FORM 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
or
|
|
|
o |
|
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)
|
|
|
Delaware
|
|
42-1612474 |
|
|
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(I.R.S. Employer
Identification No.) |
400 Chestnut Ridge Road, Woodcliff Lake, New Jersey 07677-7668
(Address of principal executive offices)
201-930-3300
(Registrants telephone number)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or
a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
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
April 27, 2007 the registrant had 109,748,616 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)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
194,662 |
|
|
$ |
231,975 |
|
Marketable securities |
|
|
647,489 |
|
|
|
673,746 |
|
Accounts
receivable, net of reserves of $251,379 and $238,311, respectively |
|
|
452,793 |
|
|
|
515,303 |
|
Other receivables, net |
|
|
59,338 |
|
|
|
76,491 |
|
Inventories |
|
|
428,537 |
|
|
|
429,592 |
|
Deferred income taxes |
|
|
82,064 |
|
|
|
82,597 |
|
Prepaid expenses and other current assets |
|
|
40,783 |
|
|
|
35,936 |
|
Current assets held for sale |
|
|
47,038 |
|
|
|
42,359 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,952,704 |
|
|
|
2,087,999 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net of accumulated depreciation of $216,810
and $196,709, respectively |
|
|
1,034,229 |
|
|
|
1,004,618 |
|
Deferred income taxes |
|
|
13,831 |
|
|
|
37,872 |
|
Marketable securities |
|
|
11,800 |
|
|
|
8,946 |
|
Other intangible assets, net |
|
|
1,458,721 |
|
|
|
1,472,418 |
|
Goodwill |
|
|
255,553 |
|
|
|
276,449 |
|
Long-term assets held for sale |
|
|
9,808 |
|
|
|
9,820 |
|
Other assets |
|
|
62,743 |
|
|
|
63,740 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
4,799,389 |
|
|
$ |
4,961,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
138,719 |
|
|
$ |
144,807 |
|
Accrued liabilities |
|
|
262,909 |
|
|
|
280,636 |
|
Current portion of long-term debt and capital lease obligations |
|
|
650,921 |
|
|
|
742,192 |
|
Income taxes payable |
|
|
4,088 |
|
|
|
21,359 |
|
Deferred tax liabilities |
|
|
22 |
|
|
|
8,266 |
|
Current liabilities held for sale |
|
|
13,243 |
|
|
|
14,633 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,069,902 |
|
|
|
1,211,893 |
|
|
|
|
|
|
|
|
|
|
Long-term
debt and capital lease obligations |
|
|
1,879,882 |
|
|
|
1,935,477 |
|
Deferred tax liabilities |
|
|
211,287 |
|
|
|
221,471 |
|
Long-term liabilities held for sale |
|
|
2,203 |
|
|
|
2,201 |
|
Other liabilities |
|
|
98,244 |
|
|
|
84,494 |
|
|
|
|
|
|
|
|
|
|
Commitments & Contingencies (Note 13) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minority interest |
|
|
39,038 |
|
|
|
41,098 |
|
|
|
|
|
|
|
|
|
|
Shareholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $1 par value per share; authorized 2,000,000; none issued |
|
|
|
|
|
|
|
|
Common stock, $.01 par value per share; authorized 200,000,000;
issued 109,743,073 and 109,536,481,
respectively |
|
|
1,097 |
|
|
|
1,095 |
|
Additional paid-in capital |
|
|
624,873 |
|
|
|
610,232 |
|
Retained earnings |
|
|
889,563 |
|
|
|
877,991 |
|
Accumulated other comprehensive income |
|
|
83,990 |
|
|
|
76,600 |
|
Treasury stock at cost: 2,972,997 shares |
|
|
(100,690 |
) |
|
|
(100,690 |
) |
|
|
|
|
|
|
|
Total shareholders equity |
|
|
1,498,833 |
|
|
|
1,465,228 |
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
$ |
4,799,389 |
|
|
$ |
4,961,862 |
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product sales |
|
$ |
563,818 |
|
|
$ |
293,521 |
|
Alliance and development revenue |
|
|
25,121 |
|
|
|
33,320 |
|
Other revenue |
|
|
10,439 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
599,378 |
|
|
|
326,841 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of sales |
|
|
302,535 |
|
|
|
98,507 |
|
Selling, general and administrative |
|
|
182,359 |
|
|
|
78,214 |
|
Research and development |
|
|
61,224 |
|
|
|
37,705 |
|
Write-off of in-process research and development |
|
|
1,549 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings from operations |
|
|
51,711 |
|
|
|
112,415 |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
10,622 |
|
|
|
4,213 |
|
Interest expense |
|
|
40,275 |
|
|
|
110 |
|
Other income, net |
|
|
1,096 |
|
|
|
1,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income taxes and minority interest |
|
|
23,154 |
|
|
|
117,589 |
|
|
Income tax expense |
|
|
9,725 |
|
|
|
41,493 |
|
Minority interest |
|
|
(1,535 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings from continuing operations |
|
|
11,894 |
|
|
|
76,096 |
|
|
Loss from discontinued operations, net of taxes |
|
|
(322 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
11,572 |
|
|
$ |
76,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic: |
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.11 |
|
|
$ |
0.72 |
|
Earnings per common share discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings per common share basic |
|
$ |
0.11 |
|
|
$ |
0.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted: |
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.11 |
|
|
$ |
0.70 |
|
Earnings per common share discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings per common share diluted |
|
$ |
0.11 |
|
|
$ |
0.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares basic |
|
|
106,715 |
|
|
|
105,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
108,044 |
|
|
|
108,547 |
|
|
|
|
|
|
|
|
SEE ACCOMPANYING NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
4
Barr Pharmaceuticals, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
11,572 |
|
|
$ |
76,096 |
|
Adjustments to reconcile net earnings to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
72,308 |
|
|
|
18,014 |
|
Minority interest |
|
|
1,526 |
|
|
|
|
|
Stock-based compensation expense |
|
|
7,299 |
|
|
|
6,933 |
|
Deferred income tax expense (benefit) |
|
|
2,004 |
|
|
|
(886 |
) |
Loss on derivative instruments, net |
|
|
1,514 |
|
|
|
|
|
Write-off of acquired in-process research and development |
|
|
1,549 |
|
|
|
|
|
Other |
|
|
(5,053 |
) |
|
|
(268 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
(Increase) decrease in: |
|
|
|
|
|
|
|
|
Accounts receivable and other receivables, net |
|
|
73,979 |
|
|
|
24,649 |
|
Inventories |
|
|
2,692 |
|
|
|
4,686 |
|
Prepaid expenses |
|
|
(4,097 |
) |
|
|
1,483 |
|
Other assets |
|
|
(1,176 |
) |
|
|
17 |
|
Increase (decrease) in: |
|
|
|
|
|
|
|
|
Accounts payable, accrued liabilities and other liabilities |
|
|
(14,399 |
) |
|
|
11,282 |
|
Income taxes payable |
|
|
(17,460 |
) |
|
|
13,039 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
132,258 |
|
|
|
155,045 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(23,154 |
) |
|
|
(13,639 |
) |
Proceeds from sale of property, plant and equipment and intangible assets |
|
|
594 |
|
|
|
|
|
Purchases of marketable securities |
|
|
(600,107 |
) |
|
|
(641,103 |
) |
Sales of marketable securities |
|
|
625,864 |
|
|
|
462,430 |
|
Settlement of derivative instruments |
|
|
1,636 |
|
|
|
|
|
Acquisitions, net of cash acquired |
|
|
(33,500 |
) |
|
|
(312 |
) |
Investment in debt securities |
|
|
(2,025 |
) |
|
|
|
|
Investment in venture funds and other |
|
|
206 |
|
|
|
(79 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(30,486 |
) |
|
|
(192,703 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Principal payments on long-term debt and capital leases |
|
|
(150,439 |
) |
|
|
(365 |
) |
Tax benefit of stock incentives |
|
|
2,733 |
|
|
|
2,361 |
|
Proceeds from exercise of stock options and employee stock purchases |
|
|
4,713 |
|
|
|
20,378 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(142,993 |
) |
|
|
22,374 |
|
|
|
|
|
|
|
|
Effect of exchange-rate changes on cash and cash equivalents |
|
|
3,908 |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash equivalents |
|
|
(37,313 |
) |
|
|
(15,284 |
) |
Cash and cash equivalents at beginning of period |
|
|
231,975 |
|
|
|
30,010 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
194,662 |
|
|
$ |
14,726 |
|
|
|
|
|
|
|
|
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 for the six-month
period ended December 31, 2006 (the Transition Period).
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 generally accepted accounting principles
(GAAP) in the United States. The consolidated financial statements include all companies which
Barr directly or indirectly controls (meaning it has more than 50% of voting rights in those
companies). Investments in companies where Barr owns between 20% and 50% of a companys voting
rights are accounted for by using the equity method, with Barr recording its proportionate share of
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 months ended March 31, 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 months ended March 31, 2007. These include the Companys
reclassification of amortization expense from selling, general and administrative expense to cost
of sales. See Note 7 below.
2. Recent Accounting Pronouncements
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. FIN 48 clarifies the accounting for income taxes by prescribing a minimum
recognition threshold a tax position is required to meet before being recognized in the financial
statements. Upon adoption on January 1, 2007, the Company analyzed filing positions in all of the
foreign, federal and state jurisdictions where it is required to file income tax returns, as well
as all open tax years in these jurisdictions. See Note 10.
In September 2006, the Financial Accounting Standards Board (the FASB) issued 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 Statement of Financial Accounting Standard (SFAS) No. 159
(SFAS 159), The Fair Value Option for Financial Assets and Financial Liabilities, providing
companies with an option to report selected financial assets and liabilities at fair value. The
objective of SFAS 159 is to reduce both complexity in accounting for financial instruments and the
volatility in earnings caused by measuring related assets and liabilities differently. GAAP has
required different measurement attributes for different assets and liabilities that can create
artificial volatility in earnings. SFAS 159 helps to mitigate this type of accounting-induced
volatility by enabling companies to report related assets and liabilities at fair value, which
would likely reduce the need for companies to comply with detailed rules for hedge accounting. SFAS
159 also establishes presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar types of assets and
liabilities. SFAS 159 requires companies to provide additional information that will help investors
and other users of financial statements to more easily understand the effect of the 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 of the adoption of this statement will have on its
consolidated financial statements.
6
3. Earnings Per Share
The following is a reconciliation of the numerators and denominators used to calculate
earnings per common share (EPS) as presented in the condensed consolidated statements of operations:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(table in thousands, except per share data) |
|
2007 |
|
|
2006 |
|
Numerator for basic and diluted earnings (loss) per share
|
|
|
|
|
|
|
|
|
Net earnings from continuing operations |
|
$ |
11,894 |
|
|
$ |
76,096 |
|
Net loss from discontinued operations |
|
|
(322 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
11,572 |
|
|
$ |
76,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share basic: |
|
|
|
|
|
|
|
|
Denominator: Weighted average shares |
|
|
106,715 |
|
|
|
105,924 |
|
|
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.11 |
|
|
$ |
0.72 |
|
Earnings per common share discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share basic |
|
$ |
0.11 |
|
|
$ |
0.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share diluted: |
|
|
|
|
|
|
|
|
Denominator: Weighted average shares diluted |
|
|
108,044 |
|
|
|
108,547 |
|
|
|
|
|
|
|
|
|
|
Earnings per common share continuing operations |
|
$ |
0.11 |
|
|
$ |
0.70 |
|
Earnings per common share discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share diluted |
|
$ |
0.11 |
|
|
$ |
0.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calculation of weighted average common shares diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares |
|
|
106,715 |
|
|
|
105,924 |
|
Effect of dilutive options and warrants |
|
|
1,329 |
|
|
|
2,623 |
|
|
|
|
|
|
|
|
Weighted average shares diluted |
|
|
108,044 |
|
|
|
108,547 |
|
|
|
|
|
|
|
|
|
Not included in the calculation of diluted earnings
per-share because their impact is antidilutive: |
|
|
|
|
|
|
|
|
Stock options outstanding |
|
|
151 |
|
|
|
22 |
|
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 217,531 shares on the
Croatian stock market for $31,715, including 67,578 shares totaling $9,778 purchased during the
three months ended March 31, 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 97.4% of PLIVAs voting share capital as of March 31, 2007 (17,274,508
of 17,740,016 outstanding shares).
7
The purchase price of $9,778 for the 67,578 shares acquired during the three months ended
March 31, 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), which was expensed during the three months ended March 31,
2007, was $1,549. The additional share purchases resulted in incremental goodwill of $219.
The Company continues to refine its estimates and expects to finalize the valuation and
complete the purchase price allocation for the PLIVA acquisition as soon as possible, but no later than October 24, 2007.
Refer to Note 7 below for the factors impacting the PLIVA goodwill adjustments.
Products Acquired from Hospira, Inc.
On February 6, 2007, the Company acquired four generic injectible products from Hospira, Inc., which are Morphine, Hydromorphone,
Nalbuphine and Deferoxamine. The Company entered into a supply agreement with Hospira covering all
four products, and a product development agreement for Deferoxamine. The product acquisitions
resulted from an FTC-ordered divestiture of these products in connection with Hospiras acquisition
of Mayne Pharma Ltd.
The Company recorded intangible assets in the amount of $12,000 related to the acquisition of
the four products. The defined territory for these products includes all markets in the
United States and its territories. These product rights are recorded as other intangible assets on
the condensed consolidated balance sheets and will be amortized based on estimated product sales over an
estimated useful life of 10 years.
5. Discontinued Operations
Following 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. The Company has
decided to divest or exit its operations in Spain and its animal health business. As a result, as
of March 31, 2007, the assets and liabilities relating to these businesses met the held for sale
criteria of FAS 144, Accounting for the Impairment or Disposal of Long Lived Assets. The Company
expects to sell these assets and the related liabilities held for sale within one year. Following
the divestiture, the cash flows and operations of the divested operations will be eliminated from
the Companys ongoing operations, and the Company will cease to have continuing involvement with
these operations. The Companys operations in Spain are part of the generic pharmaceuticals
segment. The Companys animal health 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
14.
The following combined amounts of our operations in Spain and the Companys animal health
business have been segregated from continuing operations and included in discontinued operations,
net of taxes, in the condensed consolidated statement of operations, as shown below:
8
|
|
|
|
|
|
|
March 31, |
|
|
|
2007 |
|
Revenues Spain
|
|
|
|
|
Generics |
|
$ |
7,460 |
|
Other |
|
|
813 |
|
|
|
|
|
Net revenues Spain |
|
$ |
8,273 |
|
|
|
|
|
|
|
|
|
|
Revenues Animal health |
|
|
|
|
Generics |
|
$ |
|
|
Other |
|
|
7,305 |
|
|
|
|
|
Net revenues Animal health |
|
$ |
7,305 |
|
|
|
|
|
Total net revenues of discontinued operations |
|
$ |
15,578 |
|
|
|
|
|
|
|
|
|
|
Loss before income taxes and minority interest |
|
|
(234 |
) |
Income tax expense |
|
|
(97 |
) |
Minority interest |
|
|
9 |
|
|
|
|
|
Loss from
discontinued
operations - net of tax |
|
$ |
(322 |
) |
|
|
|
|
The following combined amounts of assets and liabilities of those 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 March 31, 2007 and
December 31, 2006, as shown below:
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2007 |
|
2006 |
|
Accounts receivable, net |
|
$ |
22,371 |
|
$ |
17,762 |
|
Inventories |
|
|
21,839 |
|
|
22,819 |
|
Prepaid expenses and other current assets |
|
|
2,828 |
|
|
1,778 |
|
|
|
|
|
|
|
Current assets held for sale |
|
|
47,038 |
|
|
42,359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
5,597 |
|
|
5,581 |
|
Deferred income taxes |
|
|
2,332 |
|
|
2,378 |
|
Other intangible assets, net |
|
|
1,772 |
|
|
1,752 |
|
Other assets |
|
|
107 |
|
|
109 |
|
|
|
|
|
|
|
Long-term assets held for sale |
|
|
9,808 |
|
|
9,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets held for sale |
|
$ |
56,846 |
|
$ |
52,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,415 |
|
$ |
11,316 |
|
Accrued liabilities |
|
|
3,560 |
|
|
3,065 |
|
Current
portion of long-term debt and capital lease obligations |
|
|
268 |
|
|
252 |
|
|
|
|
|
|
|
Current liabilities held for sale |
|
|
13,243 |
|
|
14,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt and capital lease obligations |
|
|
1,712 |
|
|
1,738 |
|
Deferred tax liabilities |
|
|
429 |
|
|
424 |
|
Other liabilities |
|
|
62 |
|
|
39 |
|
|
|
|
|
|
|
Long-term liabilities held for sale |
|
|
2,203 |
|
|
2,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities held for sale |
|
$ |
15,446 |
|
$ |
16,834 |
|
|
|
|
|
|
|
9
6. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials and supplies |
|
$ |
165,243 |
|
|
$ |
160,345 |
|
Work-in-process |
|
|
84,193 |
|
|
|
67,798 |
|
Finished goods |
|
|
179,101 |
|
|
|
201,449 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
428,537 |
|
|
$ |
429,592 |
|
|
|
|
|
|
|
|
7. |
|
Goodwill and Other Intangible Assets |
|
|
|
Goodwill at December 31, 2006 and March 31, 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 |
|
|
219 |
|
|
|
|
|
|
|
219 |
|
PLIVA goodwill adjustments |
|
|
(23,584 |
) |
|
|
|
|
|
|
(23,584 |
) |
Currency translation effect |
|
|
2,469 |
|
|
|
|
|
|
|
2,469 |
|
|
|
|
|
|
|
|
|
|
|
Goodwill balance at March 31, 2007 |
|
$ |
207,633 |
|
|
$ |
47,920 |
|
|
$ |
255,553 |
|
|
|
|
|
|
|
|
|
|
|
PLIVA
goodwill adjustments for the three months ended March 31, 2007
presented below include purchase price allocation and valuation
revisions made based on additional information available to modify
the Companys initial etimates for certain assets and liabilities. The Company
expects to make additional valuation revisions in the next calendar
quarter for items where complete information has not been obtained.
|
|
|
|
|
Current assets |
|
$ |
206 |
|
Property, plant & equipment |
|
|
(36,265 |
) |
Other non-current assets |
|
|
291 |
|
Current liabilities |
|
|
2,000 |
|
Deferred tax liabilities |
|
|
5,870 |
|
Other liabilities |
|
|
4,314 |
|
|
|
|
|
Total PLIVA goodwill adjustments |
|
$ |
(23,584 |
) |
|
|
|
|
Intangible assets at March 31, 2007 and December 31, 2006 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
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 |
|
|
$ |
16,808 |
|
|
$ |
28,542 |
|
|
$ |
45,350 |
|
|
$ |
15,624 |
|
|
$ |
29,726 |
|
Product rights |
|
|
1,325,976 |
|
|
|
101,375 |
|
|
|
1,224,601 |
|
|
|
1,302,116 |
|
|
|
64,788 |
|
|
|
1,237,328 |
|
Land use rights |
|
|
88,668 |
|
|
|
460 |
|
|
|
88,208 |
|
|
|
88,053 |
|
|
|
166 |
|
|
|
87,887 |
|
Other |
|
|
38,705 |
|
|
|
792 |
|
|
|
37,913 |
|
|
|
38,899 |
|
|
|
188 |
|
|
|
38,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortized finite-lived intangible assets |
|
|
1,498,699 |
|
|
|
119,435 |
|
|
|
1,379,264 |
|
|
|
1,474,418 |
|
|
|
80,766 |
|
|
|
1,393,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indefinite-lived intangible assets tradenames: |
|
|
79,457 |
|
|
|
|
|
|
|
79,457 |
|
|
|
78,766 |
|
|
|
|
|
|
|
78,766 |
|
|
|
|
|
|
Total identifiable intangible assets |
|
$ |
1,578,156 |
|
|
$ |
119,435 |
|
|
$ |
1,458,721 |
|
|
$ |
1,553,184 |
|
|
$ |
80,766 |
|
|
$ |
1,472,418 |
|
|
|
|
|
|
10
The annual estimated amortization expense for the next five years on finite-lived
intangible assets is as follows:
|
|
|
|
|
Years Ending December 31, |
|
2008 |
|
$ |
144,569 |
|
2009 |
|
$ |
126,979 |
|
2010 |
|
$ |
127,334 |
|
2011 |
|
$ |
118,900 |
|
2012 |
|
$ |
111,811 |
|
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 $40,726 and
$8,865 for the three months ended March 31, 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 months ended March 31, 2006 was reclassified to conform to
that of the three months ended March 31, 2007.
8. |
|
Debt |
|
|
|
A summary of debt is as follows: |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Credit Facilities (a) |
|
$ |
2,265,700 |
|
|
$ |
2,415,703 |
|
Note due to WCC shareholders (b) |
|
|
6,500 |
|
|
|
6,500 |
|
Obligation under capital leases (c) |
|
|
2,565 |
|
|
|
2,819 |
|
Fixed rate bonds (d) |
|
|
102,721 |
|
|
|
101,780 |
|
Dual-currency syndicated credit facility (e) |
|
|
86,592 |
|
|
|
86,287 |
|
Euro commercial paper program (f) |
|
|
26,638 |
|
|
|
26,334 |
|
Dual-currency term loan facility (g) |
|
|
25,000 |
|
|
|
25,000 |
|
Multi-currency revolving credit facility (h) |
|
|
13,319 |
|
|
|
13,167 |
|
Other |
|
|
1,768 |
|
|
|
79 |
|
|
|
|
|
|
|
|
|
|
|
2,530,803 |
|
|
|
2,677,669 |
|
|
|
|
|
|
|
|
|
|
Less: current installments of debt and capital
lease obligations |
|
|
650,921 |
|
|
|
742,192 |
|
|
|
|
|
|
|
|
Total long-term debt |
|
$ |
1,879,882 |
|
|
$ |
1,935,477 |
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
In connection with the close 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 (6.10% at March 31, 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 on March 30,
2007, with the balance of $1,100,000 due at maturity in October 2011. The 364-day term facility is
due in full upon maturity in October 2007, but the Company elected to prepay $100,003 of the
outstanding amount on March 30, 2007, leaving a balance of $315,700 outstanding. 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. In connection with that acquisition, the Company issued a four-year $6,500 promissory
note to Womens Capital Corporation shareholders. The note bears a fixed interest rate of 2%. The
entire principal amount and all accrued interest is payable on February 25, 2008. |
11
|
|
|
(c) |
|
The Company has certain capital lease obligations for machinery, equipment and buildings
in the United States and the Czech Republic. These obligations were established using interest
rates available to the Company at the inception of each lease. |
|
|
The Companys long-term debt includes the following liabilities incurred by PLIVA prior to the
acquisition (Euro to U.S. dollar equivalents are based on the exchange rate in effect at March 30,
2007): |
|
|
(d) |
|
In May 2004, PLIVA issued Euro denominated fixed rate bonds with a face value of EUR
75,000 ($99,893). The bonds mature in 2011 and bear annual interest at 5.75% payable semiannually. The
Company recorded the bonds at fair value based on their prevailing market price on the PLIVA
acquisition date, pursuant to the provisions of SFAS No. 141. At that time, the aggregate fair
value of the bonds was EUR 77,401 ($103,091). The premium over face value of EUR 2,401 ($3,198)
will be amortized over the remaining life of the bonds. Amortization for the three months ended
March 31, 2007 was EUR 66 ($88). |
|
(e) |
|
On October 28, 2004, PLIVA entered into a dual-currency syndicated term loan facility
pursuant to which the lenders provided the borrowers with an aggregate amount not to exceed
$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. As of March
31, 2007, there was $59,873 outstanding with an effective interest rate of 6.13% and EUR 20,061
outstanding ($26,719) with an effective interest rate of 4.398%. The facility includes customary
covenants. |
|
(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
($332,978) and bears interest at a
variable interest rate. Currently, there is EUR 20,000 outstanding ($26,638) yielding 4.507%
that is due on July 4, 2007. |
|
(g) |
|
On September 9, 2006, PLIVA entered into a dual currency term loan facility pursuant to
which the lenders provided the borrowers an aggregate amount not to exceed $25,000, available to be
drawn in either US dollars or Euros. The facility has a one-year term and bears interest at a
variable rate based on LIBOR or Euribor plus a margin which is negotiated at the time the facility
is drawn. As of March 31, 2007, there was $25,000 outstanding with an effective interest rate of
5.33% 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
($39,957). 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 margin which is negotiated at the time the
facility is drawn. As of March 31, 2007, there was EUR 10,000 outstanding ($13,319) with an
effective interest rate of 3.857% plus a negotiated margin. The facility includes customary
covenants. |
Principal maturities of existing long-term debt and amounts due on capital leases for the next
five years and thereafter are as follows:
|
|
|
|
|
Twelve Months Ending March 31, |
|
|
|
|
2009 |
|
$ |
213,383 |
|
2010 |
|
$ |
212,677 |
|
2011 |
|
$ |
200,474 |
|
2012 |
|
$ |
1,250,216 |
|
2013 |
|
$ |
146 |
|
Thereafter |
|
$ |
124 |
|
|
|
|
|
Total principal maturities and amounts
due on capital leases |
|
$ |
1,877,020 |
|
Premium on fixed rate bond (e) |
|
$ |
2,862 |
|
|
|
|
|
Total debt and capital lease obligations |
|
$ |
1,879,882 |
|
12
9. Accumulated Other Comprehensive Income
Comprehensive income is defined as the total change in shareholders equity during the period
other than from transactions with shareholders. For the Company, comprehensive income is comprised
of net income, unrealized gains (losses) on securities classified for SFAS No. 115 purposes as
available for sale, unrealized gains (losses) on pension and other post employment benefits and
foreign currency translation adjustments. Comprehensive income for
the three months ended March 31, 2007 and March 31, 2006 is
$18,962 and $76,293, respectively.
Accumulated other comprehensive income consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Beginning balance |
|
$ |
76,600 |
|
|
$ |
(377 |
) |
Net unrealized gain on
marketable securities,
net of tax expense
$69 and $21, respectively |
|
|
985 |
|
|
|
105 |
|
Net unrealized gain on
currency translation
adjustments, net of tax
expense $109 and $12,329, respectively |
|
|
8,618 |
|
|
|
76,850 |
|
Net (loss) gain on cash flow
hedge, net of tax (benefit)
expense of ($1,345) and $11, respectively |
|
|
(2,213 |
) |
|
|
22 |
|
|
|
|
|
|
|
|
Net unrecognized gain |
|
|
7,390 |
|
|
|
76,977 |
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
83,990 |
|
|
$ |
76,600 |
|
|
|
|
|
|
|
|
10. Income Taxes
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
March 31, 2007. Included in the balance at March 31, 2007 was
$13,200 of tax positions that, if recognized, would lower the Companys effective tax rate.
The Company is nearing completion of several tax audits and the expiration of the statute of
limitations in several jurisdictions and it is possible that the amount of the liability for
unrecognized tax benefits could change during the next 52-week period. An estimate of the range of
the possible change cannot be made at this time.
Upon adoption of FIN 48, the Company has 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 January 1, 2007 which has
not changed materially as of March 31, 2007.
The Company is currently being audited by the IRS for its June 30, 2005 and 2006 tax years and
also for its December 31, 2006 tax year-end. 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 2002 to 2005. The foreign jurisdictions with significant operations currently being
audited are Croatia for 2004 and 2005 (tax years that remain subject to examination are 2003-2006),
and Poland for 2003 (tax years that remain subject to examination are 2001-2006). Additionally,
although Germany is not currently being audited, the tax years that remain subject to examination
are 2004-2006.
13
11. 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, are recognized in net earnings
in the periods after the date of adoption.
The Company recognized stock-based compensation expense for the three months ended March 31,
2007 and 2006 in the amount of $7,299 and $6,933, respectively. The Company also recorded related
tax benefits for the three months ended March 31, 2007 and 2006 in the amount of $2,412 and $2,254,
respectively. The effect on net income from recognizing stock-based compensation for the
three-month periods ended March 31, 2007 and 2006 was $4,887 and $4,679, or $0.05 and $0.04 per
basic and diluted share, respectively.
The total number of shares of common stock issuable upon the exercise of stock options and
SSARs granted during the three months ended March 31, 2007 and 2006 was 928,950 and 76,800,
respectively, with weighted-average exercise prices of $49.46 and $66.54, respectively.
For all of the Companys stock-based compensation plans, the fair value of each grant was
estimated at the date of grant using the Black-Scholes option-pricing model. Black-Scholes utilizes
assumptions related to volatility, the risk-free interest rate, the dividend yield (which is
assumed to be zero, as the Company has not paid any cash dividends) and option holder exercise
behavior. Expected volatilities utilized in the model are based mainly on the historical volatility
of the Companys stock price and other factors. The risk-free interest rate is derived from the
U.S. Treasury yield curve in effect in the period of grant. The model incorporates exercise and
post-vesting forfeiture assumptions based on an analysis of historical data. The average expected
term is derived from historical and other factors. The stock-based compensation for the awards
issued in the respective periods was determined using the following assumptions and calculated
average fair values:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2007 |
|
2006 |
Average expected term (years) |
|
|
4.0 |
|
|
|
5.0 |
|
Weighted average risk-free interest rate |
|
|
4.43 |
% |
|
|
4.35 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Volatility |
|
|
30.17 |
% |
|
|
36.85 |
% |
Weighted average grant date fair value |
|
$ |
15.16 |
|
|
$ |
26.21 |
|
As of March 31, 2007, the aggregate intrinsic value of awards outstanding and exercisable
was $77,525 and $73,761, respectively. In addition, the aggregate intrinsic value of awards
exercised during the three months ended March 31, 2007 and 2006 were $6,061 and $30,873,
respectively. The total remaining unrecognized compensation cost related to unvested awards
amounted to $52,578 at March 31, 2007 and is expected to be recognized over the next three years.
The weighted average remaining requisite service period of the unvested awards was 26 months.
14
12. Restructuring
Managements plans for the restructuring of the Companys operations as a result of its
acquisition of PLIVA are in the introductory stages. As of March 31, 2007, certain elements of the
plan that have been finalized have been recorded as a cost of the acquisition. Plans for other
restructuring activities are expected to be completed by October 24, 2007.
Through March 31, 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. Additionally, further
restructuring costs incurred as part of the Companys restructuring plan in connection with the
acquisition will be considered part of the purchase price of PLIVA and will be recorded as an
increase in goodwill. 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, |
|
|
|
|
|
March 31, |
|
|
2006 |
|
Payments |
|
2007 |
|
|
|
Involuntary termination of PLIVA employees |
|
$ |
8,277 |
|
|
$ |
611 |
|
|
$ |
7,666 |
|
Lease termination costs |
|
|
10,201 |
|
|
|
|
|
|
|
10,201 |
|
|
|
|
|
|
$ |
18,478 |
|
|
$ |
611 |
|
|
$ |
17,867 |
|
|
|
|
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 $3,004 of severance and retention bonus expense in the three months ended March 31, 2007.
13. 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 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. Except for the Ovcon Antitrust Proceedings litigation settlement
proposals summarized below, no material changes have occurred in the Companys litigation matters
since the filing of the Form 10-K/T.
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, various
state Attorneys General and certain private class action plaintiffs claiming to be direct and
indirect purchasers of Ovcon-35®. These actions, the first of which was filed by the FTC on or
about December 2, 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.
In the actions brought on behalf of the indirect purchasers, the Company has reached an
agreement in principle with the class representatives to settle plaintiffs claims. This
settlement is subject to judicial approval and 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 quarter ended March 31, 2007, the Company established a reserve (and corresponding
charge in selling, general and administrative expenses) of $6,500 related to these and other
settlement offers in the Ovcon Litigation.
15
14. 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
and 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Generic |
|
|
|
|
|
Proprietary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
March 31, 2007 |
|
Pharmaceuticals |
|
% |
|
Pharmaceuticals |
|
% |
|
Other |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
474,804 |
|
|
|
79 |
% |
|
$ |
89,014 |
|
|
|
15 |
% |
|
$ |
|
|
|
|
0 |
% |
|
$ |
563,818 |
|
|
|
94 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
25,121 |
|
|
|
4 |
% |
|
|
25,121 |
|
|
|
4 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
10,439 |
|
|
|
2 |
% |
|
|
10,439 |
|
|
|
2 |
% |
|
Total revenues |
|
$ |
474,804 |
|
|
|
79 |
% |
|
$ |
89,014 |
|
|
|
15 |
% |
|
$ |
35,560 |
|
|
|
6 |
% |
|
$ |
599,378 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
Gross Profit: |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Product sales |
|
$ |
208,927 |
|
|
|
44 |
% |
|
$ |
59,132 |
|
|
|
66 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
268,059 |
|
|
|
48 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
25,121 |
|
|
|
100 |
% |
|
|
25,121 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
3,663 |
|
|
|
35 |
% |
|
|
3,663 |
|
|
|
35 |
% |
|
Total gross profit |
|
$ |
208,927 |
|
|
|
44 |
% |
|
$ |
59,132 |
|
|
|
66 |
% |
|
$ |
28,784 |
|
|
|
81 |
% |
|
$ |
296,843 |
|
|
|
50 |
% |
|
|
Three months ended |
|
Generic |
|
|
|
|
|
Proprietary |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
March 31, 2006 |
|
Pharmaceuticals |
|
% |
|
Pharmaceuticals |
|
% |
|
Other |
|
% |
|
Consolidated |
|
revenue |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
200,370 |
|
|
|
61 |
% |
|
$ |
93,151 |
|
|
|
29 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
293,521 |
|
|
|
90 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
33,320 |
|
|
|
10 |
% |
|
|
33,320 |
|
|
|
10 |
% |
Other
revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
0 |
% |
|
Total revenues |
|
$ |
200,370 |
|
|
|
61 |
% |
|
$ |
93,151 |
|
|
|
29 |
% |
|
$ |
33,320 |
|
|
|
10 |
% |
|
$ |
326,841 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
|
|
|
|
|
Margin |
Gross Profit: (1) |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
|
|
|
|
|
% |
Product sales |
|
$ |
129,419 |
|
|
|
65 |
% |
|
$ |
65,595 |
|
|
|
70 |
% |
|
$ |
|
|
|
|
|
% |
|
$ |
195,014 |
|
|
|
66 |
% |
Alliance and development revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
33,320 |
|
|
|
100 |
% |
|
|
33,320 |
|
|
|
100 |
% |
Other revenue |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
% |
|
Total gross profit |
|
$ |
129,419 |
|
|
|
65 |
% |
|
$ |
65,595 |
|
|
|
70 |
% |
|
$ |
33,320 |
|
|
|
100 |
% |
|
$ |
228,334 |
|
|
|
70 |
% |
|
|
|
|
(1) |
|
Prior period amounts have been reclassified to include the effect of intangible
amortization and conform to the presentation for the three months ended March 31, 2007. |
Geographic Information
The Companys principal operations are in the United States and Europe. United States and Rest
of World (ROW) sales are classified based on the geographic location of the customers. The table
below presents revenues by geographic area based upon geographic location of the customer:
Product sales by geographic area
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
United States |
|
$ |
392,620 |
|
|
$ |
291,760 |
|
ROW |
|
|
171,198 |
|
|
|
1,761 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
563,818 |
|
|
$ |
293,521 |
|
|
|
|
|
|
|
|
16
The Company operates in more than 30 countries outside the United States. No single
foreign country contributes more than 10% to consolidated product sales.
The Companys generic and proprietary pharmaceutical segment net product sales are represented
in the following therapeutic categories for the following periods:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
March 31, |
|
|
2007 |
|
2006 |
Contraception |
|
$ |
165,021 |
|
|
$ |
166,104 |
|
Psychotherapeutics |
|
|
67,438 |
|
|
|
16,293 |
|
Cardiovascular |
|
|
66,463 |
|
|
|
25,664 |
|
Antibiotics, antiviral & anti-infectives |
|
|
66,925 |
|
|
|
13,916 |
|
Other (1) |
|
|
197,971 |
|
|
|
71,544 |
|
|
|
|
Total |
|
$ |
563,818 |
|
|
$ |
293,521 |
|
|
|
|
|
|
|
(1) |
|
Other includes numerous therapeutic categories, none of which
individually exceeds 10% of consolidated product sales. |
15. Subsequent Events
On April 23, 2007, the Company entered into a lease for a new U.S. headquarters facility in
Montvale, New Jersey. The Company intends to sublease its existing headquarters facility in
Woodcliff Lake. The term of the new lease is 10.5 years, and is expected to commence in August
2007, when the Company plans to begin to take possession of the leased premises. The base rent
payable during the first five years of the rental term will be $321 per month, increasing to $356
per month thereafter through expiration.
17
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 217,531 shares on the Croatian stock market for
$31.7 million, including 67,578 shares
purchased for $9.8 million during the three months ended March 31, 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 97.4% of PLIVAs voting share
capital as of March 31, 2007 (17,274,508 of 17,740,016 outstanding shares).
The fluctuations in our operating results for the three months ended March 31, 2007, as
compared to the same period ending March 31, 2006, are primarily due to the acquisition of PLIVA.
All information, data and figures provided in this report for the three months ended March 31, 2006
relate solely to Barrs financial results and do not include PLIVA.
Products Acquired from Hospira, Inc.
On February 6, 2007, we acquired four generic injectible products from Hospira, Inc., which
are Morphine, Hydromorphone, Nalbuphine and Deferoxamine. We also entered into a supply agreement
with Hospira covering all four products, and a product development
agreement for Deferoxamine. We
recorded intangible assets in the amount of $12.0 million related to the acquisition of the four
products. The defined territory for these products includes all markets in the United
States and its territories. These product rights are recorded as other intangible assets on the
condensed consolidated balance sheets and will be amortized based on estimated product sales over an
estimated useful life of 10 years. The product acquisitions resulted from an FTC-ordered
divestiture of these products in connection with Hospiras acquisition of Mayne Pharma Ltd.
18
Results of Operations
Comparison of the Three Months Ended March 31, 2007 and March 31, 2006
The following table sets forth revenue data for the three months ended March 31, 2007 and
2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Generic products: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral contraceptives |
|
$ |
113.2 |
|
|
$ |
101.2 |
|
|
$ |
12.0 |
|
|
|
12 |
% |
Other
generics |
|
|
361.6 |
|
|
|
99.1 |
|
|
|
262.5 |
|
|
|
265 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total generic products |
|
|
474.8 |
|
|
|
200.3 |
|
|
|
274.5 |
|
|
|
137 |
% |
Proprietary products |
|
|
89.0 |
|
|
|
93.2 |
|
|
|
(4.2 |
) |
|
|
-4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
563.8 |
|
|
|
293.5 |
|
|
|
270.3 |
|
|
|
92 |
% |
Alliance and development revenue |
|
|
25.1 |
|
|
|
33.3 |
|
|
|
(8.2 |
) |
|
|
-25 |
% |
Other revenue |
|
|
10.5 |
|
|
|
|
|
|
|
10.5 |
|
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
599.4 |
|
|
$ |
326.8 |
|
|
$ |
272.6 |
|
|
|
83 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Sales
Generic Oral Contraceptives
During the three months ended March 31, 2007, sales of our generic oral contraceptives
(Generic OCs) were $113.2 million, an increase of $12.0 million over the three months ended March
31, 2006. This increase was primarily due to the launch of Jolessa subsequent to March 31, 2006,
which accounted for approximately $5.2 million of the increase, and an increase of $6.2 million in
sales of our Kariva product due to an increase in both volume and price.
Other Generic Products
During the three months ended March 31, 2007, sales of our other generic products (Other
Generics) were $361.6 million, up from $99.1 million as compared to the three months ended March
31, 2006, an increase of $262.5 million. This increase was mainly due to $252.8 million of sales
attributable to PLIVA products, including sales of Azithromycin of $36.1 million. In addition to higher sales from acquired products, we recorded $16.7 million in
sales of Fentanyl Citrate, our generic version of Cephalons ACTIQ which we launched in September
2006. Partially offsetting these increases were lower sales of certain Other Generics, principally
a $6.1 million decline in sales of Desmopressin. We launched Desmopressin in July 2005 with 180
days of exclusivity as a result of a successful paragraph IV patent challenge, and this exclusivity
continued through February 2006. Since March 2006, competing generic products have reduced our
sales of Desmopressin.
Proprietary Products
During the three months ended March 31, 2007, sales of our proprietary products were $89.0
million, down from $93.2 million as compared to the three months ended March 31, 2006. This decline
of $4.2 million was driven primarily by $18.1 million of lower sales of SEASONALE due to the impact
of generic competition, and partially offset by $11.3 million of sales of Adderall IR, which we
acquired from Shire and launched in October 2006, as well as a $5.7 million increase in sales of
Plan B.
Alliance and Development Revenue
During the three months ended March 31, 2007, we recorded $25.1 million of alliance and
development revenue, down from $33.3 million in the prior year period.
The decrease was caused principally by a $14.0 million decline in revenues from our profit-sharing
arrangement with Teva on generic Allegra. As competition for generic Allegra has and may continue
to cause Tevas Allegra product sales to
decrease, our royalties have declined, and may decline further in future periods. This decline was partially
offset by $3.0 million in development revenues earned under our license and development agreement
with Shire and an increase of $3.0 million in fees we receive for the
development of the Adenovirus vaccine for the U.S.
19
Department of Defense. We expect revenues from
Shire and fees from the development of the Adenovirus vaccine will increase significantly during
2007 as we increase spending on the related development projects.
Other Revenue
We recorded $10.5 million of other revenue during the three months ended March 31, 2007. This
revenue is primarily attributable to non-core operations which include our diagnostics,
disinfectants, dialysis and infusions (DDD&I) business. This business was acquired through the
PLIVA acquisition, and as such, there are no comparable operations for the three months ended March
31, 2006.
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 three months ended March 31, 2007 and 2006 (dollars
in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Generic products |
|
$ |
265.8 |
|
|
$ |
70.9 |
|
|
$ |
194.9 |
|
|
|
275 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
44.0 |
% |
|
|
64.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proprietary products |
|
$ |
29.9 |
|
|
$ |
27.6 |
|
|
$ |
2.3 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
66.4 |
% |
|
|
70.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenue |
|
$ |
6.8 |
|
|
$ |
|
|
|
$ |
6.8 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
34.9 |
% |
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of sales |
|
$ |
302.5 |
|
|
$ |
98.5 |
|
|
$ |
204.0 |
|
|
|
207 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
47.3 |
% |
|
|
66.4 |
% |
|
|
|
|
|
|
|
|
Cost of sales includes 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. |
In prior periods, we included amortization expenses related to acquired product intangibles
in selling, general and administrative (SG&A) expenses 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 March 31, 2006
presented below to reflect this change.
Overall: Primarily as a result of our PLIVA acquisition and an increase of $270.3 million in
product sales, cost of sales on an overall basis more than tripled quarter-over-quarter. In
addition, amortization charges of $28.6 million related to intangible assets acquired from PLIVA
and a charge of $32.3 million for the stepped-up value of
inventory acquired from PLIVA that we sold during the quarter also contributed to the
year-over-year increase. As part of the purchase price allocation for the PLIVA acquisition, we
stepped-up the book value of inventory acquired to fair value by $89.6 million as of October 24,
2006. Primarily as a result of these expenses and amortization
20
charges, overall gross margins
decreased from 66.4% for the three months ended March 31, 2006 to 47.3% for the three months ended
March 31, 2007.
Generics: In our generics segment, cost of sales increased by $194.9 million in large part
due to the $262.5 million increase in Other Generics sales, as
described above, and $26.0 million
of higher amortization expense arising primarily from product intangibles created as a result of
the PLIVA acquisition. When combined with the charge related to the
$32.3 million step-up in
inventory described above, our generics margins declined from 64.6%
to 44.0%. Partially
offsetting this decrease in gross margins were higher sales of our Generic OCs and a full quarter
of sales of Fentanyl Citrate, both of which positively impacted gross margins in our generics
segment.
Proprietary: In our proprietary segment, cost of sales increased by $2.3 million and margins
were negatively impacted primarily due to a $3.2 million increase in product amortization expense.
Selling, General and Administrative Expense
The following table sets forth selling, general and administrative expense for the three
months ended March 31, 2007 and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Selling, general and administrative |
|
$ |
182.4 |
|
|
$ |
78.2 |
|
|
$ |
104.2 |
|
|
|
133 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative expenses increased by $104.2 million in the three months
ended March 31, 2007 as compared to the three months ended March 31, 2006. Of this increase,
approximately $77.2 million is directly attributable to our PLIVA operating subsidiary, including
operating selling and general administrative expenses.
In addition to the expenses attributable to PLIVA, there were increases in general and
administrative expenses relating to (1) integration costs of $11.0 million from the PLIVA
acquisition, (2) a litigation reserve of $6.5 million and (3) legal, accounting and other consulting
fees of $5.7 million.
Research and Development
The following table sets forth research and development expenses and the write-off of
acquired in-process research and development (IPR&D) for the three months ended March 31, 2007
and 2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Research and development |
|
$ |
61.2 |
|
|
$ |
37.7 |
|
|
$ |
23.5 |
|
|
|
62 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of acquired IPR&D |
|
$ |
1.5 |
|
|
$ |
|
|
|
$ |
1.5 |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development increased by $23.5 million in the three months ended March 31,
2007 as compared to the three months ended March 31, 2006. Of this 62% increase, approximately
$17.3 million is directly attributable to our PLIVA subsidiary including salaries, third party
research and development, and depreciation costs aggregating approximately $13.4 million. The remaining
increase is primarily due to a $4.7 million increase in costs associated with bio-studies and
clinical trials.
The $1.5 million write-off of IPR&D represents the allocated amount of the $9.8 million price
to acquire additional shares of PLIVA during the three months ended March 31, 2007.
21
Interest Income
The following table sets forth interest income for the three months ended March 31, 2007 and
2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Interest income |
|
$ |
10.6 |
|
|
$ |
4.2 |
|
|
$ |
6.4 |
|
|
|
152 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in interest income for the three months ended March 31, 2007 is due to higher
interest rates and cash and marketable securities balances during this period as compared to the
three months ended March 31, 2006.
Interest Expense
The following table sets forth interest expense for the three months ended March 31, 2007 and
2006 (dollars in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Interest expense |
|
$ |
40.3 |
|
|
$ |
0.1 |
|
|
$ |
40.2 |
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in interest expense for the three months ended March 31, 2007 as compared to the
three months ended March 31, 2006 is due to the $2.6 billion of debt the Company has incurred in
connection with the PLIVA acquisition (both to
finance the acquisition and debt assumed from PLIVA). As a result of the incurrence
of such debt, the Company estimates that interest expense will be
approximately $155 million in 2007.
Income Taxes
The following table sets forth income tax expense and the resulting effective tax rate stated
as a percentage of pre-tax income for the three months ended March 31, 2007 and 2006 (dollars in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Income tax expense |
|
$ |
9.7 |
|
|
$ |
41.5 |
|
|
$ |
(31.8 |
) |
|
|
-77 % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
42.0 |
% |
|
|
35.3 |
% |
|
|
|
|
|
|
|
|
The Companys effective tax rate increased in the current quarter to 42.0% from 35.3% in the
same period of the prior year. The increase is primarily attributed to effects from the PLIVA
acquisition, including: the change in
geographic mix of pre-tax income; the negative impact of purchase accounting creating pre-tax
losses in lower tax jurisdictions; the negative impact resulting from certain entities with pre-tax
losses for which the Company could not recognize a tax benefit; and the change in the current
corporate structure creating certain tax inefficiencies, which are expected to diminish over time.
22
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 quarter ended March 31, 2007 were
$132.3 million compared to
$155.0 million in the prior year period. The decrease in cash flows reflects the timing of certain
items including (1) a decrease of accounts receivable and other
receivables by $74.0 million and
(2) a decrease in accounts payable, accrued expenses and other
liabilities of $14.4 million.
Investing Activities
Our net cash used in investing activities was $30.5 million for the quarter ended March 31,
2007 compared to net cash used in investing activities of $192.7 million for the prior year period.
The decrease in net cash used for investing activities was related to higher net purchases of
marketable securities in the prior year period of $178.7 million as compared to net sales of
marketable securities of $25.8 million during the current quarter. Offsetting this decrease in net
cash used for investing activities was an increase in capital spending of $9.5 million, the $9.8
million cost of acquiring additional PLIVA shares, and the $12.0 million cost of product
acquisitions from Hospira.
Financing Activities
Net
cash used in financing activities during the quarter ended
March 31, 2007 was $143.0 million compared to net cash provided by financing activities of $22.4 million in the prior year
period. The increase in net cash used in financing activities in the current quarter primarily
reflects the $50.0 million principal payment on our $2.0 billion five-year term facility that we
made on March 30, 2007 and our prepayment of $100.0 million of the $415.7 million 364-day term facility.
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
initiated this process at a price of HRK 820 per share, the same per share price offered to
shareholders during the formal tender period. This process and the subsequent pay out to remaining
shareholders is expected to be completed by June 30, 2007. We intend to fund the payout from cash
balances on hand and anticipate that the remaining investment will be approximately $80 million.
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 revolving credit facility are adequate to
fund our operations, service our debt requirements, make planned capital expenditures and to
capitalize on strategic opportunities as they arise.
Off-Balance Sheet Arrangements
The Company does not have any material off-balance sheet arrangements that have had, or are
expected to have, an effect on our financial statements.
Critical Accounting Policies
The methods, estimates and judgments we use in applying the accounting policies most critical
to our financial statements have a significant impact on our reported results. The Securities and
Exchange Commission has defined the most critical accounting policies as the ones that are most
important to the portrayal of our financial condition and results, and/or require us to make our
most difficult and subjective judgments. Based on this definition, our most critical policies are
the following: (1) revenue recognition and provisions for estimated reductions to gross product
sales; (2) revenue recognition and provisions of alliance and development revenue; (3) inventories;
(4) income taxes; (5) contingencies; (6) acquisitions and amortization of intangible assets; (7)
derivative instruments; and (8) foreign currency translation and transactions. Although we believe
that our estimates and assumptions are reasonable, they are based upon information available at the
time the estimates and assumptions were made. We review the factors
23
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 the 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 (SFAS 159) The Fair Value Option for
Financial Assets and Financial Liabilities, providing companies with an option to report selected
financial assets and liabilities at fair value. The 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 Barrs 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
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. FIN 48 clarifies the accounting for income taxes by prescribing a minimum
recognition threshold that a tax position is required to meet before being recognized in the
financial statements. Upon adoption on January 1, 2007, we analyzed filing positions in all of the
foreign, federal and state jurisdictions where the Company is required to file income tax returns, as well
as all open tax years in these jurisdictions.
As a result of the implementation of FIN 48, we 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 million, and did not change materially as
of March 31, 2007. Included in the balance at March 31, 2007 was $13.2 million of tax positions
that, if recognized, would lower the effective tax rate. We are nearing completion of several tax
audits and the expiration of the statute of limitations in several jurisdictions and it is possible
that the amount of the liability for unrecognized tax benefits could change during the next 52-week
period. An estimate of the range of the possible change cannot be made at this time.
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 its income tax provision. We had $2.6 million
accrued for interest and penalties at January 1, 2007 which has not changed materially as of March
31, 2007.
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
24
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 FDA approvals; |
|
|
|
|
court and FDA 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 and implementing our new SAP enterprise
resource planning system; |
|
|
|
|
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.
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 $854 million, borrowings under our credit facilities of approximately $2,265.7
million and approximately $152 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
25
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 March 31, 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.
During the three months ended March 31, 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 $2.7 million.
Foreign Exchange Rate Risk
A significant portion of our revenues and earnings are generated internationally in various
currencies. We also have a number of investments in foreign subsidiaries whose net assets are
exposed to currency translation risk. We seek to manage these exposures through operational means,
to the extent possible, by matching functional currency revenues and costs and functional currency
assets and liabilities. Exposures that cannot be managed operationally are hedged using foreign
exchange forwards, swaps and option contracts.
As of March 31, 2007, a 10% depreciation in the value of the US dollar would have resulted in
a decrease of $18.5 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.
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 communicated to our management, including our Chairman and Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding
required disclosure. Management necessarily applied its judgment in assessing the costs and
benefits of such controls and procedures, which, by their nature, can provide only reasonable
assurance regarding managements control objectives.
At the conclusion of the three-month period ended March 31, 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 our disclosure
controls and procedures were effective in alerting them in a timely manner to information relating
to Barr and its consolidated subsidiaries required to be disclosed in this report.
Changes in Internal Control Over Financial Reporting.
There were no changes in the Companys internal control over financial reporting during the
quarter ended March 31, 2007 that have materially affected, or are reasonably likely to materially
affect, its internal control over financial reporting.
26
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The disclosure under Note 13 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.
27
Item 6. Exhibits
|
|
|
Exhibit No. |
|
Description |
|
10.1
|
|
Employment Agreement between Zeljko Covic and PLIVA d.d. dated
March 21, 2007 |
|
|
|
10.2
|
|
Settlement Agreement between Zeljko Covic and PLIVA d.d. dated
March 21, 2007 |
|
|
|
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. |
28
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.
|
|
|
|
|
|
BARR PHARMACEUTICALS, INC.
|
|
Dated: May 10, 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) |
|
29