
Psychotherapeutics |
|
|
159,818 |
|
|
|
17,398 |
|
|
|
142,420 |
|
|
|
12 |
|
Other (1) |
|
|
447,297 |
|
|
|
47,853 |
|
|
|
399,444 |
|
|
|
10 |
|
|
|
|
|
|
|
|
Total product rights |
|
$ |
1,429,606 |
|
|
$ |
179,163 |
|
|
$ |
1,250,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Other includes numerous therapeutic categories, none of which exceeds 10% of the
aggregate net book value of product rights. |
10. Debt
A summary of outstanding debt is as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Credit facilities (a) |
|
$ |
1,850,000 |
|
|
$ |
2,415,703 |
|
Note due to WCC shareholders (b) |
|
|
6,500 |
|
|
|
6,500 |
|
Obligation under capital leases (c) |
|
|
2,176 |
|
|
|
2,819 |
|
Fixed rate bonds (d) |
|
|
109,130 |
|
|
|
101,780 |
|
Dual-currency syndicated credit facility (e) |
|
|
65,065 |
|
|
|
86,287 |
|
Euro commercial paper program (f) |
|
|
47,856 |
|
|
|
26,334 |
|
Dual-currency term loan facility (g) |
|
|
25,000 |
|
|
|
25,000 |
|
Multi-currency revolving credit facility (h) |
|
|
42,176 |
|
|
|
13,167 |
|
Other |
|
|
1,861 |
|
|
|
79 |
|
|
|
|
|
|
|
|
|
|
|
2,149,764 |
|
|
|
2,677,669 |
|
|
|
|
|
|
|
|
|
|
Less: current installments of debt and capital
lease obligations |
|
|
344,969 |
|
|
|
742,192 |
|
|
|
|
|
|
|
|
Total long-term debt |
|
$ |
1,804,795 |
|
|
$ |
1,935,477 |
|
|
|
|
|
|
|
|
(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 $2,000,000 under
a five-year term facility and $415,703 under a 364-day term facility, both of which bear interest
at variable rates of LIBOR plus 75 basis points (6.11% at September 30, 2007). The Company is
obligated to repay the outstanding principal amount of the five-year term facility in 18
consecutive quarterly installments of $50,000, with the first payment having been made |
14
on March 30,
2007, with the balance of $1,100,000 due at maturity in October 2011. The five-year term facility
had an outstanding principal balance of $1,850,000 at September 30, 2007. The 364-day term facility
was due to mature in October 2007, however the Company repaid it in full on September 28, 2007,
using cash on hand. 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, $6,500
promissory note to WCCs former shareholders. The note bears a fixed interest rate of 2%. The
entire principal amount and all accrued interest is due 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. |
The Companys debt includes the following liabilities incurred by PLIVA. Debt incurred prior to
the acquisition on October 24, 2006 was recorded at fair value based on the prevailing market
prices on the acquisition date, pursuant to the provisions of SFAS No. 141 (Euro to U.S. dollar
equivalents are based on the exchange rate in effect at September 30, 2007):
(d) |
|
In May 2004, PLIVA issued Euro denominated fixed rate bonds with a face value of EUR 75,000
($106,308). The bonds mature in 2011 and bear interest at 5.75%, payable semiannually. At the time
of the PLIVA acquisition, the aggregate fair value of the bonds was EUR 77,475 ($109,816). The
premium over face value of EUR 2,475 ($3,509) is being amortized over the remaining life of the
bonds. The amortization for the nine month period ended September 30, 2007 was EUR 484 ($687). The facility
includes customary covenants. |
|
(e) |
|
On October 28, 2004, PLIVA entered into a dual-currency syndicated term loan facility pursuant
to which the lenders agreed to provide the borrowers up to $250,000, available to be drawn in
either US dollars or Euros. The facility has a five-year term and bears interest at a variable rate
based on LIBOR or Euribor plus 70 basis points. At September 30, 2007, there was $44,855
outstanding with an effective interest rate of 6.0469% and EUR 14,258 ($20,210) outstanding with an
effective interest rate of 4.817%. The facility includes customary covenants. On October 29, 2007,
PLIVA repaid $25,095 and EUR 11,348 ($16,085) on this loan facility. |
|
(f) |
|
In December 1998, PLIVA initiated, and in June 2003 updated, a commercial paper program that
provides for an aggregate amount of Euro denominated financing not to exceed EUR 250,000 ($354,375)
and bears interest at a variable interest rate. As of
September 30, 2007, there was EUR 33,823 ($47,856) outstanding at an effective interest rate of 5.51%. Subsequently on October 5, 2007, EUR
20,000 ($28,350) has been drawn under this program, with such amount due to be repaid on December
19, 2007. |
|
(g) |
|
On September 9, 2006, PLIVA entered into a dual currency term loan facility pursuant to which
the lender agreed to provide the borrowers up to $25,000, available to be drawn in either US
dollars or Euros at a variable rate based on LIBOR or Euribor plus a negotiated margin. On
September 7, 2007, the facility was amended and extended for an additional two-year term. At September 30, 2007, there was $25,000 outstanding with an effective interest rate of 5.72% plus a
negotiated margin. The facility includes customary covenants. |
|
(h) |
|
In June 2005, PLIVA entered into a EUR 30,000 multi-currency revolving credit facility
($42,176). The facility matures on December 31, 2007 and bears interest at a variable rate based on
LIBOR, Euribor or another relevant reference rate plus a negotiated margin. At September 30, 2007,
there was EUR 30,000 ($42,176) outstanding with an effective interest rate of 4.36% plus a
negotiated margin. The facility includes customary covenants. |
15
Principal
maturities of existing long-term debt and amounts due on capital
leases for the periods set forth in the table below are as follows:
|
|
|
|
|
Twelve Months Ending September 30, |
|
Total |
|
2009 |
|
$ |
237,847 |
|
2010 |
|
$ |
206,269 |
|
2011 |
|
$ |
256,634 |
|
2012 |
|
$ |
1,100,343 |
|
2013 |
|
$ |
367 |
|
Thereafter |
|
$ |
513 |
|
|
|
|
|
Total
principal maturities and amounts due on long-term debt and capital obligations |
|
$ |
1,801,973 |
|
Premium on fixed rate bond (see (d) above) |
|
$ |
2,822 |
|
|
|
|
|
Total
long-term debt and capital lease obligations |
|
$ |
1,804,795 |
|
|
|
|
|
11. Accumulated Other Comprehensive Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income |
|
$ |
38,925 |
|
|
$ |
52,761 |
|
|
$ |
95,842 |
|
|
$ |
211,111 |
|
Net unrealized gain on marketable securities,
net of tax |
|
|
404 |
|
|
|
206 |
|
|
|
1,187 |
|
|
|
484 |
|
Net (loss) on derivative financial instruments
designated as cash flow hedges, net of tax |
|
|
(4,540 |
) |
|
|
|
|
|
|
(4,975 |
) |
|
|
|
|
Net unrealized gain on
currency translation adjustments |
|
|
92,629 |
|
|
|
|
|
|
|
139,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
$ |
127,418 |
|
|
$ |
52,967 |
|
|
$ |
231,649 |
|
|
$ |
211,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive income, as reflected on the balance sheet, is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Cumulative unrealized gain (loss) on
marketable securities, net of tax |
|
$ |
915 |
|
|
$ |
(272 |
) |
Cumulative net (loss) on derivative financial
instruments designated as cash flow hedges, net
of tax |
|
|
(4,975 |
) |
|
|
|
|
Cumulative net unrealized gain on pension and other
post employment benefits, net of tax |
|
|
22 |
|
|
|
22 |
|
Cumulative net unrealized gain on
currency translation adjustments |
|
|
216,445 |
|
|
|
76,850 |
|
|
|
|
|
|
|
|
Accumulated other comprehensive income |
|
$ |
212,407 |
|
|
$ |
76,600 |
|
|
|
|
|
|
|
|
12. Income Taxes
In
June 2006, the FASB issued FIN No. 48 (FIN 48),
Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement 109. FIN 48
establishes a single model to address accounting for uncertain tax positions. On January 1, 2007,
the Company adopted FIN 48, and as a result, recorded a $4,500 increase in the net liability for
unrecognized tax positions, which was entirely recorded as a
$4,500 adjustment to the opening balance of goodwill relating to the PLIVA acquisition. The
total amount of gross unrecognized tax benefits as of January 1, 2007 was $25,000, and did not
change materially as of September 30,
16
2007. Included in the balance at September 30, 2007 was
$13,200 of tax positions that, if recognized, would affect the Companys effective tax rate. The
Company does not believe that the amount of the liability for unrecognized tax benefits will
materially change during the next 52-week period.
Upon adoption of FIN 48, the Company elected an accounting policy to classify accrued interest
and related penalties relating to unrecognized tax benefits in interest expense. Previously, the
Companys policy was to classify interest and penalties in its income tax provision. The Company
had $2,600 accrued for interest and penalties at September 30, 2007.
The Company is currently being audited by the IRS for its June 30 and December 31, 2006 tax
years. Prior periods have either been audited or are no longer subject to an IRS audit. Audits in
several state jurisdictions are currently underway for tax years 2004 to 2006. The foreign
jurisdictions with significant operations currently being audited are Croatia for 2004 and 2005 (tax
years that remain subject to examination are 2003 and 2006), Czech
Republic for 2003 to 2005 (tax year that remains subject to
examination is 2006) and Hungary for 2005 and 2006 (tax years that
remain subject to examination are 2002-2005). Additionally, although Germany and
Poland are not currently being audited, the tax years that remain subject to examination in Germany
are 2004-2006 and in Poland 2001-2002 and 2004-2006.
During the three months ended September 30, 2007, the German government enacted new tax
legislation reducing the statutory corporate tax rate from 39% to 30%, effective January 1, 2008. The change
reduced the Companys deferred tax liability and income tax provision by approximately $9,600
during the quarter.
13. Stock-based Compensation
The Company adopted SFAS No. 123 (revised 2004), Share-Based Payment (SFAS 123(R)), effective
July 1, 2005. SFAS 123(R) requires the recognition of the fair value of stock-based compensation in
net earnings. The Company has three stock-based employee compensation plans, two stock-based
non-employee director compensation plans and an employee stock purchase plan. Stock-based
compensation consists of stock options and stock-settled stock appreciation rights (SSARs)
granted under the employee equity compensation plans, and shares purchased under the employee stock
purchase plan. Stock options and SSARs are granted to employees at exercise prices equal to the
fair market value of the Companys stock at the dates of grant. Generally, stock options and SSARs
granted to employees fully vest three years from the grant date and have a term of 10 years. Stock
options granted to directors are generally exercisable on the date of the first annual
shareholders meeting immediately following the date of grant. The Company recognizes stock-based
compensation expense over the requisite service period of the individual grants, which generally
equals the vesting period.
The Company utilized the modified prospective transition method for adopting SFAS 123(R).
Under this method, the provisions of SFAS 123(R) apply to all awards granted or modified after the
date of adoption. In addition, the unrecognized expense of awards not yet vested at the date of
adoption, determined under the original provisions of SFAS No. 123, is recognized in net earnings
in the periods after the date of adoption.
The Company recognized stock-based compensation expense for the three months ended September
30, 2007 and 2006 of $7,947 and $7,124, respectively, and for the nine months ended September 30,
2007 and 2006 of $23,379 and $20,322, respectively. The Company also recorded related tax benefits
for the three months ended September 30, 2007 and 2006 of $2,771 and $2,125, respectively, and for
the nine months ended September 30, 2007 and 2006 of $7,874 and $6,061, respectively. The effect on
net income from recognizing stock-based compensation for the three months ended September 30, 2007
and 2006 was $5,176 and $4,999, or $0.05 per basic and $0.05 per diluted share, respectively, and
for the nine months ended September 30, 2007 and 2006 was $15,505 and $14,261, or $0.14 and $0.13
per basic and $0.14 and $0.13 per diluted share, respectively.
The total number of shares of common stock issuable upon the exercise of stock options and
SSARs granted during the nine months ended September 30, 2007 and 2006 was 1,439,950 and 1,691,100
respectively, with weighted-average exercise prices of $51.10 and $49.65, 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
17
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 |
|
Nine |
|
|
Months Ended |
|
Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Average expected term (years) |
|
|
4 |
|
|
|
5 |
|
|
|
4 |
|
|
|
5 |
|
Weighted average risk-free interest rate |
|
|
5.00 |
% |
|
|
5.10 |
% |
|
|
4.64 |
% |
|
|
5.06 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Volatility |
|
|
29.20 |
% |
|
|
32.18 |
% |
|
|
29.81 |
% |
|
|
32.41 |
% |
Weighted average grant date fair value |
|
$ |
17.03 |
|
|
$ |
18.27 |
|
|
$ |
15.71 |
|
|
$ |
18.65 |
|
As of September 30, 2007, the aggregate intrinsic value of awards outstanding and exercisable
was $142,873 and $123,195, respectively. In addition, the aggregate intrinsic value of awards
exercised during the nine months ended September 30, 2007 and 2006 was $26,723 and $35,978,
respectively. The total remaining unrecognized compensation cost related to unvested awards
amounted to $45,759 at September 30, 2007 and is expected to be recognized over the next three
years. The weighted average remaining requisite service period of the unvested awards was 24
months.
14. Restructuring
Managements plans for the restructuring of the Companys operations as a result of its
acquisition of PLIVA are completed. As of September 30, 2007, certain elements of the plan have been recorded as a cost of the acquisition.
Through September 30, 2007, 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
|
as of |
|
|
|
|
|
|
|
|
|
|
as of |
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2006 |
|
|
Payments |
|
|
Additions |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Involuntary termination of PLIVA employees |
|
$ |
8,277 |
|
|
$ |
7,005 |
|
|
$ |
328 |
|
|
$ |
1,600 |
|
Lease termination costs |
|
|
10,201 |
|
|
|
177 |
|
|
|
|
|
|
|
10,024 |
|
|
|
|
|
|
$ |
18,478 |
|
|
$ |
7,182 |
|
|
$ |
328 |
|
|
$ |
11,624 |
|
|
|
|
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 $7,044 of severance and retention bonus expense in the nine months ended September 30,
2007.
15. Commitments and Contingencies
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
18
Company also records accruals for
litigation settlement offers made by the Company, whether or not the settlement offers have been
accepted.
The Companys material litigation matters are summarized in its Transition Report on Form
10-K/T for the six month period ended December 31, 2006 and its Form 10-Qs for the quarters ended
March 31, 2007 and June 30, 2007. Except for the matters summarized below, no material changes have
occurred in the Companys litigation matters since June 30, 2007.
Fexofenadine Hydrochloride Suit
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 Court for New Jersey and denied
Barr Pharmaceutical, Inc.s motion to dismiss as moot.
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.
On November 2, 2007, the Company and the other defendants in the federal litigation filed a
motion with the United States Court of Appeals for the Second Circuit, asking the court to
immediately transfer the case to the United States Court of Appeals for the Federal Circuit or, in
the alternative, to summarily affirm the district courts judgment in favor of all defendants,
based on the Second Circuits ruling in the Tamoxifen antitrust case.
On September 19, 2003, the Circuit Court for the County of Milwaukee dismissed the Wisconsin
state class action for failure to state a claim for relief under Wisconsin state 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 plaintiffs case. The
matter has now returned to the trial court for further proceedings; no schedule or trial date has
been set.
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 requested that the court lift the stay. A hearing on the matter is currently scheduled for
November 8, 2007.
Ovcon Antitrust Proceedings
To date, the Company has been named as a co-defendant with Warner Chilcott Holdings, Co. III,
Ltd. and others in complaints filed in federal courts by the Federal Trade Commission, 34 state
Attorneys General and certain private class action plaintiffs claiming to be direct or indirect
purchasers of Ovcon-35®. These actions, the first of which was filed by the FTC in December 2005,
allege, among other things, that a March 24, 2004 agreement
between the Company and Warner Chilcott (then known as Galen Holdings PLC) constitutes an
unfair method of competition, is anticompetitive and restrains trade in the market for Ovcon-35®
and its generic equivalents.
During
the quarter ended September 30, 2007, the Company and counsel for the FTC reached an
agreement in principle, subject to FTC approval, to settle the FTCs lawsuit against the Company.
Under the proposed settlement, the FTC would dismiss its case against the Company, and the Company
would agree to refrain from entering into
19
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. On September 28, 2007, the Company and the FTC filed a joint motion with the district court
seeking to stay the FTCs case, pending FTC approval of the proposed settlement. On November 1,
2007, the FTC unanimously approved the proposed settlement. The Company anticipates that the
proposed settlement will be finalized shortly, resulting in the dismissal of the FTCs lawsuit
against the Company.
The court has ordered dispositive motions in the States case to be filed by November 14,
2007. The court has not yet set a trial date.
In the actions brought on behalf of the direct purchasers, on October 22, 2007, the Court
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. Fact and expert
discovery are now closed. The Court has ordered dispositive motions to be filed by November 14,
2007. No trial date has been set.
In the actions brought on behalf of the indirect purchasers, the Company reached an agreement
in principle with the class representatives to settle plaintiffs claims. On June 27 and 28, 2007,
the court entered orders conditionally certifying a settlement class and preliminarily approving
the parties settlement agreement. The court has scheduled a fairness hearing for November 6, 2007.
This settlement is conditioned on the number of plaintiffs who exercise their right to opt-out of
the settlement class not exceeding the threshold established by the terms of the settlement
agreement.
During the three and nine months ended September 30, 2007, the Company recorded
charges in the amounts of $7,250 and $15,250 related to these and other settlement offers in the
Ovcon litigation.
Medicaid Reimbursement Cases
The Company and numerous other pharmaceutical companies have been named as defendants 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).
In the Massachusetts case, the parties have reached a settlement under which the
Company has denied any wrongdoing, and a stipulation of dismissal has been filed with the court.
The State of Iowa case was filed in federal court in Iowa on October 9, 2007. The matter is
at an early stage. No trial date has been set.
The State of Utah case was filed in state court in Utah on September 21, 2007. The matter is
at an early stage. No trial date has been set.
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 the Company and Shire PLC concerning Shires Adderall XR product. On June 20, 2007,
the Company received a Civil Investigative Demand seeking documents and data. The FTC is
investigating whether the Company and the other parties to the litigation have engaged in unfair
methods of competition in violation of the Federal Trade Commission Act by entering into agreements
relating to Adderall XR and generic alternatives to Adderall XR, or other products for the
treatment of attention deficit hyperactivity disorder. The Company believes that its settlement
agreement is in compliance with all applicable laws and intends to cooperate with the FTC in its
investigation.
16. 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:
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Generic |
|
|
|
|
|
Proprietary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
September 30, 2007 |
|
Pharmaceuticals |
|
% |
|
Pharmaceuticals |
|
% |
|
Other |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
434,190 |
|
|
|
72 |
% |
|
$ |
124,678 |
|
|
|
21 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
558,868 |
|
|
|
93 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
31,996 |
|
|
|
5 |
% |
|
|
31,996 |
|
|
|
5 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
10,521 |
|
|
|
2 |
% |
|
|
10,521 |
|
|
|
2 |
% |
|
Total revenues |
|
$ |
434,190 |
|
|
|
72 |
% |
|
$ |
124,678 |
|
|
|
21 |
% |
|
$ |
42,517 |
|
|
|
7 |
% |
|
$ |
601,385 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
Gross Profit: |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Product sales |
|
$ |
202,989 |
|
|
|
47 |
% |
|
$ |
94,717 |
|
|
|
76 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
297,706 |
|
|
|
53 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
31,996 |
|
|
|
100 |
% |
|
|
31,996 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
4,352 |
|
|
|
41 |
% |
|
|
4,352 |
|
|
|
41 |
% |
|
Total gross profit |
|
$ |
202,989 |
|
|
|
47 |
% |
|
$ |
94,717 |
|
|
|
76 |
% |
|
$ |
36,348 |
|
|
|
85 |
% |
|
$ |
334,054 |
|
|
|
56 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Generic |
|
|
|
|
|
Proprietary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
September 30, 2006 |
|
Pharmaceuticals |
|
% |
|
Pharmaceuticals |
|
% |
|
Other |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
197,595 |
|
|
|
60 |
% |
|
$ |
103,286 |
|
|
|
31 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
300,881 |
|
|
|
91 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
31,489 |
|
|
|
9 |
% |
|
|
31,489 |
|
|
|
9 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
Total revenues |
|
$ |
197,595 |
|
|
|
60 |
% |
|
$ |
103,286 |
|
|
|
31 |
% |
|
$ |
31,489 |
|
|
|
9 |
% |
|
$ |
332,370 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
Margin |
Gross Profit: (1) |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Product sales |
|
$ |
132,047 |
|
|
|
67 |
% |
|
$ |
79,256 |
|
|
|
77 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
211,303 |
|
|
|
70 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
31,489 |
|
|
|
100 |
% |
|
|
31,489 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
Total gross profit |
|
$ |
132,047 |
|
|
|
67 |
% |
|
$ |
79,256 |
|
|
|
77 |
% |
|
$ |
31,489 |
|
|
|
100 |
% |
|
$ |
242,792 |
|
|
|
73 |
% |
|
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
Generic |
|
|
|
|
|
Proprietary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
September 30, 2007 |
|
Pharmaceuticals |
|
% |
|
Pharmaceuticals |
|
% |
|
Other |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
1,389,781 |
|
|
|
76 |
% |
|
$ |
315,992 |
|
|
|
17 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
1,705,773 |
|
|
|
93 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
93,540 |
|
|
|
5 |
% |
|
|
93,540 |
|
|
|
5 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
32,576 |
|
|
|
2 |
% |
|
|
32,576 |
|
|
|
2 |
% |
|
Total revenues |
|
$ |
1,389,781 |
|
|
|
76 |
% |
|
$ |
315,992 |
|
|
|
17 |
% |
|
$ |
126,116 |
|
|
|
7 |
% |
|
$ |
1,831,889 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
Gross Profit: |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Product sales |
|
$ |
647,261 |
|
|
|
47 |
% |
|
$ |
231,767 |
|
|
|
73 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
879,028 |
|
|
|
52 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
93,540 |
|
|
|
100 |
% |
|
|
93,540 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
14,657 |
|
|
|
45 |
% |
|
|
14,657 |
|
|
|
45 |
% |
|
Total gross profit |
|
$ |
647,261 |
|
|
|
47 |
% |
|
$ |
231,767 |
|
|
|
73 |
% |
|
$ |
108,197 |
|
|
|
86 |
% |
|
$ |
987,225 |
|
|
|
54 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
Generic |
|
|
|
|
|
Proprietary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
September 30, 2006 |
|
Pharmaceuticals |
|
% |
|
Pharmaceuticals |
|
% |
|
Other |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
620,153 |
|
|
|
61 |
% |
|
$ |
293,868 |
|
|
|
29 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
914,021 |
|
|
|
90 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
96,858 |
|
|
|
10 |
% |
|
|
96,858 |
|
|
|
10 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
Total revenues |
|
$ |
620,153 |
|
|
|
61 |
% |
|
$ |
293,868 |
|
|
|
29 |
% |
|
$ |
96,858 |
|
|
|
10 |
% |
|
$ |
1,010,879 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
Gross Profit: (1) |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Product sales |
|
$ |
406,873 |
|
|
|
66 |
% |
|
$ |
211,735 |
|
|
|
72 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
618,608 |
|
|
|
68 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
96,858 |
|
|
|
100 |
% |
|
|
96,858 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
Total gross profit |
|
$ |
406,873 |
|
|
|
66 |
% |
|
|
211,735 |
|
|
|
72 |
% |
|
$ |
96,858 |
|
|
|
100 |
% |
|
|
715,466 |
|
|
|
71 |
% |
|
|
|
|
(1) |
|
Prior period amounts have been reclassified to include the effect of intangible
amortization and to conform to the presentation for the three and nine months ended September 30,
2007. |
Geographic Information
The Companys principal operations are in the United States and Europe. Sales in the United
States and the rest of the world (ROW) are classified based on the geographic location of the
customers. The table below presents net product sales by geographic area based upon geographic
location of the customer.
Product sales by geographic area
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three |
|
|
Nine |
|
|
|
Months Ended |
|
|
Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
United States |
|
$ |
399,816 |
|
|
$ |
299,365 |
|
|
$ |
1,189,366 |
|
|
$ |
909,595 |
|
ROW |
|
|
159,052 |
|
|
|
1,516 |
|
|
|
516,407 |
|
|
|
4,426 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
558,868 |
|
|
$ |
300,881 |
|
|
$ |
1,705,773 |
|
|
$ |
914,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company operates in more than 30 countries outside the United States. No single foreign country contributes more than 10% to consolidated product sales.
22
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 |
|
|
Nine |
|
|
|
Months Ended |
|
|
Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
Contraception |
|
$ |
188,192 |
|
|
$ |
198,933 |
|
|
$ |
530,668 |
|
|
$ |
532,300 |
|
Psychotherapeutics |
|
|
62,190 |
|
|
|
11,905 |
|
|
|
201,141 |
|
|
|
51,135 |
|
Cardiovascular |
|
|
63,240 |
|
|
|
18,800 |
|
|
|
204,391 |
|
|
|
74,008 |
|
Antibiotics, antiviral & anti-infectives |
|
|
51,074 |
|
|
|
11,957 |
|
|
|
168,905 |
|
|
|
42,913 |
|
Other (1) |
|
|
194,172 |
|
|
|
59,286 |
|
|
|
600,668 |
|
|
|
213,665 |
|
|
|
|
|
|
Total |
|
$ |
558,868 |
|
|
$ |
300,881 |
|
|
$ |
1,705,773 |
|
|
$ |
914,021 |
|
|
|
|
|
|
|
|
|
(1) |
|
Other includes numerous therapeutic categories, none of which individually exceeds 10% of
consolidated product sales. |
17. Subsequent events
In connection with the planned divestiture of its non-core animal health business
(Veterina), in October 2007 the Companys PLIVA subsidiary sold 100% of the ordinary shares in
Veterina through a public offering in Croatia for approximately $35,900.
23
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis addresses material changes in the results of operations
and financial condition of Barr Pharmaceuticals, Inc. and subsidiaries for the periods presented.
This discussion and analysis should be read in conjunction with the consolidated financial
statements, the related notes to consolidated financial statements and Managements Discussion and
Analysis of Results of Operations and Financial Condition included in the Companys Transition
Report on Form 10-K/T for the six-month period ended December 31, 2006 (the Transition Report),
and the unaudited interim condensed consolidated financial statements and related notes included in
Item 1 of this report on Form 10-Q.
Business Development Activities
PLIVA Acquisition
On October 24, 2006, the Companys wholly owned subsidiary, Barr Laboratories Europe B.V.
(Barr Europe), completed the acquisition of PLIVA, headquartered in Zagreb, Croatia. Under the
terms of the cash tender offer, Barr Europe made a payment of approximately $2.4 billion based on
an offer price of HRK 820 (Croatian Kuna (HRK)) per share for all shares tendered during the
offer period. The transaction closed with 96.4% of PLIVAs total outstanding share capital being
tendered to Barr Europe (17,056,977 of 17,697,419 outstanding shares at the date of the
acquisition). Subsequent to the close of the cash tender offer, Barr Europe purchased an additional
390,809 shares on the Croatian stock market for $58.3 million, including 53,128 shares purchased
for $8.4 million during the three months ended
September 30, 2007 and 240,856 shares purchased for $36.4 million during the nine months ended September 30, 2007. As the acquisition was structured as a
purchase of equity, the amortization of purchase price assigned to assets in excess of PLIVAs
historic tax basis will not be deductible for income tax purposes. With the addition of the
treasury shares held by PLIVA, Barr Europe owned or controlled 98.12% of PLIVAs voting share
capital as of September 30, 2007 (17,447,786 of 17,781,524 outstanding shares).
O.R.C.A.pharm GmbH Acquisition
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, 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 was $38.0 million and the Company may also be required
to pay up to an additional $11.5 million based on the achievement of defined performance milestones for
2007 and 2008.
Pliva Pharma, S.p.A. Divestiture
On September 28, 2007 our PLIVA subsidiary sold 100% of the outstanding shares in Pliva
Pharma, S.p.A., its Italian subsidiary, for $3.8 million. This resulted in a loss on the sale of
$0.04 million. For the nine months ended September 30, 2007, the results of operations for the
Italian subsidiary have been segregated from continuing operations in our condensed consolidated
statement of operations and are included in discontinued operations, net of taxes, along with the
$0.04 million loss being recorded as a loss on the sale of the discontinued operations, net of
taxes.
Veterina d.d. IPO
Subsequent to the end of the quarter, our PLIVA subsidiary sold Veterina, a non-core business
unit, for approximately $35.9 million, in an offering of shares to the Croatian public. For the
nine months ended September 30, 2007, the assets and liabilities associated with Veterina were
classified as held for sale in accordance with FAS 144, Accounting for the Impairment or Disposal
of Long Lived Assets. The results of operations for Veterina have been segregated from continuing
operations and are included in discontinued operations, net of taxes.
24
The fluctuations in our operating results
for the three and nine months ended September 30,
2007, as compared to the same periods ended September 30, 2006, are primarily due to the acquisition
of PLIVA. All information, data and figures provided in this report for the three and nine months
ended September 30, 2006 relate solely to Barrs financial results and do not include PLIVA.
25
Results of Operations
Comparison of the Three and Nine Months Ended September 30, 2007 and September 30, 2006
The following table sets forth revenue data for the three and nine months ended September
30, 2007 and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Generic products: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral contraceptives |
|
$ |
112.0 |
|
|
$ |
121.4 |
|
|
$ |
(9.4 |
) |
|
|
-8 |
% |
|
$ |
341.1 |
|
|
$ |
329.6 |
|
|
$ |
11.5 |
|
|
|
3 |
% |
Other generics |
|
|
322.2 |
|
|
|
76.2 |
|
|
|
246.0 |
|
|
|
323 |
% |
|
|
1,048.7 |
|
|
|
290.6 |
|
|
|
758.1 |
|
|
|
261 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total generic products |
|
|
434.2 |
|
|
|
197.6 |
|
|
|
236.6 |
|
|
|
120 |
% |
|
|
1,389.8 |
|
|
|
620.2 |
|
|
|
769.6 |
|
|
|
124 |
% |
Proprietary products |
|
|
124.7 |
|
|
|
103.3 |
|
|
|
21.4 |
|
|
|
21 |
% |
|
|
316.0 |
|
|
|
293.8 |
|
|
|
22.2 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
558.9 |
|
|
|
300.9 |
|
|
|
258.0 |
|
|
|
86 |
% |
|
|
1,705.8 |
|
|
|
914.0 |
|
|
|
791.8 |
|
|
|
87 |
% |
Alliance and development revenue |
|
|
32.0 |
|
|
|
31.5 |
|
|
|
0.5 |
|
|
|
2 |
% |
|
|
93.5 |
|
|
|
96.9 |
|
|
|
(3.4 |
) |
|
|
-4 |
% |
Other revenue |
|
|
10.5 |
|
|
|
|
|
|
|
10.5 |
|
|
|
100 |
% |
|
|
32.6 |
|
|
|
|
|
|
|
32.6 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
601.4 |
|
|
$ |
332.4 |
|
|
$ |
269.0 |
|
|
|
81 |
% |
|
$ |
1,831.9 |
|
|
$ |
1,010.9 |
|
|
$ |
821.0 |
|
|
|
81 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Sales
Generic Oral Contraceptives
During the three months ended September 30, 2007, sales of our generic oral contraceptives
(Generic OCs) were $112.0 million, representing an 8% decrease from the prior year period. The
decrease is primarily due to lower sales of Jolessa of $7.2 million and lower sales of certain
other Generic OCs totaling approximately $10.7 million. These declines were partially offset by
higher sales of Kariva of $4.6 million, due to higher prices, and contributions from Balziva of
$3.9 million, which we launched subsequent to September 30, 2006.
During
the nine months ended September 30, 2007, sales of our Generic OCs were $341.1 million,
representing a 3% increase over the prior year period. The increase was due to a full period of
contribution from Balziva, which accounted for $8.4 million of the increase, combined with higher
sales of Kariva of $13.4 million, due to both volume and price increases. These increases more than
offset lower sales of Tri-Sprintec, which decreased by $10.9 million from the prior year period.
Other Generic Products
During
the three months ended September 30, 2007, sales of our other
generic products (Other
Generics) were $322.2 million, up from $76.2 million in the prior year period, an increase of
$246.0 million. This increase was mainly due to $214.1 million of sales attributable to PLIVA
products, including sales of Azithromycin of $26.1 million. In addition to higher sales from
acquired PLIVA products, the total sales increase included $18.7 million of higher sales of
Fentanyl Citrate, our generic version of Cephalons ACTIQ that we launched in late September 2006.
During the nine months ended September 30, 2007, sales of our Other Generics were
$1,048.7 million, up from $290.6 million as compared to the nine months ended September 30, 2006,
an increase of $758.1 million. This increase was mainly due to
$705.5 million of sales attributable
to PLIVA products, including sales of Azithromycin of $84.3 million. In addition, we recorded $69.4
million in higher sales of Fentanyl Citrate during the nine months ended September 30, 2007.
Partially offsetting these increases were lower sales of certain Other Generics, principally a
$14.3 million decline in sales of Desmopressin due to lower volume and prices.
Proprietary Products
During the three months ended September 30, 2007, sales of our proprietary products were
$124.7 million, an increase of $21.4 million as compared to the three months ended September 30,
2006. This increase was primarily
26
due to $16.4 million of higher sales of Plan B, in part resulting
from our over-the-counter (OTC) launch in November 2006. In addition, $9.2 million in sales of
Adderall IR, which we acquired from Shire and launched in October 2006, and approximately $7.4
million of sales through our Odyssey subsidiary, which we acquired in the PLIVA transaction,
contributed to this overall increase. These increases combined with other increases of our
proprietary products more than offset lower sales of SEASONALE of $14.7 million due to the impact
of generic competition. During the three months ended September 30, 2007, customer buying patterns
may have contributed to our overall sales increase, and as such we expect that proprietary sales
during our December 31, 2007 quarter will be lower than in the prior quarter.
During the nine months ended September 30, 2007, sales of our proprietary products were $316.0
million, an increase of $22.2 million as compared to the nine months ended September 30, 2006.
Contributions from our launch of SEASONIQUE during this period, combined with the acquisition of
Adderall IR and product sales recorded through our Odyssey
subsidiary, contributed $59.7 million of
total sales during the current period. In addition, we recorded higher sales of Plan B
of $33.8 million compared to the same period in the prior year, including contributions from our Plan B OTC
launch. These increases more than offset $46.2 million of lower sales of SEASONALE, lower sales of
Mircette of $7.7 million representing a shift to Kariva, our generic version of the product, and
lower sales of approximately $25.1 million of certain non-promoted proprietary products
during the period.
Alliance and Development Revenue
During the three months ended September 30, 2007,
we recorded $32.0 million of alliance and
development revenue, up slightly from the $31.5 million in the prior year period. Revenues earned
under our license and development agreement with Shire increased by $3.2 million and fees
associated with the development of the Adenovirus vaccine for the U.S. Department of Defense
increased by $1.3 million. Offsetting these increases were decreases of $2.0 million from our
profit-sharing arrangement with Teva on generic Allegra and a decrease of $2.5 million in revenues
relating to our agreements with Kos Pharmaceuticals (Kos) relating to Niaspan and Advicor.
Alliance and development revenue for the nine months ended September 30, 2007 was $93.5
million, down slightly from $96.9 million in the nine months ended September 30, 2006. This
decrease of $3.4 million was caused principally by a $15.5 million decline in revenues from our
profit-sharing arrangement with Teva on generic Allegra. As competition for generic Allegra
continues to increase, we expect that revenues will decline in future periods. In addition, we
recorded lower revenues relating to our agreements with Kos relating to Niaspan and Advicor of $5.0
million. These declines were partially offset by an increase of $10.1 million in development
revenues earned under our license and development agreement with Shire and an increase in fees we
receive for the development of the Adenovirus vaccine of $6.4 million.
We expect that revenues under our agreements with
Kos will be lower in the December 2007 quarter than in the current quarter due to the annual dollar
limit applied to our royalties. While the annual limit increases each year during the term
of our arrangement, the royalty rate and the Companys
promotion-related requirements declined
in 2007 compared to 2006, which now remains fixed throughout the
remaining term of the agreement.
Other Revenue
We recorded $10.5 million and $32.6 million of other revenue during the three and nine months
ended September 30, 2007, respectively. This revenue is primarily attributable to non-core
operations which include our diagnostics, disinfectants, dialysis and infusions business.
This business was acquired through the PLIVA acquisition, and as such, there are no comparable
operations for the three and nine months ended September 30, 2006.
27
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 and nine months ended September 30, 2007
and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Generic products |
|
$ |
231.3 |
|
|
$ |
65.6 |
|
|
$ |
165.7 |
|
|
|
253 |
% |
|
$ |
742.5 |
|
|
$ |
213.3 |
|
|
$ |
529.2 |
|
|
|
248 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
46.7 |
% |
|
|
66.8 |
% |
|
|
|
|
|
|
|
|
|
|
46.6 |
% |
|
|
65.6 |
% |
|
|
|
|
|
|
|
|
|
Proprietary products |
|
$ |
30.0 |
|
|
$ |
24.0 |
|
|
$ |
6.0 |
|
|
|
25 |
% |
|
$ |
84.3 |
|
|
$ |
82.1 |
|
|
$ |
2.2 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
75.9 |
% |
|
|
76.8 |
% |
|
|
|
|
|
|
|
|
|
|
73.3 |
% |
|
|
72.1 |
% |
|
|
|
|
|
|
|
|
|
Other revenue |
|
$ |
6.1 |
|
|
$ |
|
|
|
$ |
6.1 |
|
|
|
100 |
% |
|
$ |
17.9 |
|
|
$ |
|
|
|
$ |
17.9 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
41.9 |
% |
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
45.1 |
% |
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
Total cost of sales |
|
$ |
267.4 |
|
|
$ |
89.6 |
|
|
$ |
177.8 |
|
|
|
198 |
% |
|
$ |
844.7 |
|
|
$ |
295.4 |
|
|
$ |
549.3 |
|
|
|
186 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
53.0 |
% |
|
|
70.2 |
% |
|
|
|
|
|
|
|
|
|
|
51.4 |
% |
|
|
67.7 |
% |
|
|
|
|
|
|
|
|
Cost of sales components include the following:
|
|
|
our manufacturing and packaging costs for products we manufacture; |
|
|
|
|
amortization expense (as discussed further below); |
|
|
|
|
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. |
Prior to December 31, 2006, we included amortization expenses related to acquired product
intangibles in selling, general and administrative expenses (SG&A) rather than cost of sales. As
discussed in our Transition Report, we revised our presentation of amortization expense to include
it within cost of sales rather than SG&A. We have adjusted our discussion regarding the quarter
ended September 30, 2006 presented below to reflect this change.
Overall: As a
result of our increases in product sales of $258.0 million for the three
months ended September 30, 2007 and $791.8 million for the nine months then ended, cost of sales
more than doubled compared to the prior year periods. In addition to
greater material and production costs
associated with increased product sales, cost of sales increased due to higher amortization
charges of $32.3 million and $94.9 million for the three and nine months ended September 30, 2007,
respectively. Also included in cost of sales was a charge of $33.2 million for the nine months
ended September 30, 2007 relating to the stepped-up value of inventory acquired from PLIVA that we
sold primarily during the first quarter.
In addition to amortization and inventory step-up charges, our product sales mix changed as
compared to prior periods presented and negatively impacted our
overall margins. Generic product sales during the three and nine months ended
September 30, 2007 represented 78% and 81% of total product
sales, respectively. For the same period in the
prior year, generic product sales represented 66% and 68%, respectively. As a result of a higher
proportion of generic product sales, which, as a group, carry lower
gross margins than our proprietary line, and the charges noted above, overall gross margins, as
a percentage of total product sales, decreased
from 70.2% and 67.7% for the three and nine months ended
September 30, 2006 to 53.0% and
51.4% for the three months and nine months ended September 30, 2007, respectively.
28
Generics:
During the three months ended September 30, 2007, our generics
segment cost of sales increased due in part to the $246.0 million increase in Other
Generics sales, as described above, and $26.7 million of higher amortization expense arising
primarily from product intangibles created as a result of the PLIVA acquisition. Gross
margins declined from 66.8% in the prior period to 46.7% due to a
higher proportion of Other Generics sales, which carry lower margins
than Generic OCs, during the current period as compared to the same period in the prior year.
During the nine
months ended September 30, 2007, our generics segment cost of sales increased
by $529.2 million as compared to the nine months ended September 30, 2006 in large part due to the
$758.1 million increase in Other Generics sales, for reasons described above, and $78.1 million of
higher amortization expense. When combined with the charge related to
the $33.2 million step-up in
inventory described above, our generics margins declined from 65.6%
in the prior period to 46.6%. This margin decrease
was also negatively impacted by a higher proportion of Other Generic product sales, as a percentage of
total generic product sales, during the current nine-month period as compared to the same period in
the prior year.
Proprietary:
During the three months ended September 30, 2007, the cost of
sales in our proprietary segment increased by $6.0 million over the three months ended September 30, 2006, resulting in a
slightly lower margin of 75.9% compared to 76.8% for the prior year period. The increase in cost of
sales is primarily attributable to a 21% increase in proprietary sales as compared to the same
period in the prior year. The margin decline is a result of lower sales of higher margin products,
including SEASONALE, which now faces generic competition, and SEASONIQUE, which included sales
recorded at launch in the September 2006 quarter. Lower sales of these higher margin products were
more than offset by higher sales of promoted and non-promoted products which, in general, have
lower margins than SEASONIQUE and SEASONALE, resulting in an overall lower gross margin for the
quarter.
During
the nine months ended September 30, 2007, the cost of sales in our proprietary segment
increased by $2.2 million over the nine months ended September 30, 2006, due primarily to an
increase in product sales of $22.2 million. Gross margins during the current nine-month period
increased slightly to 73.3% from 72.1% in the prior year period, due primarily to a change in
product sales mix. Sales of Plan B and SEASONIQUE, combined with
sales of acquired products during the current period, including
Adderall IR and proprietary products acquired from PLIVA, more
than offset significantly lower sales of SEASONALE and other
non-promoted, lower margin products.
Selling, General and Administrative Expense
The following table sets forth selling, general and administrative expense for the three and
nine months ended September 30, 2007 and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Selling, general and administrative |
|
$ |
190.3 |
|
|
$ |
88.7 |
|
|
$ |
101.6 |
|
|
|
115 |
% |
|
$ |
557.2 |
|
|
$ |
271.2 |
|
|
$ |
286.0 |
|
|
|
105 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charge included in general and
administrative |
|
$ |
7.3 |
|
|
$ |
|
|
|
$ |
7.3 |
|
|
|
100 |
% |
|
$ |
15.3 |
|
|
$ |
22.5 |
|
|
$ |
(7.2 |
) |
|
|
-32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative expenses increased by $101.6 million in the three months
ended September 30, 2007 as compared to the prior year period. Of this increase, approximately
$77.8 million is directly attributable to our PLIVA subsidiary. In addition to the
expenses attributable to PLIVA, there were (1) increased legal,
accounting and other consulting fees of $8.8 million, (2) increased marketing expenses related to increased
promotions of our proprietary products in the amount of $7.8 million, and (3) a litigation
reserve of $7.3 million.
Selling,
general and administrative expenses increased by $286.0 million in the nine months
ended September 30, 2007 as compared to the nine months ended September 30, 2006. Of this increase,
approximately $239.3 million is directly attributable to PLIVA.
In addition, there were (1) integration costs of $23.7 million from the
PLIVA acquisition, (2) increased legal, accounting and other consulting fees of $13.5 million, and (3) a
litigation reserve of $15.3 million during this period.
29
Selling, general and administrative expense in the nine months ended September 30, 2006
included a charge of $22.5 million in settlement of anti-trust litigation.
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 and nine months ended September 30,
2007 and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Research and development |
|
$ |
60.4 |
|
|
$ |
40.0 |
|
|
$ |
20.4 |
|
|
|
51 |
% |
|
$ |
186.8 |
|
|
$ |
114.1 |
|
|
$ |
72.7 |
|
|
|
64 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of acquired
in-process research and
development |
|
$ |
0.2 |
|
|
$ |
|
|
|
$ |
0.2 |
|
|
|
100 |
% |
|
$ |
4.6 |
|
|
$ |
|
|
|
$ |
4.6 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development increased by $20.4 million in the three months ended September 30,
2007 as compared to the three months ended September 30, 2006. Of this 51% increase, approximately
$19.2 million is directly attributable to our PLIVA subsidiary including salaries, third party
research and development, and depreciation costs. The remaining increase is primarily due to a $1.5
million increase in development costs supporting our generic and proprietary
development activities.
Research and development increased by $72.7 million in the nine months ended September 30,
2007 as compared to the nine months ended September 30, 2006. Of this 64% increase, approximately
$58.4 million is directly attributable to our PLIVA subsidiary, as discussed above. The remaining
increase is primarily due to an $8.0 million increase in development costs supporting our generic and proprietary development activities.
During the three and nine months ended September 30, 2007, we wrote-off acquired IPR&D of $0.2
million and $4.6 million, respectively.
Interest Income
The following table sets forth interest income for the three and nine months ended September
30, 2007 and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Interest income |
|
$ |
8.5 |
|
|
$ |
6.8 |
|
|
$ |
1.7 |
|
|
|
25 |
% |
|
$ |
27.2 |
|
|
$ |
16.7 |
|
|
$ |
10.5 |
|
|
|
63 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in interest income for the three and nine months ended September 30, 2007 is due
to higher interest rates and higher average daily cash and marketable securities balances during
these periods as compared to the prior year periods.
Interest Expense
The following table sets forth interest expense for the three and nine months ended September
30, 2007 and 2006 (dollars in millions):
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Interest expense |
|
$ |
38.9 |
|
|
$ |
1.1 |
|
|
$ |
37.8 |
|
|
|
N/M |
|
|
$ |
122.5 |
|
|
$ |
1.5 |
|
|
$ |
121.0 |
|
|
|
N/M |
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|
The increase in interest expense for the three and nine months ended September 30, 2007 as
compared to the three and nine months ended September 30, 2006 is due to the $2.6 billion of debt
the Company incurred in connection with the PLIVA acquisition (both to finance the acquisition and
debt carried from PLIVA). As a result of the incurrence of such debt, the Company estimates that
interest expense will be approximately $156 million in 2007.
Other Income (Expense)
The following table sets forth other income (expense) for the three and nine months ended
September 30, 2007 and 2006 (dollars in millions):
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Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
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|
|
|
|
Change |
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|
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|
Change |
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2007 |
|
|
2006 |
|
|
$ |
|
|
% |
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|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Other income (expense) |
|
$ |
6.5 |
|
|
|
($42.9 |
) |
|
$ |
49.4 |
|
|
|
115 |
% |
|
$ |
11.7 |
|
|
|
($25.1 |
) |
|
$ |
36.8 |
|
|
|
147 |
% |
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|
Other income (expense) increased by $49.4 million for the three months ended September 30,
2007 as compared to the three months ended September 30, 2006. The increase was primarily a result
of recording a $42.8 million reduction in the value of our foreign currency option related to the
PLIVA acquisition during the three months ended September 30, 2006. This reduction in fair value
reflected several factors including the changes in the exchange rate between the Dollar and the
Euro. Additionally, in the three month period ended
September 30, 2007 we recorded net gains of approximately $5.0 million
related to foreign currency hedging activities, accounting for most of the remaining increase over
the prior year period.
Other income (expense) increased by $36.8 million for the nine months ended September 30, 2007
as compared to the nine months ended September 30, 2006. This too was primarily related to the
reduction in value of the foreign currency option discussed above. Additionally, there was an
increase of $6.1 million in our gains on foreign currency along with the Company unwinding a
treasury lock on a ten-year U.S. Treasury security for a forecasted transaction.
Income Taxes
The following table sets forth income tax expense and the resulting effective tax rate stated
as a percentage of pre-tax income for the three and nine months ended September 30, 2007 and 2006
(dollars in millions):
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|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Change |
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|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Income tax expense |
|
$ |
14.5 |
|
|
$ |
24.2 |
|
|
$ |
(9.7 |
) |
|
|
-40 |
% |
|
$ |
49.7 |
|
|
$ |
109.2 |
|
|
$ |
(59.5 |
) |
|
|
-54 |
% |
|
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|
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|
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|
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|
|
|
|
|
Effective tax rate |
|
|
24.4 |
% |
|
|
31.4 |
% |
|
|
|
|
|
|
|
|
|
|
32.1 |
% |
|
|
34.1 |
% |
|
|
|
|
|
|
|
|
The Companys effective tax rate decreased in the current quarter to 24.4% from 31.4% in the
same period of the prior year. During the three months ended September 30, 2007, the German
government enacted new tax
31
legislation
reducing the statutory corporate tax rate from 39% to 30% effective
January 1, 2008. The change reduced our deferred tax liability and income tax provision by
approximately $9.6 million during the quarter.
Liquidity and Capital Resources
Overview
Our primary source of liquidity has been 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 flows for the nine months ended September 30,
2007 were $257.3 million
compared to $428.0 million in the prior year period. The decrease in cash flows primarily reflects
higher working capital in the current year caused primarily by higher
inventories of $41.9 million
and a significant reduction in accounts payable, accrued liabilities
and other liabilities of $66.8 million.
Investing Activities
Our net cash
provided by investing activities was $226.4 million for the nine months ended September 30, 2007
compared to net cash used in investing activities of $222.7 million for the prior year period. The
increase in net cash provided by investing activities was related to higher net sales of
marketable securities in the current period of $397.7 million as compared to net purchases of
marketable securities of $72.2 million during the prior year period and the
reduction in purchases of derivative instruments of $48.9 million as compared to the prior year period.
Offsetting this increase in net cash provided by investing activities over the prior year was higher capital
spending of $46.1 million and the increase of $23.5 million in acquisitions over the prior year.
Acquisitions during the current period include $36.4 million cost of acquiring additional PLIVA shares, $28.6 million
cost associated with the purchase of ORCA, and $21.8 million of product acquisitions.
Under Croatian law, our ownership of more than 95% of the voting shares in PLIVA permits us to
undertake the necessary actions to acquire the remainder of PLIVAs outstanding share capital. We
are currently evaluating this option though we are not obligated to do so. In the meantime we may
continue to purchase shares on the open market as deemed necessary.
Financing Activities
Net cash used in financing activities during the nine months ended September 30, 2007 was
$510.2 million compared to net cash provided by financing activities of $37.9 million in the prior
year period. The increase in net cash used in financing activities in the current period primarily
reflects debt repayments, including the $150.0 million principal payment on our $2.0 billion
five-year term facility and our payment in full of our $415.7 million 364-day term facility.
Offsetting these repayments was approximately $20.0 million of
increased debt by PLIVA in part
to finance the acquisition of ORCA, and approximately
$34.8 million from proceeds from stock option exercises and tax benefits of stock incentives.
Sufficiency of Cash Resources
We believe our current cash and cash equivalents, marketable securities, investment balances,
cash flows from operations and undrawn amounts under our $300.0 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.
32
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
Transition Report on Form 10-K/T for six months ended December 31, 2006. 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 FASB issued FAS No. 157, Fair Value Measurements, which defines fair
value, establishes a framework for measuring fair value in GAAP and expands disclosure about fair
value measurements. The statement is effective for fiscal years beginning after November 15, 2007.
We are currently evaluating the impact that the adoption of this statement will have on our
consolidated financial statements.
In February 2007, the FASB issued SFAS No. 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 Standards objective 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 companies have 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 are currently evaluating the impact that the adoption of this
statement will have on our consolidated financial statements.
In June 2006, the Financial Accounting Standards Board (FASB) issued FIN No. 48 (FIN 48)
Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement 109. FIN 48
establishes a single model to address accounting for uncertain tax positions. On January 1, 2007,
we adopted FIN 48, and as a result, recorded a $4.5 million increase in the net liability for
unrecognized tax positions, which was entirely recorded as a $4.5 million adjustment to the opening
balance of goodwill relating to the PLIVA acquisition. The total amount of gross unrecognized tax
benefits as of January 1, 2007 was $25.0 million, and did not change materially as of September 30,
2007. Included in the balance at September 30, 2007 was $13.2 million of tax positions that, if
recognized, would affect our effective tax rate. We do not believe that the amount of the liability
for unrecognized tax benefits will change materially during the next 52-week period.
Upon adoption of FIN 48, we have elected an accounting policy to classify accrued interest and
related penalties relating to unrecognized tax benefits in interest expense. Previously, our policy
was to classify interest and penalties in the Companys income tax provision. We had $2.6 million
accrued for interest and penalties at January 1, 2007 which has not changed materially as of
September 30, 2007.
In June 2007, the Emerging Issues Task Force (EITF) reached a consensus on EITF Issue No.
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
33
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. We are currently evaluating the impact that
adopting this EITF will have on our 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 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, ANDAs 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 Transition
Report on Form 10-K/T for the six months ended December 31, 2006. |
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.
34
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 $470.7 million, borrowings under our credit facilities of approximately $1,850.0
million and approximately $182.0 million of other debt acquired from PLIVA. 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 95% of our portfolio matures in less than three months, or is subject
to an interest-rate reset date that occurs within that time period. The carrying value of the
investment portfolio approximates the market value at September 30, 2007 and the value at maturity.
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 September 30, 2007, a 10% increase in interest rates would have increased the net
interest expense of our combined investment, debt and financial risk management portfolios by $5.5
million per year.
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 September 30, 2007, a 10% depreciation in the value of the U.S. dollar would have
resulted in a decrease of $5.5 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 7 Derivative
Instruments included in Part I of this report is incorporated in this Part I, Item 3 by reference.
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 September 30, 2007, 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
35
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
quarter ended September 30, 2007 that have materially affected, or are reasonably likely to
materially affect, its internal control over financial reporting.
36
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The disclosure under Note 15 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 Transition Report on Form 10-K/T for
the six-month period ended December 31, 2006, which could materially affect our business, results
of operations, financial condition or liquidity. The risks described in our Transition 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 Transition Report have
not materially changed.
Item 6. Exhibits
|
|
|
Exhibit No. |
|
Description |
|
|
|
31.1
|
|
Certification of Bruce L. Downey pursuant to Exchange Act
Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification of William T. McKee pursuant to Exchange Act
Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.0
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
37
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.
|
|
|
|
|
|
|
|
Dated:
November 9, 2007
|
|
/s/ Bruce L. Downey |
|
|
|
|
|
|
|
|
|
Bruce L. Downey |
|
|
|
|
Chairman of the Board and Chief |
|
|
|
|
Executive Officer |
|
|
|
|
|
|
|
|
|
/s/ William T. McKee |
|
|
|
|
|
|
|
|
|
William T. McKee |
|
|
|
|
Executive Vice President, Chief |
|
|
|
|
Financial Officer, and Treasurer |
|
|
|
|
(Principal Financial Officer and |
|
|
|
|
Principal Accounting Officer) |
|
|
38