Allergan, Inc.
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 September 28, 2007
OR
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
COMMISSION FILE NUMBER 1-10269
ALLERGAN, INC.
(Exact name of Registrant as Specified in its Charter)
|
|
|
DELAWARE
|
|
95-1622442 |
(State or Other Jurisdiction of
|
|
(I.R.S. Employer Identification No.) |
Incorporation or Organization) |
|
|
|
|
|
2525 DUPONT DRIVE, IRVINE, CALIFORNIA
|
|
92612 |
(Address of Principal Executive Offices)
|
|
(Zip Code) |
(714) 246-4500
(Registrants Telephone Number,
Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one)
|
|
|
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 31, 2007, there were 307,511,888 shares of common stock outstanding (including
540,005 shares held in treasury).
ALLERGAN, INC.
FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 28, 2007
INDEX
|
|
|
|
|
|
|
Page |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
5 |
|
|
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
30 |
|
|
|
|
|
|
|
|
|
53 |
|
|
|
|
|
|
|
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58 |
|
|
|
|
|
|
|
|
|
58 |
|
|
|
|
|
|
|
|
|
61 |
|
|
|
|
|
|
|
|
|
61 |
|
|
|
|
|
|
|
|
|
61 |
|
|
|
|
|
|
|
|
|
61 |
|
|
|
|
|
|
|
|
|
62 |
|
|
|
|
|
|
|
|
|
64 |
|
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Allergan, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product net sales |
|
$ |
978.7 |
|
|
$ |
791.7 |
|
|
$ |
2,803.9 |
|
|
$ |
2,193.9 |
|
Other revenues |
|
|
15.0 |
|
|
|
15.1 |
|
|
|
44.4 |
|
|
|
40.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
993.7 |
|
|
|
806.8 |
|
|
|
2,848.3 |
|
|
|
2,234.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excludes amortization of acquired
intangible assets) |
|
|
173.5 |
|
|
|
167.7 |
|
|
|
493.4 |
|
|
|
433.2 |
|
Selling, general and administrative |
|
|
395.6 |
|
|
|
364.0 |
|
|
|
1,215.1 |
|
|
|
975.4 |
|
Research and development |
|
|
164.4 |
|
|
|
120.4 |
|
|
|
528.4 |
|
|
|
930.1 |
|
Amortization of acquired intangible assets |
|
|
28.7 |
|
|
|
24.9 |
|
|
|
86.1 |
|
|
|
54.8 |
|
Restructuring charges |
|
|
11.0 |
|
|
|
8.6 |
|
|
|
24.3 |
|
|
|
17.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
220.5 |
|
|
|
121.2 |
|
|
|
501.0 |
|
|
|
(176.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
18.4 |
|
|
|
12.8 |
|
|
|
48.6 |
|
|
|
34.3 |
|
Interest expense |
|
|
(17.5 |
) |
|
|
(11.9 |
) |
|
|
(53.5 |
) |
|
|
(40.2 |
) |
Unrealized gain (loss) on derivative instruments, net |
|
|
0.4 |
|
|
|
0.2 |
|
|
|
(1.3 |
) |
|
|
(1.0 |
) |
Gain on investments |
|
|
|
|
|
|
0.1 |
|
|
|
|
|
|
|
0.3 |
|
Other, net |
|
|
(10.5 |
) |
|
|
(1.7 |
) |
|
|
(15.9 |
) |
|
|
(7.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9.2 |
) |
|
|
(0.5 |
) |
|
|
(22.1 |
) |
|
|
(13.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from continuing operations before
income taxes and minority interest |
|
|
211.3 |
|
|
|
120.7 |
|
|
|
478.9 |
|
|
|
(190.1 |
) |
Provision for income taxes |
|
|
55.3 |
|
|
|
14.3 |
|
|
|
138.7 |
|
|
|
74.0 |
|
Minority interest expense |
|
|
|
|
|
|
|
|
|
|
0.4 |
|
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from continuing operations |
|
|
156.0 |
|
|
|
106.4 |
|
|
|
339.8 |
|
|
|
(264.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from discontinued operations, net of
applicable income tax expense (benefit) of $0.8
million and $(0.4) million for the three and nine
month periods ended September 28, 2007, respectively |
|
|
1.4 |
|
|
|
|
|
|
|
(0.8 |
) |
|
|
|
|
Gain on sale of discontinued operations, net of
applicable income tax expense of $0.9 million |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations |
|
|
1.4 |
|
|
|
|
|
|
|
(0.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) |
|
$ |
157.4 |
|
|
$ |
106.4 |
|
|
$ |
339.0 |
|
|
$ |
(264.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations |
|
$ |
0.51 |
|
|
$ |
0.35 |
|
|
$ |
1.11 |
|
|
$ |
(0.91 |
) |
Discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net basic earnings (loss) per share |
|
$ |
0.51 |
|
|
$ |
0.35 |
|
|
$ |
1.11 |
|
|
$ |
(0.91 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations |
|
$ |
0.50 |
|
|
$ |
0.35 |
|
|
$ |
1.10 |
|
|
$ |
(0.91 |
) |
Discontinued operations |
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net diluted earnings (loss) per share |
|
$ |
0.51 |
|
|
$ |
0.35 |
|
|
$ |
1.10 |
|
|
$ |
(0.91 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
3
Allergan, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in millions, except share data)
|
|
|
|
|
|
|
|
|
|
|
September 28, |
|
December 31, |
|
|
2007 |
|
2006 |
ASSETS
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
1,413.3 |
|
|
$ |
1,369.4 |
|
Trade receivables, net |
|
|
478.3 |
|
|
|
386.9 |
|
Inventories |
|
|
202.5 |
|
|
|
168.5 |
|
Other current assets |
|
|
322.6 |
|
|
|
205.5 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,416.7 |
|
|
|
2,130.3 |
|
Investments and other assets |
|
|
175.5 |
|
|
|
148.2 |
|
Property, plant and equipment, net |
|
|
637.6 |
|
|
|
611.4 |
|
Goodwill |
|
|
1,961.8 |
|
|
|
1,833.6 |
|
Intangibles, net |
|
|
1,105.9 |
|
|
|
1,043.6 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
6,297.5 |
|
|
$ |
5,767.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
39.6 |
|
|
$ |
102.0 |
|
Accounts payable |
|
|
187.8 |
|
|
|
142.4 |
|
Accrued compensation |
|
|
122.2 |
|
|
|
124.8 |
|
Other accrued expenses |
|
|
289.3 |
|
|
|
235.2 |
|
Income taxes |
|
|
4.6 |
|
|
|
53.7 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
643.5 |
|
|
|
658.1 |
|
Long-term debt |
|
|
827.8 |
|
|
|
856.4 |
|
Long-term convertible notes |
|
|
750.0 |
|
|
|
750.0 |
|
Deferred tax liabilities |
|
|
129.7 |
|
|
|
84.8 |
|
Other liabilities |
|
|
338.5 |
|
|
|
273.2 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Minority interest |
|
|
1.9 |
|
|
|
1.5 |
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value; authorized 5,000,000 shares; none issued |
|
|
|
|
|
|
|
|
Common stock, $.01 par value; authorized 500,000,000 shares; issued
307,512,000 shares as of September 28, 2007 and December 31, 2006 |
|
|
3.1 |
|
|
|
3.1 |
|
Additional paid-in capital |
|
|
2,422.2 |
|
|
|
2,358.0 |
|
Accumulated other comprehensive loss |
|
|
(88.1 |
) |
|
|
(127.4 |
) |
Retained earnings |
|
|
1,303.1 |
|
|
|
1,065.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3,640.3 |
|
|
|
3,299.4 |
|
Less treasury stock, at cost (610,000 shares as of September 28, 2007
and 2,974,000 shares as of December 31, 2006, respectively) |
|
|
(34.2 |
) |
|
|
(156.3 |
) |
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
3,606.1 |
|
|
|
3,143.1 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
6,297.5 |
|
|
$ |
5,767.1 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
4
Allergan, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(in millions)
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Earnings (loss) from continuing operations |
|
$ |
339.8 |
|
|
$ |
(264.2 |
) |
Non-cash items included in earnings (loss) from continuing operations: |
|
|
|
|
|
|
|
|
In-process research and development charge |
|
|
72.0 |
|
|
|
579.3 |
|
Depreciation and amortization |
|
|
155.6 |
|
|
|
108.6 |
|
Settlement of a pre-existing distribution agreement in a business combination |
|
|
2.3 |
|
|
|
|
|
Amortization of original issue discount and debt issuance costs |
|
|
3.5 |
|
|
|
8.7 |
|
Amortization of net realized gain on interest rate swap |
|
|
(0.6 |
) |
|
|
(0.6 |
) |
Deferred income tax benefit |
|
|
(30.3 |
) |
|
|
(7.0 |
) |
Loss on disposal of fixed assets and investments |
|
|
4.2 |
|
|
|
3.1 |
|
Unrealized loss on derivative instruments |
|
|
1.3 |
|
|
|
1.0 |
|
Expense of share-based compensation plans |
|
|
60.2 |
|
|
|
48.0 |
|
Minority interest expense |
|
|
0.4 |
|
|
|
0.1 |
|
Restructuring charge |
|
|
24.3 |
|
|
|
17.1 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Trade receivables |
|
|
(68.4 |
) |
|
|
(70.3 |
) |
Inventories |
|
|
(12.6 |
) |
|
|
35.6 |
|
Other current assets |
|
|
(8.5 |
) |
|
|
19.9 |
|
Other non-current assets |
|
|
(11.2 |
) |
|
|
1.3 |
|
Accounts payable |
|
|
34.3 |
|
|
|
6.3 |
|
Accrued expenses |
|
|
12.2 |
|
|
|
18.5 |
|
Income taxes |
|
|
(27.2 |
) |
|
|
(17.2 |
) |
Other liabilities |
|
|
26.5 |
|
|
|
22.5 |
|
|
|
|
|
|
|
|
|
|
Net cash provided by continuing operations |
|
|
577.8 |
|
|
|
510.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Acquisitions, net of cash acquired |
|
|
(312.9 |
) |
|
|
(1,328.6 |
) |
Issuance of note receivable |
|
|
(74.8 |
) |
|
|
|
|
Additions to property, plant and equipment |
|
|
(73.6 |
) |
|
|
(73.4 |
) |
Additions to capitalized software |
|
|
(18.7 |
) |
|
|
(13.1 |
) |
Additions to intangible assets |
|
|
(5.0 |
) |
|
|
(11.0 |
) |
Proceeds from sale of business |
|
|
16.7 |
|
|
|
|
|
Proceeds from sale of property, plant and equipment |
|
|
8.9 |
|
|
|
3.3 |
|
Proceeds from sale of investments |
|
|
|
|
|
|
0.6 |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(459.4 |
) |
|
|
(1,422.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Dividends to stockholders |
|
|
(45.6 |
) |
|
|
(43.3 |
) |
Debt issuance costs |
|
|
|
|
|
|
(19.7 |
) |
Repayments of convertible borrowings |
|
|
|
|
|
|
(521.9 |
) |
Payments to acquire treasury stock |
|
|
(61.7 |
) |
|
|
(307.8 |
) |
Net repayments of notes payable |
|
|
(105.5 |
) |
|
|
(139.5 |
) |
Bridge credit facility borrowings |
|
|
|
|
|
|
825.0 |
|
Bridge credit facility repayments |
|
|
|
|
|
|
(825.0 |
) |
Proceeds from issuance of senior notes |
|
|
|
|
|
|
797.7 |
|
Proceeds from issuance of convertible senior notes |
|
|
|
|
|
|
750.0 |
|
Sale of stock to employees |
|
|
110.3 |
|
|
|
118.1 |
|
Net proceeds from settlement of interest rate swap |
|
|
|
|
|
|
13.0 |
|
Excess tax benefits from share-based compensation |
|
|
25.1 |
|
|
|
27.9 |
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(77.4 |
) |
|
|
674.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow used in discontinued operations |
|
|
(5.4 |
) |
|
|
|
|
Effect of exchange rate changes on cash and equivalents |
|
|
8.3 |
|
|
|
2.3 |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and equivalents |
|
|
43.9 |
|
|
|
(234.7 |
) |
Cash and equivalents at beginning of period |
|
|
1,369.4 |
|
|
|
1,296.3 |
|
|
|
|
|
|
|
|
|
|
Cash and equivalents at end of period |
|
$ |
1,413.3 |
|
|
$ |
1,061.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
Cash paid for: |
|
|
|
|
|
|
|
|
Interest (net of capitalization) |
|
$ |
32.3 |
|
|
$ |
6.0 |
|
|
|
|
|
|
|
|
|
|
Income taxes, net of refunds |
|
$ |
166.5 |
|
|
$ |
115.5 |
|
|
|
|
|
|
|
|
|
|
On February 22, 2007, the Company completed the acquisition of EndoArt SA for approximately
$97.1 million in cash, net of cash acquired. In connection with the EndoArt SA acquisition, the
Company acquired assets with a fair value of $101.9 million and assumed liabilities of $4.8
million.
On January 2, 2007, the Company completed the acquisition of Groupe Cornéal Laboratoires for
$215.8 million in cash, net of cash acquired. In connection with the Groupe Cornéal Laboratoires
acquisition, the Company acquired assets with a fair value of $288.5 million and assumed
liabilities of $79.4 million.
On March 23, 2006, the Company completed the acquisition of Inamed Corporation. In exchange
for the common stock of Inamed Corporation, the Company issued common stock with a fair value of
$1,859.3 million and paid $1,328.7 million in cash, net of cash acquired. In connection with the
Inamed acquisition, the Company acquired assets with a fair value of $3,813.4 million and assumed
liabilities of $522.7 million, based on a final measurement of the purchase price as of December
31, 2006.
See accompanying notes to unaudited condensed consolidated financial statements.
5
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Note 1: Basis of Presentation
In the opinion of management, the accompanying unaudited condensed consolidated financial
statements contain all adjustments necessary (consisting only of normal recurring accruals) to
present fairly the financial information contained therein. These statements do not include all
disclosures required by accounting principles generally accepted in the United States of America
(GAAP) for annual periods and should be read in conjunction with the Companys audited consolidated
financial statements and related notes for the year ended December 31, 2006. The Company prepared
the condensed consolidated financial statements following the requirements of the Securities and
Exchange Commission for interim reporting. As permitted under those rules, certain footnotes or
other financial information that are normally required by GAAP can be condensed or omitted. The
results of operations for the three and nine month periods ended September 28, 2007 are not
necessarily indicative of the results to be expected for the year ending December 31, 2007 or any
other period(s).
Reclassifications
Certain reclassifications of prior year amounts have been made to conform with the current
year presentation. Beginning with the second fiscal quarter of 2006, the Company reports
amortization of acquired intangible assets on a separate line in its statements of operations.
Previously, amortization of intangible assets was reported in cost of sales, selling, general and
administrative (SG&A) expenses, and research and development (R&D) expenses. Intangible asset
amortization for the nine month period ended September 29, 2006 includes a total reclassification
of $5.1 million, representing the reclassification of $4.3 million, $0.1 million and $0.7 million
from cost of sales, SG&A expenses, and R&D expenses, respectively, previously reported for the
three month period ended March 31, 2006.
Common Stock Split
On June 22, 2007, the Company completed a two-for-one stock split of its common stock. The
stock split was structured in the form of a 100% stock dividend and was paid to stockholders of
record on June 11, 2007.
All share and per share data (except par value) have been adjusted to reflect the effect of
the stock split for all periods presented.
Recently Adopted Accounting Standards
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. 158, Employers Accounting for Defined Benefit Pension and Other
Postretirement Plans (SFAS No. 158). SFAS No. 158 requires the recognition of the over-funded or
under-funded status of a defined benefit pension and other postretirement plan as an asset or
liability, respectively, in the balance sheet, the recognition of changes in that funded status
through other comprehensive income in the year in which the changes occur, and the measurement of a
plans assets and obligations that determine its funded status as of the end of the employers
fiscal year. The Company adopted the balance sheet recognition and reporting provisions of SFAS No.
158 during the fourth fiscal quarter of 2006. The Company currently expects to adopt in the fourth
fiscal quarter of 2008 the provisions of SFAS No. 158 relating to the change in measurement date,
which is not expected to have a material impact on the Companys consolidated financial statements.
In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes An Interpretation of FASB Statement No. 109 (FIN 48), which prescribes a recognition
threshold and measurement attribute for the financial statement recognition and measurement of a
tax position taken or expected to be taken in a tax return. Historically, the Companys policy has
been to account for uncertainty in income taxes in accordance with the provisions of Statement of
Financial Accounting Standards No. 5, Accounting for Contingencies, which considered whether the
tax benefit from an uncertain tax position was probable of being sustained. Under FIN 48,
6
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
the tax benefit from uncertain tax positions may be recognized only if it is more likely than
not that the tax position will be sustained, based solely on its technical merits, with the taxing
authority having full knowledge of all relevant information. After initial adoption of FIN 48,
deferred tax assets and liabilities for temporary differences between the financial reporting basis
and the tax basis of the Companys assets and liabilities along with net operating loss and tax
credit carryovers are recognized only for tax positions that meet the more likely than not
recognition criteria. Additionally, recognition and derecognition of tax benefits from uncertain
tax positions are recorded as discrete tax adjustments in the first interim period that the more
likely than not threshold is met. The Company adopted FIN 48 as of the beginning of the first
quarter of 2007, which resulted in an increase to total income taxes payable of $2.8 million and
interest payable of $0.5 million and a decrease to total deferred tax assets of $1.0 million and
beginning retained earnings of $4.3 million. In addition, the Company reclassified $27.0 million of
net unrecognized tax benefit liabilities from current to non-current liabilities.
In February 2006, the FASB issued Statement of Financial Accounting Standards No. 155,
Accounting for Certain Hybrid Financial Instruments an amendment of FASB Statements No. 133 and
140 (SFAS No. 155). SFAS No. 155 permits an entity to measure at fair value any financial
instrument that contains an embedded derivative that otherwise would require bifurcation. This
statement is effective for all financial instruments acquired, issued, or subject to a
remeasurement event occurring after an entitys first fiscal year that begins after September 15,
2006. The Company adopted the provisions of SFAS No. 155 in the first fiscal quarter of 2007. The
adoption did not have a material effect on the Companys consolidated financial statements.
New Accounting Standards Not Yet Adopted
In June 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force (EITF)
in EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services
Received for Use in Future Research and Development Activities (EITF 07-3), which requires that
nonrefundable advance payments for goods or services that will be used or rendered for future R&D
activities be deferred and amortized over the period that the goods are delivered or the related
services are performed, subject to an assessment of recoverability. EITF 07-3 will be effective for
fiscal years beginning after December 15, 2007, which will be the Companys fiscal year 2008. The
Company does not expect that the adoption of EITF 07-3 will have a material impact on the Companys
consolidated financial statements.
In June 2007, the FASB ratified the consensus reached by the EITF in EITF Issue No. 06-11,
Accounting for Income Tax Benefits of Dividends on Share-Based Payment Awards (EITF 06-11), which
requires that the income tax benefits of dividends or dividend equivalents on unvested share-based
payments be recognized as an increase in additional paid-in capital and reclassified from
additional paid-in capital to the income statement when the related award is forfeited (or is no
longer expected to vest). The reclassification is limited to the amount of the entitys pool of
excess tax benefits available to absorb tax deficiencies on the date of the reclassification. EITF
06-11 will be effective for fiscal years beginning after December 15, 2007, which will be the
Companys fiscal year 2008. The Company does not expect that the adoption of EITF 06-11 will have a
material impact on the Companys consolidated financial statements.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (SFAS No. 159), which allows an
entity to voluntarily choose to measure certain financial assets and liabilities at fair value.
SFAS No. 159 will be effective for fiscal years beginning after November 15, 2007, which will be
the Companys fiscal year 2008. The Company has not yet evaluated the potential impact of adopting
SFAS No. 159 on the Companys consolidated financial statements.
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, Fair
Value Measurements (SFAS No. 157), which defines fair value, establishes a framework for measuring
fair value under GAAP, and expands disclosures about fair value measurements. SFAS No. 157 will be
effective for fiscal years beginning after November 15, 2007, which will be the Companys fiscal
year 2008. The Company has not yet evaluated the potential impact of adopting SFAS No. 157 on the
Companys consolidated financial statements.
7
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Note 2: Acquisitions
Cornéal Acquisition
On January 2, 2007, the Company purchased all of the outstanding common stock of Groupe
Cornéal Laboratoires (Cornéal), a privately held healthcare company that develops, manufactures and
markets dermal fillers, viscoelastics and a range of ophthalmic products, for an aggregate purchase
price of approximately $209.1 million, net of $2.3 million effectively paid in connection with the
settlement of a pre-existing unfavorable distribution agreement. The Company recorded the $2.3
million charge at the acquisition date to effectively settle a pre-existing unfavorable
distribution agreement between Cornéal and one of the Companys subsidiaries, primarily related to
distribution rights for Juvéderm in the United States. Prior to the acquisition, the Company also
had a $4.4 million payable to Cornéal outstanding for products purchased under the distribution
agreement, which was effectively settled upon the acquisition. As a result of the acquisition, the
Company obtained the technology, manufacturing process and worldwide distribution rights for
Juvéderm, Surgiderm® and certain other hyaluronic acid-based dermal fillers. The
acquisition was funded from the Companys cash and equivalents balances and its committed long-term
credit facility.
The following table summarizes the components of the Cornéal purchase price:
|
|
|
|
|
|
|
(in millions) |
Cash consideration, net of cash acquired |
|
$ |
212.0 |
|
Transaction costs |
|
|
3.8 |
|
|
|
|
|
|
Cash paid |
|
|
215.8 |
|
Less relief from a previously existing third-party payable |
|
|
(4.4 |
) |
Less settlement of a pre-existing distribution agreement |
|
|
(2.3 |
) |
|
|
|
|
|
|
|
$ |
209.1 |
|
|
|
|
|
|
Purchase Price Allocation
The Cornéal purchase price was allocated to tangible and intangible assets acquired and
liabilities assumed based upon their estimated fair values at the acquisition date. The excess of
the purchase price over the fair value of net assets acquired was allocated to goodwill. The
goodwill acquired in the Cornéal acquisition is not deductible for tax purposes.
The Company believes the fair values assigned to the Cornéal assets acquired and liabilities
assumed were based upon reasonable assumptions. The following table summarizes the estimated fair
values of the net assets acquired:
|
|
|
|
|
|
|
(in millions) |
Current assets |
|
$ |
38.9 |
|
Property, plant and equipment |
|
|
19.8 |
|
Identifiable intangible assets |
|
|
115.7 |
|
Goodwill |
|
|
112.6 |
|
Other non-current assets |
|
|
1.5 |
|
Accounts payable and accrued liabilities |
|
|
(19.3 |
) |
Current portion of long-term debt |
|
|
(11.6 |
) |
Deferred tax liabilities non-current |
|
|
(45.9 |
) |
Other non-current liabilities |
|
|
(2.6 |
) |
|
|
|
|
|
|
|
$ |
209.1 |
|
|
|
|
|
|
The Companys fair value estimates for the Cornéal purchase price allocation may change during
the allowable allocation period, which is up to one year from the acquisition date, if additional
information becomes available.
In-process Research and Development
In conjunction with the Cornéal acquisition, the Company determined that the R&D efforts
related to Cornéal products did not give rise to identifiable in-process research and development
assets with anticipated future economic value that could be reasonably estimated.
8
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Identifiable Intangible Assets
Acquired identified intangible assets include product rights for approved indications of
currently marketed products, core technology and trademarks. The amount assigned to each class of
intangible assets and the related weighted-average amortization periods are summarized in the
following table:
|
|
|
|
|
|
|
|
|
|
|
Value of |
|
|
|
|
Intangible Assets |
|
Weighted-average |
|
|
Acquired |
|
Amortization Period |
|
|
(in millions) |
|
|
|
|
Developed technology |
|
$ |
72.4 |
|
|
8.3 years |
|
Core technology |
|
|
39.4 |
|
|
13.0 years |
|
Trademarks |
|
|
3.9 |
|
|
9.5 years |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
115.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired developed technology assets primarily consist of the following currently marketed
Cornéal products:
|
|
|
|
|
|
|
Value of |
|
|
Intangible Assets |
|
|
Acquired |
|
|
(in millions) |
Juvéderm worldwide |
|
$ |
56.1 |
|
Surgiderm® worldwide |
|
|
13.1 |
|
Other |
|
|
3.2 |
|
|
|
|
|
|
|
|
$ |
72.4 |
|
|
|
|
|
|
Impairment evaluations in the future for acquired developed technology will occur at a
consolidated cash flow level within the Companys medical devices segment, with valuation analysis
and related potential impairment actions segregated among the United States, the European Union,
Canada, Australia, and the rest of the world, which were the markets used to originally value the
intangible assets.
The Company determined that the Cornéal assets acquired included proprietary technology which
has alternative future use in the development of aesthetics products. These assets were separately
valued and capitalized as core technology. Trademarks acquired are primarily related to Juvéderm
and Surgiderm®.
Goodwill
Goodwill represents the excess of the Cornéal purchase price over the sum of the amounts
assigned to assets acquired less liabilities assumed. The Company believes that the Cornéal
acquisition will produce the following significant benefits:
|
|
|
Control over the Manufacturing Process and Future Development. The acquisition will
allow the Company to control product quality and availability and to gain additional
expertise and intellectual property to further develop the next generation of dermal
fillers. |
|
|
|
|
Expanded Distribution Rights. The Company has expanded its exclusive distribution
rights for Juvéderm from the United States, Canada and Australia to all countries
worldwide. |
|
|
|
|
Enhanced Product Mix. The complementary nature of the Companys facial aesthetics
products with those of Cornéal should benefit current customers of both companies. |
|
|
|
|
Operating Efficiencies. The combination of the Company and Cornéal provides the
opportunity for product cost savings due to manufacturing efficiencies. |
9
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The Company believes that these primary factors support the amount of goodwill recognized as a
result of the purchase price paid for Cornéal in relation to other acquired tangible and intangible
assets.
EndoArt SA Acquisition
On February 22, 2007, the Company completed the acquisition of EndoArt SA (EndoArt), a
provider of telemetrically-controlled (or remote-controlled) implants used in the treatment of
morbid obesity and other conditions. Under the terms of the purchase agreement, the Company
acquired all of the outstanding capital stock of EndoArt for an aggregate purchase price of
approximately $97.1 million, net of cash acquired. The acquisition consideration was all cash,
funded from the Companys cash and equivalents balances.
The following table summarizes the components of the EndoArt purchase price:
|
|
|
|
|
|
|
(in millions) |
Cash consideration, net of cash acquired |
|
$ |
96.6 |
|
Transaction costs |
|
|
0.5 |
|
|
|
|
|
|
|
|
$ |
97.1 |
|
|
|
|
|
|
Purchase Price Allocation
The EndoArt purchase price was allocated to tangible and intangible assets acquired and
liabilities assumed based on their estimated fair values at the acquisition date. The excess of the
purchase price over the fair value of net assets acquired was allocated to goodwill. The goodwill
acquired in the EndoArt acquisition is not deductible for tax purposes.
The Company believes the fair values assigned to the EndoArt assets acquired and liabilities
assumed were based on reasonable assumptions. The following table summarizes the estimated fair
values of net assets acquired:
|
|
|
|
|
|
|
(in millions) |
Current assets |
|
$ |
0.8 |
|
Property, plant and equipment |
|
|
0.7 |
|
Identifiable intangible assets |
|
|
17.6 |
|
In-process research and development |
|
|
72.0 |
|
Goodwill |
|
|
10.8 |
|
Accounts payable and accrued liabilities |
|
|
(0.8 |
) |
Deferred tax liabilities |
|
|
(4.0 |
) |
|
|
|
|
|
|
|
$ |
97.1 |
|
|
|
|
|
|
The Companys fair value estimates for the EndoArt purchase price allocation may change during
the allowable allocation period, which is up to one year from the acquisition date, if additional
information becomes available.
In-process Research and Development
In conjunction with the EndoArt acquisition, the Company recorded an in-process research and
development expense of $72.0 million related to EndoArts EASYBAND® Remote Adjustable
Gastric Band System in the United States, which had not received approval by the U.S. Food and Drug
Administration (FDA) as of the EndoArt acquisition date of February 22, 2007 and had no alternative
future use.
As of the EndoArt acquisition date, the EASYBAND® Remote Adjustable Gastric Band
System was expected to be approved by the FDA in 2011. Additional R&D expenses needed prior to
expected FDA approval are expected to range from $20 million to $25 million. This range represents
managements best estimate as to the additional R&D expenses required to obtain FDA approval to
market the product in the United States. Remaining efforts will be focused on completing
discussions with the FDA regarding study design and performing a future clinical trial to pursue a
premarket approval in the United States.
10
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The estimated fair value of the in-process research and development assets was determined
based on the use of a discounted cash flow model using an income approach for the acquired
technologies. Estimated revenues were probability adjusted to take into account the stage of
completion and the risks surrounding successful development and commercialization. The estimated
after-tax cash flows were then discounted to a present value using a discount rate of 28%. At the
time of the EndoArt acquisition, material net cash inflows were estimated to begin in 2011.
The major risks and uncertainties associated with the timely and successful completion of the
acquired in-process projects consist of the ability to confirm the safety and efficacy of the
technology based on the data from clinical trials and obtaining necessary regulatory approvals. No
assurance can be given that the underlying assumptions used to forecast cash flows or the timely
and successful completion of the projects will materialize as estimated. For these reasons, among
others, actual results may vary significantly from estimated results.
Identifiable Intangible Assets
Acquired identifiable intangible assets include product rights for approved indications of
currently marketed products and core technology. The amounts assigned to each class of intangible
assets and the related weighted average amortization periods are summarized in the following table:
|
|
|
|
|
|
|
|
|
|
|
Value of |
|
|
|
|
Intangible Assets |
|
Weighted-average |
|
|
Acquired |
|
Amortization Period |
|
|
(in millions) |
|
|
|
|
Developed technology |
|
$ |
12.3 |
|
|
11.8 years |
Core technology |
|
|
5.3 |
|
|
15.8 years |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
17.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The acquired developed technology asset represents the EASYBAND® Remote Adjustable
Gastric Band System, which has been approved in Europe and is pending approval in Australia. The
Company determined that there are no substantive risks remaining in order to obtain approval in
Australia.
Impairment evaluations in the future for acquired developed technology will occur at a
consolidated cash flow level within the Companys medical devices segment, with valuation analysis
and related potential impairment actions segregated between two markets, Europe and Australia,
which were used to originally value the intangible assets.
The Company determined that the EndoArt assets acquired included proprietary technology which
has alternative future use in the development of remote adjustable gastric band products. The major
risks and uncertainties associated with the core technology consist of the Companys ability to
successfully utilize the technology in future research projects.
Goodwill
Goodwill represents the excess of the EndoArt purchase price over the sum of the amounts
assigned to assets acquired less liabilities assumed. The Company believes that the acquisition of
EndoArt will produce the following significant benefits:
|
|
|
Increased Market Presence and Opportunities. The acquisition of EndoArt should increase
the Companys market presence and opportunities for growth in sales, earnings and
stockholder returns. |
|
|
|
|
Enhanced Product Mix. The complementary nature of the Companys obesity intervention
products with those of EndoArt should benefit the Companys current target group of
patients and customers and provide the Company with the ability to access new patients and
physician customers. |
The Company believes that these primary factors support the amount of goodwill recognized as a
result of the purchase price paid for EndoArt, in relation to other acquired tangible and
intangible assets, including in-process research and development.
11
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The Company does not consider the acquisitions of Cornéal or EndoArt to be material business
combinations, either individually or in the aggregate. Accordingly, the Company has not provided
any supplemental pro forma operating results, which would not be materially different from
historical financial statements.
Inamed Acquisition
On March 23, 2006, the Company completed the acquisition of Inamed Corporation, a global
healthcare company that develops, manufactures and markets a diverse line of products, including
breast implants, a range of facial aesthetics and obesity intervention products, for approximately
$3.3 billion, consisting of approximately $1.4 billion in cash and 34,883,386 shares of the
Companys common stock.
In connection with the Inamed acquisition, the Company recorded a total in-process research
and development expense of $579.3 million in 2006 for acquired in-process research and development
assets that the Company determined were not yet complete and had no alternative future uses in
their current state. The Company recorded a $562.8 million expense for in-process research and
development during the first fiscal quarter of 2006 and an additional charge of $16.5 million
during the second fiscal quarter of 2006. The acquired in-process research and development assets
are composed of Inameds silicone breast implant technology for use in the United States, Inameds
Juvéderm dermal filler technology for use in the United States, and Inameds BIB
BioEnterics® Intragastric Balloon technology for use in the United States, which were
valued at $405.8 million, $41.2 million and $132.3 million, respectively. All of these assets had
not received approval by the FDA as of the Inamed acquisition date of March 23, 2006. Because the
in-process research and development assets had no alternative future use, they were charged to
expense on the Inamed acquisition date.
Unaudited pro forma operating results for the Company, assuming the Inamed acquisition
occurred on January 1, 2006 and excluding any pro forma charges for in-process research and
development, inventory fair value adjustments and Inamed share-based compensation expense in 2006
and transaction costs are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 29, |
|
September 29, |
(in millions, except per share amounts) |
|
2006 |
|
2006 |
Product net sales |
|
$ |
791.7 |
|
|
$ |
2,293.3 |
|
Total revenues |
|
$ |
806.8 |
|
|
$ |
2,333.6 |
|
Net earnings |
|
$ |
123.6 |
|
|
$ |
334.9 |
|
Basic earnings per share |
|
$ |
0.41 |
|
|
$ |
1.11 |
|
Diluted earnings per share |
|
$ |
0.41 |
|
|
$ |
1.09 |
|
The pro forma information is not necessarily indicative of the actual results that would have
been achieved had the acquisition occurred as of January 1, 2006, or the results that may be
achieved in the future.
Note 3: Discontinued Operations
On July 2, 2007, the Company completed the sale of the ophthalmic surgical device business
that it acquired as a part of the Cornéal acquisition in January 2007, for net cash proceeds of
$29.6 million. The net assets of the disposed business consisted of current assets of $22.9
million, non-current assets of $10.0 million and current liabilities of $4.2 million. In
conjunction with the sale, the Company recognized income tax expense of $0.9 million, resulting in
no net gain or loss on the disposal of the business.
The following amounts related to the ophthalmic surgical device business have been segregated
from continuing operations and reported as discontinued operations through the date of disposition.
The Company did not account for its ophthalmic surgical device business as a separate legal entity.
Therefore, the following selected financial data for the Companys discontinued operations is
presented for informational purposes only and does not necessarily reflect what the net sales or
earnings would have been had the business operated as a stand-alone entity. The financial
information for the Companys discontinued operations includes allocations of certain expenses to
the ophthalmic surgical device business. These amounts have been allocated to the Companys
discontinued operations on the basis that is considered by management to reflect most fairly or
reasonably the utilization of the services provided to, or
the benefit obtained by, the ophthalmic surgical device business.
12
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The following table sets forth, for the periods indicated, selected financial data of the
Companys discontinued operations. There were no comparable amounts for the corresponding periods
in 2006.
Selected Financial Data for Discontinued Operations
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 28, |
|
|
2007 |
|
2007 |
|
|
(in millions) |
Net sales |
|
$ |
|
|
|
$ |
20.0 |
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from discontinued operations
before income taxes |
|
$ |
2.2 |
|
|
$ |
(1.2 |
) |
Net earnings (loss) from discontinued operations |
|
$ |
1.4 |
|
|
$ |
(0.8 |
) |
The earnings from discontinued operations before income taxes of $2.2 million in the three
month period ended September 28, 2007 primarily relate to an adjustment to the estimated fair value
of ophthalmic surgical inventory associated with the Cornéal acquisition.
Note 4: Restructuring Charges, Integration Costs, and Transition and Duplicate Operating Expenses
Restructuring and Integration of Cornéal Operations
In connection with the January 2007 Cornéal acquisition, the Company initiated a restructuring
and integration plan to merge the Cornéal facial aesthetics business operations with the Companys
operations. Specifically, the restructuring and integration activities involve moving key business
functions to Company locations, integrating Cornéals distributor operations with the Companys
existing distribution network and integrating Cornéals information systems with the Companys
information systems. The Company currently estimates that the total pre-tax charges resulting from
the restructuring and integration of the Cornéal facial aesthetics business operations will be
between $29.0 million and $37.0 million, consisting primarily of contract termination costs,
salaries, travel and consulting costs, all of which are expected to be cash expenditures.
The foregoing estimates are based on assumptions relating to, among other things, a reduction
of approximately 19 positions, principally general and administrative positions at Cornéal
locations. Charges associated with the workforce reduction, including severance, relocation and
one-time termination benefits, and payments to public employment and training programs, are
currently expected to total approximately $5.0 million to $7.0 million. Estimated charges include
estimates for contract termination costs, including the termination of duplicative distribution
arrangements. Contract termination costs are expected to total approximately $16.0 million to $21.0
million.
The Company began to record costs associated with the restructuring and integration of the
Cornéal facial aesthetics business in the first quarter of 2007 and expects to continue to incur
costs up through and including the second quarter of 2008. The restructuring charges primarily
consist of employee severance, one-time termination benefits, employee relocation, termination of
duplicative distributor agreements and other costs related to the restructuring of the Cornéal
operations. During the three and nine month periods ended September 28, 2007, the Company recorded
$11.2 million and $13.2 million, respectively, related to the restructuring of the Cornéal
operations. The integration and transition costs primarily consist of salaries, travel,
communications, recruitment and consulting costs. During the three month period ended September 28,
2007, the Company recorded $1.3 million of integration and transition costs associated with the
Cornéal integration, consisting of $0.1 million in cost of sales and $1.2 million in SG&A expenses.
During the nine month period ended September 28, 2007, the Company recorded $6.9 million of
integration and transition costs, consisting of $0.1 million in cost of sales and $6.8 million in
SG&A expenses.
13
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The following table presents the cumulative restructuring activities related to the Cornéal
operations during the nine month period ended September 28, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
Contract Termination |
|
|
|
|
Severance |
|
Costs |
|
Total |
|
|
(in millions) |
Net charge during the nine month period ended September 28, 2007
|
|
$ |
4.9 |
|
|
$ |
8.3 |
|
|
$ |
13.2 |
|
Spending
|
|
|
|
|
|
|
(2.9 |
) |
|
|
(2.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 28, 2007 (included in Other accrued expenses)
|
|
$ |
4.9 |
|
|
$ |
5.4 |
|
|
$ |
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring and Integration of Inamed Operations
In connection with the March 2006 Inamed acquisition, the Company initiated a global
restructuring and integration plan to merge Inameds operations with the Companys operations and
to capture synergies through the centralization of certain general and administrative and
commercial functions. Specifically, the restructuring and integration activities involve
eliminating certain general and administrative positions, moving key commercial Inamed business
functions to the Companys locations around the world, integrating Inameds distributor operations
with the Companys existing distribution network and integrating Inameds information systems with
the Companys information systems.
The Company has incurred, and anticipates that it will continue to incur, charges relating to
severance, relocation and one-time termination benefits, payments to public employment and training
programs, integration and transition costs, and contract termination costs in connection with the
Inamed restructuring. The Company currently estimates that the total pre-tax charges resulting from
the restructuring, including integration and transition costs, will be between $47.0 million and
$57.0 million, all of which are expected to be cash expenditures. In addition to the pre-tax
charges, the Company expects to incur capital expenditures of approximately $15.0 million to $20.0
million, primarily related to the integration of information systems. The Company also expects to
pay an additional amount of approximately $1.5 million to $2.0 million for taxes related to
intercompany transfers of trade businesses and net assets.
The foregoing estimates are based on assumptions relating to, among other things, a reduction
of approximately 60 positions, principally general and administrative positions at Inamed
locations. These workforce reduction activities began in the second quarter of 2006 and are
expected to be substantially completed by the end of 2007. Charges associated with the workforce
reduction, including severance, relocation and one-time termination benefits, and payments to
public employment and training programs, are currently expected to total approximately $8.0 million
to $10.0 million. Estimated charges include estimates for contract and lease termination costs,
including the termination of duplicative distribution arrangements. Contract and lease termination
costs are expected to total approximately $13.0 million to $17.0 million. The Company began to
record these costs in the second quarter of 2006 and expects to continue to incur them up through
and including the fourth quarter of 2007.
On January 30, 2007, the Companys Board of Directors approved an additional plan to
restructure and eventually sell or close the collagen manufacturing facility in Fremont, California
that the Company acquired in the Inamed acquisition. This plan is the result of a reduction in
anticipated future market demand for human and bovine collagen products. In connection with the
restructuring and eventual sale or closure of the collagen manufacturing facility, the Company
estimates that total pre-tax charges for severance, lease termination and contract settlement costs
will be between $6.0 million and $8.0 million, all of which are expected to be cash expenditures.
The foregoing estimates are based on assumptions relating to, among other things, a reduction of
approximately 69 positions, consisting principally of manufacturing positions at the facility, that
are expected to result in estimated total employee severance costs of approximately $1.5 million to
$2.0 million. Estimated charges for contract and lease termination costs are expected to total
approximately $4.5 million to $6.0 million. The Company began to record these costs in the first
quarter of 2007 and expects to continue to incur them up through and including the fourth quarter
of 2008. Prior to any closure or sale of the collagen manufacturing facility, the Company intends
to manufacture a sufficient quantity of inventories of collagen products to meet estimated market
demand through 2010.
14
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
As of September 28, 2007, the Company has recorded cumulative pre-tax restructuring charges of
$23.4 million, cumulative pre-tax integration and transition costs of $25.1 million, and $1.6 million for
income tax costs related to intercompany transfers of trade businesses and net assets. The
restructuring charges primarily consist of employee severance, one-time termination benefits,
employee relocation, termination of duplicative distributor agreements and other costs related to
restructuring the former Inamed operations. During the three and nine month periods ended September
28, 2007, the Company recorded a $0.3 million restructuring charge reversal and $9.9 million of
restructuring charges, respectively. The integration and transition costs primarily consist of
salaries, travel, communications, recruitment and consulting costs. During the three month period
ended September 28, 2007, the Company recorded $0.8 million of integration and transition costs
associated with the Inamed integration, consisting of $0.1 million in cost of sales and $0.7
million in SG&A expenses. During the nine month period ended September 28, 2007, the Company
recorded $4.4 million of integration and transition costs, consisting of $0.1 million in cost of
sales and $4.3 million in SG&A expenses.
During the three and nine month periods ended September 29, 2006, the Company recorded pre-tax
restructuring charges of $6.4 million and $8.1 million, respectively, related to restructuring the
former Inamed operations. For the three month period ended September 29, 2006, the Company recorded
$5.1 million of integration and transition costs associated with the Inamed integration, consisting
of $0.2 million in cost of sales and $4.9 million in SG&A expenses. For the nine month period ended
September 29, 2006, the Company recorded $15.5 million of integration and transition costs
associated with the Inamed integration, consisting of $0.7 million in cost of sales, $14.6 million
in SG&A expenses and $0.2 million in R&D expenses. During the three month period ended September
29, 2006, the Company also paid $0.8 million for income tax costs related to intercompany transfers
of trade businesses and net assets, which the Company included in its provision for income taxes.
The following table presents the cumulative restructuring activities related to the Inamed
operations through September 28, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
Contract and Lease |
|
|
|
|
Severance |
|
Termination Costs |
|
Total |
|
|
(in millions) |
Net charge during 2006 |
|
$ |
6.1 |
|
|
$ |
7.4 |
|
|
$ |
13.5 |
|
Spending |
|
|
(2.1 |
) |
|
|
(2.5 |
) |
|
|
(4.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
4.0 |
|
|
|
4.9 |
|
|
|
8.9 |
|
Net charge during the nine month period ended September 28, 2007 |
|
|
3.4 |
|
|
|
6.5 |
|
|
|
9.9 |
|
Spending |
|
|
(4.1 |
) |
|
|
(9.1 |
) |
|
|
(13.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 28, 2007 (included in Other accrued expenses) |
|
$ |
3.3 |
|
|
$ |
2.3 |
|
|
$ |
5.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring and Streamlining of European Operations
Effective January 2005, the Companys Board of Directors approved the initiation and
implementation of a restructuring of certain activities related to the Companys European
operations to optimize operations, improve resource allocation and create a scalable, lower cost
and more efficient operating model for the Companys European R&D and commercial activities.
Specifically, the restructuring involved moving key European R&D and select commercial functions
from the Companys Mougins, France and other European locations to the Companys Irvine,
California, Marlow, United Kingdom and Dublin, Ireland facilities and streamlining functions in the
Companys European management services group. The workforce reduction began in the first quarter of
2005 and was substantially completed by the close of the second quarter of 2006.
As of December 31, 2006, the Company substantially completed all activities related to the
restructuring and streamlining of its European operations. As of December 31, 2006, the Company
recorded cumulative pre-tax restructuring charges of $37.5 million, primarily related to severance,
relocation and one-time termination benefits, payments to public employment and training programs,
contract termination costs and capital and other asset-related expenses. During the nine month
period ended September 28, 2007, the Company recorded an additional $1.0 million of restructuring
charges for an abandoned leased facility related to its European operations. During the three and
nine month periods ended September 29, 2006, the Company recorded $2.0 million and $8.1 million,
respectively, of restructuring charges related to its European operations. As of September 28,
2007, remaining accrued expenses of $6.6 million for restructuring charges related to the
restructuring and streamlining of the Companys European operations are included in Other accrued
expenses and Other liabilities in the amount of $3.1 million and $3.5 million, respectively.
15
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Additionally, as of December 31, 2006, the Company has incurred cumulative transition and
duplicate operating expenses of $11.8 million relating primarily to legal, consulting, recruiting,
information system implementation costs and taxes in connection with the European restructuring
activities. For the three month period ended September 29, 2006, the Company recorded $0.3 million
of transition and duplicate operating expenses, consisting of $0.2 million in SG&A expenses and
$0.1 million in R&D expenses. For the nine month period ended September 29, 2006, the Company
recorded $2.8 million of transition and duplicate operating expenses, consisting of $2.3 million in
SG&A expenses and $0.5 million in R&D expenses. Additionally, during the nine month period ended
September 29, 2006, the Company recorded a $3.4 million loss related to the sale of its Mougins,
France facility, which was included in SG&A expenses. There were no transition and duplicate
operating expenses related to the restructuring and streamlining of the Companys European
operations recorded in the first nine months of 2007.
Other Restructuring Activities
Included in the third quarter and first nine months of 2007 are $0.1 million and $0.2 million,
respectively, of restructuring charges related to the Companys February 2007 EndoArt acquisition.
Included in the third quarter and first nine months of 2006 are $0.2 million and $1.3 million,
respectively, of restructuring charges related to the scheduled June 2005 termination of the
Companys manufacturing and supply agreement with Advanced Medical Optics, which the Company
spun-off in June 2002. Also included in the first nine months of 2006 is a $0.4 million
restructuring charge reversal related to the streamlining of the Companys operations in Japan.
Note 5: Intangibles and Goodwill
At September 28, 2007 and December 31, 2006, the components of amortizable and unamortizable
intangibles and goodwill and certain other related information were as follows:
Intangibles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 28, 2007 |
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
Average |
|
|
Gross |
|
Accumulated |
|
Amortization |
|
Gross |
|
Accumulated |
|
Amortization |
|
|
Amount |
|
Amortization |
|
Period |
|
Amount |
|
Amortization |
|
Period |
|
|
(in millions) |
|
(in years) |
|
(in millions) |
|
(in years) |
Amortizable Intangible Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed technology |
|
$ |
887.6 |
|
|
$ |
(88.9 |
) |
|
|
14.8 |
|
|
$ |
796.4 |
|
|
$ |
(39.9 |
) |
|
|
15.4 |
|
Customer relationships |
|
|
42.3 |
|
|
|
(20.6 |
) |
|
|
3.1 |
|
|
|
42.3 |
|
|
|
(10.3 |
) |
|
|
3.1 |
|
Licensing |
|
|
154.7 |
|
|
|
(58.6 |
) |
|
|
8.0 |
|
|
|
149.4 |
|
|
|
(44.2 |
) |
|
|
8.0 |
|
Trademarks |
|
|
28.1 |
|
|
|
(9.6 |
) |
|
|
6.4 |
|
|
|
23.5 |
|
|
|
(5.7 |
) |
|
|
6.5 |
|
Core technology |
|
|
190.8 |
|
|
|
(20.8 |
) |
|
|
15.2 |
|
|
|
142.6 |
|
|
|
(11.4 |
) |
|
|
15.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,303.5 |
|
|
|
(198.5 |
) |
|
|
13.4 |
|
|
|
1,154.2 |
|
|
|
(111.5 |
) |
|
|
13.9 |
|
|
Unamortizable Intangible Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business licenses |
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,304.4 |
|
|
$ |
(198.5 |
) |
|
|
|
|
|
$ |
1,155.1 |
|
|
$ |
(111.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed technology consists primarily of current product offerings, primarily saline and
silicone breast implants, obesity intervention products and dermal fillers acquired in connection
with the Inamed, Cornéal and EndoArt acquisitions. Customer relationship assets consist of the
estimated value of relationships with customers acquired in connection with the Inamed acquisition,
primarily in the breast implant market in the United States. Licensing assets consist primarily of
capitalized payments to third party licensors related to the achievement of regulatory approvals to
commercialize products in specified markets and up-front payments associated with royalty
obligations for products that have achieved regulatory approval for marketing. Core technology
consists of proprietary technology associated with silicone breast implants and intragastric
balloon systems acquired in connection with the Inamed acquisition, dermal filler technology
acquired in connection with the Cornéal acquisition, gastric band technology acquired in connection
with the EndoArt acquisition, and a drug delivery technology acquired in connection with the
Companys 2003 acquisition of Oculex Pharmaceuticals, Inc. The increase in developed technology,
trademarks and core technology at September 28, 2007 compared to
December 31, 2006
16
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
is primarily due to the Cornéal and EndoArt acquisitions. The increase in licensing
assets is primarily due to a milestone payment incurred in 2007 related to expected annual
Restasis® net sales.
The following table provides amortization expense by major categories of acquired amortizable
intangible assets for the three and nine month periods ended September 28, 2007 and September 29,
2006, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Developed technology |
|
$ |
16.3 |
|
|
$ |
13.3 |
|
|
$ |
48.7 |
|
|
$ |
26.6 |
|
Customer relationships |
|
|
3.4 |
|
|
|
3.5 |
|
|
|
10.2 |
|
|
|
6.9 |
|
Licensing |
|
|
4.7 |
|
|
|
4.7 |
|
|
|
14.4 |
|
|
|
13.9 |
|
Trademarks |
|
|
1.2 |
|
|
|
1.1 |
|
|
|
3.6 |
|
|
|
2.3 |
|
Core technology |
|
|
3.1 |
|
|
|
2.3 |
|
|
|
9.2 |
|
|
|
5.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
28.7 |
|
|
$ |
24.9 |
|
|
$ |
86.1 |
|
|
$ |
54.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense related to acquired intangible assets generally benefits multiple
business functions within the Company, such as the Companys ability to sell, manufacture,
research, market and distribute products, compounds and intellectual property. The amount of
amortization expense excluded from cost of sales consists primarily of amounts amortized with
respect to developed technology and licensing intangible assets.
Estimated amortization expense is $115.6 million for 2007, $114.1 million for 2008, $103.9
million for 2009, $99.7 million for 2010 and $93.2 million for 2011.
Goodwill
|
|
|
|
|
|
|
|
|
|
|
September 28, |
|
December 31, |
|
|
2007 |
|
2006 |
|
|
(in millions) |
Specialty Pharmaceuticals |
|
$ |
10.0 |
|
|
$ |
9.4 |
|
Medical Devices |
|
|
1,951.8 |
|
|
|
1,824.2 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,961.8 |
|
|
$ |
1,833.6 |
|
|
|
|
|
|
|
|
|
|
Goodwill related to the Inamed, Cornéal and EndoArt acquisitions are reflected in the Medical
Devices balance above.
Note 6: Inventories
Components of inventories were:
|
|
|
|
|
|
|
|
|
|
|
September 28, |
|
December 31, |
|
|
2007 |
|
2006 |
|
|
(in millions) |
Finished products |
|
$ |
123.7 |
|
|
$ |
107.1 |
|
Work in process |
|
|
40.5 |
|
|
|
31.2 |
|
Raw materials |
|
|
38.3 |
|
|
|
30.2 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
202.5 |
|
|
$ |
168.5 |
|
|
|
|
|
|
|
|
|
|
At September 28, 2007, approximately $12.2 million of Allergans finished goods medical device
inventories, primarily breast implants, were held on consignment at a large number of doctors
offices, clinics, and hospitals worldwide. The value and quantity at any one location is not
significant.
Note 7: Income Taxes
The provision for income taxes is determined using an estimated annual effective tax rate,
which is generally less than the U.S. federal statutory rate, primarily because of lower tax rates
in certain non-U.S. jurisdictions, R&D tax credits available in the United States and other
jurisdictions, and deductions available in the United States for
17
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
domestic production activities. The Companys effective tax rate may be subject to
fluctuations during the year as new information is obtained, which may affect the assumptions
management uses to estimate the annual effective tax rate, including factors such as the Companys
mix of pre-tax earnings in the various tax jurisdictions in which it operates, valuation allowances
against deferred tax assets, the recognition or derecognition of tax benefits related to uncertain
tax positions, utilization of R&D tax credits and changes in or the interpretation of tax laws in
jurisdictions where the Company conducts operations. The Company recognizes interest on income
taxes payable as interest expense and penalties related to income taxes payable as income tax
expense in its consolidated statements of operations. The Company recognizes deferred tax assets
and liabilities for temporary differences between the financial reporting basis and the tax basis
of its assets and liabilities along with net operating loss and credit carryforwards. The Company
records a valuation allowance against its deferred tax assets to reduce the net carrying value to
an amount that it believes is more likely than not to be realized. When the Company establishes or
reduces the valuation allowance against deferred tax assets, its provision for income taxes will
increase or decrease, respectively, in the period such determination is made.
Valuation allowances against deferred tax assets were $26.6 million and $20.8 million at
September 28, 2007 and December 31, 2006, respectively. Changes in the valuation allowances are
generally a component of the estimated annual effective tax rate. The increase in the amount of
valuation allowances at September 28, 2007 compared to December 31, 2006 is primarily due to the
EndoArt acquisition.
In the first fiscal quarter of 2007, the Company adopted FIN 48, which resulted in an increase
in total income taxes payable of $2.8 million and interest payable of $0.5 million and a decrease
in total deferred tax assets of $1.0 million and beginning retained earnings of $4.3 million. In
addition, the Company reclassified $27.0 million of net unrecognized tax benefit liabilities from
current to non-current liabilities. The Companys total unrecognized tax benefit liabilities
recorded under FIN 48 as of the date of adoption were $61.7 million, including $37.1 million of
uncertain tax positions that were previously recognized as income tax expense and $18.7 million
relating to uncertain tax positions of acquired subsidiaries that existed at the time of
acquisition. Total interest accrued on income taxes payable was $7.6 million as of the date of
adoption and no income tax penalties were recorded. There have been no material changes in the
Companys total unrecognized tax benefit liabilities as of September 28, 2007.
The Company expects that during the next 12 months it is reasonably possible that unrecognized
tax benefit liabilities related to research credits, AMT credits and transfer pricing may decrease
by approximately $25.9 million due to the settlement of a U.S. Internal Revenue Service (IRS) tax
audit.
The Company has not provided for withholding and U.S. taxes for the unremitted earnings of
certain non-U.S. subsidiaries because it has currently reinvested these earnings indefinitely in
such operations, or the U.S. taxes on such earnings will be offset by appropriate credits for
foreign income taxes paid. At December 31, 2006, the Company had approximately $725.5 million in
unremitted earnings outside the United States for which withholding and U.S. taxes were not
provided. Such earnings would become taxable upon the sale or liquidation of these non-U.S.
subsidiaries or upon the remittance of dividends. It is not practicable to estimate the amount of
the deferred tax liability on such unremitted earnings. Upon remittance, certain foreign countries
impose withholding taxes that are then available, subject to certain limitations, for use as
credits against the Companys U.S. tax liability, if any. The Company annually updates its estimate
of unremitted earnings outside the United States after the completion of each fiscal year.
Note 8: Share-Based Compensation
The Company recognizes compensation expense for all share-based awards made to employees and
directors. The fair value of share-based awards is estimated at the grant date using the
Black-Scholes option-pricing model and the portion that is ultimately expected to vest is
recognized as compensation cost over the requisite service period using the straight-line single
option method.
The determination of fair value using the Black-Scholes option-pricing model is affected by
the Companys stock price as well as assumptions regarding a number of complex and subjective
variables, including expected stock price volatility, risk-free interest rate, expected dividends
and projected employee stock option exercise behaviors. The Company currently estimates stock price
volatility based upon an equal weighting of the five year
18
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
historical average and the average implied volatility of at-the-money options traded in the
open market. The Company estimates employee stock option exercise behavior based on actual
historical exercise activity and assumptions regarding future exercise activity of unexercised,
outstanding options.
Share-based compensation expense is recognized only for those awards that are ultimately
expected to vest, and the Company has applied an estimated forfeiture rate to unvested awards for
the purpose of calculating compensation cost. These estimates will be revised, if necessary, in
future periods if actual forfeitures differ from the estimates. Changes in forfeiture estimates
impact compensation cost in the period in which the change in estimate occurs.
For the three and nine month periods ended September 28, 2007 and September 29, 2006,
share-based compensation expense was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Cost of sales |
|
$ |
1.3 |
|
|
$ |
1.0 |
|
|
$ |
4.3 |
|
|
$ |
3.4 |
|
Selling, general and administrative |
|
|
13.6 |
|
|
|
11.0 |
|
|
|
41.3 |
|
|
|
32.8 |
|
Research and development |
|
|
4.1 |
|
|
|
4.0 |
|
|
|
14.6 |
|
|
|
11.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax share-based compensation expense |
|
|
19.0 |
|
|
|
16.0 |
|
|
|
60.2 |
|
|
|
48.0 |
|
Income tax benefit |
|
|
7.6 |
|
|
|
5.7 |
|
|
|
22.3 |
|
|
|
17.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net share-based compensation expense |
|
$ |
11.4 |
|
|
$ |
10.3 |
|
|
$ |
37.9 |
|
|
$ |
30.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 28, 2007, total compensation cost related to non-vested stock options and
restricted stock not yet recognized was $128.1 million, which is expected to be recognized over the
next 48 months (32 months on a weighted-average basis). The Company has not capitalized as part of
inventory any share-based compensation costs because such costs were negligible.
Note 9: Employee Retirement and Other Benefit Plans
The Company sponsors various qualified defined benefit pension plans covering a substantial
portion of its employees. In addition, the Company sponsors two supplemental nonqualified plans
covering certain management employees and officers and one retiree health plan covering U.S.
retirees and dependents.
19
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Components of net periodic benefit cost for the three and nine month periods ended September
28, 2007 and September 29, 2006, respectively, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Postretirement |
|
|
Pension Benefits |
|
Benefits |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Service cost |
|
$ |
6.2 |
|
|
$ |
5.7 |
|
|
$ |
0.7 |
|
|
$ |
0.7 |
|
Interest cost |
|
|
7.6 |
|
|
|
6.9 |
|
|
|
0.5 |
|
|
|
0.4 |
|
Expected return on plan assets |
|
|
(9.1 |
) |
|
|
(8.0 |
) |
|
|
|
|
|
|
|
|
Amortization of prior service cost |
|
|
|
|
|
|
|
|
|
|
(0.2 |
) |
|
|
(0.1 |
) |
Plans acquired in business combination |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized net actuarial loss |
|
|
2.8 |
|
|
|
3.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
7.5 |
|
|
$ |
7.8 |
|
|
$ |
1.0 |
|
|
$ |
1.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Postretirement |
|
|
Pension Benefits |
|
Benefits |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Service cost |
|
$ |
18.8 |
|
|
$ |
17.1 |
|
|
$ |
2.1 |
|
|
$ |
2.2 |
|
Interest cost |
|
|
23.2 |
|
|
|
20.5 |
|
|
|
1.5 |
|
|
|
1.3 |
|
Expected return on plan assets |
|
|
(27.7 |
) |
|
|
(24.2 |
) |
|
|
|
|
|
|
|
|
Amortization of prior service cost |
|
|
|
|
|
|
|
|
|
|
(0.6 |
) |
|
|
(0.4 |
) |
Plans acquired in business combination |
|
|
0.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized net actuarial loss |
|
|
8.6 |
|
|
|
9.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
23.4 |
|
|
$ |
23.1 |
|
|
$ |
3.0 |
|
|
$ |
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the nine months ended September 28, 2007, the Company recorded $0.5 million in pension
expense to recognize the pension liability of two non-U.S. defined benefit pension plans acquired
in connection with the Inamed acquisition that were determined to be material during the period. In
2007, the Company expects to contribute between $20.0 million and $21.0 million to its U.S. and
non-U.S. pension plans and between $0.8 million and $0.9 million to its other postretirement plan.
Note 10: Litigation
The following supplements and amends the discussion set forth under Part I, Item 3, Legal
Proceedings in the Companys Annual Report on Form 10-K for the year ended December 31, 2006 and
Part II, Item 1, Legal Proceedings in the Companys Quarterly Report on Form 10-Q for the period
ended June 29, 2007.
In June 2001, after receiving paragraph 4 invalidity and noninfringement Hatch-Waxman Act
certifications from Apotex, Inc. indicating that Apotex had filed an Abbreviated New Drug
Application (ANDA) with the FDA for a generic form of Acular®, the Company and Roche
Palo Alto, LLC, formerly known as Syntex (U.S.A.) LLC, the holder of the Acular® patent,
filed a lawsuit entitled Syntex (U.S.A.) LLC and Allergan, Inc. v. Apotex, Inc., et al. in the
United States District Court for the Northern District of California. Following a trial, the court
entered final judgment in the Companys favor in January 2004, holding that the patent at issue is
valid, enforceable and infringed by Apotexs proposed generic drug. Following an appeal by Apotex,
the United States Court of Appeals for the Federal Circuit issued an opinion in May 2005 affirming
the lower courts ruling on inequitable conduct and claim construction and reversing and remanding
the issue of obviousness. On remand, in June 2006, the district court ruled that the defendants
ANDA infringes U.S. Patent No. 5,110,493 (the 493 patent), which is owned by Syntex and licensed
by Allergan, and that the patent is valid and enforceable. The district court further ruled that
the effective date of any approval of the defendants ANDA may not occur before the patent expires
in 2009 and that the defendants, and all persons and entities acting in concert with them, are
enjoined from making any preparations to make, sell, or offer for sale ketorolac tromethamine
ophthalmic solution 0.5% in the United States. In April 2007,
20
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
the United States Court of Appeals for the Federal Circuit affirmed the district courts
ruling in all respects and entered a Judgment Per Curiam. Apotex filed a Motion to Recall and Stay
the Mandate and a Combined Petition for Panel Rehearing and Rehearing En Banc with the United
States Court of Appeals for the Federal Circuit, which motion was denied. On July 9, 2007, Apotex
filed a Petition for Writ of Certiorari in the Supreme Court of the United States. On October 1,
2007, the Supreme Court of the United States denied Apotexs Petition for Writ of Certiorari. In
June 2001, the Company filed a separate lawsuit in Canada against Apotex similarly relating to a
generic version of Acular®. On April 27, 2007, the court set a trial date in the
Canadian lawsuit for February 2, 2009.
In May 2005, after receiving a paragraph 4 invalidity and noninfringement Hatch-Waxman Act
certification from Apotex indicating that Apotex had filed an ANDA with the FDA for a generic form
of Acular LS®, the Company and Roche Palo Alto, LLC, formerly known as Syntex (U.S.A.)
LLC, the holder of the 493 patent, filed a lawsuit entitled Roche Palo Alto LLC, formerly known
as Syntex (U.S.A.) LLC and Allergan, Inc. v. Apotex, Inc., et al. in the United States District
Court for the Northern District of California. In the complaint, the Company and Roche asked the
court to find that the 493 patent is valid, enforceable and infringed by Apotexs proposed generic
drug. Apotex filed an answer to the complaint and a counterclaim against the Company and Roche.
The Company and Roche moved for summary judgment. On September 11, 2007, the court granted the
Company and Roches motion for summary judgment. On September 26, 2007, Apotex filed a Notice of
Appeal with the United States Court of Appeals for the Federal Circuit.
In February 2007, the Company received a paragraph 4 invalidity and noninfringement
Hatch-Waxman Act certification from Exela PharmSci, Inc. indicating that Exela had filed an ANDA
with the FDA for a generic form of Alphagan® P. In the certification, Exela contends
that U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337, all of which are
assigned to the Company and are listed in the Orange Book under Alphagan® P, are invalid
and/or not infringed by the proposed Exela product. In March 2007, the Company filed a complaint
against Exela in the United States District Court for the Central District of California entitled
Allergan, Inc. v. Exela PharmSci, Inc., et al. (the Exela Action). In its complaint, the
Company alleges that Exelas proposed product infringes U.S. Patent No. 6,641,834. In April 2007,
the Company filed an amended complaint adding Paddock Laboratories, Inc. and PharmaForce, Inc. as
defendants. In April 2007, Exela filed a complaint for declaratory judgment in the United States
District Court for the Eastern District of Virginia, Alexandria Division, entitled Exela PharmSci,
Inc. v. Allergan, Inc. Exelas complaint seeks a declaration of noninfringement,
unenforceability, and/or invalidity of U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834
and 6,673,337. In June 2007, Exela filed a voluntary dismissal without prejudice in the Virginia
action.
In May 2007, the Company received a paragraph 4 invalidity and noninfringement Hatch-Waxman
Act certification from Apotex, Inc. indicating that Apotex had filed ANDAs with the FDA for generic
versions of Alphagan® P and Alphagan® P 0.1%. In the certification, Apotex
contends that U.S. Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337, all of
which are assigned to the Company and are listed in the Orange Book under Alphagan® P
and Alphagan® P 0.1%, are invalid and/or not infringed by the proposed Apotex products.
In May 2007, the Company filed a complaint against Apotex in the United States District Court for
the District of Delaware entitled Allergan, Inc. v. Apotex, Inc. and Apotex Corp. (the Apotex
Action). In its complaint, the Company alleges that Apotexs proposed products infringe U.S.
Patent Nos. 5,424,078, 6,562,873, 6,627,210, 6,641,834 and 6,673,337. In June 2007, Apotex filed
an answer, defenses, and counterclaims. In July 2007, the Company filed a response to Apotexs
counterclaims.
In May 2007, the Company filed a motion with the multidistrict litigation panel to consolidate
the Exela Action and the Apotex Action in the District of Delaware. A hearing on the Companys
motion took place on July 26, 2007. On August 20, 2007, the panel granted the Companys motion and
transferred the Exela Action to the District of Delaware for coordinated or consolidated pretrial
proceedings with the Apotex Action.
On October 18, 2007, the Company received a paragraph 4 invalidity and noninfringement
Hatch-Waxman Act certification from Apotex Corp. indicating that Apotex had filed an ANDA with the
FDA for a generic version of Zymar®. In the certification, Apotex contends that U.S.
Patent Nos. 5,880,283 and 6,333,045, both of which are licensed to the Company and are listed in
the Orange Book under Zymar®, are invalid and/or not infringed by the proposed Apotex
product.
21
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Inamed Related Litigation Matters Assumed in the Companys Acquisition of Inamed
In connection with its purchase of Collagen Aesthetics, Inc. (Collagen) in September 1999, the
Companys subsidiary, Inamed, assumed certain liabilities relating to the Trilucent breast implant,
a soybean oil-filled breast implant, which had been manufactured and distributed by various
subsidiaries of Collagen between 1995 and November 1998. In November 1998, Collagen announced the
sale of its LipoMatrix, Inc. subsidiary, manufacturer of the Trilucent implants to Sierra Medical
Technologies, Inc. Collagen retained certain liabilities for Trilucent implants sold prior to
November 1998.
In March 1999, the United Kingdom Medical Devices Agency, or MDA, announced the voluntary
suspension of marketing and withdrawal of the Trilucent implant in the United Kingdom as a
precautionary measure. The MDA did not identify any immediate hazard associated with the use of the
product but stated that it sought the withdrawal because it had received reports of local
complications in a small number of women who had received those implants, involving localized
swelling. The same notice stated that there has been no evidence of permanent injury or harm to
general health as a result of these implants. In March 1999, Collagen agreed with the U.K.
National Health Service that, for a period of time, it would perform certain product surveillance
with respect to U.K. patients implanted with the Trilucent implant and pay for explants for any
U.K. women with confirmed Trilucent implant ruptures. Subsequently, LipoMatrixs notified body in
Europe suspended the products CE Mark pending further assessment of the long-term safety of the
product. Sierra Medical has since stopped sales of the product. Subsequent to acquiring Collagen,
Inamed elected to continue the voluntary program.
In June 2000, the MDA issued a hazard notice recommending that surgeons and their patients
consider explanting the Trilucent implants even if the patient is asymptomatic. The MDA also
recommended that women avoid pregnancy and breast-feeding until the explantation as a precautionary
measure stating that although there have been reports of breast swelling and discomfort in some
women with these implants, there has been no clinical evidence of any serious health problems, so
far.
Concurrently with the June 2000 MDA announcement, Inamed announced that, through its AEI, Inc.
subsidiary, it had undertaken a comprehensive program of support and assistance for women who have
received Trilucent breast implants, under which it was covering medical expenses associated with
the removal and replacement of those implants for women in the European Community, the United
States and other countries. After consulting with competent authorities in each affected country,
Inamed terminated this support program in March 2005 in all countries other than the United States
and Canada. Notwithstanding the termination of the general program, Inamed continued to pay for
explantations and related expenses in certain cases if a patient justified her delay in having her
Trilucent implants removed on medical grounds or owing to lack of notice. Under this program,
Inamed may pay a fee to any surgeon who conducts an initial consultation with any Trilucent
implantee. Inamed also pays for the explantation procedure and related costs, and for replacement
(non-Trilucent) implants for women who are candidates for and who desire them. To date, virtually
all of the U.K. residents and more than 95% of the non-U.K. residents who have requested
explantations as a result of an initial consultation have had them performed. However, there may be
other U.K. residents and non-U.K. residents who have not come forth that may request explantation.
A Spanish consumer union has commenced a single action in the Madrid district court in which
the consumer union, Avinesa, alleges that it represents 38 Spanish Trilucent explantees. To date,
approximately 65 women in Spain have commenced individual legal proceedings in court against
Inamed, of which approximately 4 were still pending as of September 28, 2007. Prior to the issuance
of a decision by an Appellate Court sitting in Madrid in the second quarter of 2005, Inamed won
approximately one-third, and lost approximately two-thirds of its Trilucent cases in the lower
courts. The average damages awarded in cases the Company lost were approximately $18,000. In the
second quarter of 2005, in a case called Gomez Martin v. AEI, for the first time an appellate court
in Spain issued a decision holding that Trilucent breast implants were not defective within the
meaning of applicable Spanish product liability law and dismissed a 60,000 (approximately
$78,000) award issued by the lower court. While this ruling was a positive development for Inamed,
it may not be followed by other Spanish appellate courts or could be modified or found inapplicable
to other cases filed in the Madrid district. Since the ruling in Gomez Martin v. AEI, Inamed has
had greater success in winning the Spanish cases than before the ruling. In 2006, the Company
settled nine Spanish litigated matters; the average compensation paid per case was under 12,000
(approximately $16,000).
22
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
As of September 28, 2007, the Company had an accrual for future Trilucent claims, costs, and
expenses of $2.7 million.
The Company is involved in various other lawsuits and claims arising in the ordinary course of
business. These other matters are, in the opinion of management, immaterial both individually and
in the aggregate with respect to the Companys consolidated financial position, liquidity or
results of operations.
Because of the uncertainties related to the incurrence, amount and range of loss on any
pending litigation, investigation or claim, management is currently unable to predict the ultimate
outcome of any litigation, investigation or claim, determine whether a liability has been incurred
or make an estimate of the reasonably possible liability that could result from an unfavorable
outcome. The Company believes, however, that the liability, if any, resulting from the aggregate
amount of uninsured damages for any outstanding litigation, investigation or claim will not have a
material adverse effect on the Companys consolidated financial position, liquidity or results of
operations. However, an adverse ruling in a patent infringement lawsuit involving the Company could
materially affect its ability to sell one or more of its products or could result in additional
competition. In view of the unpredictable nature of such matters, the Company cannot provide any
assurances regarding the outcome of any litigation, investigation or claim to which the Company is
a party or the impact on the Company of an adverse ruling in such matters. As additional
information becomes available, the Company will assess its potential liability and revise its
estimates.
Note 11: Guarantees
The Companys Certificate of Incorporation, as amended, provides that the Company will
indemnify, to the fullest extent permitted by the Delaware General Corporation Law, each person
that is involved in or is, or is threatened to be, made a party to any action, suit or proceeding
by reason of the fact that he or she, or a person of whom he or she is the legal representative, is
or was a director or officer of the Company or was serving at the request of the Company as a
director, officer, employee or agent of another corporation or of a partnership, joint venture,
trust or other enterprise. The Company has also entered into contractual indemnity agreements with
each of its directors and executive officers pursuant to which, among other things, the Company has
agreed to indemnify such directors and executive officers against any payments they are required to
make as a result of a claim brought against such executive officer or director in such capacity,
excluding claims (i) relating to the action or inaction of a director or executive officer that
resulted in such director or executive officer gaining personal profit or advantage, (ii) for an
accounting of profits made from the purchase or sale of securities of the Company within the
meaning of Section 16(b) of the Securities Exchange Act of 1934 or similar provisions of any state
law or (iii) that are based upon or arise out of such directors or executive officers knowingly
fraudulent, deliberately dishonest or willful misconduct. The maximum potential amount of future
payments that the Company could be required to make under these indemnification provisions is
unlimited. However, the Company has purchased directors and officers liability insurance policies
intended to reduce the Companys monetary exposure and to enable the Company to recover a portion
of any future amounts paid. The Company has not previously paid any material amounts to defend
lawsuits or settle claims as a result of these indemnification provisions. As a result, the Company
believes the estimated fair value of these indemnification arrangements is minimal.
The Company customarily agrees in the ordinary course of its business to indemnification
provisions in agreements with clinical trials investigators in its drug development programs, in
sponsored research agreements with academic and not-for-profit institutions, in various comparable
agreements involving parties performing services for the Company in the ordinary course of
business, and in its real estate leases. The Company also customarily agrees to certain
indemnification provisions in its drug discovery and development collaboration agreements. With
respect to the Companys clinical trials and sponsored research agreements, these indemnification
provisions typically apply to any claim asserted against the investigator or the investigators
institution relating to personal injury or property damage, violations of law or certain breaches
of the Companys contractual obligations arising out of the research or clinical testing of the
Companys compounds or drug candidates. With respect to real estate lease agreements, the
indemnification provisions typically apply to claims asserted against the landlord relating to
personal injury or property damage caused by the Company, to violations of law by the Company or to
certain breaches of the Companys contractual obligations. The indemnification provisions appearing
in the Companys collaboration agreements are similar, but in addition provide some limited
indemnification for the
23
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
collaborator in the event of third party claims alleging infringement of intellectual property
rights. In each of the above cases, the term of these indemnification provisions generally survives
the termination of the agreement. The maximum potential amount of future payments that the Company
could be required to make under these provisions is generally unlimited. The Company has purchased
insurance policies covering personal injury, property damage and general liability intended to
reduce the Companys exposure for indemnification and to enable the Company to recover a portion of
any future amounts paid. The Company has not previously paid any material amounts to defend
lawsuits or settle claims as a result of these indemnification provisions. As a result, the Company
believes the estimated fair value of these indemnification arrangements is minimal.
Note 12: Product Warranties
The Company provides warranty programs for breast implant sales primarily in the United
States, Europe, and certain other countries. Management estimates the amount of potential future
claims from these warranty programs based on actuarial analyses. Expected future obligations are
determined based on the history of product shipments and claims and are discounted to a current
value. The liability is included in both current and long-term liabilities on the Companys
consolidated balance sheet. The U.S. programs include the ConfidencePlus and ConfidencePlus
Premier warranty programs. The ConfidencePlus program currently provides lifetime product
replacement and $1,200 of financial assistance for surgical procedures within ten years of
implantation. The ConfidencePlus Premier program, which requires a low additional enrollment fee,
currently provides lifetime product replacement, $2,400 of financial assistance for surgical
procedures within ten years of implantation and contralateral implant replacement. The enrollment
fee is deferred and recognized as income over the ten year warranty period for financial
assistance. The warranty programs in non-U.S. markets have similar terms and conditions to the U.S.
programs. The Company does not warrant any level of aesthetic result and, as required by government
regulation, makes extensive disclosures concerning the risks of the use of its products and
implantation surgery. Changes to actual warranty claims incurred and interest rates could have a
material impact on the actuarial analysis and the Companys estimated liabilities. Substantially
all of the product warranty liability arises from the U.S. warranty programs. The Company does not
currently offer any similar warranty program on any other product.
The following table provides a reconciliation of the change in estimated product warranty
liabilities through September 28, 2007:
|
|
|
|
|
|
|
(in millions) |
Balance at December 31, 2006 |
|
$ |
24.8 |
|
Provision for warranties issued during the period |
|
|
5.5 |
|
Settlements made during the period |
|
|
(3.7 |
) |
|
|
|
|
|
Balance at September 28, 2007 |
|
$ |
26.6 |
|
|
|
|
|
|
|
Current portion |
|
$ |
6.3 |
|
Non-current portion |
|
|
20.3 |
|
|
|
|
|
|
Total |
|
$ |
26.6 |
|
|
|
|
|
|
24
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Note 13: Earnings Per Share
The table below presents the computation of basic and diluted earnings (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions, except per share amounts) |
Net earnings (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from continuing operations |
|
$ |
156.0 |
|
|
$ |
106.4 |
|
|
$ |
339.8 |
|
|
$ |
(264.2 |
) |
Earnings (loss) from discontinued operations |
|
|
1.4 |
|
|
|
|
|
|
|
(0.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) |
|
$ |
157.4 |
|
|
$ |
106.4 |
|
|
$ |
339.0 |
|
|
$ |
(264.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares issued |
|
|
305.9 |
|
|
|
301.8 |
|
|
|
304.9 |
|
|
|
290.7 |
|
Net shares assumed issued using the treasury
stock method for options and non-vested equity
shares and share units outstanding during each
period based on average market price |
|
|
3.4 |
|
|
|
3.3 |
|
|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
309.3 |
|
|
|
305.1 |
|
|
|
308.3 |
|
|
|
290.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations |
|
$ |
0.51 |
|
|
$ |
0.35 |
|
|
$ |
1.11 |
|
|
$ |
(0.91 |
) |
Discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net basic earnings (loss) per share |
|
$ |
0.51 |
|
|
$ |
0.35 |
|
|
$ |
1.11 |
|
|
$ |
(0.91 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations |
|
$ |
0.50 |
|
|
$ |
0.35 |
|
|
$ |
1.10 |
|
|
$ |
(0.91 |
) |
Discontinued operations |
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net diluted earnings (loss) per share |
|
$ |
0.51 |
|
|
$ |
0.35 |
|
|
$ |
1.10 |
|
|
$ |
(0.91 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three and nine month periods ended September 28, 2007, options to purchase 3.9 million
and 7.6 million shares of common stock at exercise prices ranging from $49.94 to $64.43 and $48.07
to $64.43 per share, respectively, were outstanding, but were not included in the computation of
diluted earnings per share because the effect from the assumed exercise of these options calculated
under the treasury stock method would be anti-dilutive. There were no potentially diluted common
shares related to the Companys 1.50% Convertible Senior Notes due 2026 for the three and nine
month periods ended September 28, 2007, as the Companys average stock price for the respective
periods was less than the conversion price of the notes.
For the three month period ended September 29, 2006, options to purchase 5.1 million shares of
common stock at exercise prices ranging from $44.63 to $63.76 per share were outstanding, but were
not included in the computation of diluted earnings per share because the effect from the assumed
exercise of these options calculated under the treasury stock method would be anti-dilutive. There
were no potentially diluted common shares related to the Companys 1.50% Convertible Senior Notes
due 2026 for the three and nine month periods ended September 29, 2006, as the Companys average
stock price for the respective periods was less than the conversion price of the notes. Stock
options outstanding during the nine month period ended September 29, 2006 were not included in the
computation of diluted earnings per share because the Company incurred a loss from continuing
operations and, as a result, the impact would be antidilutive. Options to purchase 21.7 million
shares of common stock at exercise prices ranging from $6.50 to $63.76 per share were outstanding
as of September 29, 2006. Additionally, for the nine month period ended September 29, 2006, the
effect of approximately 2.2 million common shares related to the Companys Zero Coupon Convertible
Senior Notes due 2022 was not included in the computation of diluted earnings per share because the
Company incurred a loss from continuing operations and, as a result, the impact would be
antidilutive.
25
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Note 14: Comprehensive Income (Loss)
The following table summarizes the components of comprehensive income (loss) for the three and
nine month periods ended September 28, 2007 and September 29, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
(in millions) |
|
September 28, 2007 |
|
September 29, 2006 |
|
|
|
|
|
|
Tax |
|
|
|
|
|
|
|
|
|
Tax |
|
|
|
|
Before-tax |
|
(Expense) |
|
Net-of-tax |
|
Before-tax |
|
(Expense) |
|
Net-of-tax |
|
|
Amount |
|
or Benefit |
|
Amount |
|
Amount |
|
or Benefit |
|
Amount |
Foreign currency translation adjustments |
|
$ |
22.7 |
|
|
$ |
|
|
|
$ |
22.7 |
|
|
$ |
(0.7 |
) |
|
$ |
|
|
|
$ |
(0.7 |
) |
Amortization of deferred holding gains
on derivatives designated as cash flow
hedges |
|
|
(0.3 |
) |
|
|
0.1 |
|
|
|
(0.2 |
) |
|
|
(0.3 |
) |
|
|
0.1 |
|
|
|
(0.2 |
) |
Unrealized holding gain on
available-for-sale securities |
|
|
0.3 |
|
|
|
(0.1 |
) |
|
|
0.2 |
|
|
|
0.2 |
|
|
|
(0.1 |
) |
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
$ |
22.7 |
|
|
$ |
|
|
|
|
22.7 |
|
|
$ |
(0.8 |
) |
|
$ |
|
|
|
|
(0.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
157.4 |
|
|
|
|
|
|
|
|
|
|
|
106.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
$ |
180.1 |
|
|
|
|
|
|
|
|
|
|
$ |
105.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
(in millions) |
|
September 28, 2007 |
|
September 29, 2006 |
|
|
|
|
|
|
Tax |
|
|
|
|
|
|
|
|
|
Tax |
|
|
|
|
Before-tax |
|
(Expense) |
|
Net-of-tax |
|
Before-tax |
|
(Expense) |
|
Net-of-tax |
|
|
Amount |
|
or Benefit |
|
Amount |
|
Amount |
|
or Benefit |
|
Amount |
Foreign currency translation adjustments |
|
$ |
38.3 |
|
|
$ |
|
|
|
$ |
38.3 |
|
|
$ |
13.1 |
|
|
$ |
|
|
|
$ |
13.1 |
|
Deferred holding gains on derivatives
designated as cash flow hedges |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.0 |
|
|
|
(5.1 |
) |
|
|
7.9 |
|
Amortization of deferred holding gains
on derivatives designated as cash flow
hedges |
|
|
(1.0 |
) |
|
|
0.4 |
|
|
|
(0.6 |
) |
|
|
(0.6 |
) |
|
|
0.2 |
|
|
|
(0.4 |
) |
Unrealized holding gain (loss) on
available-for-sale securities |
|
|
2.7 |
|
|
|
(1.1 |
) |
|
|
1.6 |
|
|
|
(0.8 |
) |
|
|
0.3 |
|
|
|
(0.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
$ |
40.0 |
|
|
$ |
(0.7 |
) |
|
|
39.3 |
|
|
$ |
24.7 |
|
|
$ |
(4.6 |
) |
|
|
20.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings (loss) |
|
|
|
|
|
|
|
|
|
|
339.0 |
|
|
|
|
|
|
|
|
|
|
|
(264.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
$ |
378.3 |
|
|
|
|
|
|
|
|
|
|
$ |
(244.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 15: Business Segment Information
Through the first fiscal quarter of 2006, the Company operated its business on the basis of a
single reportable segment specialty pharmaceuticals. Due to the Inamed acquisition, beginning
with the second fiscal quarter of 2006, the Company operates its business on the basis of two
reportable segments specialty pharmaceuticals and medical devices. The specialty pharmaceuticals
segment produces a broad range of pharmaceutical products, including: ophthalmic products for
glaucoma therapy, ocular inflammation, infection, allergy and dry eye; skin care products for acne,
psoriasis and other prescription and over-the-counter dermatological products; and
Botox® for certain therapeutic and cosmetic indications. The medical devices segment
produces breast implants for aesthetic augmentation and reconstructive surgery; facial aesthetics
products; the LAP-BAND® System designed to treat severe and morbid obesity and the BIB
System for the treatment of obesity. The Company provides global marketing strategy teams to ensure
development and execution of a consistent marketing strategy for its products in all geographic
regions that share similar distribution channels and customers.
The Company evaluates segment performance on a revenue and operating income (loss) basis
exclusive of general and administrative expenses and other indirect costs, restructuring charges,
in-process research and development expenses, amortization of identifiable intangible assets
related to the Inamed, Cornéal and EndoArt acquisitions and certain other adjustments, which are
not allocated to the Companys segments for performance assessment by the Companys chief operating
decision maker. Other adjustments excluded from the Companys segments for performance assessment
represent income or expenses that do not reflect, according to established Company-defined
criteria, operating income or expenses associated with the Companys core business activities.
Because operating segments are generally defined by the products they design and sell, they do not
make sales to each other. The Company does not discretely allocate assets to its operating
segments, nor does the Companys chief operating decision maker evaluate operating segments using
discrete asset information.
26
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Operating Segments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Product net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
783.9 |
|
|
$ |
675.4 |
|
|
$ |
2,246.8 |
|
|
$ |
1,949.3 |
|
Medical devices |
|
|
194.8 |
|
|
|
116.3 |
|
|
|
557.1 |
|
|
|
244.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product net sales |
|
|
978.7 |
|
|
|
791.7 |
|
|
|
2,803.9 |
|
|
|
2,193.9 |
|
Other corporate and indirect revenues |
|
|
15.0 |
|
|
|
15.1 |
|
|
|
44.4 |
|
|
|
40.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
993.7 |
|
|
$ |
806.8 |
|
|
$ |
2,848.3 |
|
|
$ |
2,234.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Operating income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
277.1 |
|
|
$ |
235.6 |
|
|
$ |
751.2 |
|
|
$ |
641.9 |
|
Medical devices |
|
|
52.8 |
|
|
|
36.7 |
|
|
|
163.9 |
|
|
|
88.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total segments |
|
|
329.9 |
|
|
|
272.3 |
|
|
|
915.1 |
|
|
|
730.5 |
|
General and administrative expenses, other
indirect costs and other adjustments |
|
|
74.9 |
|
|
|
122.9 |
|
|
|
247.8 |
|
|
|
271.4 |
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
72.0 |
|
|
|
579.3 |
|
Amortization of acquired intangible assets (a) |
|
|
23.5 |
|
|
|
19.6 |
|
|
|
70.0 |
|
|
|
39.1 |
|
Restructuring charges |
|
|
11.0 |
|
|
|
8.6 |
|
|
|
24.3 |
|
|
|
17.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating income (loss) |
|
$ |
220.5 |
|
|
$ |
121.2 |
|
|
$ |
501.0 |
|
|
$ |
(176.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Represents amortization of identifiable intangible assets related to the Inamed, Cornéal and
EndoArt acquisitions. |
Product net sales for the Companys various global product portfolios are presented below. The
Companys principal markets are the United States, Europe, Latin America and Asia Pacific. The U.S.
information is presented separately as it is the Companys headquarters country. U.S. sales,
including manufacturing operations, represented 65.4% and 68.1% of the Companys total consolidated
product net sales for the three month periods ended September 28, 2007 and September 29, 2006,
respectively, and 65.7% and 67.6% of the Companys total consolidated product net sales for the
nine month periods ended September 28, 2007 and September 29, 2006, respectively.
Sales to two customers in the Companys specialty pharmaceuticals segment generated over 10%
of the Companys total consolidated product net sales. Sales to McKesson Drug Company for the three
month periods ended September 28, 2007 and September 29, 2006 were 11.0% and 11.8% of the Companys
total consolidated product net sales, respectively, and 11.2% and 13.3% of the Companys total
consolidated product net sales for the nine month periods ended September 28, 2007 and September
29, 2006, respectively. Sales to Cardinal Healthcare for the three month periods ended September
28, 2007 and September 29, 2006 were 11.0% and 13.9% of the Companys total consolidated product
net sales, respectively, and 11.2% and 13.5% of the Companys total consolidated product net sales
for the nine month periods ended September 28, 2007 and September 29, 2006, respectively. No other
country or single customer generates over 10% of total product net sales. Net sales for the Europe
region also include sales to customers in Africa and the Middle East, and net sales in the Asia
Pacific region include sales to customers in Australia and New Zealand.
Long-lived assets are assigned to geographic regions based upon management responsibility for
such items.
27
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Product Net Sales by Product Line
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Specialty Pharmaceuticals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care Pharmaceuticals |
|
$ |
457.7 |
|
|
$ |
403.4 |
|
|
$ |
1,292.1 |
|
|
$ |
1,144.5 |
|
Botox®/Neuromodulators |
|
|
296.7 |
|
|
|
237.7 |
|
|
|
872.0 |
|
|
|
709.1 |
|
Skin Care |
|
|
29.5 |
|
|
|
34.3 |
|
|
|
82.7 |
|
|
|
95.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Specialty Pharmaceuticals |
|
|
783.9 |
|
|
|
675.4 |
|
|
|
2,246.8 |
|
|
|
1,949.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Aesthetics |
|
|
69.7 |
|
|
|
54.1 |
|
|
|
217.8 |
|
|
|
118.7 |
|
Obesity Intervention |
|
|
74.0 |
|
|
|
47.1 |
|
|
|
195.9 |
|
|
|
92.9 |
|
Facial Aesthetics |
|
|
49.3 |
|
|
|
15.1 |
|
|
|
141.6 |
|
|
|
33.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core Medical Devices |
|
|
193.0 |
|
|
|
116.3 |
|
|
|
555.3 |
|
|
|
244.6 |
|
Other |
|
|
1.8 |
|
|
|
|
|
|
|
1.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medical Devices |
|
|
194.8 |
|
|
|
116.3 |
|
|
|
557.1 |
|
|
|
244.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product net sales |
|
$ |
978.7 |
|
|
$ |
791.7 |
|
|
$ |
2,803.9 |
|
|
$ |
2,193.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Geographic Information
Product Net Sales by Geographic Region
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
United States |
|
$ |
638.3 |
|
|
$ |
538.0 |
|
|
$ |
1,836.4 |
|
|
$ |
1,480.0 |
|
Europe |
|
|
190.4 |
|
|
|
137.7 |
|
|
|
559.8 |
|
|
|
399.9 |
|
Latin America |
|
|
59.4 |
|
|
|
46.4 |
|
|
|
157.8 |
|
|
|
122.0 |
|
Asia Pacific |
|
|
52.4 |
|
|
|
39.8 |
|
|
|
140.8 |
|
|
|
106.7 |
|
Other |
|
|
36.1 |
|
|
|
28.2 |
|
|
|
103.8 |
|
|
|
82.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
976.6 |
|
|
|
790.1 |
|
|
|
2,798.6 |
|
|
|
2,191.1 |
|
Manufacturing operations |
|
|
2.1 |
|
|
|
1.6 |
|
|
|
5.3 |
|
|
|
2.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product net sales |
|
$ |
978.7 |
|
|
$ |
791.7 |
|
|
$ |
2,803.9 |
|
|
$ |
2,193.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Lived Assets
|
|
|
|
|
|
|
|
|
|
|
September 28, |
|
December 31, |
|
|
2007 |
|
2006 |
|
|
(in millions) |
United States |
|
$ |
2,912.5 |
|
|
$ |
2,986.4 |
|
Europe |
|
|
296.3 |
|
|
|
16.0 |
|
Latin America |
|
|
22.1 |
|
|
|
18.7 |
|
Asia Pacific |
|
|
6.9 |
|
|
|
6.6 |
|
Other |
|
|
0.1 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3,237.9 |
|
|
|
3,027.9 |
|
Manufacturing operations |
|
|
299.9 |
|
|
|
279.8 |
|
General corporate |
|
|
214.2 |
|
|
|
215.3 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,752.0 |
|
|
$ |
3,523.0 |
|
|
|
|
|
|
|
|
|
|
The increase in long-lived assets at September 28, 2007 compared to December 31, 2006 was
primarily due to the Companys 2007 Cornéal and EndoArt acquisitions. Long-lived assets related to
the Cornéal and EndoArt acquisitions, including goodwill and intangible assets, are reflected in
the Europe balance above. Goodwill and intangible assets related to the Inamed acquisition are
reflected in the United States balance above.
Note 16: Subsequent Event
On October 16, 2007, the Company completed the acquisition of Esprit Pharma Holding Company,
Inc. (Esprit), pursuant to an Agreement and Plan of Merger, dated as of September 18, 2007 (Merger
Agreement), by and among the Company, Esmeralde Acquisition, Inc., a wholly-owned subsidiary of the Company
(Merger Sub), Esprit
28
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
and the Escrow Participants Representative named in the Merger Agreement.
Pursuant to the Merger Agreement, Merger Sub was merged with and into Esprit, with Esprit surviving
and becoming a wholly-owned subsidiary of the Company. The acquisition of Esprit will provide the
Company with a dedicated urologics product line within its specialty pharmaceuticals segment. Upon
the terms set forth in the Merger Agreement, the Company paid an aggregate of $370 million in cash,
minus Esprits debt and certain transaction compensation and expenses, for all of the outstanding
equity securities of Esprit. In addition, the Company repaid all of Esprits outstanding debt at
the date of acquisition. The acquisition consideration was all cash, funded from current cash and
equivalent balances.
As of September 28, 2007, the Company had a note receivable from Esprit in the amount of $74.8
million, which is included in Other current assets. At the date of acquisition, Esprits debt
included a note payable to the Company for $74.8 million plus accrued interest, which effectively
reduced the cash consideration paid by the Company at closing.
29
ALLERGAN, INC.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This financial review presents our operating results for the three and nine month periods
ended September 28, 2007 and September 29, 2006, and our financial condition at September 28, 2007.
Except for the historical information contained herein, the following discussion contains
forward-looking statements which are subject to known and unknown risks, uncertainties and other
factors that may cause our actual results to differ materially from those expressed or implied by
such forward-looking statements. We discuss such risks, uncertainties and other factors throughout
this report and specifically under the caption Risk Factors in Item 1A of Part II below. The
following review should be read in connection with the information presented in our unaudited
condensed consolidated financial statements and related notes for the three and nine month periods
ended September 28, 2007 and our audited consolidated financial statements and related notes for
the year ended December 31, 2006.
Critical Accounting Policies
The preparation and presentation of financial statements in conformity with U.S. generally
accepted accounting principles requires us to establish policies and to make estimates and
assumptions that affect the amounts reported in our consolidated financial statements. In our
judgment, the accounting policies, estimates and assumptions described below have the greatest
potential impact on our consolidated financial statements. Accounting assumptions and estimates are
inherently uncertain and actual results may differ materially from our estimates.
Revenue Recognition
We recognize revenue from product sales when goods are shipped and title and risk of loss
transfer to our customers. A substantial portion of our revenue is generated by the sale of
specialty pharmaceutical products (primarily eye care pharmaceuticals and skin care products) to
wholesalers within the United States, and we have a policy to attempt to maintain average U.S.
wholesaler inventory levels at an amount less than eight weeks of our net sales. A portion of our
revenue is generated from consigned inventory of breast implants maintained at physician, hospital
and clinic locations. These customers are contractually obligated to maintain a specific level of
inventory and to notify us upon the use of consigned inventory. Revenue for consigned inventory is
recognized at the time we are notified by the customer that the product has been used. Notification
is usually through the replenishing of the inventory, and we periodically review consignment
inventories to confirm the accuracy of customer reporting.
We generally offer cash discounts to customers for the early payment of receivables. Those
discounts are recorded as a reduction of revenue and accounts receivable in the same period that
the related sale is recorded. The amounts reserved for cash discounts were $2.8 million and $2.3
million at September 28, 2007 and December 31, 2006, respectively. Provisions for cash discounts
deducted from consolidated sales in the third quarter of 2007 and the third quarter of 2006 were
$8.7 million and $8.1 million, respectively. Provisions for cash discounts deducted from
consolidated sales in the first nine months of 2007 and the first nine months of 2006 were $25.2
million and $23.2 million, respectively. We permit returns of product from most product lines by
any class of customer if such product is returned in a timely manner, in good condition and from
normal distribution channels. Return policies in certain international markets and for certain
medical device products, primarily breast implants, provide for more stringent guidelines in
accordance with the terms of contractual agreements with customers. Our estimates for sales returns
are based upon the historical patterns of products returned matched against the sales from which
they originated, and managements evaluation of specific factors that may increase the risk of
product returns. The amount of allowances for sales returns recognized in our consolidated balance
sheets at September 28, 2007 and December 31, 2006 were $28.6 million and $20.1 million,
respectively. Provisions for sales returns deducted from consolidated sales were $72.5 million and
$44.4 million in the third quarter of 2007 and the third quarter of 2006, respectively. Provisions
for sales returns deducted from consolidated sales were $224.2 million and $102.4 million in the
first nine months of 2007 and the first nine months of 2006, respectively. The increase in the
allowance for sales returns at September 28, 2007 compared to December 31, 2006 and the increase in
the provision for sales returns in the third quarter and first nine months of 2007 compared to the
third quarter and first nine months of 2006 were primarily due to growth in net sales of medical
device products, primarily breast implants, which generally
have a significantly higher rate of return than specialty pharmaceutical products. Historical
allowances for cash discounts and product returns have been within the amounts reserved or accrued.
30
We participate in various managed care sales rebate and other incentive programs, the largest
of which relates to Medicaid and Medicare. Sales rebate and other incentive programs also include
chargebacks, which are contractual discounts given primarily to federal government agencies, health
maintenance organizations, pharmacy benefits managers and group purchasing organizations. Sales
rebates and incentive accruals reduce revenue in the same period that the related sale is recorded
and are included in Other accrued expenses in our consolidated balance sheets. The amounts
accrued for sales rebates and other incentive programs at September 28, 2007 and December 31, 2006
were $71.0 million and $71.2 million, respectively. Provisions for sales rebates and other
incentive programs deducted from consolidated sales were $52.0 million and $160.1 million in the
third quarter and first nine months of 2007, respectively. Provisions for sales rebates and other
incentive programs deducted from consolidated sales were $38.9 million and $132.0 million in the
third quarter and first nine months of 2006, respectively. The increase in the provisions for sales
rebates and other incentive programs in the third quarter and first nine months of 2007 compared to
the third quarter and first nine months of 2006 is primarily due to an increase in U.S. specialty
pharmaceutical sales, principally eye care pharmaceutical products, which are subject to such
rebate and incentive programs. In addition, an increase in our published list prices in the United
States for pharmaceutical products, which occurred for several of our products early in each of
2007 and 2006, generally results in higher provisions for sales rebates and other incentive
programs deducted from consolidated sales.
Our procedures for estimating amounts accrued for sales rebates and other incentive programs
at the end of any period are based on available quantitative data and are supplemented by
managements judgment with respect to many factors, including but not limited to, current market
dynamics, changes in contract terms, changes in sales trends, an evaluation of current laws and
regulations and product pricing. Quantitatively, we use historical sales, product utilization and
rebate data and apply forecasting techniques in order to estimate our liability amounts.
Qualitatively, managements judgment is applied to these items to modify, if appropriate, the
estimated liability amounts. There are inherent risks in this process. For example, customers may
not achieve assumed utilization levels; customers may misreport their utilization to us; and actual
movements of the U.S. Consumer Price Index Urban (CPI-U), which affect our rebate programs with
U.S. federal and state government agencies, may differ from those estimated. On a quarterly basis,
adjustments to our estimated liabilities for sales rebates and other incentive programs related to
sales made in prior periods have not been material and have generally been less than 0.5% of
consolidated product net sales. An adjustment to our estimated liabilities of 0.5% of consolidated
product net sales on a quarterly basis would result in an increase or decrease to net sales and
earnings before income taxes of approximately $4.0 million to $5.0 million. The sensitivity of our
estimates can vary by program and type of customer. Additionally, there is a significant time lag
between the date we determine the estimated liability and when we actually pay the liability. Due
to this time lag, we record adjustments to our estimated liabilities over several periods, which
can result in a net increase to earnings or a net decrease to earnings in those periods. Material
differences may result in the amount of revenue we recognize from product sales if the actual
amount of rebates and incentives differ materially from the amounts estimated by management.
We recognize license fees, royalties and reimbursement income for services provided as other
revenues based on the facts and circumstances of each contractual agreement. In general, we
recognize income upon the signing of a contractual agreement that grants rights to products or
technology to a third party if we have no further obligation to provide products or services to the
third party after entering into the contract. We defer income under contractual agreements when we
have further obligations indicating that a separate earnings process has not been completed.
Pensions
We sponsor various pension plans in the United States and abroad in accordance with local laws
and regulations. Our U.S. pension plans account for a large majority of our aggregate pension
plans net periodic benefit costs and projected benefit obligations. In connection with these
plans, we use certain actuarial assumptions to determine the plans net periodic benefit costs and
projected benefit obligations, the most significant of which are the expected long-term rate of
return on assets and the discount rate.
Our assumption for the weighted average expected long-term rate of return on assets in our
U.S. pension plans for determining the net periodic benefit cost is 8.25% for 2007, which is the
same rate used for 2006. Our
assumptions for the weighted average expected long-term rate of return on assets in our
non-U.S. pension plans were 6.43% and 6.19% for 2007 and 2006, respectively. We determine, based
upon recommendations from our pension plans investment advisors, the expected rate of return using
a building block approach that considers diversification
31
and rebalancing for a long-term portfolio
of invested assets. Our investment advisors study historical market returns and preserve long-term
historical relationships between equities and fixed income in a manner consistent with the
widely-accepted capital market principle that assets with higher volatility generate a greater
return over the long run. They also evaluate market factors such as inflation and interest rates
before long-term capital market assumptions are determined. The expected rate of return is applied
to the market-related value of plan assets. Market conditions and other factors can vary over time
and could significantly affect our estimates of the weighted average expected long-term rate of
return on our plan assets. As a sensitivity measure, the effect of a 0.25% decline in our rate of
return on assets assumptions for our U.S. and non-U.S. pension plans would increase our expected
2007 pre-tax pension benefit cost by approximately $1.2 million.
The weighted average discount rates used to calculate our U.S. and non-U.S. pension benefit
obligations at December 31, 2006 and our net periodic benefit costs for 2007 were 5.90% and 4.65%,
respectively. The discount rates used to calculate our U.S. and non-U.S. net periodic benefit costs
for 2006 were 5.60% and 4.24%, respectively. We determine the discount rate largely based upon an
index of high-quality fixed income investments (for our U.S. plans, we use the U.S. Moodys Aa
Corporate Long Bond Index and for our non-U.S. plans, we use the iBoxx £ Corporate AA 10+ Year
Index and the iBoxx £ Corporate AA 15+ Year Index) and, for our U.S. plans, a constructed
hypothetical portfolio of high quality fixed income investments with maturities that mirror the
pension benefit obligations at the plans measurement date. Market conditions and other factors can
vary over time and could significantly affect our estimates for the discount rates used to
calculate our pension benefit obligations and net periodic pension benefit costs for future years.
As a sensitivity measure, the effect of a 0.25% decline in the discount rate assumption for our U.S
and non-U.S. pension plans would increase our expected 2007 pre-tax pension benefit costs by
approximately $3.7 million and increase our pension plans projected benefit obligations at
December 31, 2006 by approximately $27.0 million.
Share-Based Compensation
We recognize compensation expense for all share-based awards made to employees and directors.
The fair value of share-based awards is estimated at the grant date using the Black-Scholes
option-pricing model and the portion that is ultimately expected to vest is recognized as
compensation cost over the requisite service period using the straight-line single option method.
The determination of fair value using the Black-Scholes option-pricing model is affected by
our stock price as well as assumptions regarding a number of complex and subjective variables,
including expected stock price volatility, risk-free interest rate, expected dividends and
projected employee stock option exercise behaviors. We currently estimate stock price volatility
based upon an equal weighting of the five year historical average and the average implied
volatility of at-the-money options traded in the open market. We estimate employee stock option
exercise behavior based on actual historical exercise activity and assumptions regarding future
exercise activity of unexercised, outstanding options.
Share-based compensation expense is recognized only for those awards that are ultimately
expected to vest, and we have applied an estimated forfeiture rate to unvested awards for the
purpose of calculating compensation cost. These estimates will be revised, if necessary, in future
periods if actual forfeitures differ from the estimates. Changes in forfeiture estimates impact
compensation cost in the period in which the change in estimate occurs.
Income Taxes
The provision for income taxes is determined using an estimated annual effective tax rate,
which is generally less than the U.S. federal statutory rate, primarily because of lower tax rates
in certain non-U.S. jurisdictions, research and development, or R&D, tax credits available in the
United States and other jurisdictions, and deductions available in the United States for domestic
production activities. Our effective tax rate may be subject to fluctuations during the year as new
information is obtained, which may affect the assumptions we use to estimate our annual effective
tax rate, including factors such as our mix of pre-tax earnings in the various tax jurisdictions in
which we operate,
valuation allowances against deferred tax assets, the recognition or derecognition of tax
benefits related to uncertain tax positions, utilization of R&D tax credits and changes in or the
interpretation of tax laws in jurisdictions where we conduct business. We recognize deferred tax
assets and liabilities for temporary differences between the financial reporting basis and the tax
basis of our assets and liabilities along with net operating loss and tax credit
32
carryovers. We
record a valuation allowance against our deferred tax assets to reduce the net carrying value to an
amount that we believe is more likely than not to be realized. When we establish or reduce the
valuation allowance against our deferred tax assets, our provision for income taxes will increase
or decrease, respectively, in the period such determination is made.
Valuation allowances against our deferred tax assets were $26.6 million and $20.8 million at
September 28, 2007 and December 31, 2006, respectively. Changes in the valuation allowances are
recognized in the provision for income taxes as incurred and are generally included as a component
of the estimated annual effective tax rate. The increase in the amount of valuation allowances at
September 28, 2007 compared to December 31, 2006 is primarily due to our February 2007 acquisition
of EndoArt SA, or EndoArt. Material differences in the estimated amount of valuation allowances may
result in an increase or decrease in the provision for income taxes if the actual amounts for
valuation allowances required against deferred tax assets differ from the amounts we estimate.
We have not provided for withholding and U.S. taxes for the unremitted earnings of certain
non-U.S. subsidiaries because we have currently reinvested these earnings indefinitely in these
foreign operations. At December 31, 2006, we had approximately $725.5 million in unremitted
earnings outside the United States for which withholding and U.S. taxes were not provided. Income
tax expense would be incurred if these funds were remitted to the United States. It is not
practicable to estimate the amount of the deferred tax liability on such unremitted earnings. Upon
remittance, certain foreign countries impose withholding taxes that are then available, subject to
certain limitations, for use as credits against our U.S. tax liability, if any. We annually update
our estimate of unremitted earnings outside the United States after the completion of each fiscal
year.
In the first quarter of 2007, we adopted FASB Interpretation No. 48, Accounting for
Uncertainty in Income Taxes An Interpretation of FASB Statement No. 109 (FIN 48), which
prescribes a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return.
Historically, our policy has been to account for uncertainty in income taxes in accordance with the
provisions of Statement of Financial Accounting Standards No. 5, Accounting for Contingencies,
which considered whether the tax benefit from an uncertain tax position was probable of being
sustained. Under FIN 48, the tax benefit from uncertain tax positions may be recognized only if it
is more likely than not that the tax position will be sustained, based solely on its technical
merits, with the taxing authority having full knowledge of all relevant information. After initial
adoption of FIN 48, we recognize deferred tax assets and liabilities for temporary differences
between the financial reporting basis and the tax basis of our assets and liabilities along with
net operating loss and tax credit carryovers only for tax positions that meet the more likely than
not recognition criteria. Additionally, we record the recognition and derecognition of tax benefits
from uncertain tax positions as discrete tax adjustments in the first interim period that the more
likely than not threshold is met. Due to the inherit risks in the estimates and assumptions used in
determining the sustainability of our tax positions and in the measurement of the related tax, our
provision for income taxes and our effective tax rate may vary significantly from our estimates and
from amounts reported in future or prior periods. We discuss this change in accounting principle
and its effect on our consolidated financial statements in Note 7, Income Taxes, in the financial
statements under Item 1(D) of Part I of this report.
Purchase Price Allocation
The purchase price allocation for acquisitions requires extensive use of accounting estimates
and judgments to allocate the purchase price to the identifiable tangible and intangible assets
acquired, including in-process research and development, and liabilities assumed based on their
respective fair values. Additionally, we must determine whether an acquired entity is considered to
be a business or a set of net assets, because a portion of the purchase price can only be allocated
to goodwill in a business combination.
On January 2, 2007, we acquired Groupe Cornéal Laboratoires, or Cornéal, for an aggregate
purchase price of approximately $209.1 million, net of cash acquired. On February 22, 2007, we
acquired EndoArt for an aggregate
purchase price of approximately $97.1 million, net of cash acquired. The purchase prices for
the acquisitions were allocated to tangible and intangible assets acquired and liabilities assumed
based on their estimated fair values at the acquisition dates. We engaged an independent
third-party valuation firm to assist us in determining the estimated fair values of in-process
research and development, identifiable intangible assets and certain tangible assets. Such a
valuation requires significant estimates and assumptions, including but not limited to, determining
the timing and
33
estimated costs to complete the in-process projects, projecting regulatory
approvals, estimating future cash flows, and developing appropriate discount rates. We believe the
estimated fair values assigned to the assets acquired and liabilities assumed are based on
reasonable assumptions. However, the fair value estimates for the purchase price allocations may
change during the allowable allocation period, which is up to one year from the acquisition dates,
if additional information becomes available.
Discontinued Operations
On July 2, 2007, we completed the sale of the ophthalmic surgical device business that we
acquired as a part of the Cornéal acquisition in January 2007, for net cash proceeds of $29.6
million. The net assets of the disposed business consisted of current assets of $22.9 million,
non-current assets of $10.0 million and current liabilities of $4.2 million. In conjunction with
the sale, we recognized income tax expense of $0.9 million, resulting in no net gain or loss on the
disposal of the business.
The following amounts related to the ophthalmic surgical device business have been segregated
from continuing operations and reported as discontinued operations through the date of disposition.
We did not account for our ophthalmic surgical device business as a separate legal entity.
Therefore, the following selected financial data for the discontinued operations is presented for
informational purposes only and does not necessarily reflect what the net sales or earnings would
have been had the business operated as a stand-alone entity. The financial information for the
discontinued operations includes allocations of certain expenses to the ophthalmic surgical device
business. These amounts have been allocated to the discontinued operations on the basis that is
considered by management to reflect most fairly or reasonably the utilization of the services
provided to, or the benefit obtained by, the ophthalmic surgical device business.
The following table sets forth, for the periods indicated, selected financial data of the
discontinued operations. There were no comparable amounts for the corresponding periods in 2006.
Selected Financial Data for Discontinued Operations
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 28, |
|
|
2007 |
|
2007 |
|
|
(in millions) |
Net sales |
|
$ |
|
|
|
$ |
20.0 |
|
|
|
|
|
|
|
|
|
|
Earnings (loss) from discontinued operations
before income taxes |
|
$ |
2.2 |
|
|
$ |
(1.2 |
) |
Net earnings (loss) from discontinued operations |
|
$ |
1.4 |
|
|
$ |
(0.8 |
) |
The earnings from discontinued operations before income taxes of $2.2 million in the three
month period ended September 28, 2007 primarily relate to an adjustment to the estimated fair value
of ophthalmic surgical inventory associated with the Cornéal acquisition.
Continuing Operations
Headquartered in Irvine, California, we are a technology-driven, global health care company
that discovers, develops and commercializes specialty pharmaceutical and medical device products
for the ophthalmic, neurological, facial aesthetics, medical dermatological, breast aesthetics,
obesity intervention, urologics and other specialty markets. We are a pioneer in specialty
pharmaceutical research, targeting products and technologies related to specific disease areas such
as glaucoma, retinal disease, dry eye, psoriasis, acne and movement disorders. Additionally, we
discover, develop and market medical devices, aesthetic-related pharmaceuticals, and
over-the-counter products. Within these areas, we are an innovative leader in saline and silicone
gel-filled breast implants,
dermal facial fillers and obesity intervention products, therapeutic and other prescription
products, and to a limited degree, over-the-counter products that are sold in more than 100
countries around the world. We employ approximately 7,500 persons around the world. Our principal
markets are the United States, Europe, Latin America and Asia Pacific.
34
Results of Continuing Operations
Through the first fiscal quarter of 2006, we operated our business on the basis of a single
reportable segment specialty pharmaceuticals. Due to the Inamed acquisition, beginning in the
second fiscal quarter of 2006, we operate our business on the basis of two reportable segments
specialty pharmaceuticals and medical devices. The specialty pharmaceuticals segment produces a
broad range of pharmaceutical products, including: ophthalmic products for glaucoma therapy, ocular
inflammation, infection, allergy and dry eye; skin care products for acne, psoriasis and other
prescription and over-the-counter dermatological products; and Botox® for certain
therapeutic and aesthetic indications. The medical devices segment produces breast implants for
aesthetic augmentation and reconstructive surgery; facial aesthetics products; the
LAP-BAND® System designed to treat severe and morbid obesity and the BIB System for the
treatment of obesity. We provide global marketing strategy teams to coordinate the development and
execution of a consistent marketing strategy for our products in all geographic regions that share
similar distribution channels and customers.
Management evaluates our business segments and various global product portfolios on a revenue
basis, which is presented below. We also report sales performance using the non-GAAP financial
measure of constant currency sales. Constant currency sales represent current period reported
sales, adjusted for the translation effect of changes in average foreign exchange rates between the
current period and the corresponding period in the prior year. We calculate the currency effect by
comparing adjusted current period reported sales, calculated using the monthly average foreign
exchange rates for the corresponding period in the prior year, to the actual current period
reported sales. We routinely evaluate our net sales performance at constant currency so that sales
results can be viewed without the impact of changing foreign currency exchange rates, thereby
facilitating period-to-period comparisons of our sales. Generally, when the U.S. dollar either
strengthens or weakens against other currencies, the growth at constant currency rates will be
higher or lower, respectively, than growth reported at actual exchange rates.
35
The following table compares net sales by product line within each reportable segment and
certain selected pharmaceutical products for the three and nine month periods ended September 28,
2007 and September 29, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
September 28, |
|
September 29, |
|
Change in Product Net Sales |
|
Percent Change in Product Net Sales |
(in
millions) |
|
2007 |
|
2006 |
|
Total |
|
Performance |
|
Currency |
|
Total |
|
Performance |
|
Currency |
Net Sales by Product Line: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Pharmaceuticals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care Pharmaceuticals |
|
$ |
457.7 |
|
|
$ |
403.4 |
|
|
$ |
54.3 |
|
|
$ |
42.9 |
|
|
$ |
11.4 |
|
|
|
13.5 |
% |
|
|
10.6 |
% |
|
|
2.9 |
% |
Botox/Neuromodulator |
|
|
296.7 |
|
|
|
237.7 |
|
|
|
59.0 |
|
|
|
52.4 |
|
|
|
6.6 |
|
|
|
24.8 |
% |
|
|
22.0 |
% |
|
|
2.8 |
% |
Skin Care |
|
|
29.5 |
|
|
|
34.3 |
|
|
|
(4.8 |
) |
|
|
(4.8 |
) |
|
|
|
|
|
|
(14.0 |
)% |
|
|
(14.0 |
)% |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Specialty Pharmaceuticals |
|
|
783.9 |
|
|
|
675.4 |
|
|
|
108.5 |
|
|
|
90.5 |
|
|
|
18.0 |
|
|
|
16.1 |
% |
|
|
13.4 |
% |
|
|
2.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Aesthetics |
|
|
69.7 |
|
|
|
54.1 |
|
|
|
15.6 |
|
|
|
13.5 |
|
|
|
2.1 |
|
|
|
28.8 |
% |
|
|
25.0 |
% |
|
|
3.8 |
% |
Obesity Intervention |
|
|
74.0 |
|
|
|
47.1 |
|
|
|
26.9 |
|
|
|
25.8 |
|
|
|
1.1 |
|
|
|
57.1 |
% |
|
|
54.8 |
% |
|
|
2.3 |
% |
Facial Aesthetics |
|
|
49.3 |
|
|
|
15.1 |
|
|
|
34.2 |
|
|
|
33.6 |
|
|
|
0.6 |
|
|
|
226.5 |
% |
|
|
222.5 |
% |
|
|
4.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core Medical Devices |
|
|
193.0 |
|
|
|
116.3 |
|
|
|
76.7 |
|
|
|
72.9 |
|
|
|
3.8 |
|
|
|
66.0 |
% |
|
|
62.7 |
% |
|
|
3.3 |
% |
Other |
|
|
1.8 |
|
|
|
|
|
|
|
1.8 |
|
|
|
1.8 |
|
|
|
|
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medical Devices |
|
|
194.8 |
|
|
|
116.3 |
|
|
|
78.5 |
|
|
|
74.7 |
|
|
|
3.8 |
|
|
|
67.5 |
% |
|
|
64.2 |
% |
|
|
3.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product net sales |
|
$ |
978.7 |
|
|
$ |
791.7 |
|
|
$ |
187.0 |
|
|
$ |
165.2 |
|
|
$ |
21.8 |
|
|
|
23.6 |
% |
|
|
20.9 |
% |
|
|
2.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic product net sales |
|
|
65.4 |
% |
|
|
68.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International product net sales |
|
|
34.6 |
% |
|
|
31.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Product Sales (a): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alphagan P, Alphagan and Combigan |
|
$ |
89.8 |
|
|
$ |
80.0 |
|
|
$ |
9.8 |
|
|
$ |
7.4 |
|
|
$ |
2.4 |
|
|
|
12.2 |
% |
|
|
9.3 |
% |
|
|
2.9 |
% |
Lumigan and Ganfort |
|
|
100.4 |
|
|
|
86.4 |
|
|
|
14.0 |
|
|
|
11.2 |
|
|
|
2.8 |
|
|
|
16.2 |
% |
|
|
13.0 |
% |
|
|
3.2 |
% |
Other Glaucoma |
|
|
3.9 |
|
|
|
3.4 |
|
|
|
0.5 |
|
|
|
0.2 |
|
|
|
0.3 |
|
|
|
14.8 |
% |
|
|
7.3 |
% |
|
|
7.5 |
% |
Restasis |
|
|
88.2 |
|
|
|
69.3 |
|
|
|
18.9 |
|
|
|
18.9 |
|
|
|
|
|
|
|
27.3 |
% |
|
|
27.3 |
% |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
September 28, |
|
September 29, |
|
Change in Product Net Sales |
|
Percent Change in Product Net Sales |
(in millions) |
|
2007 |
|
2006 |
|
Total |
|
Performance |
|
Currency |
|
Total |
|
Performance |
|
Currency |
Net Sales by Product Line: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Pharmaceuticals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care Pharmaceuticals |
|
$ |
1,292.1 |
|
|
$ |
1,144.5 |
|
|
$ |
147.6 |
|
|
$ |
119.6 |
|
|
$ |
28.0 |
|
|
|
12.9 |
% |
|
|
10.4 |
% |
|
|
2.5 |
% |
Botox/Neuromodulator |
|
|
872.0 |
|
|
|
709.1 |
|
|
|
162.9 |
|
|
|
146.7 |
|
|
|
16.2 |
|
|
|
23.0 |
% |
|
|
20.7 |
% |
|
|
2.3 |
% |
Skin Care |
|
|
82.7 |
|
|
|
95.7 |
|
|
|
(13.0 |
) |
|
|
(13.0 |
) |
|
|
|
|
|
|
(13.6 |
)% |
|
|
(13.6 |
)% |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Specialty Pharmaceuticals |
|
|
2,246.8 |
|
|
|
1,949.3 |
|
|
|
297.5 |
|
|
|
253.3 |
|
|
|
44.2 |
|
|
|
15.3 |
% |
|
|
13.0 |
% |
|
|
2.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Devices: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Aesthetics |
|
|
217.8 |
|
|
|
118.7 |
|
|
|
99.1 |
|
|
|
94.9 |
|
|
|
4.2 |
|
|
|
83.5 |
% |
|
|
79.9 |
% |
|
|
3.6 |
% |
Obesity Intervention |
|
|
195.9 |
|
|
|
92.9 |
|
|
|
103.0 |
|
|
|
101.0 |
|
|
|
2.0 |
|
|
|
110.9 |
% |
|
|
108.7 |
% |
|
|
2.2 |
% |
Facial Aesthetics |
|
|
141.6 |
|
|
|
33.0 |
|
|
|
108.6 |
|
|
|
107.4 |
|
|
|
1.2 |
|
|
|
329.1 |
% |
|
|
325.5 |
% |
|
|
3.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core Medical Devices |
|
|
555.3 |
|
|
|
244.6 |
|
|
|
310.7 |
|
|
|
303.3 |
|
|
|
7.4 |
|
|
|
127.0 |
% |
|
|
124.0 |
% |
|
|
3.0 |
% |
Other |
|
|
1.8 |
|
|
|
|
|
|
|
1.8 |
|
|
|
1.8 |
|
|
|
|
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medical Devices |
|
|
557.1 |
|
|
|
244.6 |
|
|
|
312.5 |
|
|
|
305.1 |
|
|
|
7.4 |
|
|
|
127.8 |
% |
|
|
124.7 |
% |
|
|
3.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product net sales |
|
$ |
2,803.9 |
|
|
$ |
2,193.9 |
|
|
$ |
610.0 |
|
|
$ |
558.4 |
|
|
$ |
51.6 |
|
|
|
27.8 |
% |
|
|
25.5 |
% |
|
|
2.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic product net sales |
|
|
65.7 |
% |
|
|
67.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International product net sales |
|
|
34.3 |
% |
|
|
32.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Product Sales (a): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alphagan P, Alphagan and Combigan |
|
$ |
244.8 |
|
|
$ |
221.2 |
|
|
$ |
23.6 |
|
|
$ |
17.5 |
|
|
$ |
6.1 |
|
|
|
10.6 |
% |
|
|
7.9 |
% |
|
|
2.7 |
% |
Lumigan and Ganfort |
|
|
284.0 |
|
|
|
241.0 |
|
|
|
43.0 |
|
|
|
35.5 |
|
|
|
7.5 |
|
|
|
17.8 |
% |
|
|
14.7 |
% |
|
|
3.1 |
% |
Other Glaucoma |
|
|
11.4 |
|
|
|
12.0 |
|
|
|
(0.6 |
) |
|
|
(1.3 |
) |
|
|
0.7 |
|
|
|
(5.0 |
)% |
|
|
(10.6 |
)% |
|
|
5.6 |
% |
Restasis |
|
|
243.9 |
|
|
|
201.0 |
|
|
|
42.9 |
|
|
|
42.9 |
|
|
|
|
|
|
|
21.4 |
% |
|
|
21.4 |
% |
|
|
|
% |
|
|
|
(a) |
|
Percentage change in selected product net sales is calculated on amounts reported to the
nearest whole dollar. |
Product Net Sales
The $187.0 million increase in product net sales in the third quarter of 2007 compared to the
third quarter of 2006 primarily resulted from an increase of $108.5 million in our specialty
pharmaceuticals product net sales and an increase of $78.5 million in our medical device product
net sales. The increase in specialty pharmaceuticals product net sales is due primarily to
increases in sales of our eye care pharmaceuticals and Botox® product lines. The
increase in medical device product net sales is due primarily to increases in sales of our breast
aesthetics, obesity intervention and facial aesthetics product lines.
Eye care pharmaceuticals sales increased in the third quarter of 2007 compared to third
quarter of 2006 primarily because of strong growth in sales of Restasis®, our
therapeutic treatment for chronic dry eye disease, an increase in sales of our glaucoma drug
Lumigan®, including strong sales growth from Ganfort®, our
Lumigan® and timolol
36
combination, which we launched in 2006 in certain European markets, an increase in product net
sales of Alphagan® P 0.1%, our most recent generation of Alphagan® for the
treatment of glaucoma that we launched in the United States in the first quarter of 2006, an
increase in sales of Combigan in Europe, Latin America, Asia and Canada, an increase in sales of
Acular LS®, our more recent non-steroidal anti-inflammatory, and growth in sales of eye
drop products, primarily Refresh® and Optive, our artificial tear recently launched in
the United States, Europe and Latin America. This increase in eye care pharmaceuticals sales was
partially offset by lower sales of Alphagan® P 0.15% due to a general decline in U.S.
wholesaler demand resulting from a decrease in promotion efforts, and lower sales of
Acular®, our older generation anti-inflammatory. We continue to believe that generic
formulations of Alphagan® may have a negative effect on future net sales of our
Alphagan® franchise. We estimate the majority of the increase in our eye care
pharmaceuticals sales was due to a shift in sales mix to a greater percentage of higher priced
products, and an overall net increase in the volume of product sold. We increased the published
list prices for certain eye care pharmaceutical products in the United States, ranging from seven
percent to nine percent, effective February 3, 2007. We increased the published U.S. list price for
Restasis® by seven percent, Lumigan® by seven percent, Alphagan® P
0.15% and Alphagan® P 0.1% by eight percent, Acular LS® by nine percent,
Elestat® by seven percent, and Zymar® by seven percent. This increase in
prices had a positive net effect on our U.S. sales for the third quarter of 2007, but the actual
net effect is difficult to determine due to the various managed care sales rebate and other
incentive programs in which we participate. Wholesaler buying patterns and the change in dollar
value of prescription product mix also affected our reported net sales dollars, although we are
unable to determine the impact of these effects. We have a policy to attempt to maintain average
U.S. wholesaler inventory levels of our specialty pharmaceutical products at an amount less than
eight weeks of our net sales. At September 28, 2007, based on available external and internal
information, we believe the amount of average U.S. wholesaler inventories of our specialty
pharmaceutical products was near the lower end of our stated policy levels.
Botox® sales increased in the third quarter of 2007 compared to the third quarter
of 2006 primarily due to strong growth in demand in the United States and in international markets
for both cosmetic and therapeutic use. Effective January 1, 2007, we increased the published price
for Botox® and Botox® Cosmetic in the United States by approximately four
percent, which may have had a positive effect on our U.S. sales growth in the third quarter of
2007, primarily related to sales of Botox® Cosmetic. In the United States, the actual
net effect from the increase in price for sales of Botox® for therapeutic use is
difficult to determine, primarily due to rebate programs with U.S. federal and state government
agencies. International Botox® sales benefited from strong sales growth for both
cosmetic and therapeutic use in Europe, Latin America and Asia Pacific. We believe our worldwide
market share for neuromodulators, including Botox®, is currently over 85%.
Skin care sales decreased in the third quarter of 2007 compared to the third quarter of 2006
primarily due to lower sales of
Tazorac®
in the United States, principally due to the impact of a negative
change in formulary positions at key managed care plans from the end of 2006, and physician
dispensed creams, including M.D. Forte® and Prevage MD in the United States, partially
offset by an increase in new product sales of Vivité, a physician dispensed line of skin care
products. Net sales of Tazorac®, Zorac® and Avage® decreased $4.3
million, or 16.3%, to $22.1 million in the third quarter of 2007, compared to $26.4 million in the
third quarter of 2006. The decrease in sales of Tazorac®, Zorac® and
Avage® resulted primarily from lower U.S. wholesaler demand, partially offset by an
increase in the published U.S. list price for these products of nine percent effective February 3,
2007.
Breast aesthetics product net sales, which consist primarily of sales of silicone gel-filled
and saline-filled breast implants and tissue expanders, increased $15.6 million, or 28.8%, to $69.7
million in the third quarter of 2007 compared to $54.1 million in the third quarter of 2006
primarily due to strong sales growth in North America, Europe, Latin America and Asia. Net sales
were positively impacted in the United States in the third quarter of 2007 compared to the third
quarter of 2006 by the November 2006 U.S. Food and Drug Administration, or FDA, and Health Canada,
approvals of certain silicone gel-filled breast implants for breast augmentation, reconstruction and
revision and the transition of the market from lower priced saline products to higher priced
silicone products in North America.
Obesity intervention product net sales, which consist primarily of sales of devices used for
minimally invasive long-term treatments of obesity such as our LAP-BAND® and
LAP-BAND
APtm Systems and BIB System, increased $26.9 million, or 57.1%, to $74.0
million in the third quarter of 2007 compared to $47.1 million in the third quarter of 2006
primarily due to strong sales growth in North America, Europe and Asia. Net sales of obesity
intervention products were also positively benefited in the third quarter of 2007 compared to the
third quarter of
37
2006 by an approximately three percent increase in the published U.S. list price for our
LAP-BAND® System effective July 2, 2007 and the introduction in the United States of a
premium priced, next generation Advanced Platform (AP) Band.
Facial aesthetics product net sales, which consist primarily of sales of hyaluronic acid-based
and collagen-based dermal fillers used to correct facial wrinkles, increased $34.2 million, or
226.5%, to $49.3 million in the third quarter of 2007 compared to $15.1 million in the third
quarter of 2006 primarily due to strong sales growth in North America, Europe and Asia Pacific. Net
sales were positively impacted in the United States in the third quarter of 2007 compared to the
third quarter of 2006 by the January 2007 launch of our FDA approved hyaluronic acid-based dermal
fillers Juvéderm Ultra and Juvéderm Ultra Plus. This increase in net sales was partially offset
by a general decline in sales of collagen-based dermal fillers due to reduced promotion efforts.
Net sales of facial aesthetic products in Europe and Asia were positively impacted in the third
quarter of 2007 compared to the third quarter of 2006 by the acquisition of Cornéal in January
2007.
Net sales of other medical devices were $1.8 million in the third quarter of 2007 and consist
of sales of ophthalmic surgical devices under a manufacturing and supply agreement. The
manufacturing and supply agreement was entered into in conjunction with the July 2007 sale of the
former Cornéal ophthalmic surgical device business, and we currently expect this agreement to be
substantially completed by the end of 2007.
Foreign currency changes increased product net sales by $21.8 million in the third quarter of
2007 compared to the third quarter of 2006, primarily due to the strengthening of the euro,
Brazilian real, Canadian dollar, Australian dollar and the British pound compared to the U.S.
dollar.
U.S. sales as a percentage of total product net sales decreased by 2.7 percentage points to
65.4% in the third quarter of 2007 compared to U.S. sales of 68.1% in the third quarter of 2006,
primarily due to an increase in international specialty pharmaceutical product net sales as a
percentage of total product net sales. The increase in the international specialty pharmaceuticals
net sales as a percentage of total product net sales was primarily due to growth in international
product net sales of Botox® and eye care pharmaceuticals, partially offset by a decrease
in U.S. skin care net sales.
The $610.0 million increase in product net sales in the first nine months of 2007 compared to
the same period in 2006 primarily resulted from an increase of $297.5 million in our specialty
pharmaceuticals product net sales and an increase of $312.5 million in our medical device product
net sales. The increase in product net sales for the first nine months of 2007 is primarily due to
the same factors discussed above with respect to the increase in product net sales in the third
quarter of 2007. In addition, net sales of eye care pharmaceuticals benefited from an increase in
net sales of Elestat®, our topical antihistamine used for the prevention of itching
associated with allergic conjunctivitis, and Zymar®, an ophthalmic anti-infective
product for the treatment of bacterial conjunctivitis, in the first nine months of 2007 compared to
the first nine months of 2006. The increase in medical device product net sales for the first nine
months of 2007 compared to the first nine months of 2006 was also positively benefited by the March
2006 Inamed and January 2007 Cornéal acquisitions.
Foreign currency changes increased product net sales by $51.6 million in the first nine months
of 2007 compared to the same period in 2006, primarily due to the strengthening of the euro,
Brazilian real, British pound, Australian dollar and the Canadian dollar compared to the U.S.
dollar.
U.S. sales as a percentage of total product net sales decreased by 1.9 percentage points to
65.7% in the first nine months of 2007 compared to U.S. sales of 67.6% in the first nine months of
2006, due primarily to an increase in total medical device net sales, which have a higher
percentage of international product net sales than our specialty pharmaceutical net sales, and an
increase in international specialty pharmaceutical product net sales as a percentage of total
specialty pharmaceutical net sales. The increase in the international percentage of specialty
pharmaceutical net sales was primarily due to growth in international product net sales of
Botox® and eye care pharmaceuticals, partially offset by a decrease in U.S. skin care
net sales.
38
Other Revenues
Other revenues decreased $0.1 million to $15.0 million in the third quarter of 2007 compared
to $15.1 million in
the third quarter of 2006. The decrease in other revenues is due to a $1.3 million decrease in
reimbursement income, primarily related to services provided in connection with a contractual
agreement for the development of Posurdex® for the ophthalmic specialty pharmaceutical
market in Japan, partially offset by an increase of approximately $1.2 million in royalty income
earned, principally from sales of Botox® in Japan and China by GlaxoSmithKline, or GSK,
under a license agreement, and other miscellaneous royalty income.
Other revenues increased $4.1 million to $44.4 million in the first nine months of 2007
compared to $40.3 million in the first nine months of 2006 primarily due to a $6.7 million increase
in royalty income earned, partially offset by a $2.6 million decrease in reimbursement income,
principally due to the same factors described above with respect to the decrease in reimbursement
income and increase in royalty income in the third quarter of 2007.
Cost of Sales
Cost of sales increased $5.8 million, or 3.5%, in the third quarter of 2007 to $173.5 million,
or 17.7% of product net sales, compared to $167.7 million, or 21.2% of product net sales, in the
third quarter of 2006. Cost of sales includes charges of $0.5 million in the third quarter of 2007
and $23.9 million in the third quarter of 2006 for purchase accounting fair-market value inventory
adjustment rollouts related to the January 2007 acquisition of Cornéal and the March 2006
acquisition of Inamed, respectively. Excluding the effect of these purchase accounting charges,
cost of sales increased $29.2 million, or 20.3%, in the third quarter of 2007 compared to the third
quarter of 2006. This increase in cost of sales, excluding the effect of purchase accounting
charges, is primarily a result of the 23.6% increase in product net sales and an increase in the
mix of medical device product net sales as a percentage of total product net sales. Our medical
device product net sales generally have a higher cost of sales percentage compared to our specialty
pharmaceutical products. Cost of sales as a percentage of product net sales in the third quarter of
2007 compared to the third quarter of 2006 also benefited from an increase in the mix of sales
related to the January 2007 launch of Juvéderm Ultra, Juvéderm Ultra Plus and the November 2006
FDA approval of certain silicone gel-filled breast implants in the United States, which generally
have lower cost of sales as a percentage of product net sales compared to our collagen-based dermal
fillers and saline-filled breast implants.
Cost of sales increased $60.2 million, or 13.9%, in the first nine months of 2007 to $493.4
million, or 17.6% of product net sales, compared to $433.2 million, or 19.7% of product net sales,
in the first nine months of 2006. Cost of sales includes charges of $0.5 million in the first nine
months of 2007 and $47.9 million in the first nine months of 2006 for purchase accounting
fair-market value inventory adjustment rollouts related to the January 2007 acquisition of Cornéal
and the March 2006 acquisition of Inamed, respectively. Excluding the effect of these purchase
accounting charges, cost of sales increased $107.6 million, or 27.9%, in the first nine months of
2007 compared to the first nine months of 2006. This increase in cost of sales, excluding the
effect of purchase accounting charges, in the first nine months of 2007 compared to the first nine
months of 2006 is primarily a result of the 27.8% increase in product net sales. Cost of sales as a
percentage of product net sales, excluding the effect of purchase accounting charges, in the first
nine months of 2007 compared to the first nine months of 2006 was negatively impacted by the
increase in medical device product net sales, which generally have a higher cost of sales
percentage compared to our specialty pharmaceutical products.
Selling, General and Administrative
Selling, general and administrative, or SG&A, expenses increased $31.6 million, or 8.7%, to
$395.6 million, or 40.4% of product net sales, in the third quarter of 2007 compared to $364.0
million, or 46.0% of product net sales, in the third quarter of 2006. The increase in SG&A expenses
in dollars primarily relates to an increase in promotion, selling and marketing expenses, partially
offset by a reduction in general and administrative expenses. Promotion expenses primarily
increased due to additional costs to promote our medical device product lines that we obtained in
the Inamed acquisition, including an increase in direct-to-consumer advertising and other
promotional costs for our LAP-BAND® System, Juvédermtm Ultra and
Juvédermtm
Ultra Plus dermal fillers, and Natrelle® silicone breast implant
products. The increase in selling and marketing expenses principally relate to personnel and
related incentive compensation costs driven by the expansion of our U.S. and European facial
aesthetics, neuroscience, breast implant and obesity intervention sales forces. General and
administrative expenses decreased in the third quarter of 2007 compared to the third quarter of
2006 primarily due to the impact of a $28.5 million contribution in the third quarter of 2006 to
The Allergan Foundation, partially offset by an increase in legal, finance, information systems and
facilities costs in the third quarter of 2007 compared to the third quarter of 2006. In the third
quarter of 2007, SG&A expenses
39
included $1.9 million of integration and transition costs related to the Inamed and Cornéal
acquisitions. In the third quarter of 2006, SG&A expenses included $4.9 million of integration and
transition costs related to the acquisition of Inamed and $0.2 million of transition and duplicate
operating expenses primarily related to the restructuring and streamlining of our European
operations.
SG&A expenses increased $239.7 million, or 24.6%, to $1,215.1 million, or 43.3% of product net
sales, in the first nine months of 2007 compared to $975.4 million, or 44.5% of product net sales,
in the first nine months of 2006. The increase in SG&A expenses in the first nine months of 2007
compared to the same period in 2006 primarily resulted from the same factors described above with
respect to the increase in SG&A expenses in the third quarter of 2007. The increase in selling and
marketing expenses in the first nine months of 2007 compared to the first nine months of 2006 was
also impacted by an increase in our U.S. and European ophthalmology sales forces. Additionally, we
did not incur any significant SG&A expenses related to our medical device product lines prior to
our acquisition of Inamed on March 23, 2006. In the first nine months of 2007, SG&A expenses also
include $11.1 million of integration and transition costs related to the Inamed and Cornéal
acquisitions, $6.4 million of expenses associated with the settlement of a patent dispute assumed
in the Inamed acquisition that related to tissue expanders and $2.3 million of expenses associated
with the settlement of a pre-existing unfavorable distribution agreement with Cornéal. In the first
nine months of 2006, SG&A expenses included a $28.5 million contribution to The Allergan
Foundation, $14.6 million of integration and transition costs related to the acquisition of Inamed
and $5.7 million of transition and duplicate operating expenses, including a loss of $3.4 million
on the sale of our Mougins, France facility, primarily related to the restructuring and
streamlining of our European operations.
Research and Development
Research and development, or R&D, expenses increased $44.0 million, or 36.5%, to $164.4
million in the third quarter of 2007, or 16.8% of product net sales, compared to $120.4 million, or
15.2% of product net sales, in the third quarter of 2006. The increase in R&D expenses primarily
resulted from higher rates of investment in our eye care pharmaceuticals and Botox®
product lines, increased spending for new pharmaceutical technologies, and the addition of
development expenses associated with our medical device products acquired in the Inamed, Cornéal
and EndoArt acquisitions. R&D spending increases in the third quarter of 2007 compared to the third
quarter of 2006 were primarily driven by an increase in clinical trial costs associated with
Posurdex®, Trivaristm, certain Botox® indications for
overactive bladder and migraine headache, and alpha agonists for the treatment of neuropathic pain,
an increase in costs related to breast implant follow-up studies, and additional spending on
obesity intervention technologies.
R&D expenses decreased $401.7 million, or 43.2%, to $528.4 million in the first nine months of
2007, or 18.8% of product net sales, compared to $930.1 million, or 42.4% of product net sales, in
the first nine months of 2006. R&D expenses for the first nine months of 2007 include a charge of
$72.0 million for in-process research and development assets acquired in the EndoArt acquisition,
and for the first nine months of 2006 include a charge of $579.3 million for in-process research
and development assets acquired in the Inamed acquisition. In-process research and development
represents an estimate of the fair value of purchased in-process technology as of the date of
acquisition that had not reached technical feasibility and had no alternative future uses in its
current state. Excluding the effect of the in-process research and development charges, R&D
expenses increased by $105.6 million, or 30.1%, to $456.4 million in the first nine months of 2007,
or 16.3% of product net sales, compared to $350.8 million, or 16.0% of product net sales in first
nine months of 2006. The increase in R&D expenses in dollars, excluding the in-process research and
development charges, was primarily a result of the same factors described above with respect to the
increase in R&D expenses in the third quarter of 2007.
Amortization of Acquired Intangible Assets
Amortization of acquired intangible assets increased $3.8 million to $28.7 million in the
third quarter of 2007, or 2.9% of product net sales, compared to $24.9 million, or 3.1% of product
net sales, in the third quarter of 2006. This increase in amortization expense is primarily due to
an increase in amortization of acquired intangible assets related to the Cornéal and EndoArt
acquisitions.
Amortization of acquired intangible assets increased $31.3 million to $86.1 million in the
first nine months of 2007, or 3.1% of product net sales, compared to $54.8 million, or 2.5% of
product net sales, in the first nine months
40
of 2006. This increase in amortization expense in dollars and as a percentage of product net
sales is primarily due to an increase in amortization of acquired intangible assets related to the
Inamed, Cornéal and EndoArt acquisitions.
Restructuring Charges, Integration Costs, and Transition and Duplicate Operating Expenses
Restructuring charges in the third quarter of 2007 were $11.0 million compared to $8.6 million
in the third quarter of 2006. Restructuring charges in the first nine months of 2007 were $24.3
million compared to $17.1 million in the first nine months of 2006. The $2.4 million increase in
restructuring charges in the third quarter of 2007 compared to the third quarter of 2006 was
primarily due to an increase in restructuring costs associated with the integration of the Cornéal
operations, partially offset by a decrease in restructuring costs associated with the integration
of the Inamed operations and the streamlining of our European operations. The $7.2 million increase
in restructuring charges in the first nine months of 2007 compared to the first nine months of 2006
was primarily due to an increase in restructuring costs associated with the integration of the
Cornéal and Inamed operations, partially offset by a decrease in restructuring costs associated
with the streamlining of our European operations.
Restructuring and Integration of Cornéal Operations
In connection with our January 2007 Cornéal acquisition, we initiated a restructuring and
integration plan to merge the Cornéal facial aesthetics business operations with our operations.
Specifically, the restructuring and integration activities involve moving key business functions to
our locations, integrating Cornéals distributor operations with our existing distribution network
and integrating Cornéals information systems with our information systems. We currently estimate
that the total pre-tax charges resulting from the restructuring and integration of the Cornéal
facial aesthetics business operations will be between $29.0 million and $37.0 million, consisting
primarily of contract termination costs, salaries, travel and consulting costs, all of which are
expected to be cash expenditures.
The foregoing estimates are based on assumptions relating to, among other things, a reduction
of approximately 19 positions, principally general and administrative positions at Cornéal
locations. Charges associated with the workforce reduction, including severance, relocation and
one-time termination benefits, and payments to public employment and training programs, are
currently expected to total approximately $5.0 million to $7.0 million. Estimated charges include
estimates for contract termination costs, including the termination of duplicative distribution
arrangements. Contract termination costs are expected to total approximately $16.0 million to $21.0
million.
We began to record costs associated with the restructuring and integration of the Cornéal
facial aesthetics business in the first quarter of 2007 and expect to continue to incur costs up
through and including the second quarter of 2008. The restructuring charges primarily consist of
employee severance, one-time termination benefits, employee relocation, termination of duplicative
distributor agreements and other costs related to the restructuring of the Cornéal operations.
During the three and nine month periods ended September 28, 2007, we recorded $11.2 million and
$13.2 million, respectively, related to the restructuring of the Cornéal operations. The
integration and transition costs primarily consist of salaries, travel, communications, recruitment
and consulting costs. During the three month period ended September 28, 2007, we recorded $1.3
million of integration and transition costs associated with the Cornéal integration, consisting of
$0.1 million in cost of sales and $1.2 million in SG&A expenses. During the nine month period ended
September 28, 2007, we recorded $6.9 million of integration and transition costs, consisting of
$0.1 million in cost of sales and $6.8 million in SG&A expenses.
The following table presents the cumulative restructuring activities related to the Cornéal
operations during the nine month period ended September 28, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
Contract Termination |
|
|
|
|
Severance |
|
Costs |
|
Total |
|
|
(in millions) |
Net charge during the nine month period ended September 28, 2007 |
|
$ |
4.9 |
|
|
$ |
8.3 |
|
|
$ |
13.2 |
|
Spending |
|
|
|
|
|
|
(2.9 |
) |
|
|
(2.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 28, 2007 (included in Other accrued expenses) |
|
$ |
4.9 |
|
|
$ |
5.4 |
|
|
$ |
10.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41
Restructuring and Integration of Inamed Operations
In connection with the March 2006 Inamed acquisition, we initiated a global restructuring and
integration plan to merge Inameds operations with our operations and to capture synergies through
the centralization of certain general and administrative and commercial functions. Specifically,
the restructuring and integration activities involve eliminating certain general and administrative
positions, moving key commercial Inamed business functions to our locations around the world,
integrating Inameds distributor operations with our existing distribution network and integrating
Inameds information systems with our information systems.
We have incurred, and anticipate that we will continue to incur, charges relating to
severance, relocation and one-time termination benefits, payments to public employment and training
programs, integration and transition costs, and contract termination costs in connection with the
Inamed restructuring. We currently estimate that the total pre-tax charges resulting from the
restructuring, including integration and transition costs, will be between $47.0 million and $57.0
million, all of which are expected to be cash expenditures. In addition to the pre-tax charges, we
expect to incur capital expenditures of approximately $15.0 million to $20.0 million, primarily
related to the integration of information systems. We also expect to pay an additional amount of
approximately $1.5 million to $2.0 million for taxes related to intercompany transfers of trade
businesses and net assets.
The foregoing estimates are based on assumptions relating to, among other things, a reduction
of approximately 60 positions, principally general and administrative positions at Inamed
locations. These workforce reduction activities began in the second quarter of 2006 and are
expected to be substantially completed by the end of 2007. Charges associated with the workforce
reduction, including severance, relocation and one-time termination benefits, and payments to
public employment and training programs, are currently expected to total approximately $8.0 million
to $10.0 million. Estimated charges include estimates for contract and lease termination costs,
including the termination of duplicative distribution arrangements. Contract and lease termination
costs are expected to total approximately $13.0 million to $17.0 million. We began to record these
costs in the second quarter of 2006 and expect to continue to incur them up through and including
the fourth quarter of 2007.
On January 30, 2007, our Board of Directors approved an additional plan to restructure and
eventually sell or close our collagen manufacturing facility in Fremont, California that we
acquired in the Inamed acquisition. This plan is the result of a reduction in anticipated future
market demand for human and bovine collagen products. In connection with the restructuring and
eventual sale or closure of the collagen manufacturing facility, we estimate that total pre-tax
charges for severance, lease termination and contract settlement costs will be between $6.0 million
and $8.0 million, all of which are expected to be cash expenditures. The foregoing estimates are
based on assumptions relating to, among other things, a reduction of approximately 69 positions,
consisting principally of manufacturing positions at our facility, that are expected to result in
estimated total employee severance costs of approximately $1.5 million to $2.0 million. Estimated
charges for contract and lease termination costs are expected to total approximately $4.5 million
to $6.0 million. We began to record these costs in the first quarter of 2007 and expect to continue
to incur them up through and including the fourth quarter of 2008. Prior to any closure or sale of
the collagen manufacturing facility, we intend to manufacture a sufficient quantity of inventories
of collagen products to meet estimated market demand through 2010.
As of September 28, 2007, we have recorded cumulative pre-tax restructuring charges of $23.4
million, cumulative pre-tax integration and transition costs of $25.1 million, and $1.6 million for
income tax costs related to intercompany transfers of trade businesses and net assets. The
restructuring charges primarily consist of employee severance, one-time termination benefits,
employee relocation, termination of duplicative distributor agreements and other costs related to
restructuring the former Inamed operations. During the three and nine month periods ended September
28, 2007, we recorded a $0.3 million restructuring charge reversal and $9.9 million of
restructuring charges, respectively. The integration and transition costs primarily consist of
salaries, travel, communications, recruitment and consulting costs. During the three month period
ended September 28, 2007, we recorded $0.8 million of integration and transition costs associated
with the Inamed integration, consisting of $0.1 million in cost of sales and $0.7 million in SG&A
expenses. During the nine month period ended September 28, 2007, we recorded $4.4 million of
integration and transition costs, consisting of $0.1 million in cost of sales and $4.3 million in
SG&A expenses.
42
During the three and nine month periods ended September 29, 2006, we recorded pre-tax
restructuring charges of $6.4 million and $8.1 million, respectively, related to restructuring the
former Inamed operations. For the three month period ended September 29, 2006, we recorded $5.1
million of integration and transition costs associated with the Inamed integration, consisting of
$0.2 million in cost of sales and $4.9 million in SG&A expenses. For the nine month period ended
September 29, 2006, we recorded $15.5 million of integration and transition costs associated with
the Inamed integration, consisting of $0.7 million in cost of sales, $14.6 million in SG&A expenses
and $0.2 million in R&D expenses. During the three month period ended September 29, 2006, we also
paid $0.8 million for income tax costs related to intercompany transfers of trade businesses and
net assets, which we included in our provision for income taxes.
The following table presents the cumulative restructuring activities related to the Inamed
operations through September 28, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
Contract and Lease |
|
|
|
|
Severance |
|
Termination Costs |
|
Total |
|
|
(in millions) |
Net charge during 2006 |
|
$ |
6.1 |
|
|
$ |
7.4 |
|
|
$ |
13.5 |
|
Spending |
|
|
(2.1 |
) |
|
|
(2.5 |
) |
|
|
(4.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
4.0 |
|
|
|
4.9 |
|
|
|
8.9 |
|
Net charge during the nine month period ended September 28, 2007 |
|
|
3.4 |
|
|
|
6.5 |
|
|
|
9.9 |
|
Spending |
|
|
(4.1 |
) |
|
|
(9.1 |
) |
|
|
(13.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 28, 2007 (included in Other accrued expenses) |
|
$ |
3.3 |
|
|
$ |
2.3 |
|
|
$ |
5.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring and Streamlining of European Operations
Effective January 2005, our Board of Directors approved the initiation and implementation of a
restructuring of certain activities related to our European operations to optimize operations,
improve resource allocation and create a scalable, lower cost and more efficient operating model
for our European R&D and commercial activities. Specifically, the restructuring involved moving key
European R&D and select commercial functions from our Mougins, France and other European locations
to our Irvine, California, Marlow, United Kingdom and Dublin, Ireland facilities and streamlining
functions in our European management services group. The workforce reduction began in the first
quarter of 2005 and was substantially completed by the close of the second quarter of 2006.
As of December 31, 2006, we substantially completed all activities related to the
restructuring and streamlining of our European operations. As of December 31, 2006, we recorded
cumulative pre-tax restructuring charges of $37.5 million, primarily related to severance,
relocation and one-time termination benefits, payments to public employment and training programs,
contract termination costs and capital and other asset-related expenses. During the first nine
months of 2007, we recorded an additional $1.0 million of restructuring charges for an abandoned
leased facility related to our European operations. During the three and nine month periods ended
September 29, 2006, we recorded $2.0 million and $8.1 million, respectively, of restructuring
charges related to our European operations. As of September 28, 2007, remaining accrued expenses of
$6.6 million for restructuring charges related to the restructuring and streamlining of our
European operations are included in Other accrued expenses and Other liabilities in the amount
of $3.1 million and $3.5 million, respectively.
Additionally, as of December 31, 2006, we have incurred cumulative transition and duplicate
operating expenses of $11.8 million relating primarily to legal, consulting, recruiting,
information system implementation costs and taxes in connection with the European restructuring
activities. For the three month period ended September 29, 2006, we recorded $0.3 million of
transition and duplicate operating expenses, consisting of $0.2 million in SG&A expenses and $0.1
million in R&D expenses. For the nine month period ended September 29, 2006, we recorded $2.8
million of transition and duplicate operating expenses, consisting of $2.3 million in SG&A expenses
and $0.5 million in R&D expenses. Additionally, during the nine month period ended September 29,
2006, we recorded a $3.4 million loss related to the sale of our Mougins, France facility, which
was included in SG&A expenses. There were no transition and duplicate operating expenses related to
the restructuring and streamlining of our European operations recorded in the first nine months of
2007.
43
Other Restructuring Activities
Included in the third quarter and first nine months of 2007 are $0.1 million and $0.2 million,
respectively, in restructuring charges related to the February 2007 EndoArt acquisition. Included
in the third quarter and first nine months of 2006 are $0.2 million and $1.3 million, respectively,
of restructuring charges related to the scheduled June 2005 termination of our manufacturing and
supply agreement with Advanced Medical Optics, which was spun-off in June 2002. Also included in
the first nine months of 2006 is a $0.4 million restructuring charge reversal related to the
streamlining of our operations in Japan.
Operating Income (Loss)
Management evaluates business segment performance on an operating income (loss) basis
exclusive of general and administrative expenses and other indirect costs, restructuring charges,
in-process research and development expenses, amortization of identifiable intangible assets
related to business acquisitions and certain other adjustments, which are not allocated to our
business segments for performance assessment by our chief operating decision maker. Other
adjustments excluded from our business segments for purposes of performance assessment represent
income or expenses that do not reflect, according to established company-defined criteria,
operating income or expenses associated with our core business activities.
General and administrative expenses, other indirect costs and other adjustments not allocated
to our business segments for purposes of performance assessment consisted of the following items:
for the third quarter of 2007, general and administrative expenses of $69.4 million, integration
and transition costs related to the Inamed and Cornéal acquisitions of $2.1 million, a purchase
accounting fair-market value inventory adjustment related to the Cornéal acquisition of $0.5
million and other net indirect costs of $2.9 million; for the third quarter of 2006, general and
administrative expenses of $64.6 million, a contribution to The Allergan Foundation of $28.5
million, a purchase accounting fair-market value inventory adjustment related to the Inamed
acquisition of $23.9 million, integration and transition costs related to the former Inamed
operations of $5.1 million, transition and duplicate operating expenses related to the
restructuring and streamlining of our operations in Europe of $0.3 million and other net indirect
costs of $0.5 million; for the first nine months of 2007, general and administrative expenses of
$213.6 million, integration and transition costs related to the Inamed and Cornéal acquisitions of
$11.3 million, $6.4 million of expenses associated with the settlement of a patent dispute, $2.3
million of expenses associated with the settlement of a pre-existing unfavorable distribution
agreement with Cornéal, a purchase accounting fair-market value inventory adjustment related to the
Cornéal acquisition of $0.5 million and other net indirect costs of $13.7 million; and for the
first nine months of 2006, general and administrative expenses of $173.2 million, a contribution to
The Allergan Foundation of $28.5 million, a purchase accounting fair-market value inventory
adjustment related to the Inamed acquisition of $47.9 million, integration and transition costs
related to the former Inamed operations of $15.5 million, transition and duplicate operating
expenses related to the restructuring and streamlining of our operations in Europe of $6.2 million
and other net indirect costs of $0.1 million.
44
The following table presents operating income for each reportable segment for the three and
nine month periods ended September 28, 2007 and September 29, 2006 and a reconciliation of our
segments operating income to consolidated operating income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 28, |
|
September 29, |
|
September 28, |
|
September 29, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
(in millions) |
|
(in millions) |
Operating income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
277.1 |
|
|
$ |
235.6 |
|
|
$ |
751.2 |
|
|
$ |
641.9 |
|
Medical devices |
|
|
52.8 |
|
|
|
36.7 |
|
|
|
163.9 |
|
|
|
88.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total segments |
|
|
329.9 |
|
|
|
272.3 |
|
|
|
915.1 |
|
|
|
730.5 |
|
General and administrative expenses,
other
indirect costs and other adjustments |
|
|
74.9 |
|
|
|
122.9 |
|
|
|
247.8 |
|
|
|
271.4 |
|
In-process research and development |
|
|
|
|
|
|
|
|
|
|
72.0 |
|
|
|
579.3 |
|
Amortization of acquired intangible assets (a) |
|
|
23.5 |
|
|
|
19.6 |
|
|
|
70.0 |
|
|
|
39.1 |
|
Restructuring charges |
|
|
11.0 |
|
|
|
8.6 |
|
|
|
24.3 |
|
|
|
17.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating income (loss) |
|
$ |
220.5 |
|
|
$ |
121.2 |
|
|
$ |
501.0 |
|
|
$ |
(176.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Represents amortization of identifiable intangible assets related to the Inamed, Cornéal and
EndoArt acquisitions. |
Our consolidated operating income in the third quarter of 2007 was $220.5 million, or 22.5% of
product net sales, compared to consolidated operating income of $121.2 million, or 15.3% of product
net sales in the third quarter of 2006. The $99.3 million increase in consolidated operating income
was due to a $187.0 million increase in product net sales, partially offset by a $0.1 million
decrease in other revenues, a $5.8 million increase in cost of sales, a $31.6 million increase in
SG&A expenses, a $44.0 million increase in R&D expenses, a $3.8 million increase in amortization of
acquired intangible assets and a $2.4 million increase in restructuring charges.
Our specialty pharmaceuticals segment operating income in the third quarter of 2007 was $277.1
million, compared to operating income of $235.6 million in the third quarter of 2006. The $41.5
million increase in specialty pharmaceuticals segment operating income was due primarily to an
increase in product net sales of our eye care pharmaceuticals and Botox® product lines,
partially offset by an increase in cost of sales, an increase in promotion, selling and marketing
expenses, primarily due to increased sales personnel costs and additional promotion and marketing
expenses to support our expanded selling efforts, and an increase in R&D expenses.
Our medical devices segment operating income in the third quarter of 2007 was $52.8 million,
compared to operating income of $36.7 million in the third quarter of 2006. The increase in our
medical devices segment operating income of $16.1 million in the third quarter of 2007 was due
primarily to an increase in product net sales, and the combined operating results of the Cornéal
and EndoArt acquisitions, partially offset by an increase in cost of sales, an increase in
promotion, selling and marketing expenses, including an increase in direct-to-consumer advertising
expenses, and an increase in R&D expenses.
Our consolidated operating income in the first nine months of 2007 was $501.0 million, or
17.9% of product net sales, compared to a consolidated operating loss of $176.4 million, or (8.0)%
of product net sales in the first nine months of 2006. The $677.4 million increase in consolidated
operating income was due to a $610.0 million increase in product net sales, a $4.1 million increase
in other revenues, and a $401.7 million decrease in R&D expenses, partially offset by a $60.2
million increase in cost of sales, a $239.7 million increase in SG&A expenses, a $31.3 million
increase in amortization of acquired intangible assets and a $7.2 million increase in restructuring
charges.
Our specialty pharmaceuticals segment operating income for the nine month period ended
September 28, 2007 was $751.2 million, compared to operating income of $641.9 million for the nine
month period ended September 29, 2006. The $109.3 million increase in specialty pharmaceuticals
segment operating income was due primarily to the same reasons discussed in the analysis of the
third quarter of 2007.
Our medical devices segment operating income for the nine month period ended September 28,
2007 was $163.9 million, compared to operating income of $88.6 million for the nine month period
ended September 29, 2006. The
45
increase in our medical devices segment operating income of $75.3 million was due to the
combined operating results of the Inamed, Cornéal and EndoArt acquisitions in 2007 compared to only
six months of operating results for the Inamed acquisition only in 2006.
Non-Operating Income and Expenses
Total net non-operating expenses in the third quarter of 2007 were $9.2 million compared to
$0.5 million in the third quarter of 2006. Interest income in the third quarter of 2007 was $18.4
million compared to interest income of $12.8 million in the third quarter of 2006. The increase in
interest income was primarily due to higher average cash equivalent balances, earning interest, of
approximately $329 million and an increase in average interest rates earned on all cash equivalent
balances earning interest of approximately 0.1% in the third quarter of 2007 compared to the third
quarter of 2006. Interest expense increased $5.6 million to $17.5 million in the third quarter of
2007 compared to $11.9 million in the third quarter of 2006 primarily due to a $4.3 million
reversal of previously accrued statutory interest expense included in the third quarter of 2006
associated with the resolution of several significant uncertain income tax audit issues. During the
third quarter of 2007, we recorded a net unrealized gain on derivative instruments of $0.4 million
compared to a net unrealized gain of $0.2 million in the third quarter of 2006. Other, net expense
was $10.5 million in the third quarter of 2007, consisting primarily of $10.3 million in net
realized losses from foreign currency transactions. Other, net expense was $1.7 million in the
third quarter of 2006, which includes net realized losses from foreign currency transactions of
$1.4 million.
Total net non-operating expenses in the first nine months of 2007 were $22.1 million compared
to $13.7 million in the first nine months of 2006. Interest income in the first nine months of 2007
was $48.6 million compared to interest income of $34.3 million in the first nine months of 2006.
The increase in interest income was primarily due to a $4.9 million reversal of previously
recognized estimated statutory interest income included in the first nine months of 2006 related to
a matter involving the recovery of previously paid state income taxes, higher average cash
equivalent balances, earning interest, of approximately $200 million and an increase in average
interest rates earned on all cash equivalent balances earning interest of approximately 0.3% in the
first nine months of 2007 compared to the same period in 2006. Interest expense increased $13.3
million to $53.5 million in the first nine months of 2007 compared to $40.2 million in the first
nine months of 2006, primarily due to an increase in average outstanding borrowings for the first
nine months of 2007 compared to the same period in 2006 and a $4.9 million reversal of previously
accrued statutory interest expense included in the first nine months of 2006 associated with the
resolution of several significant uncertain income tax audit issues, partially offset by the
write-off of unamortized debt origination fees of $4.4 million in the first nine months of 2006 due
to the redemption of our Zero Coupon Convertible Senior Notes due 2022. We incurred a substantial
increase in borrowings to fund the Inamed acquisition on March 23, 2006. During the first nine
months of 2007, we recorded a net unrealized loss on derivative instruments of $1.3 million
compared to a net unrealized loss of $1.0 million in the first nine months of 2006. We recorded a
net gain of $0.3 million on the sale of third party equity investments in the first nine months of
2006. Other, net expense was $15.9 million in the first nine months of 2007, consisting primarily
of $15.9 million in net realized losses from foreign currency transactions. Other, net expense was
$7.1 million in the first nine months of 2006, which includes $4.8 million of accrued costs for a
previously disclosed contingency involving non-income taxes in Brazil and net realized losses from
foreign currency transactions of $2.5 million.
Income Taxes
Our effective tax rate for the third quarter of 2007 was 26.2%. Included in our operating
income for the third quarter of 2007 are total integration and transition costs of $2.1 million
related to the Inamed and Cornéal acquisitions and total restructuring charges of $11.0 million. In
the third quarter of 2007, we recorded income tax benefits of $0.6 million related to the total
integration and transition costs and $3.6 million related to the total restructuring charges.
Excluding the impact of the total pre-tax charges of $13.1 million and the total net income tax
benefit of $4.2 million for the items discussed above, our adjusted effective tax rate for the
third quarter of 2007 was 26.5%. We believe the use of an adjusted effective tax rate provides a
more meaningful measure of the impact of income taxes on our results of operations because it
excludes the effect of certain items that are not included as part of our core business activities.
This allows stockholders to better determine the effective tax rate associated with our core
business activities.
46
The calculation of our adjusted effective tax rate for the third quarter of 2007 is summarized
below:
|
|
|
|
|
|
|
2007 |
|
|
(in millions) |
Earnings from continuing operations before income taxes and minority interest, as reported |
|
$ |
211.3 |
|
Total integration and transition costs |
|
|
2.1 |
|
Total restructuring charges |
|
|
11.0 |
|
|
|
|
|
|
|
|
$ |
224.4 |
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes, as reported |
|
$ |
55.3 |
|
Income tax benefit for: |
|
|
|
|
Total integration and transition costs |
|
|
0.6 |
|
Total restructuring charges |
|
|
3.6 |
|
|
|
|
|
|
|
|
$ |
59.5 |
|
|
|
|
|
|
|
|
|
|
|
Adjusted effective tax rate |
|
|
26.5 |
% |
|
|
|
|
|
Our effective tax rate for the first nine months of 2007 was 29.0%. Included in our operating
income for the first nine months of 2007 are pre-tax charges of $72.0 million for in-process
research and development acquired in the EndoArt acquisition, $2.3 million of expenses associated
with the settlement of a pre-existing unfavorable distribution agreement with Cornéal, total
integration and transition costs of $11.3 million related to the Inamed and Cornéal acquisitions,
total restructuring charges of $24.3 million and a legal settlement cost of $6.4 million. In the
first nine months of 2007, we recorded income tax benefits of $2.6 million related to the total
integration and transition costs, $6.9 million related to the total restructuring charges and $2.5
million related to the legal settlement cost. We did not record any income tax benefit for the
in-process research and development charges or the expenses associated with the settlement of the
pre-existing unfavorable distribution agreement with Cornéal. Included in the provision for income
taxes in the first nine months of 2007 is $1.6 million of tax benefit related to state income tax
refunds resulting from the settlement of tax audits. Excluding the impact of the total pre-tax
charges of $116.3 million and the total net income tax benefit of $13.6 million for the items
discussed above, our adjusted effective tax rate for the first nine months of 2007 was 25.6%.
The calculation of our adjusted effective tax rate for the first nine months of 2007 is
summarized below:
|
|
|
|
|
|
|
2007 |
|
|
(in millions) |
Earnings from continuing operations before income taxes and minority interest, as reported |
|
$ |
478.9 |
|
In-process research and development expense |
|
|
72.0 |
|
Settlement of pre-existing unfavorable distribution agreement with Cornéal |
|
|
2.3 |
|
Total integration and transition costs |
|
|
11.3 |
|
Total restructuring charges |
|
|
24.3 |
|
Legal settlement cost |
|
|
6.4 |
|
|
|
|
|
|
|
|
$ |
595.2 |
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes, as reported |
|
$ |
138.7 |
|
Income tax benefit for: |
|
|
|
|
Total integration and transition costs |
|
|
2.6 |
|
Total restructuring charges |
|
|
6.9 |
|
Legal settlement cost |
|
|
2.5 |
|
State income tax refunds |
|
|
1.6 |
|
|
|
|
|
|
|
|
$ |
152.3 |
|
|
|
|
|
|
|
|
|
|
|
Adjusted effective tax rate |
|
|
25.6 |
% |
|
|
|
|
|
47
Our effective tax rates for the third quarter and the first nine months of 2006 were 11.8% and
38.9%, respectively, our effective tax rate for the year ended December 31, 2006 was 551.3%, and
our adjusted effective tax rate for the year ended December 31, 2006 was 25.9%. Included in our
operating loss for the year ended December 31, 2006 are pre-tax charges of $579.3 million for in-process research and development
acquired in the Inamed acquisition, a $47.9 million charge to cost of sales associated with the
Inamed purchase accounting fair-market value inventory adjustment rollout, total integration,
transition and duplicate operating expenses of $26.9 million related to the Inamed acquisition and
restructuring and streamlining of our European operations, a $28.5 million contribution to The
Allergan Foundation and total restructuring charges of $22.3 million. In 2006, we recorded income
tax benefits of $15.7 million related to the Inamed purchase accounting fair-market value inventory
adjustment rollout, $9.1 million related to total integration, transition and duplicate operating
expenses, $11.3 million related to the contribution to The Allergan Foundation and $3.5 million
related to total restructuring charges. Also included in the provision for income taxes in 2006 is
a $17.2 million reduction in the provision for income taxes due to the reversal of the valuation
allowance against a deferred tax asset that we have determined is now realizable, a reduction of
$14.5 million in estimated income taxes payable primarily due to the resolution of several
significant previously uncertain income tax audit issues associated with the completion of an audit
by the U.S. Internal Revenue Service for tax years 2000 to 2002, a $2.8 million reduction in income
taxes payable previously estimated for the 2005 repatriation of foreign earnings that had been
permanently re-invested outside the United States, a beneficial change of $1.2 million for the
expected income tax benefit for previously paid state income taxes, which became recoverable due to
a favorable state court decision concluded in 2004, an unfavorable adjustment of $3.9 million for a
previously filed income tax return currently under examination and a provision for income taxes of
$1.6 million related to intercompany transfers of trade businesses and net assets associated with
the Inamed acquisition. Excluding the impact of the total pre-tax charges of $704.9 million and the
total net income tax benefits of $69.8 million for the items discussed above, our adjusted
effective tax rate for the year ended December 31, 2006 was 25.9%.
The calculation of our adjusted effective tax rate for the year ended December 31, 2006 is
summarized below:
|
|
|
|
|
|
|
2006 |
|
|
(in millions) |
Earnings from continuing operations before income taxes and minority interest, as reported |
|
$ |
(19.5 |
) |
In-process research and development expense |
|
|
579.3 |
|
Inamed fair-market value inventory rollout |
|
|
47.9 |
|
Total integration, transition and duplicate operating expenses |
|
|
26.9 |
|
Contribution to The Allergan Foundation |
|
|
28.5 |
|
Total restructuring charges |
|
|
22.3 |
|
|
|
|
|
|
|
|
$ |
685.4 |
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes, as reported |
|
$ |
107.5 |
|
Income tax (provision) benefit for: |
|
|
|
|
Inamed fair-market value inventory rollout |
|
|
15.7 |
|
Total integration, transition and duplicate operating expenses |
|
|
9.1 |
|
Contribution to The Allergan Foundation |
|
|
11.3 |
|
Total restructuring charges |
|
|
3.5 |
|
Reduction in
valuation allowance associated with a deferred tax asset |
|
|
17.2 |
|
Resolution of uncertain income tax audit issues |
|
|
14.5 |
|
Adjustment to estimated taxes on 2005 repatriation of foreign earnings |
|
|
2.8 |
|
Recovery of previously paid state income taxes |
|
|
1.2 |
|
Unfavorable adjustment for previously filed tax return currently under examination |
|
|
(3.9 |
) |
Intercompany transfers of trade businesses and net assets |
|
|
(1.6 |
) |
|
|
|
|
|
|
|
$ |
177.3 |
|
|
|
|
|
|
|
|
|
|
|
Adjusted effective tax rate |
|
|
25.9 |
% |
|
|
|
|
|
The decrease in the adjusted effective tax rate to 25.6% in the first nine months of 2007
compared to the adjusted effective tax rate for the year ended December 31, 2006 of 25.9% is
primarily due to fluctuations in the mix of earnings, including increased deductions in the United
States for interest expense, and the beneficial tax rate effect from increased deductions related
to the amortization of acquired intangible assets for the full fiscal year 2007 compared to
approximately nine months of such beneficial tax rate effect in fiscal year 2006.
48
Earnings (Loss) from Continuing Operations
Our earnings from continuing operations in the third quarter of 2007 were $156.0 million
compared to earnings from continuing operations of $106.4 million in the third quarter of 2006. The
$49.6 million increase in earnings from continuing operations was primarily the result of the
increase in operating income of $99.3 million, partially offset by the increase in net
non-operating expense of $8.7 million and the increase in the provision for income taxes of $41.0
million.
Our earnings from continuing operations in the first nine months of 2007 were $339.8 million
compared to a loss from continuing operations of $264.2 million in the first nine months of 2006.
The $604.0 million increase in earnings from continuing operations was primarily the result of the
increase in operating income of $677.4 million, partially offset by the increase in net
non-operating expense of $8.4 million and the increase in the provision for income taxes of $64.7
million.
LIQUIDITY AND CAPITAL RESOURCES
We assess our liquidity by our ability to generate cash to fund our operations. Significant
factors in the management of liquidity are: funds generated by operations; levels of accounts
receivable, inventories, accounts payable and capital expenditures; the extent of our stock
repurchase program; funds required for acquisitions; adequate credit facilities; and financial
flexibility to attract long-term capital on satisfactory terms.
Historically, we have generated cash from operations in excess of working capital
requirements. The net cash provided by continuing operations for the nine month period ended
September 28, 2007 was $577.8 million compared to cash provided of $510.7 million for the nine
month period ended September 29, 2006. The increase in net cash provided by continuing operations
of $67.1 million was primarily due to an increase in earnings, including the effect of adjusting
for non-cash items, of $138.6 million, partially offset by a net increase in cash required to fund
growth in net operating assets and liabilities and an increase in income taxes paid.
Net cash used in investing activities in the first nine months of 2007 was $459.4 million. Net
cash used in investing activities in the first nine months of 2006 was $1,422.2 million. In the
first nine months of 2007, we paid $312.9 million, net of cash acquired, for the acquisitions of
Cornéal and EndoArt. In the first nine months of 2006, we paid $1,328.6 million, net of cash
acquired, for the cash portion of the Inamed acquisition. In August 2007, we issued a note
receivable of $74.8 million to Esprit Pharma Holding Company, Inc., or Esprit. The note receivable
plus accrued interest was effectively settled as a result of our acquisition of Esprit on October
16, 2007 as discussed below. In the first nine months of 2007, we received $16.7 million from the
sale of the ophthalmic surgical device business that we acquired as a part of the Cornéal
acquisition. We invested $73.6 million in new facilities and equipment during the first nine months
of 2007 compared to $73.4 million during the same period in 2006. Additionally, in the first nine
months of 2007, we capitalized as intangible assets total milestone payments of $5.0 million
related to Restasis® and collected $8.9 million on a receivable related to the 2006 sale
of our Mougins, France facility. In the first nine months of 2006, we capitalized as intangible
assets total milestone fees of $11.0 million paid in connection with obtaining regulatory approvals
to commercialize the Juvédermtm dermal filler family of products in the United
States and Australia and collected $3.3 million primarily from the sale of our Mougins, France
facility. Net cash used in investing activities also includes $18.7 million and $13.1 million to
acquire software during the first nine months of 2007 and 2006, respectively. We currently expect
to invest between $140 million and $150 million in capital expenditures for administrative and
manufacturing facilities and other property, plant and equipment during 2007. In July 2007, our
Board of Directors approved the investment of up to $95 million for the construction of a new
office building at our main facility in Irvine, California. We currently expect to incur design
related costs for this office building in 2008, followed by major construction activities beginning
in 2009.
Net cash used in financing activities was $77.4 million in the first nine months of 2007
compared to net cash provided by financing activities of $674.5 million in the first nine months of
2006. In the first nine months of 2007, we repurchased approximately 1.1 million shares of our
common stock for $61.7 million, had net repayments of notes payable of $105.5 million and paid
$45.6 million in dividends. This use of cash was partially offset by $110.3 million received from
the sale of stock to employees and $25.1 million in excess tax benefits from share-based
compensation. In the first nine months of 2006, we borrowed $825.0 million under a bridge credit
facility entered into in connection with the transaction in order to fund part of the cash portion
of the Inamed purchase price. On
49
April 12, 2006, we completed concurrent private placements of $750 million in aggregate
principal amount of 1.50% Convertible Senior Notes due 2026, or 2026 Convertible Notes, and $800
million in aggregate principal amount of 5.75% Senior Notes due 2016, or 2016 Notes. We used part
of the proceeds from these debt issuances to repay all borrowings under the bridge credit facility.
Additionally, in the first nine months of 2006 we received $118.1 million from the sale of stock to
employees, $13.0 million upon termination of an interest rate swap contract related to the 2016
Notes and $27.9 million in excess tax benefits from share-based compensation. These amounts were
partially offset by net repayments of notes payable of $139.5 million, cash payments of $19.7
million in offering fees related to the issuance of the 2026 Convertible Notes and the 2016 Notes,
cash paid on the conversion of our Zero Coupon Convertible Senior Notes due 2022 of $521.9 million,
repurchase of approximately 5.8 million shares of our common stock for approximately $307.8 million
and $43.3 million in dividends paid to stockholders. Effective October 30, 2007, our Board of
Directors declared a quarterly cash dividend of $0.05 per share, payable on November 30, 2007 to
stockholders of record on November 9, 2007. We maintain an evergreen stock repurchase program. Our
evergreen stock repurchase program authorizes us to repurchase our common stock for the primary
purpose of funding our stock-based benefit plans. Under the stock repurchase program, we may
maintain up to 18.4 million repurchased shares in our treasury account at any one time. As of
September 28, 2007, we held approximately 0.6 million treasury shares under this program. We are
uncertain as to the level of stock repurchases, if any, to be made in the future.
Net cash used by discontinued operations was $5.4 million for the nine month period ended
September 28, 2007.
The 2026 Convertible Notes, pay interest semi-annually at a rate of 1.50% per annum and are
convertible, at the holders option, at an initial conversion rate of 15.7904 shares per $1,000
principal amount of notes. In certain circumstances the 2026 Convertible Notes may be convertible
into cash in an amount equal to the lesser of their principal amount or their conversion value. If
the conversion value of the 2026 Convertible Notes exceeds their principal amount at the time of
conversion, we will also deliver common stock or, at our election, a combination of cash and common
stock for the conversion value in excess of the principal amount. We will not be permitted to
redeem the 2026 Convertible Notes prior to April 5, 2009, will be permitted to redeem the 2026
Convertible Notes from and after April 5, 2009 to April 4, 2011 if the closing price of our common
stock reaches a specified threshold, and will be permitted to redeem the 2026 Convertible Notes at
any time on or after April 5, 2011. Holders of the 2026 Convertible Notes will also be able to
require us to redeem the 2026 Convertible Notes on April 1, 2011, April 1, 2016 and April 1, 2021
or upon a change in control of us. The 2026 Convertible Notes mature on April 1, 2026, unless
previously redeemed by us or earlier converted by the note holders.
The 2016 Notes, were sold at 99.717% of par value with an effective interest rate of 5.79%,
will pay interest semi-annually at a rate of 5.75% per annum, and are redeemable at any time at our
option, subject to a make-whole provision based on the present value of remaining interest payments
at the time of the redemption. The aggregate outstanding principal amount of the 2016 Notes will be
due and payable on April 1, 2016, unless earlier redeemed by us.
On January 31, 2007, we entered into a nine-year, two-month interest rate swap with a $300.0
million notional amount with semi-annual settlements and quarterly interest rate reset dates. The
swap receives interest at a fixed rate of 5.75% and pays interest at a variable interest rate equal
to LIBOR plus 0.368%, and effectively converts $300.0 million of our 2016 Notes to a variable
interest rate. Based on the structure of the hedging relationship, the hedge meets the criteria for
using the short-cut method for a fair value hedge under the provisions of Statement of Financial
Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS
No. 133). Under the provisions of SFAS No. 133, the investment in the derivative and the related
long-term debt are recorded at fair-value. As a result, we have recognized an asset associated with
the fair-value of the derivative of $4.7 million reported in Investments and other assets and a
corresponding increase in Long-term debt of $4.7 million reported in our unaudited condensed
consolidated balance sheet as of September 28, 2007. As the hedge meets the criteria for using the
short-cut method under the provisions of SFAS No. 133, the change in the fair-value of the
derivative is assumed to exactly equal the related change in the fair-value of the 2016 Notes, so
there is no gain or loss reported in our unaudited condensed consolidated statements of operations
related to the interest rate hedge.
At September 28, 2007, we had a committed long-term credit facility, a commercial paper
program, a medium term note program, an unused debt shelf registration statement that we may use
for a new medium term note
50
program and other issuances of debt securities, and various foreign bank facilities. In May
2007, we amended the termination date of our committed long-term credit facility to May 2012. The
termination date can be further extended from time to time upon our request and acceptance by the
issuer of the facility for a period of one year from the last scheduled termination date for each
request accepted. The committed long-term credit facility allows for borrowings of up to $800
million. The commercial paper program also provides for up to $600 million in borrowings. The
current medium term note program allows us to issue up to an additional $5.7 million in registered
notes on a non-revolving basis. The debt shelf registration statement provides for up to $350
million in additional debt securities. Borrowings under the committed long-term credit facility and
medium-term note program are subject to certain financial and operating covenants that include,
among other provisions, maintaining maximum leverage ratios. Certain covenants also limit
subsidiary debt. We believe we were in compliance with these covenants at September 28, 2007. As of
September 28, 2007, we had no borrowings under our committed long-term credit facility, $59.3
million in borrowings outstanding under the medium term note program, $5.3 million in borrowings
outstanding under various foreign bank facilities and no borrowings under our commercial paper
program.
At December 31, 2006, we had consolidated unrecognized net actuarial losses of $162.1 million
which were included in our accrued pension benefit liabilities. The unrecognized net actuarial
losses resulted primarily from lower than expected investment returns on pension plan assets in
2002 and 2001 and decreases in the discount rates used to measure projected benefit obligations
that occurred from 2001 to 2005. Assuming constant actuarial assumptions estimated as of our
pension plans measurement date of September 30, 2006, we expect the amortization of these
unrecognized net actuarial losses, which is a component of our annual pension cost, to be
approximately $11.3 million in 2007 compared to $13.0 million in 2006. The future amortization of
the unrecognized net actuarial losses is not expected to materially affect future pension
contribution requirements. In the first nine months of 2007 and 2006, we paid pension contributions
of $7.3 million and $7.0 million, respectively, to our U.S. defined benefit pension plan. In 2007,
we expect to pay pension contributions of between approximately $20.0 million and $21.0 million for
our U.S. and non-U.S. pension plans.
In connection with our March 2006 Inamed acquisition, we initiated a global restructuring and
integration plan to merge the Inamed operations with our operations and to capture synergies
through the centralization of certain general and administrative functions. In addition, in January
2007, we initiated an additional plan to restructure and eventually sell or close our collagen
manufacturing facility in Fremont, California that we acquired in connection with the Inamed
acquisition. As of September 28, 2007, we have recorded cumulative pre-tax restructuring and
integration charges of $48.5 million and $1.6 million of income tax costs related to intercompany
transfers of trade businesses and net assets. We currently estimate that the total pre-tax charges
resulting from the restructurings, including integration and transition costs, will be between
$53.0 million and $65.0 million, all of which are expected to be cash expenditures. In addition to
the pre-tax charges, we expect to incur capital expenditures of approximately $15.0 million to
$20.0 million, primarily related to the integration of information systems, and to pay an
additional amount of approximately $1.5 million to $2.0 million for taxes related to intercompany
transfers of trade businesses and net assets.
In connection with our January 2007 Cornéal acquisition, we initiated a restructuring and
integration plan to merge the Cornéal facial aesthetics business operations with our operations. As
of September 28, 2007, we have recorded pre-tax restructuring and integration costs of $20.1
million. We currently estimate that the total pre-tax charges resulting from the restructuring and
integration of the Cornéal facial aesthetics business operations will be between $29.0 million and
$37.0 million, all of which are expected to be cash expenditures.
On October 16, 2007, we completed the acquisition of Esprit, pursuant to an Agreement and Plan
of Merger, dated as of September 18, 2007, or Merger Agreement, by and among us, Esmeralde
Acquisition, Inc., our wholly-owned subsidiary, or Merger Sub, Esprit and the Escrow Participants
Representative named in the Merger Agreement. Pursuant to the Merger Agreement, Merger Sub was
merged with and into Esprit, with Esprit surviving and becoming our wholly-owned subsidiary. The
acquisition of Esprit will provide us with a dedicated urologics product line within our specialty
pharmaceuticals segment. Upon the terms set forth in the Merger Agreement, we paid an aggregate of
$370 million in cash, minus Esprits debt and certain transaction compensation and expenses, for
all of the outstanding equity securities of Esprit. In addition, we repaid all of Esprits
outstanding debt at the date of acquisition. The acquisition consideration was all cash, funded
from current cash and equivalent balances. At the
51
date of acquisition, Esprits debt included a note payable to us for $74.8 million plus
accrued interest, which effectively reduced the cash consideration paid by us at closing.
A significant amount of our existing cash and equivalents are held by non-U.S. subsidiaries.
We currently plan to use these funds in our operations outside the United States. Withholding and
U.S. taxes have not been provided for unremitted earnings of certain non-U.S. subsidiaries because
we have reinvested these earnings indefinitely in such operations. As of December 31, 2006, we had
approximately $725.5 million in unremitted earnings outside the United States for which withholding
and U.S. taxes were not provided. Tax costs would be incurred if these funds were remitted to the
United States.
We believe that the net cash provided by operating activities, supplemented as necessary with
borrowings available under our existing credit facilities and existing cash and equivalents, will
provide us with sufficient resources to meet our current expected obligations, working capital
requirements, debt service and other cash needs over the next year.
52
ALLERGAN, INC.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
In the normal course of business, our operations are exposed to risks associated with
fluctuations in foreign currency exchange rates and interest rates. We address these risks through
controlled risk management that includes the use of derivative financial instruments to
economically hedge or reduce these exposures. We do not enter into financial instruments for
trading or speculative purposes.
To ensure the adequacy and effectiveness of our interest rate and foreign exchange hedge
positions, we continually monitor our interest rate swap positions and foreign exchange forward and
option positions both on a stand-alone basis and in conjunction with our underlying interest rate
and foreign currency exposures, from an accounting and economic perspective.
However, given the inherent limitations of forecasting and the anticipatory nature of the
exposures intended to be hedged, we cannot assure you that such programs will offset more than a
portion of the adverse financial impact resulting from unfavorable movements in either interest or
foreign exchange rates. In addition, the timing of the accounting for recognition of gains and
losses related to mark-to-market instruments for any given period may not coincide with the timing
of gains and losses related to the underlying economic exposures and, therefore, may adversely
affect our consolidated operating results and financial position.
Interest Rate Risk
Our interest income and expense is more sensitive to fluctuations in the general level of U.S.
interest rates than to changes in rates in other markets. Changes in U.S. interest rates affect the
interest earned on our cash and equivalents, interest expense on our debt as well as costs
associated with foreign currency contracts.
In February 2006, we entered into interest rate swap contracts based on the 3-month LIBOR with
an aggregate notional amount of $800 million, a swap period of 10 years and a starting swap rate of
5.198%. We entered into these swap contracts as a cash flow hedge to effectively fix the future
interest rate for our $800 million aggregate principal amount 2016 Notes issued in April 2006. In
April 2006, we terminated the interest rate swap contracts and received approximately $13.0
million. The total gain is being amortized as a reduction to interest expense over a 10 year period
to match the term of the 2016 Notes. As of September 28, 2007, the remaining unrecognized gain, net
of tax, of $6.7 million is recorded as a component of accumulated other comprehensive loss.
On January 31, 2007, we entered into a nine-year, two-month interest rate swap with a $300.0
million notional amount with semi-annual settlements and quarterly interest rate reset dates. The
swap receives interest at a fixed rate of 5.75% and pays interest at a variable interest rate equal
to LIBOR plus 0.368%, and effectively converts $300.0 million of our 2016 Notes to a variable
interest rate. Based on the structure of the hedging relationship, the hedge meets the criteria for
using the short-cut method for a fair value hedge under the provisions of SFAS No. 133. Under the
provisions of SFAS No. 133, the investment in the derivative and the related long-term debt are
recorded at fair value. At September 28, 2007, we have recognized an asset associated with the
fair-value of the derivative of $4.7 million reported in Investments and other assets and a
corresponding increase in Long-term debt of $4.7 million reported in our unaudited condensed
consolidated balance sheet. The differential to be paid or received as interest rates change is
accrued and recognized as an adjustment of interest expense related to the 2016 Notes. The
adjustment of interest expense in the nine month period ended September 28, 2007 is immaterial.
At September 28, 2007, we had approximately $4.8 million of variable rate debt compared to
$102.0 million of variable rate debt at December 31, 2006. If interest rates were to increase or
decrease by 1% for the year, annual interest expense, including the effect of the $300.0 million
notional amount of our interest rate swap entered into on January 31, 2007, would increase or
decrease by approximately $3.0 million.
53
The tables below present information about certain of our investment portfolio and our debt
obligations at September 28, 2007 and December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 28, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair |
|
|
Maturing in |
|
Market |
|
|
2007 |
|
2008 |
|
2009 |
|
2010 |
|
2011 |
|
Thereafter |
|
Total |
|
Value |
|
|
(in millions, except interest rates) |
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial Paper |
|
$ |
850.9 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
850.9 |
|
|
$ |
850.9 |
|
Weighted Average Interest Rate |
|
|
5.05 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.05 |
% |
|
|
|
|
Foreign Time Deposits |
|
|
102.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102.3 |
|
|
|
102.3 |
|
Weighted Average Interest Rate |
|
|
4.12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.12 |
% |
|
|
|
|
Other Cash Equivalents |
|
|
395.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
395.5 |
|
|
|
395.5 |
|
Weighted Average Interest Rate |
|
|
5.09 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.09 |
% |
|
|
|
|
Total Cash Equivalents |
|
$ |
1,348.7 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,348.7 |
|
|
$ |
1,348.7 |
|
Weighted Average Interest Rate |
|
|
4.99 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.99 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Obligations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed Rate (US$) |
|
$ |
|
|
|
$ |
34.3 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
750.0 |
|
|
$ |
823.1 |
|
|
$ |
1,607.4 |
|
|
$ |
1,728.0 |
|
Weighted Average Interest Rate |
|
|
|
|
|
|
6.91 |
% |
|
|
|
|
|
|
|
|
|
|
1.50 |
% |
|
|
5.84 |
% |
|
|
3.84 |
% |
|
|
|
|
Fixed Rate (non-US$) |
|
|
0.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.5 |
|
|
|
0.5 |
|
Weighted Average Interest Rate |
|
|
4.15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.15 |
% |
|
|
|
|
Other Variable Rate (non-US$) |
|
|
4.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.8 |
|
|
|
4.8 |
|
Weighted Average Interest Rate |
|
|
5.45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.45 |
% |
|
|
|
|
Total Debt Obligations (a) |
|
$ |
5.3 |
|
|
$ |
34.3 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
750.0 |
|
|
$ |
823.1 |
|
|
$ |
1,612.7 |
|
|
$ |
1,733.3 |
|
Weighted Average Interest Rate |
|
|
5.33 |
% |
|
|
6.91 |
% |
|
|
|
|
|
|
|
|
|
|
1.50 |
% |
|
|
5.84 |
% |
|
|
3.84 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTEREST RATE DERIVATIVES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Rate Swaps: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed to Variable (US$) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
300.0 |
|
|
$ |
300.0 |
|
|
$ |
4.7 |
|
Average Pay Rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.60 |
% |
|
|
5.60 |
% |
|
|
|
|
Average Receive Rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.75 |
% |
|
|
5.75 |
% |
|
|
|
|
|
|
|
(a) |
|
Total debt obligations in the unaudited condensed consolidated balance sheet at September 28,
2007 include debt obligations of $1,612.7 million and the interest rate swap fair value
adjustment of $4.7 million. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair |
|
|
Maturing in |
|
Market |
|
|
2007 |
|
2008 |
|
2009 |
|
2010 |
|
2011 |
|
Thereafter |
|
Total |
|
Value |
|
|
(in millions, except interest rates) |
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase Agreements |
|
$ |
130.0 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
130.0 |
|
|
$ |
130.0 |
|
Weighted Average Interest Rate |
|
|
5.35 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.35 |
% |
|
|
|
|
Commercial Paper |
|
|
771.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
771.0 |
|
|
|
771.0 |
|
Weighted Average Interest Rate |
|
|
5.29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.29 |
% |
|
|
|
|
Foreign Time Deposits |
|
|
288.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
288.6 |
|
|
|
288.6 |
|
Weighted Average Interest Rate |
|
|
3.75 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.75 |
% |
|
|
|
|
Other Cash Equivalents |
|
|
138.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
138.7 |
|
|
|
138.7 |
|
Weighted Average Interest Rate |
|
|
5.91 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.91 |
% |
|
|
|
|
Total Cash Equivalents |
|
$ |
1,328.3 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,328.3 |
|
|
$ |
1,328.3 |
|
Weighted Average Interest Rate |
|
|
5.03 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.03 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Obligations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed Rate (US$) |
|
$ |
|
|
|
$ |
33.5 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
750.0 |
|
|
$ |
822.9 |
|
|
$ |
1,606.4 |
|
|
$ |
1,686.7 |
|
Weighted Average Interest Rate |
|
|
|
|
|
|
6.91 |
% |
|
|
|
|
|
|
|
|
|
|
1.50 |
% |
|
|
5.84 |
% |
|
|
3.84 |
% |
|
|
|
|
Other Variable Rate (non-US$) |
|
|
102.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102.0 |
|
|
|
102.0 |
|
Weighted Average Interest Rate |
|
|
5.46 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.46 |
% |
|
|
|
|
Total Debt Obligations |
|
$ |
102.0 |
|
|
$ |
33.5 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
750.0 |
|
|
$ |
822.9 |
|
|
$ |
1,708.4 |
|
|
$ |
1,788.7 |
|
Weighted Average Interest Rate |
|
|
5.46 |
% |
|
|
6.91 |
% |
|
|
|
|
|
|
|
|
|
|
1.50 |
% |
|
|
5.84 |
% |
|
|
3.93 |
% |
|
|
|
|
54
Foreign Currency Risk
Overall, we are a net recipient of currencies other than the U.S. dollar and, as such, benefit
from a weaker dollar and are adversely affected by a stronger dollar relative to major currencies
worldwide. Accordingly, changes in exchange rates, and in particular a strengthening of the U.S.
dollar, may negatively affect our consolidated revenues or operating costs and expenses as
expressed in U.S. dollars.
From time to time, we enter into foreign currency option and forward contracts to reduce
earnings and cash flow volatility associated with foreign exchange rate changes to allow our
management to focus its attention on our core business issues. Accordingly, we enter into various
contracts which change in value as foreign exchange rates change to economically offset the effect
of changes in the value of foreign currency assets and liabilities, commitments and anticipated
foreign currency denominated sales and operating expenses. We enter into foreign currency option
and forward contracts in amounts between minimum and maximum anticipated foreign exchange
exposures, generally for periods not to exceed one year.
We use foreign currency option contracts, which provide for the purchase or sale of foreign
currencies to offset foreign currency exposures expected to arise in the normal course of our
business. While these instruments are subject to fluctuations in value, such fluctuations are
anticipated to offset changes in the value of the underlying exposures.
All of our outstanding foreign currency option contracts are entered into to reduce the
volatility of earnings generated in currencies other than the U.S. dollar, primarily earnings
denominated in the Canadian dollar, Mexican peso, Australian dollar, Brazilian real, euro, Japanese
yen, Swedish krona, Swiss franc and U.K. pound. Current changes in the fair value of open foreign
currency option contracts are recorded through earnings as Unrealized gain (loss) on derivative
instruments, net while any realized gains (losses) on settled contracts are recorded through
earnings as Other, net in the accompanying unaudited condensed consolidated statements of
operations. The premium costs of purchased foreign exchange option contracts are recorded in Other
current assets and amortized to Other, net over the life of the options.
All of our outstanding foreign exchange forward contracts are entered into to protect the
value of intercompany receivables denominated in currencies other than the lenders functional
currency. The realized and unrealized gains and losses from foreign currency forward contracts and
the revaluation of the foreign denominated intercompany receivables are recorded through Other,
net in the accompanying unaudited condensed consolidated statements of operations.
55
The following table provides information about our foreign currency derivative financial
instruments outstanding as of September 28, 2007 and December 31, 2006. The information is provided
in U.S. dollars, as presented in our unaudited condensed consolidated financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 28, 2007 |
|
December 31, 2006 |
|
|
|
|
Average Contract |
|
|
|
Average Contract |
|
|
Notional |
|
Rate or Strike |
|
Notional |
|
Rate or Strike |
|
|
Amount |
|
Amount |
|
Amount |
|
Amount |
|
|
(in millions) |
|
|
|
(in millions) |
|
|
Foreign currency forward contracts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Receive U.S. dollar/pay foreign currency) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Euro |
|
$ |
132.3 |
|
|
|
1.39 |
|
|
$ |
142.3 |
|
|
|
1.32 |
|
Canadian dollar |
|
|
5.4 |
|
|
|
1.02 |
|
|
|
1.8 |
|
|
|
1.15 |
|
Australian dollar |
|
|
16.2 |
|
|
|
0.83 |
|
|
|
9.1 |
|
|
|
0.78 |
|
Swiss franc |
|
|
2.0 |
|
|
|
1.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
155.9 |
|
|
|
|
|
|
$ |
153.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value |
|
$ |
(4.9 |
) |
|
|
|
|
|
$ |
(0.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency sold put options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canadian dollar |
|
$ |
9.9 |
|
|
|
1.14 |
|
|
$ |
35.0 |
|
|
|
1.14 |
|
Mexican peso |
|
|
3.9 |
|
|
|
11.09 |
|
|
|
14.3 |
|
|
|
11.00 |
|
Australian dollar |
|
|
7.0 |
|
|
|
0.78 |
|
|
|
20.6 |
|
|
|
0.78 |
|
Brazilian real |
|
|
4.0 |
|
|
|
2.29 |
|
|
|
11.7 |
|
|
|
2.24 |
|
Euro |
|
|
20.3 |
|
|
|
1.34 |
|
|
|
73.0 |
|
|
|
1.34 |
|
Japanese yen |
|
|
2.6 |
|
|
|
111.35 |
|
|
|
9.6 |
|
|
|
113.06 |
|
Swedish krona |
|
|
2.0 |
|
|
|
6.75 |
|
|
|
7.7 |
|
|
|
6.79 |
|
Swiss franc |
|
|
1.8 |
|
|
|
1.17 |
|
|
|
6.1 |
|
|
|
1.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
51.5 |
|
|
|
|
|
|
$ |
178.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value |
|
$ |
0.1 |
|
|
|
|
|
|
$ |
3.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency purchased call options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.K. pound |
|
$ |
1.8 |
|
|
|
1.96 |
|
|
$ |
15.3 |
|
|
|
1.96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value |
|
$ |
0.1 |
|
|
|
|
|
|
$ |
0.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56
ALLERGAN, INC.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms, and that such information is accumulated and communicated to our management, including our
Principal Executive Officer and our Principal Financial Officer, as appropriate, to allow timely
decisions regarding required disclosures. Our management, including our Principal Executive Officer
and our Principal Financial Officer, does not expect that our disclosure controls or procedures
will prevent all error and all fraud. A control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are
met. Further, the benefits of controls must be considered relative to their costs. Because of the
inherent limitations in all control systems, no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within Allergan have been
detected. These inherent limitations include the realities that judgments in decision-making can be
faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people, or
by management override of the control. The design of any system of controls is also based in part
upon certain assumptions about the likelihood of future events, and there can be no assurance that
any design will succeed in achieving its stated goals under all potential future conditions.
Because of the inherent limitations in a cost-effective control system, misstatements due to error
or fraud may occur and not be detected. Also, we have investments in certain unconsolidated
entities. As we do not control or manage these entities, our disclosure controls and procedures
with respect to such entities are necessarily substantially more limited than those we maintain
with respect to our consolidated subsidiaries.
We carried out an evaluation, under the supervision and with the participation of our
management, including our Principal Executive Officer and our Principal Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and procedures as of September
28, 2007, the end of the quarterly period covered by this report. Based on the foregoing, our
Principal Executive Officer and our Principal Financial Officer concluded that, as of the end of
the period covered by this report, our disclosure controls and procedures were effective and were
operating at the reasonable assurance level.
Further, management determined that, as of September 28, 2007, there were no changes in our
internal control over financial reporting that occurred during the first nine month period of 2007
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting, except for the potential impact from reporting the Inamed and Cornéal
acquisitions, as more fully disclosed in Note 2, Acquisitions, to the unaudited condensed
consolidated financial statements under Item 1(D) of Part I of this report. We are currently in the
process of assessing and integrating Inameds and Cornéals internal controls over financial
reporting into our financial reporting systems and expect to complete our integration activities
related to internal controls over financial reporting by December 31, 2007.
57
ALLERGAN, INC.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
The information required by this Item is incorporated herein by reference to Note 10,
Litigation, to the unaudited condensed consolidated financial statements under Item 1(D) of Part I
of this report.
Item 1A. Risk Factors
The risk factors presented below supplement and amend the risk factors previously disclosed by
us in Part II, Item 1A of our Quarterly Report on Form 10-Q for the three month periods ended June
29, 2007 and March 30, 2007 and Part I, Item 1A of our Annual Report on Form 10-K for the fiscal
year ended December 31, 2006.
We operate in a highly competitive business.
The pharmaceutical and medical device industries are highly competitive and they require an
ongoing, extensive search for technological innovation. They also require, among other things, the
ability to effectively discover, develop, test and obtain regulatory approvals for products, as
well as the ability to effectively commercialize, market and promote approved products, including
communicating the effectiveness, safety and value of products to actual and prospective customers
and medical professionals.
Many of our competitors have greater resources than we have. This enables them, among other
things, to make greater research and development, or R&D, investments and spread their R&D costs,
as well as their marketing and promotion costs, over a broader revenue base. Our competitors may
also have more experience and expertise in obtaining marketing approvals from the U.S. Food and
Drug Administration, or FDA, and other regulatory authorities. In addition to product development,
testing, approval and promotion, other competitive factors in the pharmaceutical and medical device
industries include industry consolidation, product quality and price, product technology,
reputation, customer service and access to technical information.
It is possible that developments by our competitors could make our products or technologies
less competitive or obsolete. Our future growth depends, in part, on our ability to develop
products which are more effective. For instance, for our eye care products to be successful, we
must be able to manufacture and effectively market those products and persuade a sufficient number
of eye care professionals to use or continue to use our current products and the new products we
may introduce. Glaucoma must be treated over an extended period and doctors may be reluctant to
switch a patient to a new treatment if the patients current treatment for glaucoma remains
effective. Sales of our existing products may decline rapidly if a new product is introduced by one
of our competitors or if we announce a new product that, in either case, represents a substantial
improvement over our existing products. Similarly, if we fail to make sufficient investments in R&D
programs, our current and planned products could be surpassed by more effective or advanced
products developed by our competitors.
Until December 2000, Botox® was the only neuromodulator approved by the FDA. At
that time, the FDA approved Myobloc®, a neuromodulator formerly marketed by Elan
Pharmaceuticals and now marketed by Solstice Neurosciences, Inc. Ipsen Ltd. is seeking FDA approval
of its Dysport® neuromodulator for certain therapeutic indications, and Medicis, its
licensee for the United States, Canada and Japan, is seeking approval of Reloxin® for
cosmetic indications. Ipsen has marketed Dysport® in Europe since 1991, prior to our
European commercialization of Botox® in 1992. In June 2006, Ipsen received the marketing
authorization for a cosmetic indication for Dysport® in Germany. In 2007, Ipsen granted
an exclusive development and marketing license for Dysport® to Galderma in the European
Union, Russia, Eastern Europe and the Middle East, and first rights of negotiation for other
countries around the world, except the United States, Canada and Japan. Reloxin® is also
currently under review for use in aesthetic medicine indications by the French regulatory
authorities as part of an application for a license across the European Union.
Mentor Corporation is conducting clinical trials for a competing neuromodulator in the United
States. In addition, we are aware of competing neuromodulators currently being developed and
commercialized in Asia,
58
Europe, South America and other markets. A Chinese entity received approval to market a
botulinum toxin in China in 1997, and we believe that it has launched or is planning to launch its
botulinum toxin product in other lightly regulated markets in Asia, South America and Central
America. These lightly regulated markets may not require adherence to the FDAs current Good
Manufacturing Practice, or cGMP, regulations or the regulatory requirements of the European Medical
Evaluation Agency or other regulatory agencies in countries that are members of the Organization
for Economic Cooperation and Development. Therefore, companies operating in these markets may be
able to produce products at a lower cost than we can. In addition, Merz received approval from
German authorities for Xeomin® and launched its product in July 2005. Merz is currently
in clinical trials in the United States for cervical dystonia, blepharospasm and cosmetic
indications and is awaiting therapeutic licenses for Xeomin® in approximately ten
countries across the European Union. A Korean botulinum toxin, Meditoxin®, was approved
for sale in Korea in June 2006. The company, Medy-Tox Inc., received exportation approval from
Korean authorities in early 2005 to ship their product under the tradename Neuronox®. In
February 2007, Q-Med announced a worldwide license for Neuronox®, with the exception of
certain countries in Asia where Medy-Tox may retain the marketing rights. Our sales of
Botox® could be materially and negatively impacted by this competition or competition
from other companies that might obtain FDA approval or approval from other regulatory authorities
to market a neuromodulator.
Mentor Corporation is our principal competitor in the United States for breast implants.
Mentor announced that, like us, it received FDA approval in November 2006 to sell its silicone
breast implants. The conditions under which Mentor is allowed to market its silicone breast
implants in the United States are similar to ours, including indications for use and the
requirement to conduct post-marketing studies. If patients or physicians prefer Mentors breast
implant products to ours or perceive that Mentors breast implant products are safer than ours, our
sales of breast implants could materially suffer. We are aware of several companies conducting
clinical studies of breast implant products in the United States. Internationally, we compete with
several manufacturers, including Mentor Corporation, Silimed, Medicor Corporation, Poly Implant
Prostheses, Nagor, Laboratoires Sebbin and LPI.
Medicis Pharmaceutical Corporation began marketing Restylane®, a dermal filler, in
January 2004. Through our purchase of Inamed, we acquired the rights to sell a competing dermal
filler, Juvéderm, in the United States, Canada and Australia and Hydrafill in certain European
countries. Juvéderm was approved by the FDA for sale in the United States in June 2006, and we
announced nationwide availability of Juvéderm in January 2007. We cannot assure you that Juvéderm
will offer equivalent or greater facial aesthetic benefits to competitive dermal filler products,
that it will be competitive in price or gain acceptance in the marketplace.
Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, announced a September 2007 FDA
approval of its gastric band product, the Realize Adjustable Gastric Band, which will compete
against our LAP-BAND® System in the U.S. market. The LAP-BAND® System also
competes with surgical obesity procedures, including gastric bypass, vertical banded gastroplasty,
sleeve gastrectomy and biliopancreatic diversion.
We also face competition from generic drug manufacturers in the United States and
internationally. For instance, Falcon Pharmaceuticals, Ltd., an affiliate of Alcon Laboratories,
Inc., attempted to obtain FDA approval for a brimonidine product to compete with our
Alphagan® P product. However, pursuant to our March 2006 settlement with Alcon, Alcon
agreed not to sell, offer for sale or distribute its brimonidine product until September 30, 2009,
or earlier if specified market conditions occur. The primary market condition will have occurred if
the extent to which prescriptions of Alphagan® P have been converted to other
brimonidine-containing products we market has increased to a specified threshold. In October 2007,
we received a paragraph 4 Hatch-Waxman Act certification from Apotex Corp. in which it purports to
have sought FDA approval to market a generic gatifloxacin 0.3% ophthalmic solution.
Uncertainties exist in integrating the business and operations of Inamed, Cornéal and Esprit into
our own.
We are currently integrating certain of Inameds, Cornéals and Esprits functions and
operations into our own, although there can be no assurance that we will be successful in this
endeavor. There are inherent challenges in integrating the operations that could result in a delay
or the failure to achieve the anticipated synergies and, therefore, any potential cost savings and
increases in earnings. Issues that must be addressed in integrating the operations of Inamed,
Cornéal and Esprit into our own include, among other things:
59
|
|
|
conforming standards, controls, procedures and policies, business cultures and
compensation structures between the companies; |
|
|
|
|
conforming information technology and accounting systems; |
|
|
|
|
consolidating corporate and administrative infrastructures; |
|
|
|
|
consolidating sales and marketing operations; |
|
|
|
|
retaining existing customers and attracting new customers; |
|
|
|
|
retaining key employees; |
|
|
|
|
identifying and eliminating redundant and underperforming operations and assets; |
|
|
|
|
minimizing the diversion of managements attention from ongoing business concerns; |
|
|
|
|
coordinating geographically dispersed organizations; |
|
|
|
|
managing tax costs or inefficiencies associated with integrating the operations of the
combined company; and |
|
|
|
|
making any necessary modifications to operating control standards to comply with the
Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated thereunder. |
If we are not able to adequately address these challenges, we may not realize the anticipated
benefits of the integration of the companies. Actual cost and sales synergies, if achieved at all,
may be lower than we expect and may take longer to achieve than we anticipate.
If our collaborative partners do not perform, we will be unable to develop and market products as
anticipated.
We have entered into collaborative arrangements with third parties to develop and market
certain products, including our arrangement with GlaxoSmithKline to market Botox® in
Japan and China and certain other products in the United States and our arrangement with Indevus
Pharmaceuticals, Inc. to market Sanctura XR in the United States. We cannot assure you that these
collaborations will be successful, lead to significant sales of our products in our partners
territories or lead to the creation of additional products. If we fail to maintain our existing
collaborative arrangements or fail to enter into additional collaborative arrangements, our
licensing revenues and/or the number of products from which we could receive future revenues could
decline.
Our dependence on collaborative arrangements with third parties subjects us to a number of
risks. These collaborative arrangements may not be on terms favorable to us. Agreements with
collaborative partners typically allow partners significant discretion in marketing our products or
electing whether or not to pursue any of the planned activities. We cannot fully control the amount
and timing of resources our collaborative partners may devote to products based on the
collaboration, and our partners may choose to pursue alternative products to the detriment of our
collaboration. In addition, our partners may not perform their obligations as expected. Business
combinations, significant changes in a collaborative partners business strategy, or its access to
financial resources may adversely affect a partners willingness or ability to complete its
obligations. Moreover, we could become involved in disputes with our partners, which could lead to
delays or termination of the collaborations and time-consuming and expensive litigation or
arbitration. Even if we fulfill our obligations under a collaborative agreement, our partner can
terminate the agreement under certain circumstances. If any collaborative partners were to
terminate or breach our agreements with them, or otherwise fail to complete their obligations in a
timely manner, we could be materially and adversely affected.
60
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table discloses the purchases of our equity securities during the third fiscal
quarter of 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number |
|
|
|
|
|
|
|
|
|
|
|
|
of Shares |
|
Maximum Number |
|
|
|
|
|
|
|
|
|
|
Purchased as |
|
(or Approximate |
|
|
|
|
|
|
|
|
|
|
Part of |
|
Dollar Value) of |
|
|
|
|
|
|
|
|
|
|
Publicly |
|
Shares that May |
|
|
Total Number |
|
Average |
|
Announced |
|
Yet Be Purchased |
|
|
of Shares |
|
Price Paid |
|
Plans |
|
Under the Plans |
Period |
|
Purchased(1) |
|
per Share |
|
or Programs |
|
or Programs(2) |
June 30, 2007 to July 31, 2007 |
|
|
0 |
|
|
|
N/A |
|
|
|
0 |
|
|
|
16,825,591 |
|
August 1, 2007 to August 31, 2007 |
|
|
0 |
|
|
|
N/A |
|
|
|
0 |
|
|
|
17,702,810 |
|
September 1, 2007 to September 28, 2007 |
|
|
0 |
|
|
|
N/A |
|
|
|
0 |
|
|
|
17,789,592 |
|
Total |
|
|
0 |
|
|
|
N/A |
|
|
|
0 |
|
|
|
N/A |
|
|
|
|
(1) |
|
We maintain an evergreen stock repurchase program, which we first announced on September 28,
1993. Under the stock repurchase program after giving effect to our June 22, 2007 two-for-one
stock split, we may maintain up to 18.4 million repurchased shares in our treasury account at
any one time. As of September 28, 2007, we held approximately 0.6 million treasury shares
under this program. |
|
(2) |
|
The share numbers reflect the maximum number of shares that may be purchased under our stock
repurchase program and are as of the end of each of the respective periods. The share numbers
also reflect our June 22, 2007 two-for-one stock split. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
61
Item 6. Exhibits
Exhibits (numbered in accordance with Item 601 of Regulation S-K)
|
|
|
2.1
|
|
Agreement and Plan of Merger, dated as of September 18, 2007, by and
among Allergan, Inc., Esmeralde Acquisition, Inc., Esprit Pharma
Holding Company, Inc. and the Escrow Participants Representative
(incorporated by reference to Exhibit 2.1 to Allergan, Inc.s
Current Report on Form 8-K/A filed on September 24, 2007) |
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Allergan, Inc., as filed
with the State of Delaware on May 22, 1989 (incorporated by
reference to Exhibit 3.1 to Allergan, Inc.s Registration Statement
on Form S-1 No. 33-28855, filed on May 24, 1989) |
|
|
|
3.2
|
|
Certificate of Amendment of Certificate of Incorporation of
Allergan, Inc. (incorporated by reference to Exhibit 3 to Allergan,
Inc.s Report on Form 10-Q for the Quarter ended June 30, 2000) |
|
|
|
3.3
|
|
Certificate of Amendment of Restated Certificate of Incorporation of
Allergan, Inc. (incorporated by reference to Exhibit 3.1 to
Allergan, Inc.s Current Report on Form 8-K filed on September 20,
2006) |
|
|
|
3.4
|
|
Allergan, Inc. Bylaws (originally filed as Exhibit 3 to Allergan,
Inc.s Report on Form 10-Q for the Quarter ended June 30, 1995 and
re-filed herewith pursuant to Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.5
|
|
First Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Report on Form 10-Q for the Quarter
ended September 24, 1999 and re-filed herewith pursuant to
Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.6
|
|
Second Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.5 to Allergan, Inc.s Report on Form 10-K for the Fiscal
Year ended December 31, 2002 and re-filed herewith pursuant to
Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.7
|
|
Third Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.6 to Allergan, Inc.s Report on Form 10-K for the Fiscal
Year ended December 31, 2003 and re-filed herewith pursuant to
Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.8
|
|
Fourth Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Current Report on Form 8-K filed on
August 1, 2007 and re-filed herewith pursuant to Regulation S-K Item
601(b)(3)(ii)) |
|
|
|
3.9
|
|
Fifth Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Current Report on Form 8-K filed on
September 25, 2007 and re-filed herewith pursuant to Regulation S-K
Item 601(b)(3)(ii)) |
|
|
|
3.10
|
|
Sixth Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Current Report on Form 8-K filed on
October 30, 2007 and re-filed herewith pursuant to Regulation S-K
Item 601(b)(3)(ii)) |
|
|
|
4.1
|
|
Indenture, dated as of April 12, 2006, between Allergan, Inc. and
Wells Fargo, National Association relating to the $750,000,000 1.50%
Convertible Senior Notes due 2026 (incorporated by reference to
Exhibit 4.1 to Allergan, Inc.s Current Report on Form 8-K filed on
April 12, 2006) |
|
|
|
4.2
|
|
Indenture, dated as of April 12, 2006, between Allergan, Inc. and
Wells Fargo, National Association relating to the $800,000,000 5.75%
Senior Notes due 2016 (incorporated by reference to Exhibit 4.2 to
Allergan, Inc.s Current Report on Form 8-K filed on April 12, 2006) |
62
|
|
|
4.3
|
|
Form of 1.50% Convertible Senior Note due 2026 (incorporated by
reference to (and included in) the Indenture dated as of April 12,
2006 between Allergan, Inc. and Wells Fargo, National Association at
Exhibit 4.1 to Allergan, Inc.s Current Report on Form 8-K filed on
April 12, 2006) |
|
|
|
4.4
|
|
Form of 5.75% Senior Note due 2016 (incorporated by reference to
(and included in) the Indenture dated as of April 12, 2006 between
Allergan, Inc. and Wells Fargo, National Association at Exhibit 4.2
to Allergan, Inc.s Current Report on Form 8-K filed on April 12,
2006) |
|
|
|
4.5
|
|
Registration Rights Agreement, dated as of April 12, 2006, among
Allergan, Inc. and Banc of America Securities LLC and Citigroup
Global Markets Inc., as representatives of the Initial Purchasers
named therein, relating to the $750,000,000 1.50% Convertible Senior
Notes due 2026 (incorporated by reference to Exhibit 4.3 to
Allergan, Inc.s Current Report on Form 8-K filed on April 12, 2006) |
|
|
|
4.6
|
|
Registration Rights Agreement, dated as of April 12, 2006, among
Allergan, Inc. and Morgan Stanley & Co., Incorporated, as
representative of the Initial Purchasers named therein, relating to
the $800,000,000 5.75% Senior Notes due 2016 (incorporated by
reference to Exhibit 4.4 to Allergan, Inc.s Current Report on Form
8-K filed on April 12, 2006) |
|
|
|
10.1
|
|
Severance and General Release Agreement between Allergan, Inc. and
Roy J. Wilson, dated as of October 6, 2006 (incorporated by
reference to Exhibit 10.1 to Allergan, Inc.s Current Report on Form
8-K filed on October 10, 2006) |
|
|
|
10.2
|
|
Stock Sale and Purchase Agreement, dated as of October 31, 2006, by
and among Allergan, Inc., Allergan Holdings France, SAS, Waldemar
Kita, the European Pre-Floatation Fund II and the other minority
stockholders of Groupe Cornéal Laboratories and its subsidiaries
(incorporated by reference to Exhibit 10.1 to Allergan, Inc.s
Current Report on Form 8-K filed on November 2, 2006) |
|
|
|
10.3
|
|
First Amendment to Stock Sale and Purchase Agreement, dated as of
February 19, 2007, by and among Allergan, Inc., Allergan Holdings
France, SAS, Waldemar Kita, the European Pre-Floatation Fund II and
the other minority stockholders of Groupe Cornéal Laboratories and
its subsidiaries (incorporated by reference to Exhibit 10.3 to
Allergan, Inc.s Report on Form 10-Q for the Quarter ended March 30,
2007) |
|
|
|
10.4
|
|
Allergan, Inc. Deferred
Directors Fee Program (Restated July 30, 2007) |
|
|
|
10.5
|
|
Amended and Restated License, Commercialization and Supply
Agreement, dated as of September 18, 2007, by and among Esprit
Pharma, Inc. and Indevus Pharmaceuticals, Inc. (incorporated by
reference to (and included as Exhibit C to) the Agreement and Plan
of Merger, dated as of September 18, 2007, by and among Allergan,
Inc., Esmeralde Acquisition, Inc., Esprit Pharma Holding Company,
Inc. and the Escrow Participants Representative at Exhibit 2.1 to
Allergan, Inc.s Current Report on Form 8-K/A filed on September 24,
2007) (Portions of this exhibit have been omitted pursuant to a
request for confidential treatment, which was granted by the SEC on
October 12, 2007) |
|
|
|
31.1
|
|
Certification of Principal Executive Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
31.2
|
|
Certification of Principal Financial Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
32
|
|
Certification of Principal Executive Officer and Principal Financial
Officer Required Under Rule 13a-14(b) of the Securities Exchange Act
of 1934, as amended, and 18 U.S.C. Section 1350 |
63
SIGNATURE
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.
Date: November 6, 2007
|
|
|
|
|
|
ALLERGAN, INC.
|
|
|
/s/ Jeffrey L. Edwards
|
|
|
Jeffrey L. Edwards |
|
|
Executive Vice President,
Finance and Business Development,
Chief Financial Officer
(Principal Financial Officer) |
|
|
64
INDEX OF EXHIBITS
|
|
|
2.1
|
|
Agreement and Plan of Merger, dated as of September 18, 2007, by and
among Allergan, Inc., Esmeralde Acquisition, Inc., Esprit Pharma
Holding Company, Inc. and the Escrow Participants Representative
(incorporated by reference to Exhibit 2.1 to Allergan, Inc.s
Current Report on Form 8-K/A filed on September 24, 2007) |
|
|
|
3.1
|
|
Restated Certificate of Incorporation of Allergan, Inc., as filed
with the State of Delaware on May 22, 1989 (incorporated by
reference to Exhibit 3.1 to Allergan, Inc.s Registration Statement
on Form S-1 No. 33-28855, filed on May 24, 1989) |
|
|
|
3.2
|
|
Certificate of Amendment of Certificate of Incorporation of
Allergan, Inc. (incorporated by reference to Exhibit 3 to Allergan,
Inc.s Report on Form 10-Q for the Quarter ended June 30, 2000) |
|
|
|
3.3
|
|
Certificate of Amendment of Restated Certificate of Incorporation of
Allergan, Inc. (incorporated by reference to Exhibit 3.1 to
Allergan, Inc.s Current Report on Form 8-K filed on September 20,
2006) |
|
|
|
3.4
|
|
Allergan, Inc. Bylaws (originally filed as Exhibit 3 to Allergan,
Inc.s Report on Form 10-Q for the Quarter ended June 30, 1995 and
re-filed herewith pursuant to Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.5
|
|
First Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Report on Form 10-Q for the Quarter
ended September 24, 1999 and re-filed herewith pursuant to
Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.6
|
|
Second Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.5 to Allergan, Inc.s Report on Form 10-K for the Fiscal
Year ended December 31, 2002 and re-filed herewith pursuant to
Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.7
|
|
Third Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.6 to Allergan, Inc.s Report on Form 10-K for the Fiscal
Year ended December 31, 2003 and re-filed herewith pursuant to
Regulation S-K Item 601(b)(3)(ii)) |
|
|
|
3.8
|
|
Fourth Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Current Report on Form 8-K filed on
August 1, 2007 and re-filed herewith pursuant to Regulation S-K Item
601(b)(3)(ii)) |
|
|
|
3.9
|
|
Fifth Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Current Report on Form 8-K filed on
September 25, 2007 and re-filed herewith pursuant to Regulation S-K
Item 601(b)(3)(ii)) |
|
|
|
3.10
|
|
Sixth Amendment to Allergan, Inc. Bylaws (originally filed as
Exhibit 3.1 to Allergan, Inc.s Current Report on Form 8-K filed on
October 30, 2007 and re-filed herewith pursuant to Regulation S-K
Item 601(b)(3)(ii)) |
|
|
|
4.1
|
|
Indenture, dated as of April 12, 2006, between Allergan, Inc. and
Wells Fargo, National Association relating to the $750,000,000 1.50%
Convertible Senior Notes due 2026 (incorporated by reference to
Exhibit 4.1 to Allergan, Inc.s Current Report on Form 8-K filed on
April 12, 2006) |
|
|
|
4.2
|
|
Indenture, dated as of April 12, 2006, between Allergan, Inc. and
Wells Fargo, National Association relating to the $800,000,000 5.75%
Senior Notes due 2016 (incorporated by reference to Exhibit 4.2 to
Allergan, Inc.s Current Report on Form 8-K filed on April 12, 2006) |
|
|
|
4.3
|
|
Form of 1.50% Convertible Senior Note due 2026 (incorporated by
reference to (and included in) the Indenture dated as of April 12,
2006 between Allergan, Inc. and Wells Fargo, National Association at
Exhibit 4.1 to Allergan, Inc.s Current Report on Form 8-K filed on
April 12, 2006) |
|
|
|
4.4
|
|
Form of 5.75% Senior Note due 2016 (incorporated by reference to
(and included in) the Indenture dated as of April 12, 2006 between
Allergan, Inc. and Wells Fargo, National Association at Exhibit 4.2
to Allergan, Inc.s Current Report on Form 8-K filed on April 12,
2006) |
|
|
|
4.5
|
|
Registration Rights Agreement, dated as of April 12, 2006, among
Allergan, Inc. and Banc of America Securities LLC and Citigroup
Global Markets Inc., as representatives of the Initial Purchasers
named therein, relating to the $750,000,000 1.50% Convertible Senior
Notes due 2026 (incorporated by reference to Exhibit 4.3 to
Allergan, Inc.s Current Report on Form 8-K filed on April 12, 2006) |
|
|
|
4.6
|
|
Registration Rights Agreement, dated as of April 12, 2006, among
Allergan, Inc. and Morgan Stanley & Co., Incorporated, as
representative of the Initial Purchasers named therein, relating to
the $800,000,000 5.75% Senior Notes due 2016 (incorporated by
reference to Exhibit 4.4 to Allergan, Inc.s Current Report on Form
8-K filed on April 12, 2006) |
|
|
|
10.1
|
|
Severance and General Release Agreement between Allergan, Inc. and
Roy J. Wilson, dated as of October 6, 2006 (incorporated by
reference to Exhibit 10.1 to Allergan, Inc.s Current Report on Form
8-K filed on October 10, 2006) |
|
|
|
10.2
|
|
Stock Sale and Purchase Agreement, dated as of October 31, 2006, by
and among Allergan, Inc., Allergan Holdings France, SAS, Waldemar
Kita, the European Pre-Floatation Fund II and the other minority
stockholders of Groupe Cornéal Laboratories and its subsidiaries
(incorporated by reference to Exhibit 10.1 to Allergan, Inc.s
Current Report on Form 8-K filed on November 2, 2006) |
|
|
|
10.3
|
|
First Amendment to Stock Sale and Purchase Agreement, dated as of
February 19, 2007, by and among Allergan, Inc., Allergan Holdings
France, SAS, Waldemar Kita, the European Pre-Floatation Fund II and
the other minority stockholders of Groupe Cornéal Laboratories and
its subsidiaries (incorporated by reference to Exhibit 10.3 to
Allergan, Inc.s Report on Form 10-Q for the Quarter ended March 30,
2007) |
|
|
|
10.4
|
|
Allergan, Inc. Deferred
Directors Fee Program (Restated July 30, 2007) |
|
|
|
10.5
|
|
Amended and Restated License, Commercialization and Supply
Agreement, dated as of September 18, 2007, by and among Esprit
Pharma, Inc. and Indevus Pharmaceuticals, Inc. (incorporated by
reference to (and included as Exhibit C to) the Agreement and Plan
of Merger, dated as of September 18, 2007, by and among Allergan,
Inc., Esmeralde Acquisition, Inc., Esprit Pharma Holding Company,
Inc. and the Escrow Participants Representative at Exhibit 2.1 to
Allergan, Inc.s Current Report on Form 8-K/A filed on September 24,
2007) (Portions of this exhibit have been omitted pursuant to a
request for confidential treatment, which was granted by the SEC on
October 12, 2007) |
|
|
|
31.1
|
|
Certification of Principal Executive Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
31.2
|
|
Certification of Principal Financial Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
32
|
|
Certification of Principal Executive Officer and Principal Financial
Officer Required Under Rule 13a-14(b) of the Securities Exchange Act
of 1934, as amended, and 18 U.S.C. Section 1350 |