e10vq
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-Q
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(Mark One)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended
June 30, 2006
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or
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period
from to
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Commission file number: 1-11397
Valeant Pharmaceuticals
International
(Exact name of registrant as
specified in its charter)
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Delaware
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33-0628076
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(State or other jurisdiction
of
incorporation or organization)
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(I.R.S. Employer Identification No.)
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3300 Hyland Avenue
Costa Mesa, California
(Address of principal
executive offices)
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92626
(Zip Code)
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(714) 545-0100
(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
The number of outstanding shares of the registrants Common
Stock, $0.01 par value, as of August 3, 2006 was 92,980,528.
VALEANT
PHARMACEUTICALS INTERNATIONAL
INDEX
1
PART I
FINANCIAL INFORMATION
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Item 1.
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Financial
Statements
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VALEANT
PHARMACEUTICALS INTERNATIONAL
As of June 30, 2006 and December 31, 2005
(In thousands, except par value data)
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June 30,
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December 31,
|
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2006
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2005
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(Unaudited)
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ASSETS
|
Current Assets:
|
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|
|
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|
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Cash and cash equivalents
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$
|
244,607
|
|
|
$
|
224,856
|
|
Marketable securities
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|
|
8,208
|
|
|
|
10,210
|
|
Accounts receivable, net
|
|
|
201,567
|
|
|
|
187,987
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|
Inventories, net
|
|
|
144,505
|
|
|
|
136,034
|
|
Prepaid expenses and other current
assets
|
|
|
33,118
|
|
|
|
36,652
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
632,005
|
|
|
|
595,739
|
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Property, plant and equipment, net
|
|
|
174,648
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|
|
|
230,126
|
|
Deferred tax assets, net
|
|
|
24,767
|
|
|
|
45,904
|
|
Goodwill
|
|
|
79,977
|
|
|
|
79,486
|
|
Intangible assets, net
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506,117
|
|
|
|
536,319
|
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Other assets
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|
48,781
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|
|
43,176
|
|
Assets of discontinued operations
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|
49
|
|
|
|
127
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
|
|
834,339
|
|
|
|
935,138
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,466,344
|
|
|
$
|
1,530,877
|
|
|
|
|
|
|
|
|
|
|
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LIABILITIES AND
STOCKHOLDERS EQUITY
|
Current Liabilities:
|
|
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|
|
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|
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Trade payables
|
|
$
|
59,587
|
|
|
$
|
55,279
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Accrued liabilities
|
|
|
141,808
|
|
|
|
136,701
|
|
Notes payable and current portion
of long-term debt
|
|
|
487
|
|
|
|
495
|
|
Income taxes
|
|
|
40,648
|
|
|
|
42,452
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
242,530
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|
|
|
234,927
|
|
Long-term debt, less current
portion
|
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|
779,483
|
|
|
|
788,439
|
|
Deferred tax liabilities, net
|
|
|
2,796
|
|
|
|
28,770
|
|
Other liabilities
|
|
|
22,542
|
|
|
|
16,372
|
|
Liabilities of discontinued
operations
|
|
|
23,078
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|
|
|
23,118
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|
|
|
|
|
|
|
|
|
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Total non-current liabilities
|
|
|
827,899
|
|
|
|
856,699
|
|
|
|
|
|
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Commitments and contingencies
|
|
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|
|
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Stockholders Equity:
|
|
|
|
|
|
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|
|
Common stock, $0.01 par
value; 200,000 shares authorized; 92,873 (June 30,
2006) and 92,760 (December 31, 2005) shares
outstanding (after deducting shares in treasury of 1,068 as of
June 30, 2006 and December 31, 2005)
|
|
|
929
|
|
|
|
928
|
|
Additional capital
|
|
|
1,216,908
|
|
|
|
1,203,814
|
|
Accumulated deficit
|
|
|
(809,740
|
)
|
|
|
(743,950
|
)
|
Accumulated other comprehensive
income (loss)
|
|
|
(12,182
|
)
|
|
|
(21,541
|
)
|
|
|
|
|
|
|
|
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|
Total stockholders equity
|
|
|
395,915
|
|
|
|
439,251
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,466,344
|
|
|
$
|
1,530,877
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated condensed financial statements.
2
VALEANT
PHARMACEUTICALS INTERNATIONAL
For the three months and six months ended June 30,
2006 and 2005
(Unaudited, in thousands, except per share data)
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|
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Three Months Ended
|
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Six Months Ended
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|
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|
June 30,
|
|
|
June 30,
|
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|
|
2006
|
|
|
2005
|
|
|
2006
|
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|
2005
|
|
|
Revenues:
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
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Product sales
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$
|
208,517
|
|
|
$
|
180,828
|
|
|
$
|
389,274
|
|
|
$
|
342,631
|
|
Ribavirin royalties
|
|
|
21,635
|
|
|
|
24,206
|
|
|
|
39,726
|
|
|
|
43,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total revenues
|
|
|
230,152
|
|
|
|
205,034
|
|
|
|
429,000
|
|
|
|
386,172
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding
amortization)
|
|
|
65,744
|
|
|
|
52,940
|
|
|
|
124,324
|
|
|
|
101,661
|
|
Selling expenses
|
|
|
66,268
|
|
|
|
61,454
|
|
|
|
130,538
|
|
|
|
114,269
|
|
General and administrative expenses
|
|
|
31,553
|
|
|
|
25,985
|
|
|
|
60,093
|
|
|
|
50,562
|
|
Research and development costs
|
|
|
26,842
|
|
|
|
27,559
|
|
|
|
56,377
|
|
|
|
53,283
|
|
Acquired in-process research and
development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126,399
|
|
Gain on litigation settlement
|
|
|
|
|
|
|
|
|
|
|
(34,000
|
)
|
|
|
|
|
Restructuring charges
|
|
|
53,082
|
|
|
|
(1,324
|
)
|
|
|
79,548
|
|
|
|
371
|
|
Amortization expense
|
|
|
17,514
|
|
|
|
17,211
|
|
|
|
35,037
|
|
|
|
31,179
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
261,003
|
|
|
|
183,825
|
|
|
|
451,917
|
|
|
|
477,724
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
(30,851
|
)
|
|
|
21,209
|
|
|
|
(22,917
|
)
|
|
|
(91,552
|
)
|
Other income (loss), net,
including translation and exchange
|
|
|
757
|
|
|
|
(2,631
|
)
|
|
|
1,694
|
|
|
|
(4,422
|
)
|
Interest income
|
|
|
2,715
|
|
|
|
3,119
|
|
|
|
5,372
|
|
|
|
6,134
|
|
Interest expense
|
|
|
(10,861
|
)
|
|
|
(10,063
|
)
|
|
|
(21,298
|
)
|
|
|
(19,744
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing
operations before income taxes and minority interest
|
|
|
(38,240
|
)
|
|
|
11,634
|
|
|
|
(37,149
|
)
|
|
|
(109,584
|
)
|
Provision (benefit) for income
taxes
|
|
|
6,633
|
|
|
|
10,059
|
|
|
|
13,875
|
|
|
|
26,426
|
|
Minority interest, net
|
|
|
|
|
|
|
134
|
|
|
|
1
|
|
|
|
305
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing
operations
|
|
|
(44,873
|
)
|
|
|
1,441
|
|
|
|
(51,025
|
)
|
|
|
(136,315
|
)
|
Loss from discontinued operations
|
|
|
(197
|
)
|
|
|
(1,988
|
)
|
|
|
(409
|
)
|
|
|
(3,491
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(45,070
|
)
|
|
$
|
(547
|
)
|
|
$
|
(51,434
|
)
|
|
$
|
(139,806
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted income (loss)
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing
operations
|
|
$
|
(0.49
|
)
|
|
$
|
0.02
|
|
|
$
|
(0.55
|
)
|
|
$
|
(1.50
|
)
|
Loss from discontinued operations
|
|
|
(0.00
|
)
|
|
|
(0.03
|
)
|
|
|
(0.00
|
)
|
|
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(0.49
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.55
|
)
|
|
$
|
(1.54
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in per share
computation
|
|
|
92,818
|
|
|
|
92,568
|
|
|
|
92,794
|
|
|
|
90,712
|
|
Dividends paid per share of common
stock
|
|
$
|
0.08
|
|
|
$
|
0.08
|
|
|
$
|
0.16
|
|
|
$
|
0.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared per share of
common stock
|
|
$
|
0.08
|
|
|
$
|
0.08
|
|
|
$
|
0.16
|
|
|
$
|
0.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated condensed financial statements.
3
VALEANT
PHARMACEUTICALS INTERNATIONAL
For the three months and six months ended June 30,
2006 and 2005
(Unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Net loss
|
|
$
|
(45,070
|
)
|
|
$
|
(547
|
)
|
|
$
|
(51,434
|
)
|
|
$
|
(139,806
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
adjustments
|
|
|
(4,643
|
)
|
|
|
(16,378
|
)
|
|
|
10,626
|
|
|
|
(31,740
|
)
|
Unrealized gain (loss) on
marketable equity securities and other
|
|
|
(144
|
)
|
|
|
2,993
|
|
|
|
(1,267
|
)
|
|
|
6,251
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive (loss)
|
|
$
|
(49,857
|
)
|
|
$
|
(13,932
|
)
|
|
$
|
(42,075
|
)
|
|
$
|
(165,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated condensed financial statements.
4
VALEANT
PHARMACEUTICALS
For the six months ended June 30, 2006 and 2005
(Unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$
|
(51,434
|
)
|
|
$
|
(139,806
|
)
|
Loss from discontinued operations
|
|
|
(409
|
)
|
|
|
(3,491
|
)
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(51,025
|
)
|
|
|
(136,315
|
)
|
Adjustments to reconcile net loss
to net cash provided by operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
47,070
|
|
|
|
45,498
|
|
Provision for losses on accounts
receivable and inventory obsolescence
|
|
|
7,671
|
|
|
|
3,805
|
|
Stock compensation expense
|
|
|
10,700
|
|
|
|
1,052
|
|
Translation and exchange (gains)
losses, net
|
|
|
(1,694
|
)
|
|
|
4,422
|
|
Impairment charges and other
non-cash items
|
|
|
67,913
|
|
|
|
1,355
|
|
Acquired in-process research and
development
|
|
|
|
|
|
|
126,399
|
|
Deferred income taxes
|
|
|
(3,787
|
)
|
|
|
(18,215
|
)
|
Change in assets and liabilities,
net of effects of acquisitions:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(11,428
|
)
|
|
|
2,154
|
|
Inventories
|
|
|
(12,435
|
)
|
|
|
(13,518
|
)
|
Prepaid expenses and other assets
|
|
|
(1,933
|
)
|
|
|
3,916
|
|
Trade payables and accrued
liabilities
|
|
|
4,787
|
|
|
|
(21,176
|
)
|
Income taxes payable
|
|
|
(6,442
|
)
|
|
|
21,744
|
|
Other liabilities
|
|
|
1,732
|
|
|
|
1,284
|
|
|
|
|
|
|
|
|
|
|
Cash flow from operating
activities in continuing operations
|
|
|
51,129
|
|
|
|
22,405
|
|
Cash flow from operating
activities in discontinued operations
|
|
|
(418
|
)
|
|
|
(1,129
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating
activities
|
|
|
50,711
|
|
|
|
21,276
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(19,840
|
)
|
|
|
(15,021
|
)
|
Proceeds from sale of assets
|
|
|
8,037
|
|
|
|
5,876
|
|
Proceeds from investments
|
|
|
6,665
|
|
|
|
506,600
|
|
Purchase of investments
|
|
|
(8,900
|
)
|
|
|
(299,672
|
)
|
Acquisition of businesses, license
rights and product lines
|
|
|
(2,932
|
)
|
|
|
(281,781
|
)
|
|
|
|
|
|
|
|
|
|
Cash flow from investing
activities in continuing operations
|
|
|
(16,970
|
)
|
|
|
(83,998
|
)
|
Cash flow from investing
activities in discontinued operations
|
|
|
(1
|
)
|
|
|
(132
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities
|
|
|
(16,971
|
)
|
|
|
(84,130
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
Payments on long-term debt and
notes payable
|
|
|
(6,137
|
)
|
|
|
(708
|
)
|
Proceeds capitalized lease
financing
|
|
|
578
|
|
|
|
|
|
Stock option exercises and
employee stock purchases
|
|
|
2,395
|
|
|
|
1,646
|
|
Proceeds from stock offering
|
|
|
|
|
|
|
189,030
|
|
Dividends paid
|
|
|
(14,354
|
)
|
|
|
(13,650
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
financing activities
|
|
|
(17,518
|
)
|
|
|
176,318
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on
cash and cash equivalents
|
|
|
3,501
|
|
|
|
(9,033
|
)
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash
and cash equivalents
|
|
|
19,723
|
|
|
|
104,431
|
|
Cash and cash equivalents at
beginning of period
|
|
|
224,903
|
|
|
|
222,719
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end
of period
|
|
|
244,626
|
|
|
|
327,150
|
|
Cash and cash equivalents
classified as part of discontinued operations
|
|
|
(19
|
)
|
|
|
(995
|
)
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents of
continuing operations
|
|
$
|
244,607
|
|
|
$
|
326,155
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated condensed financial statements.
5
In the consolidated condensed financial statements included
herein, we, us, our,
Valeant and the Company refer to Valeant
Pharmaceuticals International and its subsidiaries. The
condensed consolidated financial statements have been prepared
by the Company, without audit, pursuant to the rules and
regulations of the Securities and Exchange Commission
(SEC). Certain information and footnote disclosures
normally included in financial statements prepared on the basis
of accounting principles generally accepted in the United States
of America have been condensed or omitted pursuant to such rules
and regulations. The results of operations presented herein are
not necessarily indicative of the results to be expected for a
full year. Although we believe that all adjustments (consisting
only of normal, recurring adjustments) necessary for a fair
presentation of the interim periods presented are included and
that the disclosures are adequate to make the information
presented not misleading, these consolidated condensed financial
statements should be read in conjunction with the consolidated
financial statements and notes thereto included in the
Companys Annual Report on
Form 10-K
for the year ended December 31, 2005.
|
|
1.
|
Organization
and Summary of Significant Accounting Policies
|
Organization: We are a global specialty
pharmaceutical company that develops, manufactures and markets a
broad range of pharmaceutical products. In addition, we generate
royalty revenues from the sale of ribavirin by Schering-Plough
Ltd. (Schering-Plough) and F. Hoffman-LaRoche
(Roche).
Principles of Consolidation: The accompanying
consolidated condensed financial statements include the accounts
of Valeant Pharmaceuticals International, its wholly owned
subsidiaries and all of its majority-owned subsidiaries.
Minority interest in results of operations of consolidated
subsidiaries represents the minority stockholders share of
the income or loss of the consolidated subsidiaries. All
significant intercompany account balances and transactions have
been eliminated.
Marketable Securities: We invest in
investment-grade securities and classify these securities as
available-for-sale
as they typically have maturities of one year or less and are
highly liquid. As of June 30, 2006 and December 31,
2005, the fair market value of these securities approximated
cost.
Acquired In-Process Research and Development
(IPR&D): We value IPR&D
acquired in a business combination based on an approach
consistent with the AICPA Practice Aid, Assets Acquired in a
Business Combination to Be Used in Research and Development
Activities: A Focus on Software, Electronic Devices, and
Pharmaceutical Industries. Amounts expensed as IPR&D
represent an estimate of the fair value of purchased in-process
technology for projects that, as of the acquisition date, had
not yet reached technological feasibility and had no alternative
future use. The data used to determine fair value requires
significant judgment. Differences in these judgments would have
the impact of changing the allocation of purchase price to
goodwill, which is an intangible asset that is not amortized.
The estimated fair value of these projects is based on the use
of a discounted cash flow model (based on an estimate of future
sales). For each project, the estimated after-tax cash flows
(using a tax rate of 35%) are probability-weighted to take
account of the stage of completion and the risks surrounding
successful development and commercialization. These cash flows
are then discounted to a present value using a discount rate
which is estimated from our after-tax, adjusted weighted average
cost of capital.
The major risks and uncertainties associated with the timely and
successful completion of these 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. In addition, no assurance can be given that the
underlying assumptions used to forecast the cash flows or the
timely and successful completion of such projects will
materialize as estimated. For these reasons, among others,
actual results may vary significantly from the estimated results.
6
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
Derivative Financial Instruments: Our
accounting policies for derivative instruments are based on
whether they meet our criteria for designation as hedging
transactions, either as cash flow or fair value hedges. Our
derivative instruments are recorded at fair value and are
included in other current assets, other assets, accrued
liabilities or debt. For hedging transactions, changes in the
fair value of the hedged item are either offset against the
change in the fair value of the hedged item through earnings or
recognized in other comprehensive income until the hedged item
is recognized in earnings.
Comprehensive Income: We have adopted the
provisions of Statement of Financial Accounting Standards
(SFAS) No. 130, Reporting Comprehensive
Income. Accumulated other comprehensive loss consists of
accumulated foreign currency translation adjustments, unrealized
losses on marketable equity securities, minimum pension
liability and changes in the fair value of derivative financial
instruments.
Per Share Information: Basic earnings per
share are computed by dividing income available to common
stockholders by the weighted-average number of common shares
outstanding. In computing diluted earnings per share, the
weighted-average number of common shares outstanding is adjusted
to reflect the effect of potentially dilutive securities
including options, warrants, and convertible debt; income
available to common stockholders is adjusted to reflect any
changes in income or loss that would result from the issuance of
the dilutive common shares.
Stock-Based Compensation Expense: On
January 1, 2006, we adopted Statement of Financial
Accounting Standards No. 123 (revised 2004),
Share-Based Payment, (SFAS 123(R))
utilizing the prospective transition method. SFAS 123(R)
requires companies to estimate the fair value of share-based
payment awards on the date of grant using an option-pricing
model. The value of the portion of the award that is ultimately
expected to vest is recognized as expense over the requisite
service periods in the consolidated condensed statement of
operations. In prior years, we accounted for stock-based awards
to employees and directors using the intrinsic value method
under which stock-based compensation was not recorded as an
expense other than that related to restricted stock unit grants.
We have determined the value of stock option grants using the
Black-Scholes option-pricing model (Black-Scholes
model). Our determination of fair value of share-based
payment awards on the date of grant using an option-pricing
model is affected by our stock price as well as assumptions
regarding a number of highly complex and subjective variables.
These variables include, but are not limited to our expected
stock price volatility over the term of the awards, and actual
and projected employee stock option exercise behaviors (See
Note 8). The value of stock options that are expected to
vest is amortized to expense using the graded vesting method
over the vesting period of each stock option granted.
Previously, for purposes of the disclosure only calculations
under SFAS 123, the aggregate value of stock option grants
was amortized to expense on a straight-line basis.
Compensation expense associated with our stock-based employee
incentive programs is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Three Months Ended June 30,
|
|
|
Ended June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Employee stock options
|
|
$
|
4,483
|
|
|
$
|
|
|
|
$
|
9,408
|
|
|
$
|
|
|
Employee Stock Purchase Plan
|
|
|
148
|
|
|
|
|
|
|
|
268
|
|
|
|
|
|
Restricted stock grants
|
|
|
387
|
|
|
|
544
|
|
|
|
1,024
|
|
|
|
1,052
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock compensation expense
|
|
$
|
5,018
|
|
|
$
|
544
|
|
|
$
|
10,700
|
|
|
$
|
1,052
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Had we applied SFAS 123(R) in 2005, compensation expense
would have increased by $5,073,000 and $10,122,000 in the
three-month and six-month periods ended June 30, 2005,
respectively. This would have increased the reported net losses
to $5,620,000 and $149,832,000 or $.06 and $1.65 per share
in the three-month and six-month periods ended June 30,
2005, respectively.
Income tax benefits in the United States that are associated
with the our stock option programs and stock compensation
expense have been recorded net of a completely offsetting
valuation allowance because, at this time,
7
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
there is insufficient objective evidence to assure that we will
have sufficient U.S. taxable income to realize such
benefits.
Recent
Accounting Pronouncement
In June 2006, the Financial Accounting Standards Board
(FASB) issued FASB Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an
interpretation of FASB Statement No. 109
(FIN 48), which prescribes accounting for and
disclosure of uncertainty in tax positions. This interpretation
defines the criteria that must be met for the benefits of a tax
position to be recognized in the financial statements and the
measurement of tax benefits recognized. The provisions of
FIN 48 are effective as of the beginning of the
Companys 2007 fiscal year, with the cumulative effect of
the change in accounting principle recorded as an adjustment to
opening retained earnings. We are currently evaluating the
impact of adopting FIN 48 on our consolidated financial
statements.
Dividends: We have paid quarterly cash
dividends of $0.0775 per share for each quarter in 2005 and
the first two quarters of 2006. However, we cannot assure that
we will continue to do so.
Use of Estimates: The preparation of financial
statements in conformity with accounting principles generally
accepted in the United States of America requires us to make
estimates and assumptions that affect the reported amount of
assets and liabilities, the disclosure of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting
periods. Actual results could differ materially from those
estimates.
On April 3, 2006, we announced a restructuring program to
reduce costs and accelerate earnings growth.
The program is primarily focused on our research and development
and manufacturing operations. The objective of the restructuring
program as it relates to research and development activities is
to focus our efforts and expenditures on two late stage projects
currently in development. The restructuring program is designed
to rationalize our investments in research and development
efforts in line with our financial resources. We intend to sell
rights to, out-license or secure partners to share the costs of
other major clinical projects and discovery programs that the
research and development division has underway. Also as a result
of the restructuring of our research and development activities,
we are exploring the sale of our headquarters facility where our
research laboratories are located. At this time, no loss is
anticipated in the sale of this facility. The objective of the
restructuring program as it relates to manufacturing is to
further rationalize our manufacturing operations to reflect the
regional nature of our existing products and further reduce our
excess capacity after considering the delay in the launch of
Viramidine (taribavirin).
The restructuring program is expected to reduce selling, general
and administrative expenses primarily through consolidation of
the management functions in fewer administrative groups to
achieve greater economies of scale. Management and
administrative responsibilities for our regional operations in
Australia, Africa and Asia (AAA), which had been
managed as a separate business unit, have been combined with
those of other regions.
We recorded a charge of $53,082,000 in the three months ended
June 30, 2006 in connection with our decision to implement
the restructuring program. The severance charges recorded in the
three months ended June 30, 2006 of $5,369,000 relate to
employees whose positions were eliminated in the restructuring.
In the first and second quarters of 2006, 135 employees have
been severed.
These charges also include the impairment charges related to
estimated future losses that may occur upon the disposition of
specific assets related to our manufacturing operations in
Switzerland and Puerto Rico, as well as assets of other
operations that we expect will be sold or abandoned. These
restructuring charges also include employee severance costs
resulting from a reduction of 135 employees in the first six
months of 2006. When completed, we anticipate that approximately
750 employees in total will be impacted by the restructuring,
the
8
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
majority of whom work in the two manufacturing facilities
selected for disposition. The following table summarizes the
restructuring costs incurred in the first and second quarters of
2006. Cash-related charges relate to severance payments and
other costs which have been either paid with cash expenditures
or have been accrued and will be paid with cash in future
quarters.
Restructuring
Charge Details
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2006
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Employee Severances
(135 Employees)
|
|
$
|
6,644
|
|
|
$
|
5,369
|
|
|
$
|
12,013
|
|
Contract cancellation and other
cash costs
|
|
|
|
|
|
|
992
|
|
|
|
992
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subtotal: Cash-related Charges
|
|
|
6,644
|
|
|
|
6,361
|
|
|
|
13,005
|
|
Abandoned software and other
capital assets
|
|
|
19,822
|
|
|
|
3,031
|
|
|
|
22,853
|
|
Impairment of manufacturing assets
|
|
|
|
|
|
|
43,690
|
|
|
|
43,690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subtotal: Non-cash charges
|
|
|
19,822
|
|
|
|
46,721
|
|
|
|
66,543
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total:
|
|
$
|
26,466
|
|
|
$
|
53,082
|
|
|
$
|
79,548
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation
of Cash Restructuring Payments with Restructuring
Accrual
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Opening Accrual
|
|
$
|
|
|
|
$
|
5,425
|
|
Cash Charges
|
|
|
6,644
|
|
|
|
5,369
|
|
Cash Paid
|
|
|
(1,219
|
)
|
|
|
(3,235
|
)
|
|
|
|
|
|
|
|
|
|
Closing Accrual
|
|
$
|
5,425
|
|
|
$
|
7,559
|
|
|
|
|
|
|
|
|
|
|
We have recorded impairment charges of $18,576,000 related to
our manufacturing plant in Humacao, Puerto Rico and $25,114,000
related to a manufacturing plant in Birsfelden, Switzerland in
the three months ended June 30, 2006. We are continuing to
develop specific plans for the sale of these facilities which is
expected to be completed within 12 to 18 months.
Restructuring charges in the three- and six-month periods ended
June 30, 2005 relate to the decision to dispose of the
Companys manufacturing facility in China offset in part by
the gain on the sale of a manufacturing plant in Argentina.
Infergen: On December 30, 2005, we
acquired the United States and Canadian rights to the Infergen
business of InterMune, Inc. Infergen is indicated for the
treatment of hepatitis C in patients who have not responded
to other treatments or have relapsed after such treatment. In
connection with this transaction we acquired the rights to the
Infergen product as currently approved by the FDA and rights to
a clinical trial underway to expand the clinical
9
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
applications of Infergen. We also employed certain individuals
from InterMune and acquired third party contracts for the
manufacture of Infergen. We paid InterMune consideration of
$120,000,000 in cash at the closing. Additionally, we have
agreed to pay up to an additional $22,400,000 of which
$20,000,000 is contingent on certain milestones being reached.
As part of the transaction, we assumed a contract with Amgen for
the manufacture of Infergen which requires that we acquire
specific levels of supply through the term of the agreement. As
a result of the timing of these required purchases, we expect to
see an increase in the level of our finished goods inventories
through 2006. In addition, we assumed a contract for transfer of
Infergen manufacturing. Under the contract, we are obligated to
pay a new third party supplier up to approximately $12,400,000
upon the attainment of separate milestones tied to the
manufacturing process transfer.
Xcel Pharmaceuticals, Inc.: On March 1,
2005, we acquired Xcel, a specialty pharmaceutical company
focused on the treatment of disorders of the central nervous
system for $280,000,000 in cash and transaction costs of
approximately $5,400,000. Under the terms of the purchase
agreement, we paid an additional $7,470,000 for a working
capital adjustment. Xcels portfolio consisted of four
products that are sold within the United States, and retigabine,
a late-stage clinical product candidate that is an adjunctive
treatment for partial-onset seizures in patients with epilepsy.
Approximately $44,000,000 of the cash consideration was used to
retire Xcels outstanding long-term debt.
In connection with the Xcel acquisition, we completed an
offering of 8,280,000 shares of our common stock in
February 2005. After underwriting discounts and commissions, we
received net proceeds of $189,393,000, which were used to
partially fund the Xcel acquisition. The remainder of the funds
required for the Xcel acquisition was provided by existing cash
on hand and other investments.
A portion of the purchase price for the Xcel acquisition was
placed in an escrow account to cover potential claims under the
purchase agreement that would arise within one year of the
acquisition date. Prior to such date, we filed a claim for
indemnification from the former Xcel stockholders with respect
to certain breaches of representation and warranties made by
Xcel under the Xcel purchase agreement relating to Medicaid
rebates on preacquisition sales and certain third-party claims.
As of June 30, 2006, approximately $5,116,000 of the Xcel
purchase price was in an escrow fund to pay indemnification
claims.
The following unaudited pro forma financial information presents
the combined results of operations of Valeant, Infergen and Xcel
for the three- and six- month periods ended June 30, 2005
as if the acquisitions had occurred as of January 1, 2005.
The unaudited pro forma financial information is not intended to
represent or be indicative of the Companys consolidated
results of operations or financial condition that would have
been reported had the acquisitions been completed as of
January 1, 2005, and should not be taken as representative
of our future consolidated results of operations or financial
condition (in thousands except per share information).
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2005
|
|
|
2005
|
|
|
Net revenues
|
|
$
|
212,412
|
|
|
$
|
412,883
|
|
Loss from continuing operations
|
|
|
(12,367
|
)
|
|
|
(207,889
|
)
|
Net loss
|
|
|
(14,355
|
)
|
|
|
(211,380
|
)
|
Basic and diluted net loss per
share:
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(0.13
|
)
|
|
$
|
(2.25
|
)
|
Net loss
|
|
$
|
(0.16
|
)
|
|
$
|
(2.28
|
)
|
The above pro forma financial information includes charges for
acquired in-process research and development of $126,399,000
with respect to Xcel and $47,200,000 with respect to Infergen
and adjustments for amortization of identifiable intangible
assets acquired and interest expense as a result of the
retirement of Xcels long-term debt. The effect of the
IPR&D charges of Xcel and Infergen on the pro forma loss per
share is $1.89.
10
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
|
|
4.
|
Discontinued
Operations
|
In the second half of 2002, we made a strategic decision to
divest our Photonics business, Circe unit, Russian
Pharmaceuticals segment, biomedicals segment, raw materials
businesses, and manufacturing facilities in Central Europe.
During 2003, we disposed of the Russian Pharmaceuticals segment,
biomedicals segment, Photonics business and Circe unit. During
2004, we disposed of one of the raw materials businesses and
manufacturing facilities in Central Europe. During 2005 we
completed the sale of the remaining raw materials business and
manufacturing facility in Central Europe. In 2006 losses from
discontinued operations primarily consist of disposal of one
facility requiring environmental remediation and the wind down
of administrative activities associated with these operations.
Summarized selected financial information for discontinued
operations for the three and six months ended June 30, 2006
and 2005 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Revenues
|
|
$
|
|
|
|
$
|
5,630
|
|
|
$
|
|
|
|
$
|
7,722
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
$
|
(82
|
)
|
|
$
|
(2,421
|
)
|
|
$
|
(325
|
)
|
|
$
|
(3,706
|
)
|
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations,
net
|
|
|
(82
|
)
|
|
|
(2,421
|
)
|
|
|
(325
|
)
|
|
|
(3,706
|
)
|
Income (loss) on disposal of
discontinued operation
|
|
|
(114
|
)
|
|
|
433
|
|
|
|
(83
|
)
|
|
|
215
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued
operations
|
|
$
|
(197
|
)
|
|
$
|
(1,988
|
)
|
|
$
|
(409
|
)
|
|
$
|
(3,491
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The assets and liabilities of discontinued operations are stated
separately as of June 30, 2006 and December 31, 2005
on the accompanying consolidated condensed balance sheets. The
major assets and liabilities categories are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Cash
|
|
$
|
19
|
|
|
$
|
47
|
|
Accounts receivable, net
|
|
|
30
|
|
|
|
45
|
|
Property, plant and equipment, net
|
|
|
|
|
|
|
18
|
|
Other assets
|
|
|
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
Assets of discontinued operations
|
|
$
|
49
|
|
|
$
|
127
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
7
|
|
|
$
|
13
|
|
Accrued liabilities
|
|
|
18,888
|
|
|
|
19,118
|
|
Other liabilities
|
|
|
4,183
|
|
|
|
3,987
|
|
|
|
|
|
|
|
|
|
|
Liabilities of discontinued
operations
|
|
$
|
23,078
|
|
|
$
|
23,118
|
|
|
|
|
|
|
|
|
|
|
Environmental contamination has been identified in the soil
under a facility built by the Company which housed operations of
the discontinued biomedicals segment and is currently vacant.
Remediation of the site will involve excavation and disposal of
the waste at appropriately licensed sites. Environmental
reserves have been provided for remediation and related costs
that we can reasonably estimate. Remediation costs are applied
against these environmental reserves as they are incurred. As
assessments and remediation progress, these liabilities will be
reviewed and adjusted to reflect additional information that
becomes available. Total environmental reserves for this site
were $18,792,000 and $19,023,000 as of June 30, 2006 and
December 31, 2005, respectively, and are included in the
liabilities of discontinued operations. Although we believe that
the reserves are adequate, there can
11
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
be no assurance that the amount of expenditures and other
expenses, which will be required relating to remediation actions
and compliance with applicable environmental laws will not
exceed the amounts reflected in reserves or will not have a
material adverse effect on our consolidated financial condition,
results of operations or cash flows. Any possible loss that may
be incurred in excess of amounts provided for as of
June 30, 2006 cannot be reasonably estimated.
The following table sets forth the computation of basic and
diluted earnings per share (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for basic and dilutive
earnings per share loss to stockholders
|
|
$
|
(45,070
|
)
|
|
$
|
(547
|
)
|
|
$
|
(51,434
|
)
|
|
$
|
(139,806
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic and dilutive
earnings per share adjusted weighted-average shares
after assumed conversions
|
|
|
92,818
|
|
|
|
92,568
|
|
|
|
92,794
|
|
|
|
90,712
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted income (loss)
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing
operations
|
|
$
|
(0.49
|
)
|
|
$
|
0.02
|
|
|
$
|
(0.55
|
)
|
|
$
|
(1.50
|
)
|
Loss from discontinued operations
|
|
|
(0.00
|
)
|
|
|
(0.03
|
)
|
|
|
(0.00
|
)
|
|
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
(0.49
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.55
|
)
|
|
$
|
(1.54
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, 2006 and 2005, options
to purchase 1,723,000 and 2,149,000 weighted average shares of
common stock, respectively, were not included in the computation
of earnings per share because we incurred a loss and the effect
would have been anti-dilutive. For the six months ended
June 30, 2006 and 2005, options to purchase 1,733,000 and
2,505,000 weighted average shares of common stock, respectively,
were not included in the computation of earnings per share
because we incurred a loss and the effect would have been
anti-dilutive.
For the three months ended June 30, 2006 and 2005, options
to purchase 9,246,000 and 4,452,000 weighted average shares of
common stock, respectively, were also not included in the
computation of earnings per share because the option exercise
prices were greater than the average market price of the
Companys common stock and, therefore, the effect would
have been anti-dilutive. For the six months ended June 30,
2006 and 2005, options to purchase 9,277,000 and 4,320,000
weighted average shares of common stock, respectively, were also
not included in the computation of earnings per share because
the option exercise prices were greater than the average market
price of the Companys common stock and, therefore, the
effect would have been anti-dilutive.
12
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
|
|
6.
|
Detail of
Certain Accounts
|
The following tables present the details of certain amounts
included in the consolidated balance sheet at June 30, 2006
and December 31, 2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Accounts receivable,
net:
|
|
|
|
|
|
|
|
|
Trade accounts receivable
|
|
$
|
154,297
|
|
|
$
|
149,017
|
|
Royalties receivable
|
|
|
22,888
|
|
|
|
27,306
|
|
Other receivables
|
|
|
29,567
|
|
|
|
17,149
|
|
|
|
|
|
|
|
|
|
|
|
|
|
206,752
|
|
|
|
193,472
|
|
Allowance for doubtful accounts
|
|
|
(5,185
|
)
|
|
|
(5,485
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
201,567
|
|
|
$
|
187,987
|
|
|
|
|
|
|
|
|
|
|
Inventories, net:
|
|
|
|
|
|
|
|
|
Raw materials and supplies
|
|
$
|
37,176
|
|
|
$
|
34,931
|
|
Work-in-process
|
|
|
26,875
|
|
|
|
28,726
|
|
Finished goods
|
|
|
97,105
|
|
|
|
85,152
|
|
|
|
|
|
|
|
|
|
|
|
|
|
161,156
|
|
|
|
148,809
|
|
Allowance for inventory
obsolescence
|
|
|
(16,651
|
)
|
|
|
(12,775
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
144,505
|
|
|
$
|
136,034
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment,
net:
|
|
|
|
|
|
|
|
|
Property, plant and equipment, at
cost
|
|
$
|
389,239
|
|
|
$
|
401,613
|
|
Accumulated depreciation and
amortization
|
|
|
(214,591
|
)
|
|
|
(171,487
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
174,648
|
|
|
$
|
230,126
|
|
|
|
|
|
|
|
|
|
|
Intangible assets: As of June 30, 2006
and December 31, 2005, intangible assets were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006
|
|
|
December 31, 2005
|
|
|
|
Gross
|
|
|
Accumulated
|
|
|
Gross
|
|
|
Accumulated
|
|
|
|
Amount
|
|
|
Amortization
|
|
|
Amount
|
|
|
Amortization
|
|
|
Intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights
|
|
$
|
769,601
|
|
|
$
|
(287,213
|
)
|
|
$
|
763,652
|
|
|
$
|
(257,379
|
)
|
License agreement
|
|
|
67,376
|
|
|
|
(43,647
|
)
|
|
|
67,376
|
|
|
|
(37,330
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$
|
836,977
|
|
|
$
|
(330,860
|
)
|
|
$
|
831,028
|
|
|
$
|
(294,709
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense for the three and six months ended
June 30, 2006 was $17,514,000 and $35,037,000,
respectively, of which $14,357,000 and $28,720,000,
respectively, related to amortization of acquired product rights.
We incur losses in the U.S. where our research and
development activities are conducted and our corporate offices
are located. We anticipate that we will realize the tax benefits
associated with these losses through offsetting such losses
against future taxable income resulting from products in our
development pipeline, further growth in US product sales and
other measures. However, at this time, there is insufficient
objective evidence of the timing and
13
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
amounts of such future U.S. taxable income to assure
realization of the tax benefits, and valuation allowances have
been established to reserve those benefits. The increase in the
valuation allowance for the six months ended June 30, 2006
was approximately $15,736,000 resulting in a provision for
income taxes of $13,875,000 for this period. The income tax
provision primarily represents the taxes payable on earnings in
tax jurisdictions outside the U.S., net of tax benefits outside
the U.S. resulting from restructuring charges, foreign
withholding taxes, interest on U.S. liabilities recorded in
connection with the 1997 through 2001 IRS examination and state
and local taxes.
Our effective tax rate for the six months ended June 30,
2005 was affected by pre-tax losses resulting from a
restructuring charge of $1,695,000 and the write-off of acquired
IPR&D expenses in connection with the Xcel acquisition of
$126,399,000. These charges are not deductible for income tax
purposes. The tax provision in the six months ended
June 30, 2005 relates to the expected taxes on earnings in
tax jurisdictions outside the U.S., net of valuation allowance
adjustments, plus recording a liability for the 1997 through
2001 IRS examination.
The adjustments related to the 1997 through 2001 IRS examination
are being challenged through the IRS appeals process.
One of our Singapore subsidiaries has borrowed money from one of
our U.S. subsidiaries. A Singapore withholding tax applies
to the interest payments that accrue under this intercompany
lending arrangement. The liability for these payments that arose
in 2004, 2005 and the first and second quarters of 2006 is
recorded as a component of income tax expense for the three
months ended June 30, 2006, with no corresponding
U.S. tax benefit due to valuation allowances having been
established. These amounts are $206,000, $964,000, $300,000, and
$307,000, respectively.
In 2002, the Company failed to withhold U.S. federal taxes
on the fees, bonus amounts and the value of stock options
subject to accelerated vesting which were paid to an individual
who was then a member of the Board of Directors, and who was a
resident of Switzerland. The amount that should have been
withheld is $740,000. With interest, the amount due the
U.S. Government at June 30, 2006 is $920,000. The
charge associated with this liability has been recorded as a
component of general and administrative expense for the three
months ended June 30, 2006.
|
|
8.
|
Common
Stock and Share Compensation
|
We have two stockholder-approved programs designed for the
purpose of providing equity incentives to our directors,
officers and employees. Both programs are designed to align the
incentives of our management and employees with increasing
shareholder value.
2006 Equity Incentive Plan: The 2006 Equity
Incentive Plan (the 2006 Plan) was approved by
stockholders in May 2006 and is the successor to and
continuation of our 2003 Equity Incentive Plan. The 2006 Plan
increased the number of shares of common stock available for
issuance by 4,200,000 shares. The 2006 Plan provides for
the grant of incentive stock options, nonqualified stock
options, restricted stock awards, restricted stock unit awards,
stock appreciation rights, performance stock awards and other
forms of equity compensation, as well as performance cash awards
to employees (including officers), consultants, and directors of
our Company and our affiliates. Options granted under the 2006
Plan must have an exercise price that is not less than 100% of
the fair market value of the common stock on the date of grant
and a term not exceeding 10 years (except that in certain
cases, the maximum term is five years). Generally, options vest
ratably over a four-year period from the date of grant. Under
the 2006 Plan, 500,000 shares may be issued as phantom
stock awards or restricted stock awards for which a participant
pays less than the fair market value of the common stock on the
date of grant.
14
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
Stock Options Issued Under our Equity Incentive
Plans: The following table sets forth information
relating to stock options issued under our equity incentive
plans (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
Number of
|
|
|
Exercise
|
|
|
|
Shares
|
|
|
Price
|
|
|
Shares under option,
December 31, 2004
|
|
|
13,336
|
|
|
|
17.93
|
|
Granted
|
|
|
2,192
|
|
|
|
18.16
|
|
Exercised
|
|
|
(160
|
)
|
|
|
20.10
|
|
Canceled
|
|
|
(736
|
)
|
|
|
22.28
|
|
|
|
|
|
|
|
|
|
|
Shares under option,
December 31, 2005
|
|
|
14,632
|
|
|
|
17.80
|
|
Granted
|
|
|
152
|
|
|
|
17.14
|
|
Exercised
|
|
|
(114
|
)
|
|
|
12.78
|
|
Canceled
|
|
|
(828
|
)
|
|
|
16.83
|
|
|
|
|
|
|
|
|
|
|
Shares Under Option,
June 30, 2006
|
|
|
13,842
|
|
|
$
|
17.66
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31,
2005
|
|
|
7,197
|
|
|
$
|
17.82
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2006
|
|
|
7,675
|
|
|
$
|
17.28
|
|
|
|
|
|
|
|
|
|
|
Options available for grant at
December 31, 2005
|
|
|
513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options available for grant at
June 30, 2006
|
|
|
5,358
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The schedule below reflects the number of outstanding and
exercisable options as of June 30, 2006 segregated by price
range (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
|
|
|
Exercisable
|
|
|
Weighted
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
|
Number
|
|
|
Exercise
|
|
|
Number
|
|
|
Exercise
|
|
|
Contractual
|
|
Range of Exercise Prices
|
|
of Shares
|
|
|
Price
|
|
|
of Shares
|
|
|
Price
|
|
|
Life (Years)
|
|
|
$8.10 to $13.83
|
|
|
4,726
|
|
|
$
|
10.32
|
|
|
|
3,632
|
|
|
$
|
10.34
|
|
|
|
6.47
|
|
$14.99 to $18.55
|
|
|
4,894
|
|
|
$
|
17.99
|
|
|
|
1,581
|
|
|
$
|
18.19
|
|
|
|
8.14
|
|
$18.70 to $46.25
|
|
|
4,222
|
|
|
$
|
25.50
|
|
|
|
2,462
|
|
|
$
|
26.94
|
|
|
|
6.86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,842
|
|
|
|
|
|
|
|
7,675
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value of options granted in 2006 and 2005 was estimated
at the date of grant using the Black-Scholes option-pricing
model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
2005
|
|
|
Weighted-average life (years)
|
|
|
4.1
|
|
|
|
4.1
|
|
Volatility
|
|
|
38
|
%
|
|
|
41
|
%
|
Expected dividend per share
|
|
$
|
0.31
|
|
|
$
|
0.31
|
|
Risk-free interest rate
|
|
|
4.88
|
%
|
|
|
4.33
|
%
|
Weighted-average fair value of
options
|
|
$
|
5.47
|
|
|
$
|
6.10
|
|
The aggregate intrinsic value of the stock options outstanding
at June 30, 2006 was $31,567,000. The aggregate intrinsic
value of the stock options that are both outstanding and
exercisable at June 30, 2006 was $24,110,000. During the
six months ended June 30, 2006 stock options with an
aggregate intrinsic value of $504,000 were exercised. Intrinsic
value is the in the money valuation of the options
or the difference between
15
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
market and exercise prices. The fair value of options that
vested in the six months ended June 30, 2006 as determined
using the Black Scholes valuation model, was $5,635,000.
Restricted Stock Units Issued Under our Incentive
Plan: During 2006 and 2005, pursuant to our
approved director compensation plan, we granted our non-employee
directors 57,416 and 57,465 shares of restricted stock
units, respectively. Additionally in 2005 we granted certain
officers of the Company, in the aggregate, 90,000 restricted
stock units. The restricted stock units issued had a fair value
(equal to the market price of the Companys stock on the
grant date) of $960,000 and $2,752,000 in 2006 and 2005,
respectively. Each restricted stock unit granted to non-employee
directors vests over one year, is entitled to dividend
equivalent shares and is exchanged for a share of the
Companys common stock one year after the director ceases
to serve as a member of the Companys Board. Each
restricted stock unit granted to certain officers of the company
vests 50 percent three years after grant with the balance
vesting equally in years four and five after grant, is entitled
to dividend-equivalent shares and is exchanged for a share of
the Companys common stock upon vesting. As of
June 30, 2006 and December 31, 2005, there were
281,216 and 242,000 restricted stock units outstanding,
respectively.
2003 Employee Stock Purchase Plan: In
May 2003, our stockholders approved the Valeant Pharmaceuticals
International 2003 Employee Stock Purchase Plan (the
ESPP). The ESPP provides employees with an
opportunity to purchase common stock at a 15% discount to market
price. Additionally, the market prices under the ESPP program
are the lower of the Companys stock price at the beginning
or end of each six-month ESPP enrollment period. There are
7,000,000 shares of common stock reserved for issuance
under the Purchase Plan, plus an annual increase on the first
day of our fiscal year for a period of ten years, ending on
January 1, 2015, equal to the lower of (i) 1.5% of the
shares of common stock outstanding on each calculation date,
(ii) 1,500,000 shares of common stock, or (iii) a
number of shares that may be determined by the Compensation
Committee. In the year ending 2005, we issued
100,000 shares of common stock for proceeds of $1,644,000.
In the three-month period ended June 30, 2006,
63,880 shares were issued. Under SFAS 123(R) we
recorded $149,000 and $268,000 as compensation expense in the
three and six month periods ended June 30, 2006,
respectively, for shares expected to be purchased under this
plan. This amount consists of the 15% discount to market price
offered to participating employees under the ESPP plus the
additional value, determined under the Black-Scholes model, of
the plan feature allowing purchased share price to be based on
the lower of the Companys share price at the beginning or
end of each ESPP enrollment period.
The components of stock compensation expense and the amounts of
future expense that relate to outstanding but unvested stock
options and restricted stock awards are set forth in the table
below (amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
To Be
|
|
|
|
Recorded as
|
|
|
Recorded as
|
|
|
|
Expense in the
|
|
|
Expense in
|
|
|
|
Six Months Ended
|
|
|
Future
|
|
|
|
June 30, 2006
|
|
|
Periods
|
|
|
Employee stock options
|
|
$
|
9,408
|
|
|
$
|
18,809
|
|
Phantom and restricted stock units
|
|
|
1,024
|
|
|
|
1,970
|
|
Employee stock purchase plan
|
|
|
268
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation
expense
|
|
$
|
10,700
|
|
|
$
|
20,779
|
|
|
|
|
|
|
|
|
|
|
16
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
Stock compensation expense for the three months and six months
ended June 30, 2006 was recorded in the following expense
classifications:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30, 2006
|
|
|
June 30, 2006
|
|
|
Cost of goods sold
|
|
$
|
352
|
|
|
$
|
765
|
|
Selling expenses
|
|
|
858
|
|
|
|
1,705
|
|
General and administrative expenses
|
|
|
3,050
|
|
|
|
6,692
|
|
Research and development costs
|
|
|
758
|
|
|
|
1,538
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
5,018
|
|
|
$
|
10,700
|
|
|
|
|
|
|
|
|
|
|
The amounts of future stock compensation expense associated with
outstanding stock options and restricted stock units is
scheduled to be charged to expense as follows:
|
|
|
|
|
Remainder of 2006
|
|
$
|
8,284
|
|
2007
|
|
|
8,492
|
|
2008
|
|
|
3,188
|
|
2009 and thereafter
|
|
|
815
|
|
|
|
|
|
|
|
|
$
|
20,779
|
|
|
|
|
|
|
|
|
9.
|
Legal
Proceedings and Contingencies
|
We are involved in several legal proceedings, including the
following matters (Valeant was formerly known as ICN
Pharmaceuticals, Inc.):
Securities
Class Actions:
Section 10b-5
Litigation: Since July 25, 2002, multiple
class actions were filed against us and some of our current and
former executive officers alleging that the defendants violated
Sections 10(b) and 20(a) of the Securities Exchange Act of
1934, and
Rule 10b-5
promulgated thereunder, by issuing false and misleading
financial results to the market during different class periods
ranging from May 3, 2001 to July 10, 2002, thereby
artificially inflating the price of our stock. The lawsuits
generally claimed that we issued false and misleading statements
regarding our earnings prospects and sales figures (based upon
channel stuffing allegations), our operations in
Russia, the marketing of Efudex, and the earnings and sales of
our Photonics division. The plaintiffs generally sought to
recover compensatory damages, including interest.
All the actions have been consolidated to the Central District
of California. On June 24, 2004, the court dismissed the
Second Amended Complaint as to the channel stuffing claim. The
plaintiffs then stipulated to a dismissal of all the claims
against us and filed an appeal to the Ninth Circuit Court of
Appeals. On June 16, 2006, the Ninth Circuit affirmed the
dismissals of the claims.
Derivative Actions: We are a nominal defendant
in a shareholder derivative lawsuit pending in state court in
Orange County, California, styled James Herrig, IRA v.
Milan Panic et al. This lawsuit, which was filed on
June 6, 2002, purports to assert derivative claims on our
behalf against certain of our current
and/or
former officers and directors. The lawsuit asserts claims for
breach of fiduciary duties, abuse of control, gross
mismanagement and waste of corporate assets. The plaintiff
seeks, among other things, damages and a constructive trust over
cash bonuses paid to the officer and director defendants in
connection with the Ribapharm offering.
On October 1, 2002, several of our former and current
directors, as individuals, as well as Valeant, as a nominal
defendant, were named as defendants in a second
shareholders derivative complaint filed in the Delaware
Court of Chancery, styled Paul Gerstley v. Norman
Barker, Jr. et al. The original complaint in the
Delaware action purported
17
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
to state causes of action for violation of Delaware General
Corporation Law Section 144, breach of fiduciary duties and
waste of corporate assets in connection with the
defendants management of our company. The allegations in
the Delaware action were similar to those contained in the
derivative lawsuit filed in Orange County, California, but
included additional claims asserting that the defendants
breached their fiduciary duties by disseminating materially
misleading and inaccurate information.
We established a Special Litigation Committee to evaluate the
plaintiffs claims in both derivative actions. The Special
Litigation Committee concluded that it would not be in the best
interest of our shareholders to pursue many of the claims in
these two lawsuits, but decided to pursue, through litigation or
settlement, claims arising from the April 2002 decision of the
Board to approve the payment of approximately $50,000,000 in
bonuses to various members of the Board and management in
connection with the initial public offering of Ribapharm (the
Ribapharm Bonuses). The Court granted our motion to
stay the California proceedings in favor of the similar Delaware
proceedings.
We have settled the litigation with respect to ten of the
defendants, nine of whom each received Ribapharm Bonuses of
$330,500, and one who received a Ribapharm Bonus of $500,000. On
May 18, 2005, the Delaware Court of Chancery approved all
of the settlements and dismissed all claims except those related
to the Ribapharm Bonuses. Three of the settling
defendants were first elected to our Board of Directors in 2001
(the 2001 Directors), only one of whom
currently serves on the Board of Directors. Pursuant to the
settlements, the 2001 Directors forfeited their 2003 annual
Board of Directors stipend and all of their restricted
stock units in exchange for a release from further liability in
the lawsuit (the 2001 Director Settlement). The
2001 Director Settlement further provides that, in the
event we negotiate a settlement with certain defendants on
financial terms that are materially better than those set forth
in the settlement agreements with the 2001 Directors, we
agree to adjust the 2001 Directors settlement payment
by a comparable proportion. Following court-sponsored mediation
in the Delaware Court of Chancery, we entered into settlement
agreements with seven other defendants. Pursuant to these
settlements, six of these defendants (the Outside Director
Defendants) are required to pay to us $150,000 in exchange
for a release from further liability in the lawsuit. The Outside
Director Defendants will receive an offset credit of $50,000 for
release of their claimed right to payments for the automatic
conversion of stock options that were not issued to them in
2002. As provided in the settlement agreements, five of the
Outside Director Defendants have each paid $100,000 in cash to
us in settlement payments. The sixth settling former director
has paid $80,000 to us pursuant to his settlement agreement with
us in exchange for a release from further liability in the
lawsuit. The Company filed a motion in the Delaware Court of
Chancery to enforce the settlement against the lone Outside
Director Defendant who has not made any settlement payment. A
hearing on that motion has not yet been scheduled. Following the
mediated settlement agreements with the Outside Director
Defendants, counsel for the 2001 Directors notified us
that, in the 2001 Directors opinion, the settlement
agreements with the Outside Director Defendants are on financial
terms that are materially better than those set forth in the
settlements with the 2001 Directors and have demanded that
we pay to the 2001 Directors the sum of $50,000 each. We
have advised the 2001 Directors that the settlement
agreements reached with the other defendants do not trigger this
provision. If it is deemed that the financial terms of the
settlement with the Outside Director Defendants are on financial
terms that are materially better than those set forth in the
settlement with the 2001 Directors, the
2001 Directors settlement payment will be adjusted by
a comparable proportion.
The claims with respect to defendants Milan Panic and Adam
Jerney, who received Ribapharm Bonuses of $33,050,000 and
$3,000,000, respectively, were tried in Delaware Chancery Court
in a one-week trial beginning February 27, 2006. On
July 28, 2006, we settled the claims with respect to
Mr. Panic for $20 million. The settlement requires an
initial cash payment to the Company of $8 million in the
third quarter of 2006, with the remainder due within one year of
the settlement. The settlement resolves all outstanding claims
between Mr. Panic and the Company.
Indemnification of Directors: The Company, as
well as other unrelated entities, may be responsible for
indemnification obligations in connection with a lawsuit filed
on March 24, 2006, by former chairman and chief
18
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
executive officer, Milan Panic in State of California, Orange
County, Superior Court styled Milan Panic v. Robert W.
OLeary and Randy Thurman, Case No. 06CC04425, against
Robert W. OLeary and Randy Thurman, current and former
directors of the Company, respectively. Plaintiff Panic purports
to assert direct claims against the two individual defendants
for fraud, conspiracy, breach of fiduciary duties, and
violations of California Business & Professions Code
§ 17200 et seq. in connection with a 2002 proxy
context and subsequent receipt by defendants of compensation
from the Company. Plaintiff alleges, among other things, damages
in excess of $20 million, and purportedly seeks the costs
of the lawsuit, attorneys fees, punitive damages,
restitution and other injunctive relief. The July 28, 2006
settlement between Mr. Panic and us provides the suit
against Messrs. OLeary and Thurman will be dismissed.
Patent Oppositions: Various parties are
opposing our ribavirin patents in actions before the European
Patent Office (E.P.O.), and we are responding to these
oppositions. One patent has been revoked by the Opposition
Division of the E.P.O., and we have filed an appeal within the
E.P.O. The revoked patent benefited from patent extensions in
the major European countries that provided market protection
until 2010. A second European patent is also the subject of an
opposition proceeding in the E.P.O.
Should the opponents ultimately prevail against both of our
ribavirin patents, the ribavirin component of the combination
therapies marketed by Schering-Plough and Roche would lose
patent protection in Europe. Although data exclusivity applies
to these products until 2010, if no ribavirin patents remain in
force in Europe, we will no longer receive royalties from Roche.
Argentina Antitrust Matter: In July 2004, we
were advised that the Argentine Antitrust Agency had issued a
notice unfavorable to us in a proceeding against our Argentine
subsidiary. The proceeding involves allegations that the
subsidiary in Argentina abused a dominant market position in
1999 by increasing its price on Mestinon in Argentina and not
supplying the market for approximately two months. The
subsidiary filed documents with the agency offering an
explanation justifying its actions, but the agency has now
rejected the explanation. The agency is collecting evidence
prior to issuing a new decision. Argentinean law permits a fine
to be levied of up to $5,000,000 plus 20% of profits realized
due to the alleged wrongful conduct. Counsel in the matter
advises that the size of the transactions alleged to have
violated the law will unlikely draw the maximum penalty.
Permax Product Liability Cases. On
July 18, 2005, we were served a complaint in a case
captioned Barbara E. Hermansen and Robert B.
Wilcox, Jr. v. Eli Lilly & Company, Elan
Corporation, plc, Amarin Corporation plc and Valeant
Pharmaceuticals International, Case No. 05 L 007276 in the
Circuit Court of Cook County, Illinois, which case has
subsequently been removed to federal court. This case alleges
that the use of Permax caused the plaintiff to become a
compulsive gambler, and as a result, she has suffered
significant economic loss and severe emotional and mental
distress.
Eli Lilly, the former holder of the right granted by the FDA to
market and sell Permax in the United States, though such right
was licensed to Amarin, and the source of the manufactured
product, has also been named in the suits. Under an agreement
between us and Eli Lilly, Eli Lilly will bear a portion of the
liability, if any, and defense costs associated with these
claims. This case is in a preliminary stage and it is difficult
to assess whether we will have any liability and, if such
liability exists, what the extent of the liability would be.
Product liability insurance exists with respect to this claim.
There can be no assurance that the insurance will be sufficient
to cover this claim, and there can be no assurance that
defending against any future similar claims and any resulting
settlements or judgments will not, individually or in the
aggregate, have a material adverse affect on our consolidated
financial position, results of operation or liquidity.
Kali Litigation: In March 2004, Kali
Laboratories, Inc. submitted Abbreviated New Drug Application
(ANDA)
No. 76-843
with the FDA seeking approval for a generic version of
Diastat®
(a diazepam rectal gel). In July 2004, Xcel Pharmaceuticals,
Inc., which we acquired on March 1, 2005, filed a complaint
against Kali for patent infringement of U.S. Patent
No. 5,462,740 Civil Case
No. 04-3238
(JCL) pending in the United States District Court of New Jersey.
The complaint alleges that Kalis filing of ANDA
No. 76-843
is an act of infringement
19
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
under 35 U.S.C. §271(e)(4) of one or more claims of
U.S. Patent No. 5,462,740. Kali has filed an answer
and counterclaims, denying all allegations of the complaint and
asserting affirmative defenses and counterclaims for
non-infringement, invalidity and unenforceability under the
doctrine of patent misuse due to improper filing of the lawsuit.
Xcel filed a reply to the counterclaims, denying all
allegations. In October 2005, Kali filed an amended answer and
counterclaims asserting affirmative defenses and counterclaims
for non-infringement, invalidity, unenforceability due to
inequitable conduct during prosecution of the patent, and
unenforceability under the doctrine of patent misuse due to
improper filing of the lawsuit. In November 2005, we filed a
reply to the amended counterclaims, denying all allegations. We
will vigorously defend ourselves against Kalis
allegations. Fact and expert discovery has closed. The parties
attended a pretrial conference on June 12, 2006. No trial
date has been set.
Xcel filed this suit within forty-five days of Kalis
Paragraph IV certification. As a result, The Drug Price
Competition and Patent Restoration Act of 1984 (the
Hatch-Waxman Act) provides an automatic stay on the
FDAs approval of Kalis ANDA for thirty months. The
thirty month stay expires on November 28, 2006. If Xcel
prevails in the lawsuit, then Kalis ANDA cannot be
effective until after the expiration of U.S. Patent
No. 5,462,740 in 2013. If Kali prevails in the lawsuit at
the district court level prior to the end of the thirty month
stay, or the thirty-month stay expires prior to a ruling in the
lawsuit, then the FDA may approve Kalis ANDA at such time.
Trademark litigation: Valent U.S.A.
Corporation and its wholly owned subsidiary Valent Biosciences
Corporation (together Valent Biosciences) have
expressed concerns regarding the possible confusion between
Valent Biosciences VALENT trademark registered in
connection with various chemical and agricultural products and
the companys VALEANT trademark. Valent Biosciences has
opposed the registration of the VALEANT trademark by us in
certain jurisdictions, including Argentina, Australia, Brazil,
Chile, Colombia, Czech Republic, European Union, France,
Germany, Indonesia, Israel, Japan, Malaysia, New Zealand,
Romania, Slovak Republic, Spain, Switzerland, Turkey, Taiwan,
Venezuela, the United Kingdom and the United States. Valent
Biosciences oppositions in Colombia, Czech Republic,
France, Japan, Romania, Spain and Turkey have been denied.
Valent Biosciences unsuccessfully appealed the French decision
and has appeals pending in Colombia, Romania, Spain and Turkey.
While some or all of Valent Biosciences oppositions in
Chile and Switzerland have been sustained, we have appealed
those decisions, and our appeal in Switzerland was successful.
We have also initiated actions to cancel trademark registrations
owned by Valent Biosciences in Germany, Israel and South Korea
and have opposed Valents application to register the
VALENT mark in Switzerland in connection with pharmaceuticals.
We have responded or will respond to all opposition proceedings
that have been filed and discovery is ongoing in the opposition
proceeding in the United States. Valent Biosciences has also
filed for cancellation of the VALEANT trademark in Austria. If
the cancellation filing or any of the opposition proceedings are
successful, we would have no trademark registration for the
VALEANT mark in that particular jurisdiction and, in addition,
in those jurisdictions where trademark rights accrue solely
through the registration process, may have no trademark rights
in the VALEANT mark those particular jurisdictions.
Breach of Contract: On March 11, 2005,
Caleel + Hayden, LLC sued in the Superior Court of the State of
California for the County of Orange alleging that our
termination of their distribution agreement for Kinerase was a
breach of the contract and constituted fraud. Plaintiff sought
substantial damages, alleging, among other things, lost profits.
On July 6, 2006, the jury returned a verdict on the breach
of contract action in favor of Caleel + Hayden and awarded
$2,355,000 million in damages, which we have recorded as an
expense in the three months ended June 30, 2006. We are
exploring an appeal of this verdict.
Other: We are a party to other pending
lawsuits and subject to a number of threatened lawsuits. While
the ultimate outcome of pending and threatened lawsuits or
pending violations cannot be predicted with certainty, and an
unfavorable outcome could have a negative impact on us, at this
time in the opinion of management, the ultimate resolution of
these matters will not have a material effect on our
consolidated financial position, results of operations or
liquidity.
20
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
In the 2006 strategic restructuring, the pharmaceutical segment
formerly described as Asia, Africa, and Australia (AAA) was
eliminated for segment reporting purposes, with the operations
in this former segment combined with the remaining three
segments. We thus now have three reportable pharmaceutical
segments, which comprise our pharmaceutical operations in:
|
|
|
|
|
North America, comprising the United States and Canada.
|
|
|
|
International. The Latin America, Asia, and Australasia regions
are now described as International.
|
|
|
|
Europe, Middle East, and Africa (EMEA).
|
In addition, we have a research and development division. As
part of the restructuring announced on April 3, 2006, the
discovery and pre-clinical development operations will be
separated from the development division, with the objective
being to sell or out-license these operations.
The segment information below for the three and six months ended
June 30, 2005 has been restated from our previous
presentations to reflect our new segment structure as described
above.
21
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
The following table sets forth the amounts of segment revenues
and operating income of the Company for the three and six months
ended June 30, 2006 and 2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$
|
72,065
|
|
|
$
|
60,398
|
|
|
$
|
147,277
|
|
|
$
|
109,341
|
|
International
|
|
|
64,471
|
|
|
|
54,430
|
|
|
|
109,661
|
|
|
|
96,346
|
|
EMEA
|
|
|
71,981
|
|
|
|
66,000
|
|
|
|
132,336
|
|
|
|
136,944
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
208,517
|
|
|
|
180,828
|
|
|
|
389,274
|
|
|
|
342,631
|
|
Ribavirin royalties
|
|
|
21,635
|
|
|
|
24,206
|
|
|
|
39,726
|
|
|
|
43,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated revenues
|
|
$
|
230,152
|
|
|
$
|
205,034
|
|
|
$
|
429,000
|
|
|
$
|
386,172
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Income
(Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
|
13,850
|
|
|
|
16,552
|
|
|
|
36,342
|
|
|
|
33,246
|
|
International
|
|
|
22,934
|
|
|
|
15,431
|
|
|
|
32,106
|
|
|
|
25,761
|
|
EMEA
|
|
|
12,393
|
|
|
|
8,867
|
|
|
|
16,609
|
|
|
|
20,879
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49,177
|
|
|
|
40,850
|
|
|
|
85,057
|
|
|
|
79,886
|
|
Corporate expenses(1)
|
|
|
(16,262
|
)
|
|
|
(14,344
|
)
|
|
|
(39,452
|
)
|
|
|
(28,711
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
32,915
|
|
|
|
26,506
|
|
|
|
45,605
|
|
|
|
51,175
|
|
Restructuring charges(2)
|
|
|
(53,082
|
)
|
|
|
1,324
|
|
|
|
(79,548
|
)
|
|
|
(371
|
)
|
Gain on litigation settlement
|
|
|
|
|
|
|
|
|
|
|
34,000
|
|
|
|
|
|
Research and development
|
|
|
(10,684
|
)
|
|
|
(6,621
|
)
|
|
|
(22,974
|
)
|
|
|
(15,957
|
)
|
Acquired IPR&D(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(126,399
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated segment operating
income (loss)
|
|
|
(30,851
|
)
|
|
|
21,209
|
|
|
|
(22,917
|
)
|
|
|
(91,552
|
)
|
Interest income
|
|
|
2,715
|
|
|
|
3,119
|
|
|
|
5,372
|
|
|
|
6,134
|
|
Interest expense
|
|
|
(10,861
|
)
|
|
|
(10,063
|
)
|
|
|
(21,298
|
)
|
|
|
(19,744
|
)
|
Other, net
|
|
|
757
|
|
|
|
(2,631
|
)
|
|
|
1,694
|
|
|
|
(4,422
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing
operations before provision for income taxes and minority
interest
|
|
$
|
(38,240
|
)
|
|
$
|
11,634
|
|
|
$
|
(37,149
|
)
|
|
$
|
(109,584
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
All stock-based compensation expense has been considered a
corporate cost as management excludes this item in assessing the
financial performance of individual business segments and
considers it a function of valuation factors that pertain to
overall corporate stock performance. |
|
(2) |
|
Restructuring charges and IPR&D are not included in the
applicable segments as management excludes these items in
assessing the financial performance of these segments, primarily
due to their non-operational nature. |
22
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
The following table sets forth the total assets of the Company
by segment as of June 30, 2006 and December 31, 2005
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
North America
|
|
$
|
489,121
|
|
|
$
|
503,196
|
|
International
|
|
|
184,787
|
|
|
|
183,740
|
|
EMEA
|
|
|
373,987
|
|
|
|
384,191
|
|
Corporate
|
|
|
208,746
|
|
|
|
240,680
|
|
Research and Development Division
|
|
|
209,654
|
|
|
|
218,943
|
|
Discontinued operations
|
|
|
49
|
|
|
|
127
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,466,344
|
|
|
$
|
1,530,877
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth the long term assets of the
Company by segment as of June 30, 2006 and
December 31, 2005 (in thousands)
|
|
|
|
|
|
|
|
|
|
|
Long Term Assets
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
North America
|
|
$
|
392,841
|
|
|
$
|
426,745
|
|
International
|
|
|
60,578
|
|
|
|
61,049
|
|
EMEA
|
|
|
115,746
|
|
|
|
129,952
|
|
Corporate
|
|
|
117,556
|
|
|
|
158,801
|
|
Research and Development Division
|
|
|
147,618
|
|
|
|
158,464
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
834,339
|
|
|
$
|
935,011
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the largest of our product lines
by therapeutic class based on sales for the three months and six
months ended June 30, 2006 and 2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Dermatology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Efudix/Efudex®(P)
|
|
$
|
14,978
|
|
|
$
|
12,231
|
|
|
$
|
30,560
|
|
|
$
|
31,507
|
|
Kinerase®(P)
|
|
|
9,024
|
|
|
|
5,821
|
|
|
|
15,884
|
|
|
|
10,256
|
|
Oxsoralen-Ultra®(P)
|
|
|
3,593
|
|
|
|
4,126
|
|
|
|
7,101
|
|
|
|
7,094
|
|
Dermatixtm(P)
|
|
|
2,977
|
|
|
|
2,566
|
|
|
|
4,811
|
|
|
|
4,462
|
|
Eldoquin(P)
|
|
|
1,571
|
|
|
|
1,116
|
|
|
|
2,753
|
|
|
|
2,521
|
|
Other Dermatology
|
|
|
10,612
|
|
|
|
7,783
|
|
|
|
17,826
|
|
|
|
14,511
|
|
Infectious Disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infergen®(P)(a)
|
|
|
11,309
|
|
|
|
|
|
|
|
25,014
|
|
|
|
|
|
Virazole®(P)
|
|
|
3,541
|
|
|
|
4,039
|
|
|
|
8,698
|
|
|
|
8,234
|
|
Other Infectious Disease
|
|
|
4,890
|
|
|
|
4,245
|
|
|
|
9,622
|
|
|
|
10,098
|
|
23
VALEANT
PHARMACEUTICALS INTERNATIONAL
NOTES TO
CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
Neurology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diastat(P)(b)
|
|
|
11,709
|
|
|
|
14,291
|
|
|
|
23,731
|
|
|
|
19,468
|
|
Mestinon®(P)
|
|
|
12,326
|
|
|
|
10,434
|
|
|
|
22,143
|
|
|
|
20,294
|
|
Librax(P)
|
|
|
5,004
|
|
|
|
1,670
|
|
|
|
7,924
|
|
|
|
5,751
|
|
Cesamet(P)
|
|
|
4,042
|
|
|
|
1,919
|
|
|
|
7,345
|
|
|
|
3,974
|
|
Migranal(P)(b)
|
|
|
2,701
|
|
|
|
4,130
|
|
|
|
5,816
|
|
|
|
4,904
|
|
Dalmane/Dalmadorm(P)
|
|
|
2,544
|
|
|
|
3,329
|
|
|
|
5,010
|
|
|
|
5,971
|
|
Tasmar®(P)
|
|
|
1,666
|
|
|
|
1,533
|
|
|
|
2,851
|
|
|
|
2,472
|
|
Limbitrol(P)
|
|
|
1,318
|
|
|
|
1,623
|
|
|
|
2,828
|
|
|
|
2,917
|
|
Other Neurology
|
|
|
15,575
|
|
|
|
15,525
|
|
|
|
30,165
|
|
|
|
26,092
|
|
Other Therapeutic
Classes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bedoyectatm(P)
|
|
|
12,512
|
|
|
|
10,976
|
|
|
|
23,092
|
|
|
|
20,220
|
|
Solcoseryl
|
|
|
4,597
|
|
|
|
3,911
|
|
|
|
7,974
|
|
|
|
8,105
|
|
Bisocard(P)
|
|
|
3,912
|
|
|
|
3,363
|
|
|
|
7,477
|
|
|
|
6,018
|
|
Nyal(P)
|
|
|
4,803
|
|
|
|
5,366
|
|
|
|
6,557
|
|
|
|
7,840
|
|
Calcitonin(P)
|
|
|
2,228
|
|
|
|
2,733
|
|
|
|
4,078
|
|
|
|
5,318
|
|
Espaven(P)
|
|
|
2,983
|
|
|
|
1,509
|
|
|
|
4,285
|
|
|
|
3,071
|
|
Aclotin(P)
|
|
|
1,219
|
|
|
|
1,370
|
|
|
|
2,591
|
|
|
|
2,890
|
|
Other Pharmaceutical Products
|
|
|
56,883
|
|
|
|
55,219
|
|
|
|
103,138
|
|
|
|
108,643
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
$
|
208,517
|
|
|
$
|
180,828
|
|
|
$
|
389,274
|
|
|
$
|
342,631
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Promoted Product sales(P)
|
|
$
|
120,557
|
|
|
$
|
98,056
|
|
|
$
|
228,523
|
|
|
$
|
183,287
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Infergen was acquired from InterMune on December 30, 2005. |
|
(b) |
|
Diastat and Migranal were acquired with the Xcel transaction on
March 1, 2005. |
|
|
|
(P) |
|
Promoted Products represent products promoted in at least one
major territory with estimated global annual sales greater than
$5 million. |
During the three months ended June 30, 2006 one customer,
McKesson Corporation, accounted for more than 10% of
consolidated product sales. Sales to McKesson Corporation and
its affiliates in the United States, Canada, and Mexico were
$38,675,000 in the three-month period ended June 30, 2006,
representing 18.6% of our product sales. Sales to Cardinal
Health in the three-month period were $18,943,253, representing
9.1% of our product sales. In the six-month period ended
June 30, 2006, sales to McKesson Corporation were
$69,057,000 and sales to Cardinal Health were $37,056,000,
representing 17.7% and 9.5%, respectively. In prior years no
single customer accounted for more than 10% of product sales in
any period.
24
|
|
Item 2.
|
Managements
Discussion and Analysis of Financial Condition and Results of
Operations
|
Overview
We are a global specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical
products. We focus our greatest resources and attention
principally in the therapeutic areas of neurology, infectious
disease and dermatology. Our marketing and promotion efforts
focus on our Promoted Products, which include products marketed
globally, regionally and locally with annual sales in excess of
$5 million. Our products are currently sold in more than
100 markets around the world, with our primary focus on the
United States, Canada, Mexico, the United Kingdom, France,
Italy, Poland, Germany, and Spain.
Our primary value driver is a specialty pharmaceutical business
with a global platform. We believe that our global reach and
marketing agility make us unique among specialty pharmaceutical
companies, and provide us with the ability to leverage compounds
in the clinical stage and commercialize them in major markets
around the world. In addition, we receive royalties from the
sale of ribavirin by Schering-Plough and Roche, although such
royalties currently represent a much smaller contribution to our
revenues than they have in the past.
Specialty
Pharmaceuticals
Specialty Pharmaceutical Revenues: Product
sales from the Companys specialty pharmaceutical segments
increased $27,689,000 (15%) and $46,643,000 (14%) for the three
and six months ended June 30, 2006, respectively, over the
same periods in 2005. Sales from products related to the
acquisition of Xcel in March 2005 contributed $17,451,000 and
$35,780,000 to product sales in the three and six months ended
June 30, 2006, respectively, reflecting declines in
non-promoted products acquired from Xcel and lower sales of
Diastat and Migranal in the second quarter than in the same
period in the prior year. Sales from Infergen, acquired on
Dec. 30, 2005, contributed $11,309,000 and $25,014,000 in
the three and six months ended June 30, 2006, respectively.
Product sales from the Companys Promoted Products
increased $22,501,000 (24%) and $45,236,000 (25%) for the three
and six months ended June 30, 2006, respectively, over the
same period from 2005.
Clinical
Development
We seek to develop and commercialize innovative products for the
treatment of significant unmet medical needs, principally in the
areas of infectious diseases and neurology. Research and
development expenses were $26,842,000 and $56,377,000 for the
three and six months ended June 30, 2006, respectively,
compared to $27,559,000 and $53,283,000 for the same periods in
2005, resulting in a decrease of $717,000 (3%) in the
three-month period and an increase of $3,094,000 (6%) in the
six-month period, respectively.
In April 2006 we announced a major restructuring program which
will result in a reduction of the size and scope of our research
and development activities. See Company Strategy and
Restructuring below.
Ribavirin
Royalties
Ribavirin royalty revenues decreased $2,571,000 (11%) and
accounted for 9% of our total revenues from continuing
operations for the three months ended June 30, 2006 as
compared to 12% in the similar three-month period in 2005.
Ribavirin royalty revenues decreased $3,815,000 (9%) and
accounted for 10% of our total revenues from continuing
operations for the six months ended June 30, 2006 as
compared to 13% in the similar six-month period in 2005. The
year-to-date
decrease in ribavirin royalties includes the effects of generic
competition in the United States, partially offset by increased
royalties in Japan.
Company
Strategy and Restructuring
The key elements of our strategy, as refined by the
restructuring program announced on April 3, 2006, include
the following:
Targeted Growth of Existing Products. We focus
our business on key markets, across three therapeutic areas. We
believe that our core therapeutic areas are positioned for
further growth and that it is possible for a
25
mid-sized company to attain a leadership position within these
categories. We intend to continue to pursue life cycle
management strategies for our regional and local brands.
Efficient Manufacturing and Supply Chain
Organization. The objective of the restructuring
program as it relates to manufacturing is to further rationalize
our manufacturing operations and further reduce our excess
capacity. Under our global manufacturing strategy, we also seek
to minimize our costs of goods sold by increasing capacity
utilization in our manufacturing facilities or by outsourcing
and by other actions to improve efficiencies. We have undertaken
major process improvement initiatives and the deployment of lean
six sigma process improvements, affecting all phases of our
operations, from raw material and supply logistics, to
manufacturing, warehousing and distribution.
Clinical Development Activities. We are
focusing efforts and expenditures on two late stage development
projects: Viramidine (taribavirin), a potential treatments for
hepatitis C and retigabine, a potential treatment for
partial onset seizures in patients with epilepsy. The
restructuring program is designed to rationalize our investments
in research and development efforts in line with our financial
resources. We intend to sell rights to, out-license or secure
partners to share the costs of other major clinical projects and
discovery programs that the research and development division
has underway.
Product Acquisitions. We plan to selectively
license or acquire product candidates, technologies and
businesses from third parties which complement our existing
business and provide for effective life cycle management of key
products. We believe that our drug development and
commercialization expertise will allow us to recognize licensing
opportunities and to capitalize on research initially conducted
and funded by others.
The restructuring program will result in reduced selling,
general and administrative expenses primarily through
consolidation of our management functions into fewer
administrative groups to achieve greater economies of scale.
Management and administrative responsibilities for our regional
operations in Asia, Africa and Australia, (AAA),
which were formerly managed as a separate business unit, will be
combined with those of other regions. As a result we now have
three reportable pharmaceutical segments, which comprise our
pharmaceutical operations in:
|
|
|
|
|
North America, comprising the United States and Canada.
|
|
|
|
International. The Latin America, Asia, and Australasia regions
are now described as International.
|
|
|
|
Europe, Middle East, and Africa (EMEA).
|
We anticipate that the total restructuring program will result
in charges that will range between $90,000,000 and $115,000,000.
These charges include impairment charges resulting from the
planned sale of our manufacturing facilities in Puerto Rico and
Switzerland. The anticipated charges also include employee
severance costs resulting from a total reduction of
approximately 750 employees, the majority of whom work in the
manufacturing facilities which will be sold.
We recorded provisions of $53,082,000 and $79,548,000 in the
three and six months ended June 30, 2006, respectively, in
connection with the restructuring program. These charges consist
of the impairment charges for our manufacturing sites in Puerto
Rico and Switzerland of $18,576,000 and $25,114,000,
respectively. The fair value of these sites was determined based
on independent appraisals. The restructuring charges also
consist of other costs as detailed below. The restructuring
charges in the three months ended June 30, 2006 were
$18,577,000 and $28,898,000 for the North American and EMEA
segments, respectively.
26
Restructuring
Charge Details
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
Anticipated Total
|
|
(In thousands)
|
|
March 31, 2006
|
|
|
June 30, 2006
|
|
|
June 30, 2006
|
|
|
Restructuring Charge
|
|
Employee Severances (135 Employees)
|
|
$
|
6,644
|
|
|
$
|
5,369
|
|
|
$
|
12,013
|
|
|
$
|
19,000 - 28,000
|
|
Contract cancellation and other
cash costs
|
|
|
|
|
|
|
992
|
|
|
|
992
|
|
|
|
1,000 - 2,000
|
|
Subtotal: Cash-related Charges
|
|
|
6,644
|
|
|
|
6,361
|
|
|
|
13,005
|
|
|
|
20,000 - 30,000
|
|
Abandoned software and other
capital assets
|
|
|
19,822
|
|
|
|
3,031
|
|
|
|
22,853
|
|
|
|
23,000 - 24,000
|
|
Impairment of manufacturing assets
|
|
|
|
|
|
|
43,690
|
|
|
|
43,690
|
|
|
|
47,000 - 71,000
|
|
Subtotal: Non-cash charges
|
|
|
19,822
|
|
|
|
46,721
|
|
|
|
66,543
|
|
|
|
70,000 - 95,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total:
|
|
$
|
26,466
|
|
|
$
|
53,082
|
|
|
$
|
79,548
|
|
|
$
|
90,000-$115,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation
of Cash Restructuring Payments with Restructuring
Accrual
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
March 31, 2006
|
|
|
June 30, 2006
|
|
Opening Accrual
|
|
$
|
|
|
|
$
|
5,425
|
|
Cash Charges
|
|
|
6,644
|
|
|
|
5,369
|
|
Cash Paid
|
|
|
(1,219
|
)
|
|
|
(2,243
|
)
|
|
|
|
|
|
|
|
|
|
Closing Accrual
|
|
$
|
5,425
|
|
|
$
|
8,551
|
|
|
|
|
|
|
|
|
|
|
Results
of Operations
Our three reportable pharmaceutical segments comprise
pharmaceuticals operations in North America; International; and
Europe, Middle East, and Africa. In addition, we have a research
and development division. Certain financial information for our
business segments is set forth below. This discussion of our
results of operations should be read in conjunction with our
consolidated condensed financial statements included elsewhere
in this quarterly report. For additional financial information
by business segment, see Note 10 of notes to consolidated
condensed financial statements included elsewhere in this
quarterly report.
27
The following tables compare 2006 and 2005 revenues by
reportable segments and operating expenses for the three months
and six months ended June 30, 2006 and 2005 (in thousands,
except percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
Increase/
|
|
|
Percent
|
|
|
|
2006
|
|
|
2005
|
|
|
(Decrease)
|
|
|
Change
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$
|
72,065
|
|
|
$
|
60,398
|
|
|
$
|
11,667
|
|
|
|
19
|
%
|
International
|
|
|
64,471
|
|
|
|
54,430
|
|
|
|
10,041
|
|
|
|
18
|
|
EMEA
|
|
|
71,981
|
|
|
|
66,000
|
|
|
|
5,981
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
208,517
|
|
|
|
180,828
|
|
|
|
27,689
|
|
|
|
15
|
|
Ribavirin royalties
|
|
|
21,635
|
|
|
|
24,206
|
|
|
|
(2,571
|
)
|
|
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
230,152
|
|
|
|
205,034
|
|
|
|
25,118
|
|
|
|
12
|
|
Costs and Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding
amortization)
|
|
|
65,744
|
|
|
|
52,940
|
|
|
|
12,804
|
|
|
|
24
|
|
Selling expenses
|
|
|
66,268
|
|
|
|
61,454
|
|
|
|
4,814
|
|
|
|
8
|
|
General and administrative expenses
|
|
|
31,553
|
|
|
|
25,985
|
|
|
|
5,568
|
|
|
|
21
|
|
Research and development costs
|
|
|
26,842
|
|
|
|
27,559
|
|
|
|
(718
|
)
|
|
|
(3
|
)
|
Restructuring charges
|
|
|
53,082
|
|
|
|
(1,324
|
)
|
|
|
54,406
|
|
|
|
NM
|
|
Amortization expense
|
|
|
17,514
|
|
|
|
17,211
|
|
|
|
303
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
$
|
(30,851
|
)
|
|
$
|
21,209
|
|
|
$
|
(52,060
|
)
|
|
|
NM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit on product sales
(excluding amortization)
|
|
$
|
142,773
|
|
|
$
|
127,888
|
|
|
$
|
14,885
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit margin on product
sales
|
|
|
68
|
%
|
|
|
71
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
Increase/
|
|
|
Percent
|
|
|
|
2006
|
|
|
2005
|
|
|
(Decrease)
|
|
|
Change
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$
|
147,277
|
|
|
$
|
109,341
|
|
|
$
|
37,936
|
|
|
|
35
|
%
|
International
|
|
|
109,661
|
|
|
|
96,346
|
|
|
|
13,315
|
|
|
|
14
|
|
EMEA
|
|
|
132,336
|
|
|
|
136,944
|
|
|
|
(4,608
|
)
|
|
|
(3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
389,274
|
|
|
|
342,631
|
|
|
|
46,643
|
|
|
|
14
|
|
Ribavirin royalties
|
|
|
39,726
|
|
|
|
43,541
|
|
|
|
(3,815
|
)
|
|
|
(9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
429,000
|
|
|
|
386,172
|
|
|
|
42,828
|
|
|
|
11
|
|
Costs and Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding
amortization)
|
|
|
124,324
|
|
|
|
101,661
|
|
|
|
22,663
|
|
|
|
22
|
|
Selling expenses
|
|
|
130,538
|
|
|
|
114,269
|
|
|
|
16,269
|
|
|
|
14
|
|
General and administrative expenses
|
|
|
60,093
|
|
|
|
50,562
|
|
|
|
9,531
|
|
|
|
19
|
|
Research and development costs
|
|
|
56,377
|
|
|
|
53,283
|
|
|
|
3,094
|
|
|
|
6
|
|
IPR&D
|
|
|
|
|
|
|
126,399
|
|
|
|
(126,399
|
)
|
|
|
NM
|
|
Gain on litigation settlement
|
|
|
(34,000
|
)
|
|
|
|
|
|
|
|
|
|
|
NM
|
|
Restructuring charges
|
|
|
79,548
|
|
|
|
371
|
|
|
|
79,177
|
|
|
|
NM
|
|
Amortization expense
|
|
|
35,037
|
|
|
|
31,179
|
|
|
|
3,858
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
$
|
(22,917
|
)
|
|
$
|
(91,552
|
)
|
|
$
|
34,635
|
|
|
|
(38
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit on product sales
(excluding amortization)
|
|
$
|
264,950
|
|
|
$
|
240,970
|
|
|
$
|
23,980
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit margin on product
sales
|
|
|
68
|
%
|
|
|
70
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the North America pharmaceuticals segment, revenues for the
three months ended June 30, 2006 were $72,065,000, compared
to $60,398,000 for the same period in 2005, representing an
increase of $11,667,000 (19%). The increase is primarily related
to the acquisition of Infergen which contributed $11,309,000 and
$25,014,000 in the three and six months ended June 30,
2006, respectively. Revenues for the six months ended
June 30, 2006 were $147,277,000 compared to $109,341,000
for 2005, an increase of $37,93,000 (35%).The sales for the
six months ended June 30, 2006 also benefited from the
full six months of Xcel products compared with only
four months in 2005. The region reported increased sales in
the second quarter of Efudex, Kinerase, and Cesamet, which were
offset by declines in sales of Diastat and Migranal in the
period, along with decreased sales of non-promoted products.
Product sales in the North America region were 35% and 38% of
total product sales in the three and six months ended
June 30, 2006, respectively, compared to 33% and 32% of
total product sales for the same periods in 2005. Canadian sales
benefited from the increased strength of the Canadian dollar
relative to the U.S. dollar, which contributed $918,000 and
$1,407,000 to sales in the three- and six-month periods ended
June 30, 2006, respectively.
In the International pharmaceuticals segment, revenues for the
three months ended June 30, 2006 were $64,471,000 compared
to $54,430,000 for 2005, an increase of $10,041,000 (18%). The
increase was due to the acquisition of Melleril in Brazil and an
increase in sales of Bedoyecta and several other products.
Revenues for the six months ended June 30, 2006 were
$109,661,000 compared to $96,346,000 for 2005, an increase of
$13,315,000 (14%). The impact of currency in International
decreased reported revenue by $891,000 in the three months ended
June 30, 2006 but increased revenue by $838,000 in the six
months ended June 30, 2006.
In the EMEA pharmaceuticals segment, revenues for the three
months ended June 30, 2006 were $71,981,000, compared to
$66,000,000 for the same period in 2005, an increase of
$5,981,000 (9%). Revenues for the six months ended June 30,
2006 were $132,336,000 compared to $136,944,000 for 2005, a
decrease of $4,608,000 (3%). The
29
EMEA region reported increased sales in the second quarter of
Kinerase, Librax, Solcoseryl, and Mestinon, which were offset in
part by declines in Calcitonin, and Omeprazol. The impact of
currency in EMEA increased reported revenue by $584,000 in the
three months ended June 30, 2006 but decreased revenue by
$3,185,000 in the six months ended June 30, 2006.
Europe continues to be impacted by government imposed price
reductions and lower sales volume of non-promoted products.
Ribavirin Royalties: Ribavirin royalties
represent amounts earned under the license and supply agreements
with Schering-Plough and Roche. Under a license and supply
agreement, Schering-Plough licensed all oral forms of ribavirin
for the treatment of chronic hepatitis C. The Company
receives royalty fees from Roche under a license agreement on
sale of Roches version of ribavirin, Copegus, for use in
combination with interferon alfa or pegylated interferon alfa.
Ribavirin royalties from Schering-Plough and Roche for the three
and six months ended June 30, 2006 were $21,635,000 and
$39,726,000, respectively, compared to $24,206,000 and
$43,541,000 for 2005, representing decreases of $2,571,000 and
$3,815,000, respectively. The decline in ribavirin royalties is
primarily due to reductions in reserves against royalties in the
second quarter of 2005.
Gross Profit Margin (excluding
amortization): Gross profit margin on product
sales decreased to 68% for the second quarter of 2005, compared
to 71% for the same period in 2005. Gross profit margin on
product sales for the six months ended June 30, 2006 was
68% compared to 70% for the same period in 2005. The decrease in
gross profit margin is primarily due to inventory write offs,
product mix, and certain manufacturing inefficiencies. Cost of
goods sold in 2006 includes a provision of $352,000 and $765,000
related to employee stock options and purchase programs
following the implementation of SFAS 123(R) in the three-
and six- month periods ended June 30, 2006, respectively.
Selling Expenses: Selling expenses were
$66,268,000 and $130,538,000 for the three and six months ended
June 30, 2006, respectively, compared to $61,454,000 and
$114,269,000 for the same periods in 2005, resulting in
increases of $4,814,000 (8%) and $16,269,000 (14%),
respectively. As a percent of product sales, selling expenses
were 32% and 34% for the three and six months ended
June 30, 2006, respectively, compared to 34% for each of
the same periods in 2005. The quarterly increase in selling
expenses primarily reflects the additional sales force
associated with the acquisition of Infergen and includes costs
related to the launch of line extensions and new products. The
decrease in selling expense as a percent of sales reflects the
Companys efforts to target its selling efforts on
responsive products, the impact of leveraging an increased level
of sales, and savings from the Companys restructuring.
Selling expenses in 2006 includes a provision of $858,000 and
$1,705,000 related to employee stock options and purchase
programs following the implementation of SFAS 123(R) in the
three- and six- month periods ended June 30, 2006,
respectively.
General and Administrative Expenses: General
and administrative expenses were $31,553,000 and $60,093,000 for
the three and six months ended June 30, 2006, respectively,
compared to $25,985,000 and $50,562,000 for the same periods in
2005, resulting in increases of $5,568,000 (21%) and $9,531,000
(19%), respectively. As a percent of product sales, general and
administrative expenses were 15% for the three and six months
ended June 30, 2006 compared to 14% and 15% for the same
periods in 2005. General and administrative expense in the three
months ended June 30, 2006 include $2,355,000 in damages
awarded against us in the Caleel + Hayden case, the recording of
$920,000 for a withholding obligation for a former member of the
Board of Directors of the Company in early 2002 for which the
Company did not withhold federal taxes, and a provision of
$3,050,000 related to employee stock options and purchase
programs following the implementation of SFAS 123(R). The
corresponding SFAS 123(R) provision in general and
administrative expenses for the six months ended June 30,
2006 was $6,691,000.
Research and Development: Research and
development expenses were $26,842,000 and $56,377,000 for the
three and six months ended June 30, 2006, respectively,
compared to $27,559,000 and $53,283,000 for the same periods in
2005, resulting in a decrease of $717,000 (3%) and an increase
of $3,094,000 (6%), respectively. Research and development costs
are expected to decrease in 2006 due to the restructuring
program. Research and development expenses include provisions of
$758,000 and $1,538,000 related to employee stock options and
purchase programs following the implementation of
SFAS 123(R) in the three- and six-month periods ended
June 30, 2006, respectively.
30
Acquired In-Process Research and
Development: In the six months ended
June 30, 2005, the Company incurred an expense of
$126,399,000, associated with IPR&D related to the
acquisition of Xcel Pharmaceuticals, Inc. The amount expensed as
IPR&D represents the Companys estimate of fair value
of purchased in-process technology for projects that, as of the
acquisition date, had not yet reached technological feasibility
and had no alternative future use.
Restructuring Charges: In the three and six
months ended June 30, 2006, the Company incurred
restructuring charges of $53,082,000 and $79,548,000,
respectively. This program is discussed in more detail in the
Company Strategy and Restructuring above. These restructuring
charges comprised the write-off of costs related to assets to be
abandoned, including abandoned software projects ($22,853,000),
a portion of the severance costs of the employees who will be
terminated in the program ($12,013,000), and impairment charges
on our manufacturing sites in Puerto Rico and Switzerland
($43,690,000).
Amortization: Amortization expense was
$17,514,000 and $35,037,000 for the three and six months ended
June 30, 2006, respectively, compared to $17,211,000 and
$31,179,000 for the same periods in 2005, resulting in increases
of $303,000 (2%) and $3,858,000 (12%), respectively. The
increase was primarily due to amortization of the intangible
assets acquired in the Xcel and Infergen acquisitions.
Other Income (expense),Net, Including Translation and
Exchange: Other income, net, including
translation and exchange was $757,000 and $1,694,000 for the
three and six months ended June 30, 2006, respectively,
compared to losses of $2,631,000 and $4,422,000 for the same
periods in 2005. In the second quarter of 2006, translation
gains principally consisted of translation and exchange gains of
$601,000 in International and $258,000 in EMEA. In the six
months ended June 30, 2006, translation gains principally
consisted of gains of $1,503,000 in International and $240,000
in EMEA.
Interest Expense, net: Interest expense net of
interest income increased $1,202,000 (17%) and $2,316,000 (17%)
during the three and six months ended June 30, 2006,
respectively, compared to the same periods in 2005, primarily as
a result of higher interest rates on variable rate debt and
lower interest income as a result of lower cash and investment
securities balances.
Income Taxes: The tax provisions in the second
quarters of both 2006 and 2005 relate to the profits of our
foreign operations, foreign withholding taxes, liabilities
associated with the 1997 through 2001 IRS examination and, state
and local taxes in the U.S. Our U.S. operations, which
include our research and development activities, generate
substantial net operating losses for US income tax reporting
purposes. Since, at this time, there is insufficient objective
evidence that we will generate sufficient U.S. taxable
income to utilize these net operating loss benefits, a valuation
allowance has been provided against the tax benefits associated
with U.S. operating losses. In addition, the Company
recognized the cumulative withholding obligation on intercompany
payables associated with its Singapore subsidiary for the
periods since inception in 2004, having an impact of $1,777,000
in the second quarter of 2006. Of this amount, $1,470,000
relates to periods prior to April 2006 and $307,000 relates to
the three months ended June 30, 2006. In 2005 a significant
portion of the loss relates to a charge for IPR&D associated
with the Xcel acquisition that will not be deductible for tax
purposes since that acquisition was structured as a stock
purchase.
Loss from Discontinued Operations, Net of
Taxes: Our loss from discontinued operations was
$197,000 and $409,000 for the three- and six- month periods
ended June 30, 2006, respectively. These losses compare to
$1,988,000 and $3,491,000 in the three- and six- month periods
ended June 30, 2005, respectively. The losses in 2006
relate to closure and wind up of our remaining administrative
activities associated with the discontinued manufacturing
operations in Central Europe, the last of which was disposed of
in 2005. Valeant signed an agreement on July 14, 2006 to
sell assets related to its former Russian pharmaceutical
distribution company, OAO Pharmsnabsbyt (PSS).
Proceeds from this sale will be approximately $2.0 million,
with the first installment due in the third quarter of 2006
and the remaining payments to be backed by a bank guarantee.
This sale will generate a gain of approximately $2 million
within discontinued operations in the third quarter of 2006.
31
Liquidity
and Capital Resources
Cash and marketable securities totaled $252,815,000 at
June 30, 2006 compared to $235,066,000 at December 31,
2005. Working capital was $389,474,000 at June 30, 2006
compared to $360,812,000 at December 31, 2005. The increase
in working capital of $28,662,000 was benefited by the
settlement of claims with the Serbian government and further
benefited by operations, partially offset by cash used in
inventory purchase commitments, research and development
activities, severance, and other restructuring costs.
Cash provided by operating activities is expected to be our
primary source of funds in 2006. During the six months ended
June 30, 2006, cash provided by operating activities
totaled $50,711,000 compared to $21,276,000 in the same period
in 2005, an increase of $29,435,000. The increase in cash
provided by operating activities is primarily due to increases
in sales and gross profits offset in part by a reduction in
royalty revenues.
Cash used in investing activities was $16,971,000 for the six
months ended June 30, 2006 compared to $84,130,000 for
2005. In 2006 cash used in investing activities consisted
primarily of capital expenditures on corporate programs and
existing facilities, offset in part by cash proceeds from sales
of assets, including the Warsaw manufacturing facility. In 2005,
net cash used in investing activities consisted of payments for
the acquisition of Xcel and various other product rights of
$281,781,000 and capital expenditures of $15,021,000, partially
offset by net proceeds from investments of $206,928,000 and
proceeds from the sale of assets of $5,876,000.
Cash used in financing activities was $17,518,000 in the six
months ended June 30, 2006 and principally consisted of
dividends paid on common stock of $14,354,000. and debt
retirements of $6,137,000. Cash generated from financing
activities for the six months ended June 30, 2005 was
$176,318,000, which includes proceeds from our stock offering in
connection with the Xcel acquisition of $189,030,000, partially
offset by cash dividends paid on common stock of $13,650,000.
In January 2005, the Company entered into an interest rate swap
agreement with respect to $150,000,000 principal amount of its
7.0% Senior Notes due 2011. The interest rate on the swap
is variable at LIBOR plus 2.41%. The effect of this transaction
was to initially lower our effective interest rate by exchanging
fixed rate payments for floating rate payments. On a prospective
basis, the effective interest rate will float and correlate to
the variable interest earned on our cash held.
We have collateral requirements on the interest rate swap
agreement. The amount of collateral varies monthly depending on
the fair value of the underlying swap contract. As of
June 30, 2006, we have collateral of $12,200,000 comprising
marketable securities and included in other assets in the
accompanying balance sheet.
Management believes that its existing cash and cash equivalents
and funds generated from operations will be sufficient to meet
its operating requirements at least through June 30, 2007,
and to provide cash needed to fund capital expenditures and its
clinical development program. While we have no current intent to
issue additional debt or equity securities, we may seek
additional debt financing or issue additional equity securities
to finance future acquisitions or for other purposes. We fund
our cash requirements primarily from cash provided by operating
activities. Our sources of liquidity are cash and cash
equivalent balances and cash flow from operations.
While we have historically paid quarterly cash dividends, there
can be no assurance that we will continue to do so in the future.
Off-Balance
Sheet Arrangements
We do not use special purpose entities or other off-balance
sheet financing techniques except for operating leases disclosed
in our annual report on
Form 10-K.
Our 3% and 4% convertible subordinated notes include conversion
features that are considered as off-balance sheet arrangements
under SEC requirements.
Products
in Development
Late
Stage Development of New Chemical Entities
Viramidine (taribavirin): Viramidine is a
nucleoside (guanisine) analog that is converted into ribavirin
by adenosine deaminase in the liver and intestine. We are
developing Viramidine (taribavirin), in oral form, for
32
administration in combination with pegylated interferon for the
treatment of chronic hepatitis C in treatment-naïve
patients.
On March 21, 2006, we reported the results of the first of
two pivotal Phase 3 trials for Viramidine (taribavirin).
The VISER1 (VISER stands for Viramidine Safety and Efficacy
Versus Ribavirin) trial included two co-primary endpoints: one
for safety (superiority to ribavirin in incidence of anemia) and
one for efficacy (non-inferiority to ribavirin in sustained
viral response, SVR). The results of VISER1 met the safety
criteria but did not meet the efficacy criteria.
The results of the study were significantly impacted by the
VISER1 dosing methodology which was a fixed dose of Viramidine
(taribavirin) for all patients and a variable dose of ribavirin
based on a patients weight. The results of the study
indicate that the dosage of Viramidine (taribavirin), like
ribavirin, likely needs to be based on a patients weight
to achieve efficacy equal or superior to that of ribavirin.
VISER2, our second Phase 3 trial, concluded in May 2006.
VISER2 is similar in design to VISER1 (a fixed dose of
Viramidine (taribavirin) and a weight-based, variable dose of
ribavirin). We locked the database in the trial as of early
August and are performing the expected analysis. Once we have
completed our analysis, we intend to meet with the FDA and
European regulatory authorities and decide on a strategy. We
will communicate these developments at a later date.
The timeline and path to regulatory approval is uncertain at
this time. Further development of Viramidine (taribavirin) may
require the completion of another Phase 3 trial which could
add significantly to the drugs development cost and the
time it takes to complete development, thereby delaying the
commercial launch of Viramidine (taribavirin) and possibly
weakening its position in relation to competing treatments. We
will evaluate the economics of the Viramidine (taribavirin)
development program and decide on its course of action by the
end of the year. Our external research and development expenses
for Viramidine (taribavirin) were $4,548,000 and $11,238,000 for
the three- and the six-month periods ended June 30, 2006.
For the three- and six month-periods ended June 30, 2005,
these external research and development expenses for Viramidine
(taribavirin) were $8,374,000 and $18,168,000, respectively.
Retigabine: We are developing retigabine as
adjunctive treatment for partial-onset seizures in patients with
epilepsy. Retigabine is believed to have a unique, dual-acting
mechanism and has undergone several Phase 2 clinical
trials. The Phase 2 trials included more than
600 patients in several dose-ranging studies compared to
placebo. We successfully completed an
End-of-Phase 2
meeting concerning retigabine with the FDA in November 2005. The
results of the key Phase 2 study indicate that the compound
is potentially efficacious with a demonstrated reduction in
monthly seizure rates of 23% to 35% as adjunctive therapy in
patients with partial seizures. Response rates in the two higher
doses were statistically significant compared to placebo
(p<0.001).
Following a Special Protocol Assessment by the FDA two
Phase 3 trials of retigabine were initiated in 2005. One
Phase 3 trial (RESTORE1; RESTORE stands for Retigabine
Efficacy and Safety Trial for partial Onset Epilepsy) will be
conducted at approximately 50 sites, mainly in the Americas
(U.S., Central/South America); the second Phase 3 trial
(RESTORE2) will be conducted at 60 sites, mainly in Europe. The
first patient in the RESTORE1 trial was enrolled in September
2005. Enrollment of the first patient in the RESTORE2 trial
occurred in December 2005. The enrollment period in epilepsy
studies can be lengthy, frequently requiring twelve to eighteen
months to complete. Supportive Phase 1 trials for
retigabine in healthy volunteers start in 2006. Assuming
successful completion of the Phase 3 trials, we expect
availability of the trials results in the second half of
2007. Assuming approval by the FDA, we expect to launch
retigabine in late 2008 or early 2009. For the three- and
six-month periods ended June 30, 2006, the external
research and development expenses for retigabine were $5,173,000
an $9,188,000, respectively. For the three-month period ended
June 30, 2005, the external research and development
expenses for retigabine were $3,056,000. We acquired Xcel
Pharmaceuticals, Inc. on March 1, 2005 and did not incur
external research and development expenses for retigabine in the
three months ended March 31, 2005.
Other
Development Activities
Infergen: On December 30, 2005, we
completed the acquisition of the United States and Canadian
rights to the hepatitis C drug Infergen (interferon
alfacon-1) from InterMune. Infergen, or consensus interferon, is
a bio-optimized, selective and highly potent type 1 interferon
alpha originally developed by Amgen and launched in the United
States in 1997. It is currently indicated as monotherapy for the
treatment of adult patients suffering from
33
chronic hepatitis C viral infections with compensated liver
disease who have not responded to other treatments or have
relapsed after such treatment. Infergen is the only interferon
with data in the label regarding use in patients following
relapse or non-response to certain previous treatments.
In connection with this transaction, we acquired patent rights
and rights to a clinical trial underway to expand the
applications of Infergen. In the DIRECT trial (001) which
started in the second quarter of 2004, 343 patients were
enrolled. As of June 30, 2006, 62 patients remained in
the trial. We expect to submit interim
24-week data
on all patients in the first trial to an upcoming scientific
meeting for communication in the last quarter of 2006. An
Extension to the DIRECT trial (IHRC-002) has enrolled
144 patients and is underway for some of the patients who
participated in the first trial. As of June 30, 2006,
62 patients remained in this trial. Both of the DIRECT
trials are reviewed on a regular basis by an independent Data
Monitoring Committee to monitor the safety of each trial. An
Extension to the DIRECT trial (002) is underway for some of
the patients who participated in the first trial. Post-treatment
follow-up
for the DIRECT trials are expected to be completed (i.e., last
patient visit) in the first and third quarters of 2007,
respectively. We expect to report and publish the results from
these studies sometime in late 2007.
Zelapar: Zelapar was approved by the FDA on
June 14, 2006 as an adjunct treatment in the management of
patients with Parkinsons disease being treated with
levodopa/carbidopa. Zelapar is the first Parkinsons
disease treatment to use the patented
Zydis®
fast-dissolving technology, which allows the tablets to dissolve
within seconds in the mouth and deliver more active drug at a
lower dose. We launched Zelapar in the U.S. market on
July 18, 2006.
Pradefovir (formerly called
remofovir): Pradefovir is a compound that we
licensed from Metabasis Therapeutics, Inc., or Metabasis, in
October 2001. We are engaged in the development of this compound
into an oral
once-a-day
monotherapy for patients with chronic hepatitis B infection. The
active molecule in this compound exhibits anti-hepatitis B
activity against both the wild type and lamivudine
drug-resistant hepatitis B. We have completed Phase 1 and
Phase 2 clinical trials of pradefovir. As announced in our
restructuring program, we intend to out-license pradefovir
before the initiation of Phase 3 clinical trials.
Foreign
Operations
Approximately 70% and 75% of our revenues from continuing
operations, which includes royalties, for the six months ended
June 30, 2006 and 2005, respectively, were generated from
operations outside the United States. All of our foreign
operations are subject to risks inherent in conducting business
abroad, including possible nationalization or expropriation,
price and currency exchange controls, fluctuations in the
relative values of currencies, political instability and
restrictive governmental actions. Changes in the relative values
of currencies occur from time to time and may, in some
instances, materially affect our results of operations. The
effect of these risks remains difficult to predict.
In January 2006, the parent company of one of our toll
manufacturers in Europe filed for bankruptcy. Sales of products
obtained from this manufacturer are estimated to be
approximately $60 million in 2006. The manufacturer has
developed a business plan to continue to successfully operate
and we have developed plans to respond to a disruption should it
occur. The manufacturer has submitted a proposal to emerge from
the bankruptcy to the bankruptcy court and its creditors. The
requisite creditors have approved the plan and the manufacturer
is awaiting court approval to emerge from bankruptcy. To date,
this bankruptcy has had no significant effect on our operations.
Critical
Accounting Estimates
The consolidated condensed financial statements appearing
elsewhere in this quarterly report have been prepared in
conformity with accounting principles generally accepted in the
United States. The preparation of these statements requires us
to make estimates and assumptions that affect the reported
amounts of assets and liabilities, the disclosure of contingent
assets and liabilities at the date of the financial statements
and the reported amounts of revenues and expenses during the
reporting periods. On an on-going basis, we evaluate our
estimates, including those related to product returns,
collectibility of receivables, inventories, intangible assets,
income taxes and contingencies and litigation. The actual
results could differ materially from those estimates.
We believe the following critical accounting policies affect our
more significant judgments and estimates used in the preparation
of our consolidated condensed financial statements.
34
Revenue
Recognition
We recognize revenues from product sales when title and risk of
ownership transfers to the customer. Revenues are recorded net
of provisions for rebates, discounts and returns, which are
estimated and recorded at the time of sale. Allowances for
future returns of products sold to our direct and indirect
customers, who include wholesalers, retail pharmacies and
hospitals, are calculated as a percent of sales based on
historical return percentages taking into account additional
available information on competitive products and contract
changes.
Our product sales are subject to a variety of deductions,
primarily representing rebates and discounts to government
agencies, wholesalers and managed care organizations. These
deductions represent estimates of the related obligations and,
as such, judgment is required when estimating the impact of
these sales deductions on revenues for a reporting period.
In the United States we record provisions for Medicaid and
contract rebates based upon our actual experience ratio of
rebates paid and actual prescriptions written during prior
quarters. We apply the experience ratio to the respective
periods sales to determine the rebate accrual and related
expense. This experience ratio is evaluated regularly and
adjusted if necessary to ensure that the historical trends are
as current as practicable. We adjust the ratio to better match
our current experience or our expected future experience, as
appropriate. In developing this ratio, we consider current
contract terms, such as changes in formulary status and discount
rates. Because our revenues in the United States include newly
acquired products and have increased significantly in the last
few years, ratios based on our historical experience may not be
indicative of future experience. If our ratio is not indicative
of future experience, our results could be materially affected.
Outside of the United States, the majority of our rebates are
contractual or legislatively mandated and our estimates are
based on actual invoiced sales within each period; both of these
elements help to reduce the risk of variations in the estimation
process. Some European countries base their rebates on the
governments unbudgeted pharmaceutical spending and we use
an estimated allocation factor against our actual invoiced sales
to project the expected level of reimbursement. We obtain third
party information that helps us to monitor the adequacy of these
accruals. If our estimates are not indicative of actual
unbudgeted spending, our results could be materially affected.
Historically, our adjustments to actual have not been material;
on a quarterly basis, they generally have been less than 2% of
product sales. The sensitivity of our estimates can vary by
program, type of customer and geographic location. However,
estimates associated with U.S. Medicaid, Medicare and
contract rebates are most at-risk for material adjustment
because of the extensive time delay between the recording of the
accrual and its ultimate settlement. This interval can range up
to one year. Because of this time lag, in any given quarter, our
adjustments to actual can incorporate revisions of several prior
quarters.
We record sales incentives as a reduction of revenues at the
time the related revenues are recorded or when the incentive is
offered, whichever is later. We estimate the cost of our sales
incentives based on our historical experience with similar
incentives programs.
In some markets customers have the right to return products to
us under certain conditions. Historically and in the three and
six month periods ended June 30, 2006 and 2005, the
provision for sales returns was less than 2% of product sales.
We conduct a review of the current methodology and assess the
adequacy of the allowance for returns on a quarterly basis,
adjusting for changes in assumptions, historical results and
business practices, as necessary. We use third-party data, when
available, to estimate the level of product inventories,
expiration dating, and product demand at our major wholesalers.
Actual results could be materially different from our estimates,
resulting in future adjustments to revenue.
We earn ribavirin royalties as a result of sales of products by
third-party licensees, Schering-Plough and Roche. Ribavirin
royalties are earned at the time the products subject to the
royalty are sold by the third party and are reduced by an
estimate for discounts and rebates that will be paid in
subsequent periods for those products sold during the current
period. We rely on a limited amount of financial information
provided by Schering-Plough and Roche to estimate the amounts
due to us under the royalty agreements.
35
Sales
Incentives
In the U.S. market, our current practice is to offer sales
incentives primarily in connection with launches of new products
or changes of existing products where demand has not yet been
established. We monitor and restrict sales in the
U.S. market in order to limit wholesaler purchases in
excess of their
ordinary-course-of-business
inventory levels. We operate Inventory Management Agreements
(IMAs) with major wholesalers in the United States. However,
specific events such as the case of sales incentives described
above or seasonal demand (e.g. antivirals during an outbreak)
may justify larger purchases by wholesalers. We may offer sales
incentives primarily in international markets, where typically
no right of return exists except for goods damaged in transit,
product recalls or replacement of existing products due to
packaging or labeling changes. Our revenue recognition policy on
these types of purchases and on incentives in international
markets is consistent with the policies described above.
Income
Taxes
Our income tax returns are subject to audit in various
jurisdictions. Existing and future audits by, or other disputes
with, tax authorities may not be resolved favorably for us and
could have a material adverse effect on our reported effective
tax rate and after-tax cash flows. We record liabilities for
potential tax assessments based on our estimate of the potential
exposure. New laws and new interpretations of laws and rulings
by tax authorities may affect the liability for potential tax
assessments. Due to the subjectivity and complex nature of the
underlying issues, actual payments or assessments may differ
from our estimates. To the extent that our estimates differ from
amounts eventually assessed and paid our income and cash flows
can be materially and adversely affected.
We assess whether it is more likely than not that we will
realize the tax benefits associated with our deferred tax assets
and establish a valuation allowance for assets that are not
expected to result in a realized tax benefit. A significant
amount of judgment is used in this process, including
preparation of forecasts of future taxable income and evaluation
of tax planning initiatives. If we revise these forecasts or
determine that certain planning events will not occur, an
adjustment to the valuation allowance will be made to tax
expense in the period such determination is made. We have
increased the valuation allowance significantly since 2004 to
recognize the uncertainty of realizing the benefits of the
U.S. net operating losses and research credits.
The tax provisions in the second quarters of both 2006 and 2005
relate to the profits of our foreign operations, foreign
withholding taxes, liabilities associated with the 1997 through
2001 IRS examination and, state and local taxes in the
U.S. Our US operations, which include our research and
development activities, generate substantial net operating
losses for US income tax reporting purposes. Since, at this
time, there is insufficient objective evidence that we will
generate sufficient U.S. taxable income to utilize these
net operating loss benefits, the tax benefits associated with
U.S. operating losses have been fully reserved.
Additionally, in 2005 a significant portion of the loss relates
to a charge for IPR&D associated with the Xcel acquisition
that is not deductible for tax purposes since that acquisition
was structured as a stock purchase.
We operate in numerous countries where our income tax returns
are subject to audit. Internal and external tax professionals
are employed to minimize tax audit adjustments where possible.
We consider the expected outcome of these audits in the
calculation of our tax provision.
We assesses whether it is more likely than not that we will
realize the tax benefit associated with our deferred tax assets
and establish a valuation allowance for assets that are not
expected to result in a realized tax benefit. A significant
amount of judgment is used in this process, including
preparation of forecasts of future taxable income and evaluation
of tax planning initiatives. If we revise these forecasts or
determine that certain planning events will not occur, an
adjustment to the valuation allowance will be made to tax
expense in the period such determination is made.
Impairment
of Property, Plant and Equipment
We evaluate the carrying value of property, plant and equipment
when conditions indicate a potential impairment. We determine
whether there has been impairment by comparing the anticipated
undiscounted future cash flows expected to be generated by the
property, plant and equipment with its carrying value. If the
undiscounted cash flows are less than the carrying value, the
amount of the impairment, if any, is then determined
36
by comparing the carrying value of the property, plant and
equipment with its fair value. Fair value is generally based on
a discounted cash flows analysis, independent appraisals or
preliminary offers from prospective buyers.
Valuation
of Intangible Assets
We periodically review intangible assets for impairment using an
undiscounted net cash flows approach. We determine whether there
has been impairment by comparing the anticipated undiscounted
future operating cash flows of the products associated with the
intangible asset with its carrying value. If the undiscounted
operating income is less than the carrying value, the amount of
the impairment, if any, will be determined by comparing the
value of each intangible asset with its fair value. Fair value
is generally based on a discounted cash flows analysis.
We use a discounted cash flow model to value acquired intangible
assets and for the assessment of impairment. The discounted cash
flow model requires assumptions about the timing and amount of
future cash inflows and outflows, risk, the cost of capital, and
terminal values. Each of these factors can significantly affect
the value of the intangible asset.
The estimates of future cash flows, based on reasonable and
supportable assumptions and projections, require
managements judgment. Any changes in key assumptions about
our businesses and their prospects, or changes in market
conditions, could result in an impairment charge. Some of the
more significant estimates and assumptions inherent in the
intangible asset impairment estimation process include: the
timing and amount of projected future cash flows; the discount
rate selected to measure the risks inherent in the future cash
flows; and the assessment of the assets life cycle and the
competitive trends impacting the asset, including consideration
of any technical, legal or regulatory trends.
Purchase
Price Allocation Including Acquired In-Process Research and
Development
The purchase price for the Infergen, Xcel, Amarin, and Ribapharm
acquisitions were allocated to the tangible and identifiable
intangible assets acquired and liabilities assumed based on
their estimated fair values at the acquisition date. Such a
valuation requires significant estimates and assumptions,
including but not limited to: determining the timing and
expected costs to complete the in-process projects; projecting
regulatory approvals; estimating future cash flows from product
sales resulting from completed products and in-process projects;
and developing appropriate discount rates and probability rates
by project. We believe the fair values assigned to the assets
acquired and liabilities assumed are based on reasonable
assumptions. However, these assumptions may be incomplete or
inaccurate, and unanticipated events and circumstances may
occur. Additionally, estimates for the purchase price
allocations may change as subsequent information becomes
available.
We value IPR&D acquired in a business combination based on
an approach consistent with the AICPA Practice Aid, Assets
Acquired in Business Combinations to be Used in Research and
Development Activities: A Focus in Software, Electronic Devices
and Pharmaceutical Industries. The amounts expensed as
acquired IPR&D represents an estimate of the fair value of
purchased in-process technology for projects that, as of the
acquisition date, had not yet reached technological feasibility
and had no alternative future use. The data used to determine
fair value requires significant judgment. The estimated fair
values were based on our use of a discounted cash flow model.
For each project, the estimated after-tax cash flows were
probability weighted to take account of the stage of completion
and the risks surrounding the successful development and
commercialization. The assumed tax rates are our estimate of the
effective tax rates that will apply to the expected cash flows.
These cash flows were then discounted to a present value using
discount rates between 15% and 20%.
The major risks and uncertainties associated with the timely and
successful completion of these projects include the uncertainty
of our ability to confirm the safety and efficacy of product
candidates based on the data from clinical trials and of
obtaining necessary regulatory approvals. In addition, no
assurance can be given that the underlying assumptions we used
to forecast the cash flows or the timely and successful
completion of these projects will materialize as estimated. For
these reasons, among others, actual results may vary
significantly from the estimated results.
37
Stock-based
Compensation Expense
On January 1, 2006, we adopted Statement of Financial
Accounting Standards No. 123 (revised 2004),
Share-Based Payment, (SFAS 123(R))
which requires the measurement and recognition of compensation
expense for all share-based payment awards made to our employees
and directors, including employee stock options and employee
stock purchases related to the Employee Stock Purchase Plan,
based on estimated fair values. Stock-based compensation expense
recognized under SFAS 123(R) for the three months ended
June 30, 2006 was $5,682,000, which consisted of
stock-based compensation expense related to employee stock
options and the Employee Stock Purchase Plan of $5,045,000, and
stock-based compensation expense related to restricted stock
awards and acquisitions of $637,000. We adopted SFAS 123(R)
on a prospective basis and have not restated financial
statements for prior years. Stock-based compensation expense of
$544,000 for the three months ended June 30, 2005, was
related to restricted stock awards and acquisitions which the
Company had been recognizing under previous accounting standards
(see Note 1 to Consolidated Condensed Financial
Statements). If the Company had recognized stock compensation
expense for stock options and the Employee Stock Purchase Plan
in 2005 the net loss for the three months ended June 30,
2005 would have been $144,309,000 or $1.62 per share, an
increase of $5,050,000 or $0.05 per share from the amounts
reported.
We estimate the value of employee stock options on the date of
grant using the Black-Scholes model. The determination of fair
value of share-based payment awards on the date of grant using
an option-pricing model is affected by our stock price as well
as assumptions regarding a number of highly complex and
subjective variables. These variables include, but are not
limited to the expected stock price volatility over the term of
the awards, and actual and projected employee stock option
exercise behaviors. The weighted-average estimated value of
employee stock options granted during the six months ended
June 30, 2006 was $5.47 determined using the Black Scholes
model and the following weighted-average assumptions:
|
|
|
|
|
|
|
2006
|
|
|
Weighted-average life (years)
|
|
|
4.1
|
|
Volatility
|
|
|
38
|
%
|
Expected dividend per share
|
|
$
|
0.31
|
|
Risk-free interest rate
|
|
|
4.88
|
%
|
Weighted-average fair value of
options
|
|
$
|
5.47
|
|
As stock-based compensation expense recognized in the
consolidated statement of operations in 2006 is based on awards
ultimately expected to vest, it has been reduced for estimated
forfeitures. SFAS 123(R) requires forfeitures to be
estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those
estimates. Forfeitures were estimated based on historical
experience.
The total future compensation costs associated with employee
stock options and restricted stock awards that were outstanding
at June 30, 2006 is $20,779,000. This will be amortized to
expense as follows: $8,284,000 in the remaining quarters of
2006, $8,492,000 in 2007, $3,188,000 in 2008 and $815,000 in
2009 and thereafter.
If factors change and we employ different assumptions in the
application of SFAS 123(R) in future periods, the
compensation expense that we record under SFAS 123(R) may
differ significantly from what we have recorded in the current
period.
Contingencies
We are exposed to contingencies in the ordinary course of
business, such as legal proceedings and business-related claims
which range from product and environmental liabilities to tax
matters. In addition, we may have indemnification obligations,
including commitments to current and former directors in certain
circumstances. In accordance, with SFAS No. 5,
Accounting for Contingencies, we record accruals for such
contingencies when it is probable that a liability will be
incurred and the amount of loss can be reasonably estimated. The
estimates are refined each accounting period, as additional
information is known. See Note 9 of notes to consolidated
condensed financial statements for a discussion of contingencies.
38
Other
Financial Information
With respect to the unaudited condensed consolidated financial
information of Valeant Pharmaceutical International for the
three and six months ended June 30, 2006 and 2005,
PricewaterhouseCoopers LLP reported that they have applied
limited procedures in accordance with professional standards for
a review of such information. However, their report dated
August 7, 2006, appearing herein, states that they did not
audit and they do not express an opinion on that unaudited
condensed consolidated financial information. Accordingly, the
degree of reliance on their report on such information should be
restricted in light of the limited nature of the review
procedures applied. PricewaterhouseCoopers is not subject to the
liability provisions of Section 11 of the Securities Act of
1933 (the Act) for their report on the unaudited
condensed consolidated financial information because that report
is not a report or a part of a
registration statement prepared or certified by
PricewaterhouseCoopers within the meaning of Sections 7 and
11 of the Act.
Forward-Looking
Statements
Except for the historical information contained herein, the
matters addressed in Managements Discussion and
Analysis of Financial Condition and Results of Operations
and elsewhere in this quarterly report on
Form 10-Q
constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as
amended and Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements may be identified
by the use of the words anticipates,
expects, intends, plans, and
variations or similar expressions. Forward-looking statements
include, among other things, statements regarding the effects
and success of our restructuring program, our products in
development, the information and expectations concerning our
future financial performance, business strategy, projected plans
and objectives, and our estimates with respect to future
operating results. These forward-looking statements are subject
to a variety of risks and uncertainties, including those
discussed below and elsewhere in this quarterly report on
Form 10-Q,
which could cause actual results to differ materially from those
anticipated by our management. You should consider these in
evaluating our prospects and future financial performance. In
addition, the information set forth in our annual report on
Form 10-K
for the fiscal year ended December 31, 2005 and this
quarterly report on
Form 10-Q
describes certain additional risks and uncertainties that could
cause actual results to vary materially from the future results
covered in such forward-looking statements. Readers are
cautioned not to place undue reliance on any of these
forward-looking statements, which speak only as of the date of
this report. We undertake no obligation to update any of these
forward-looking statements to reflect events or circumstances
after the date of this report or to reflect actual outcomes or
any obligation to explain the reasons why actual results may
differ.
Our actual results could differ materially from these
anticipated in this report as a result of various factors,
including those set forth below.
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The future growth of our business depends on the development,
approval, and commercialization of new products, including
Viramidine (taribavirin) and retigabine. The process of
developing new drugs has an inherent risk of failure. For
example, product candidates may turn out to be ineffective or
unsafe in clinical testing; their patent protection may become
compromised; other therapies may prove safer or more effective;
or the prevalence of the disease for which they are being
developed may decrease. Our inability to successfully develop
our products due to these or other factors could have a material
adverse effect on future revenues.
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We can protect our products from generic substitution by third
parties only to the extent that our technologies are covered by
valid and enforceable patents, are effectively maintained as
trade secrets or are protected by data exclusivity. However, our
pending or future patent applications may not issue as patents.
Any patent issued may be challenged, invalidated, held
unenforceable or circumvented. Furthermore, our patents may not
be sufficiently broad to prevent third parties competing
products. The expiration of patent protection for ribavirin has
resulted in significant competition from generic substitutes and
declining royalty revenues and may negatively impact future
financial results.
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Trade secret protection is less effective than patent protection
because competitors may discover the technology or develop
parallel technology.
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39
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The scope of protection afforded by a patent can be highly
uncertain. A pending claim or a result unfavorable to us in a
patent dispute may preclude development or commercialization of
products or impact sales of existing products, result in
cessation of royalty payments to us
and/or
result in payment of monetary damages.
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Obtaining drug approval in the United States and other countries
is costly and time consuming. Uncertainties and delays inherent
in the process can preclude or delay development and
commercialization of our products.
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Our current business plan includes targeted expansion through
acquisitions of compatible businesses and product lines and the
formation of strategic alliances, joint ventures and other
business combinations, in addition to the development of new
products. If we are unable to successfully execute on our
expansion plans to find attractive acquisition candidates at
appropriate prices, and to integrate successfully any acquired
companies or products, the expected growth of our business may
be negatively affected.
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We and our competitors are always striving to develop products
that are more effective, safer, more easily tolerated or less
costly. If our competitors succeed in developing better
alternatives to our current products before we do, we will lose
sales and revenues to their alternative products. If vaccines
are introduced to prevent the diseases treated by our products,
our potential sales and revenues will decrease.
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|
The pharmaceutical industry is subject to substantial government
regulation, including the approval of new pharmaceutical
products, labeling, advertising and, in most countries, pricing,
as well as inspection and approval of manufacturing facilities.
The costs of complying with these regulations are high, and
failure to comply could result in fines or interruption in our
business.
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We collect and pay a substantial portion of our sales and
expenditures in currencies other than the U.S. dollar. As a
result, fluctuations in foreign currency exchange rates affect
our operating results. Additionally, future exchange rate
movements, inflation or other related factors may have a
material adverse effect on our sales, gross profit or operating
expenses. At June 30, 2006 we have in place foreign
currency hedge transactions to reduce our exposure to
variability in the Polish Zloty. We continue to evaluate the
possibility of entering into additional hedge arrangements.
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A significant part of our revenue is derived from products
manufactured by third parties. We rely on their quality level,
compliance with the FDA regulations or similar regulatory
requirements enforced by regulatory agencies in other countries
and continuity of supply. Any failure by them in these areas
could disrupt our product supply and negatively impact our
revenues.
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Our flexibility in maximizing commercialization opportunities
for our compounds may be limited by our obligations to
Schering-Plough. In November 2000, we entered into an agreement
that provides Schering-Plough with an option to acquire the
rights to up to three of our products intended to treat
hepatitis C that Schering-Plough designates prior to our
entering Phase 2 clinical trials and a right for first/last
refusal to license various compounds we may develop and elect to
license to others. Viramidine (taribavirin) was not subject to
the option of Schering-Plough, but it would be subject to their
right of first/last refusal if we elected to license it to a
third party. The interest of potential collaborators in
obtaining rights to our compounds or the terms of any agreement
we ultimately enter into for these rights may be hindered by our
agreement with Schering-Plough.
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To purchase our products, many patients rely on reimbursement by
third party payors such as insurance companies, HMOs and
government agencies. These third party payors are increasingly
attempting to contain costs by limiting both coverage and the
level of reimbursement of new drug products. The reimbursement
levels established by third party payors in the future may not
be sufficient for us to realize an appropriate return on our
investment in product development and our continued manufacture
and sale of existing drugs.
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All drugs have potential harmful side effects and can expose
drug manufacturers and distributors to liability. In the event
one or more of our products is found to have harmed an
individual or individuals, we may be responsible for paying all
or substantially all damages awarded. A successful product
liability claim against us could have a material negative impact
on our financial position and results of operations.
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40
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Our debt agreements permit us to incur additional debt, subject
to certain restrictions, but there is no guaranty that we will
actually be able to borrow any money should the need for it
arise.
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We are involved in several legal proceedings, including those
described in Note 9 to notes to consolidated condensed
financial statements, any of which could result in substantial
cost and divert managements attention and resources.
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Dependence on key personnel leaves us vulnerable to a negative
impact if they leave. Our continued success will depend, to a
significant extent, upon the efforts and abilities of the key
members of management. The loss of their services could have a
negative impact on us.
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Our research and development activities involve the controlled
use of potentially harmful biological materials as wells as
hazardous materials, chemicals and various radioactive
compounds. We cannot completely eliminate the risk of accidental
contamination or injury from the use, storage, handling or
disposal of these materials. In the event of contamination or
injury, we could be held liable for damages that result. Any
liability could exceed our resources.
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Our stockholder rights plan, provisions of our certificate of
incorporation and provisions of the Delaware General Corporation
Law could provide our Board of Directors with the ability to
deter hostile takeovers or delay, deter or prevent a change in
control of our company, including transactions in which
stockholders might otherwise receive a premium for their shares
over then current market prices.
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We are authorized to issue, without stockholder approval,
approximately 10,000,000 shares of preferred stock,
200,000,000 shares of common stock and securities
convertible into either shares of common stock or preferred
stock. If we issue additional equity securities, the price of
our securities may be materially and adversely affected. The
Board of Directors can also use issuances of preferred or common
stock to deter a hostile takeover or change in control of our
company.
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We are subject to a consent order with the Securities and
Exchange Commission, which permanently enjoins us from violating
securities laws and regulations. The consent order also
precludes protection for forward-looking statements under the
safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 with respect to forward-looking statements we
made prior to November 28, 2005. The existence of the
permanent injunction under the consent order, and the lack of
protection under the safe harbor with respect to forward-looking
statements made prior to November 28, 2005 may limit our
ability to defend against future allegations.
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41
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Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
Our business and financial results are affected by fluctuations
in world financial markets. We evaluate our exposure to such
risks on an ongoing basis, and seek ways to manage these risks
to an acceptable level, based on managements judgment of
the appropriate trade-off between risk, opportunity and cost. We
do not hold any significant amount of market risk sensitive
instruments whose value is subject to market price risk. Our
significant foreign currency exposure relates to the Euro, the
Mexican Peso, the Polish Zloty, the Swiss Franc, the Canadian
Dollar, and the Japanese Yen. We seek to manage our foreign
currency exposure through operational means by managing local
currency revenues in relation to local currency costs. We take
steps to mitigate the impact of foreign currency on the income
statement, which include hedging our foreign currency exposure.
In the normal course of business, we also face risks that are
either non-financial or non-quantifiable. Such risks principally
include country risk, credit risk and legal risk and are not
discussed or quantified in the following analysis. At
June 30, 2006, the fair values of the Companys
financial instruments were as follows (in thousands):
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Notional/
|
|
|
Assets (Liabilities)
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|
|
|
Contract
|
|
|
Carrying
|
|
|
Fair
|
|
Description
|
|
Amount
|
|
|
Value
|
|
|
Value
|
|
|
Forward contracts
|
|
$
|
45,376
|
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|
$
|
(2,698
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)
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|
$
|
(2,698
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)
|
Interest rate swaps
|
|
|
150,000
|
|
|
|
(9,092
|
)
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|
(9,092
|
)
|
Outstanding fixed-rate debt
|
|
|
780,000
|
|
|
|
(780,000
|
)
|
|
|
(712,000
|
)
|
We currently do not hold financial instruments for trading or
speculative purposes. Our financial assets are not subject to
significant interest rate risk due to their short duration. At
June 30, 2006, we had $7,153,000 of foreign denominated
variable rate debt that would subject it to both interest rate
and currency risks. A 100 basis-point increase in interest rates
affecting our financial instruments would not have had a
material effect on our second quarter 2006 pretax earnings. In
addition, we have $780,000,000 of fixed rate debt as of
June 30, 2006, that requires U.S. dollar repayment. To
the extent that we require, as a source of debt repayment,
earnings and cash flow from some of our subsidiary units located
in foreign countries, we are subject to risk of changes in the
value of certain currencies relative to the U.S. dollar.
However, the increase of 100 basis-points in interest rates
would have reduced the fair value of our remaining fixed-rate
debt instruments by approximately $32,600,000 as of
June 30, 2006.
We estimated the sensitivity of the fair value of our derivative
foreign exchange contracts to a hypothetical 10% strengthening
and 10% weakening of the spot exchange rates for the
U.S. dollar against the Zloty at June 30, 2006. The
analysis showed that a 10% strengthening of the U.S. dollar
would have resulted in a gain from a fair value change of
$4,423,000 and a 10% weakening of the U.S. dollar would
have resulted in a loss from a fair value change of $5,406,000
in these instruments. Losses and gains on the underlying
transactions being hedged would have largely offset any gains
and losses on the fair value of derivative contracts. These
offsetting gains and losses are not reflected in the above
analysis.
42
|
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Item 4.
|
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 SECs
rules and forms and that such information is accumulated and
communicated to our management, including the Chief Executive
Officer and Chief Financial Officer, as appropriate, to allow
timely decisions regarding required disclosure. In designing and
evaluating the disclosure controls and procedures, we recognize
that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving
the desired control objectives, and that we necessarily are
required to apply our judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
As of June 30, 2006, we conducted an evaluation of the
effectiveness of the design and operation of our disclosure
controls and procedures. This evaluation was carried out under
the supervision and with the participation of our management,
including the Chief Executive Officer and Chief Financial
Officer. Based upon the foregoing, our Chief Executive Officer
and Chief Financial Officer concluded that our disclosure
controls and procedures were effective.
There has been no change in our internal controls over financial
reporting that occurred during the three months ended
June 30, 2006 that has materially affected, or is
reasonably likely to materially affect, the internal controls
over financial reporting.
43
PART II
OTHER INFORMATION
|
|
Item 1.
|
Legal
Proceedings
|
See Note 9 of notes to consolidated condensed financial
statements in Item 1 of Part I of this quarterly
report, which is incorporated herein by reference.
Our Annual Report on
Form 10-K
for the year ended December 31, 2005 includes a detailed
discussion of our risk factors. Pursuant to the instructions to
Form 10-Q,
we have provided below only those risk factors that are new or
that have been materially amended since the time that we filed
our most recent Annual Report on
Form 10-K.
Accordingly, the information presented below should be read in
conjunction with the risk factors and information disclosed in
our most recent
Form 10-K
and the other risks described in this
Form 10-Q.
If we
do not realize the expected benefits from the restructuring plan
we announced in April 2006, our operating results and financial
conditions would be negatively impacted.
In April 2006, we announced a strategic restructuring of our
company designed to focus our resources on programs and products
that have the greatest opportunity for success. Accordingly, we
elected to rationalize certain of our assets, including our
discovery program and certain manufacturing facilities. We will
attempt to sell, out-license, or secure partners to share the
costs of major clinical projects and discretionary programs. It
is possible that we could be unsuccessful in our attempts to
sell or out-license these assets. In the event that we are
successful in selling or out-licensing any of our discovery
assets, the structure of such transactions may provide for only
future compensation contingent upon the third partys
successful development of a product
and/or
program. Such success is subject to the risks inherent in
developing and obtaining approval for pharmaceutical products.
Accordingly, it is possible that we may not receive any
financial benefit from any sale or out license of these assets.
In addition, if we are unable to realize the expected
operational efficiencies from our restructuring plan, our
operating results and financial condition would be adversely
affected.
If we
or our third-party manufacturers are unable to manufacture our
products or the manufacturing process is interrupted due to
failure to comply with regulations or for other reasons, the
manufacture of our products could be interrupted.
We manufacture and have contracted with third parties to
manufacture some of our drug products, including products under
the rights acquired from other pharmaceutical companies.
Manufacturers are required to adhere to current good
manufacturing (cGMP) regulations enforced by the FDA
or similar regulations required by regulatory agencies in other
countries. Compliance with the FDAs cGMP requirements
applies to both drug products seeking regulatory approval and to
approved drug products. Our manufacturing facilities and those
of our contract manufacturers must be inspected and found to be
in full compliance with cGMP standards before approval for
marketing. We and contract manufacturers of our approved
products are subject to ongoing regulation by the FDA, including
compliance with cGMP requirements, and to similar regulatory
requirements enforced by regulatory agencies in other countries.
Our dependence upon others to manufacture our products may
adversely affect our profit margins and our ability to develop
and obtain approval for our products on a timely and competitive
basis, if at all. Our failure or that of our contract
manufacturers to comply with cGMP regulations or similar
regulations outside of the United States can result in
enforcement action by the FDA or its foreign counterparts,
including, among other things, warning letters, fines,
injunctions, civil penalties, recall or seizure of products,
total or partial suspension of production, refusal of the
government to renew marketing applications and criminal
prosecution. In addition, delays or difficulties with our
contract manufacturers in producing, packaging, or distributing
our products could adversely affect the sales of our current
products or introduction of other products.
Schering-Plough manufactures and sells ribavirin under license
from us. In May 2002, Schering-Plough signed a consent decree of
permanent injunction with the FDA, agreeing to measures to
assure that the drug products manufactured at their Puerto Rico
plant are made in compliance with FDAs current good
manufacturing practice
44
regulations. While Schering-Plough has advised us that the
deficiencies were not specifically applicable to the production
of ribavirin, the consent decree covers the facility producing
ribavirin. Schering-Ploughs ability to manufacture and
ship ribavirin could be affected by temporary interruption of
some production lines to install system upgrades and further
enhance compliance, and other technical production and equipment
qualification issues. If the FDA is not satisfied with
Schering-Ploughs compliance under the consent decree, the
FDA could take further regulatory actions against
Schering-Plough, including the seizure of products, an
injunction against further manufacture, a product recall or
other actions that could interrupt production of ribavirin.
Interruption of ribavirin production for a sustained period of
time could materially reduce our royalty revenue.
In addition to regulatory compliance risks, our contract
manufacturers in the United States and in other countries are
subject to a wide range of business risks, such as seizure of
assets by governmental authorities, natural disasters, and
domestic and international economic conditions. Were any of our
contract manufacturers not able to manufacture our products
because of regulatory, business or any other reasons, the
manufacture of our products would be interrupted. This could
have a negative impact on our sales, financial condition and
competitive position. In January 2006, the parent company of one
of our toll manufacturers in Europe filed for bankruptcy. Sales
of products obtained from this manufacturer are estimated to be
approximately $60 million in 2006. Although the
manufacturer is awaiting court approval to emerge from
bankruptcy and we have developed plans to respond to a
disruption in supply by this manufacturer, there can be no
assurance that, should a disruption in supply occur, we will be
able to respond in time with alternative sources of supply or
have sufficient levels of inventory to prevent a material
negative impact on revenues. In addition, we cannot assure you
that the supplier will emerge from bankruptcy, and if so,
whether it will be able to meet our supply needs.
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Item 5.
|
Other
Information
|
See Note 2, Restructuring, of notes to consolidated
condensed financial statements in Item 1 of Part I of
this quarterly report, which is incorporated herein by reference.
|
|
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
|
|
10
|
.1
|
|
Valeant Pharmaceuticals
International Executive Incentive Plan, previously described in
Item 1.01 of Registrants Current Report on
Form 8-K
filed on April 19, 2006, which is incorporated herein by
reference.
|
|
10
|
.2
|
|
Valeant Pharmaceuticals
International 2006 Equity Incentive Plan, previously filed as
Exhibit 10.1 to the Current Report on
Form 8-K
filed on May 25, 2006, which is incorporated herein by
reference.
|
|
10
|
.3
|
|
Form of Restricted Stock Unit
Award Agreement under the 2003 Equity Incentive Plan, previously
filed as Exhibit 99.1 to the Current Report on
Form 8-K
filed on June 27, 2006, which is incorporated herein by
reference.
|
|
15
|
.1
|
|
Review Report of Independent
Registered Public Accounting Firm.
|
|
15
|
.2
|
|
Awareness Letter of Independent
Registered Public Accounting Firm.
|
|
31
|
.1
|
|
Certification of Chief Executive
Officer pursuant to
Rule 13a-14(a)
under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31
|
.2
|
|
Certification of Chief Financial
Officer pursuant to
Rule 13a-14(a)
under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32
|
.1
|
|
Certification of Chief Executive
Officer and Chief Financial Officer of Periodic Financial
Reports pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002, 18 U.S.C. § 1350.
|
|
|
|
|
|
Management contract or compensatory plan or arrangement. |
45
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this quarterly report on
Form 10-Q
to be signed on its behalf by the undersigned thereunto duly
authorized.
Valeant Pharmaceuticals
International
Registrant
Timothy C. Tyson
President and Chief Executive Officer
Date: August 7, 2006
Bary G. Bailey
Executive Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
Date: August 7, 2006
46
EXHIBIT INDEX
|
|
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
|
|
10
|
.1
|
|
Valeant Pharmaceuticals
International Executive Incentive Plan, previously described in
Item 1.01 of Registrants Current Report on
Form 8-K
filed on April 19, 2006, which is incorporated herein by
reference.
|
|
10
|
.2
|
|
Valeant Pharmaceuticals
International 2006 Equity Incentive Plan, previously filed as
Exhibit 10.1 to the Current Report on
Form 8-K
filed on May 25, 2006, which is incorporated herein by
reference.
|
|
10
|
.3
|
|
Form of Restricted Stock Unit
Award Agreement under the 2003 Equity Incentive Plan, previously
filed as Exhibit 99.1 to the Current Report on
Form 8-K
filed on June 27, 2006, which is incorporated herein by
reference.
|
|
15
|
.1
|
|
Review Report of Independent
Registered Public Accounting Firm.
|
|
15
|
.2
|
|
Awareness Letter of Independent
Registered Public Accounting Firm.
|
|
31
|
.1
|
|
Certification of Chief Executive
Officer pursuant to
Rule 13a-14(a)
under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31
|
.2
|
|
Certification of Chief Financial
Officer pursuant to
Rule 13a-14(a)
under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32
|
.1
|
|
Certification of Chief Executive
Officer and Chief Financial Officer of Periodic Financial
Reports pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002, 18 U.S.C. § 1350.
|
|
|
|
|
|
Management contract or compensatory plan or arrangement. |
47