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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 March 31, 2005 |
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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 |
Commission file number: 1-11397
Valeant Pharmaceuticals International
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization) |
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33-0628076
(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) |
(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 an accelerated
filer (as defined in Exchange Act
Rule 12b-2). Yes þ No o
The number of outstanding shares of the registrants Common
Stock, $0.01 par value, as of May 3, 2005 was
92,542,268.
VALEANT PHARMACEUTICALS INTERNATIONAL
INDEX
1
PART I FINANCIAL INFORMATION
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Item 1. |
Financial Statements |
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED CONDENSED BALANCE SHEETS
As of March 31, 2005 and December 31, 2004
(Unaudited, in thousands, except par value data)
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March 31, | |
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December 31, | |
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2005 | |
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2004 | |
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ASSETS |
Current Assets:
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Cash and cash equivalents
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$ |
325,446 |
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$ |
222,590 |
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Marketable securities
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36,119 |
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238,918 |
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Accounts receivable, net
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169,651 |
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171,860 |
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Inventories, net
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125,859 |
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112,250 |
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Prepaid expenses and other current assets
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23,107 |
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25,049 |
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Total current assets
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680,182 |
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770,667 |
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Property, plant and equipment, net
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226,102 |
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233,258 |
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Deferred tax assets, net
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855 |
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Goodwill
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74,018 |
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20,499 |
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Intangible assets, net
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519,679 |
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432,277 |
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Other assets
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43,976 |
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41,280 |
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Total non-current assets
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864,630 |
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727,314 |
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Assets of discontinued operations
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16,609 |
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23,894 |
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$ |
1,561,421 |
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$ |
1,521,875 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
Current Liabilities:
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Trade payables
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$ |
51,502 |
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$ |
48,713 |
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Accrued liabilities
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126,661 |
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122,297 |
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Notes payable and current portion of long-term debt
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452 |
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929 |
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Income taxes payable
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35,900 |
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20,266 |
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Total current liabilities
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214,515 |
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192,205 |
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Long-term debt, less current portion
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790,074 |
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793,139 |
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Deferred tax liabilities, net
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13,823 |
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Other liabilities
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17,602 |
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14,429 |
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Total non-current liabilities
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807,676 |
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821,391 |
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Liabilities of discontinued operations
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30,948 |
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32,056 |
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Commitments and contingencies
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Stockholders Equity:
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Common stock, $0.01 par value; 200,000 shares
authorized; 92,540 (March 31, 2005) and 84,219
(December 31, 2004) shares outstanding (after deducting
shares in treasury of 1,068 as of March 31, 2005 and
December 31, 2004
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925 |
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842 |
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Additional capital
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1,195,369 |
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1,004,875 |
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Accumulated deficit
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(680,618 |
) |
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(534,205 |
) |
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Accumulated other comprehensive income (loss)
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(7,394 |
) |
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4,711 |
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Total stockholders equity
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508,282 |
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476,223 |
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$ |
1,561,421 |
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$ |
1,521,875 |
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The accompanying notes are an integral part of these
consolidated condensed financial statements.
2
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
For the three months ended March 31, 2005 and 2004
(Unaudited, in thousands, except per share data)
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Three Months Ended | |
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March 31, | |
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2005 | |
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2004 | |
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Revenues:
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Product sales
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$ |
161,803 |
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$ |
132,325 |
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Ribavirin royalties
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19,335 |
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25,377 |
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Total revenues
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181,138 |
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157,702 |
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Costs and expenses:
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Cost of goods sold (excluding amortization)
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48,721 |
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46,712 |
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Selling expenses
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52,815 |
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47,742 |
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General and administrative expenses
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24,052 |
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23,875 |
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Research and development costs
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25,724 |
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18,463 |
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Acquired in-process research and development
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126,399 |
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11,386 |
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Restructuring charges
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2,220 |
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Amortization expense
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13,968 |
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13,287 |
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Total costs and expenses
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293,899 |
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161,465 |
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Loss from operations
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(112,761 |
) |
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(3,763 |
) |
Other income (loss), net, including translation and exchange
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(1,791 |
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(1,046 |
) |
Interest income
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3,015 |
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3,060 |
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Interest expense
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(9,681 |
) |
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(14,959 |
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Loss from continuing operations before income taxes and minority
interest
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(121,218 |
) |
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(16,708 |
) |
Provision (benefit) for income taxes
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16,367 |
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(6,182 |
) |
Minority interest, net
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171 |
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(14 |
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Loss from continuing operations
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(137,756 |
) |
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(10,512 |
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Loss from discontinued operations
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(1,503 |
) |
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(3,061 |
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Net loss
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$ |
(139,259 |
) |
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$ |
(13,573 |
) |
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Basic and diluted loss per share:
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Loss from continuing operations
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$ |
(1.55 |
) |
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$ |
(0.12 |
) |
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Loss from discontinued operations
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(0.02 |
) |
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(0.04 |
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Basic and diluted net loss per share
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$ |
(1.57 |
) |
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$ |
(0.16 |
) |
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Basic and diluted shares used in per share computation
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88,836 |
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83,447 |
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Dividends paid per share of common stock
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$ |
0.08 |
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$ |
0.08 |
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Dividends declared per share of common stock
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$ |
0.08 |
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$ |
0.08 |
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The accompanying notes are an integral part of these
consolidated condensed financial statements.
3
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE LOSS
For the three months ended March 31, 2005 and 2004
(Unaudited, in thousands)
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Three Months Ended | |
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March 31, | |
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2005 | |
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2004 | |
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Net loss
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$ |
(139,259 |
) |
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$ |
(13,573 |
) |
Other comprehensive income (loss):
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Foreign currency translation adjustments
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(15,363 |
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(5,004 |
) |
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Unrealized gain (loss) on marketable equity securities and other
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3,258 |
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(177 |
) |
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Reclassification adjustment for loss realized included in net
income
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1,505 |
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Comprehensive loss
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$ |
(151,364 |
) |
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$ |
(17,249 |
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The accompanying notes are an integral part of these
consolidated condensed financial statements.
4
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2005 and 2004
(Unaudited, in thousands)
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Three Months Ended | |
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March 31, | |
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2005 | |
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2004 | |
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Cash flows from operating activities:
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Loss from continuing operations
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$ |
(137,756 |
) |
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$ |
(10,512 |
) |
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Adjustments to reconcile net loss to net cash provided by
operating activities:
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Depreciation and amortization
|
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21,038 |
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|
21,657 |
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Provision for losses on accounts receivable and inventory
obsolescence
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|
1,594 |
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|
689 |
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Translation and exchange (gains) losses, net
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|
1,791 |
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|
103 |
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Other non-cash items
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|
310 |
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1,512 |
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Impairment charges
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|
2,220 |
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Acquired in-process research and development
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126,399 |
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11,386 |
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Deferred income taxes
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|
(14,026 |
) |
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|
(12,542 |
) |
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Minority interest
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(171 |
) |
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(14 |
) |
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Change in assets and liabilities, net of effects of acquisitions:
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Accounts receivable
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|
6,482 |
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|
25,044 |
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Inventories
|
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(10,951 |
) |
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|
(5,584 |
) |
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Prepaid expenses and other assets
|
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|
(129 |
) |
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|
1,796 |
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|
Trade payables and accrued liabilities
|
|
|
(7,740 |
) |
|
|
(14,022 |
) |
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Income taxes payable
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|
15,960 |
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|
(4,321 |
) |
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Other liabilities
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|
3,641 |
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|
4,306 |
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Cash flow from operating activities in continuing operations
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|
8,662 |
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|
19,498 |
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Cash flow from operating activities in discontinued operations
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(471 |
) |
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(624 |
) |
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Net cash provided by operating activities
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|
8,191 |
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|
18,874 |
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Cash flows from investing activities:
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Capital expenditures
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(4,848 |
) |
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(3,971 |
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Proceeds from sale of assets
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|
762 |
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|
11,208 |
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Proceeds from investments
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|
498,600 |
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Purchase of investments
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(296,213 |
) |
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(5,894 |
) |
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Cash acquired in connection with acquisition
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11,198 |
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Acquisition of businesses
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(292,905 |
) |
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(39,912 |
) |
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Acquisition of license rights and product lines
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(71 |
) |
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(4,446 |
) |
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Cash flow from investing activities in continuing operations
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|
(83,477 |
) |
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|
(43,015 |
) |
|
Cash flow from investing activities in discontinued operations
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|
1 |
|
|
|
23 |
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|
|
|
|
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Net cash used in investing activities
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|
(83,476 |
) |
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|
(42,992 |
) |
|
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Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
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Payments on long-term debt and notes payable
|
|
|
(593 |
) |
|
|
(568 |
) |
|
Proceeds from issuance of stock
|
|
|
640 |
|
|
|
4,938 |
|
|
Proceeds from stock offering
|
|
|
189,393 |
|
|
|
|
|
|
Dividends paid
|
|
|
(6,502 |
) |
|
|
(6,432 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
182,938 |
|
|
|
(2,062 |
) |
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
(4,794 |
) |
|
|
(871 |
) |
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
102,859 |
|
|
|
(27,051 |
) |
Cash and cash equivalents at beginning of period
|
|
|
222,719 |
|
|
|
872,969 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
|
325,578 |
|
|
|
845,918 |
|
Cash and cash equivalents classified as part of discontinued
operations
|
|
|
(132 |
) |
|
|
(402 |
) |
|
|
|
|
|
|
|
Cash and cash equivalents of continuing operations
|
|
$ |
325,446 |
|
|
$ |
845,516 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated condensed financial statements.
5
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
(Unaudited)
The consolidated condensed financial statements included herein
have been prepared by the Company, without audit, pursuant to
the rules and regulations of the Securities and Exchange
Commission. 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 the Company believes 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, 2004.
|
|
1. |
Organization and Summary of Significant Accounting
Policies |
Organization: Valeant Pharmaceuticals International
(Valeant, formerly known as ICN Pharmaceuticals,
Inc.) and its subsidiaries (collectively, the
Company) is a global, research-based, specialty
pharmaceutical company that discovers, develops, manufactures,
and markets a broad range of pharmaceutical products. In
addition, the Company generates 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, 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 these
consolidated subsidiaries. All significant intercompany account
balances and transactions have been eliminated.
Marketable Securities: The Company invests in investment
grade securities and classifies these securities as
available-for-sale as they typically have maturities of one year
or less and are highly liquid. As of March 31, 2005, the
fair market value of these securities approximated cost.
Included in marketable securities is restricted cash of
$8,495,000 related to collateral on foreign currency hedges as
of March 31, 2005.
Acquired In-Process Research and Development: In the
three months ended March 31, 2005 and 2004, the Company
incurred an expense of $126,399,000 and $11,386,000,
respectively, associated with acquired in-process research and
development (IPR&D) related to the acquisition
of Xcel Pharmaceuticals, Inc. (Xcel) in 2005 and
Amarin Pharmaceuticals, Inc. (Amarin) in 2004.
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 those judgments would have the impact of changing the
allocation of purchase price to goodwill, which is an
unamortizable intangible asset.
The estimated fair value of these projects was based on the use
of discounted cash flow model (based on an estimate of future
sales and an average gross margin of 80% and 66% for Xcel and
Amarin, respectively). For each project, the estimated after-tax
cash flows (using a tax rate of 35% and 40% for Xcel and Amarin,
respectively) 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 the
Companys estimate of the effective tax rate for
acquisitions of similar types of assets. These cash flows were
then discounted to a present value using discount rates ranging
from 17% to 20%, which represent the Companys risk
adjusted after tax weighted average cost of capital for each
product.
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
6
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
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.
Derivative Financial Instruments: The Companys
accounting policies for derivative instruments are based on
whether they meet the Companys criteria for designation as
hedging transactions, either as cash flow or fair value hedges.
The Companys derivative instruments are recorded at fair
value and are included in other current assets, other assets,
accrued liabilities or debt. Depending on the nature of the
hedge, 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 Loss: The Company has 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
gains and losses on marketable equity securities 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 or preferred stock; 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.
In March 2005, the Companys Board of Directors declared a
first quarter cash dividend of $0.0775 per share, which was
paid on April 27, 2005. While the Company has historically
paid quarterly cash dividends, there can be no assurance that it
will continue to do so.
Stock-Based Compensation: The Company has adopted the
disclosure-only provision of SFAS No. 123,
Accounting for Stock-Based Compensation
(SFAS No. 123) and
SFAS No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure.
Compensation cost for stock-based compensation issued to
employees has been measured using the intrinsic value method
provided by Accounting Principles Board (APB)
Opinion No. 25. Accordingly, no compensation cost has been
recognized for options granted under the Companys 2003
Equity Incentive Plan (the Incentive Plan), as all
options granted under the Incentive Plan had an exercise price
equal to the market value of the underlying common stock on the
date of grant.
Had compensation cost for the Incentive Plan been determined
based on the fair value at the grant date for awards in the
three months ended March 31, 2005 and 2004, consistent with
the provisions of SFAS No. 123, the Companys net
loss and loss per share would have been the unaudited pro forma
amounts indicated below (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net loss as reported
|
|
$ |
(139,259 |
) |
|
$ |
(13,573 |
) |
Compensation costs related to the Companys employee stock
compensation plan, net of tax
|
|
|
|
|
|
|
96 |
|
Stock-based employee compensation expense determined under fair
value based method, net of related tax effects
|
|
|
(5,050 |
) |
|
|
(2,653 |
) |
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(144,309 |
) |
|
$ |
(16,130 |
) |
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted as reported
|
|
$ |
(1.57 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
Basic and diluted pro forma
|
|
$ |
(1.62 |
) |
|
$ |
(0.19 |
) |
|
|
|
|
|
|
|
7
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
Prior to April 2004, pro forma compensation expense has been
calculated using the Black-Scholes model based on a
single-option valuation approach using the straight-line method
of amortization. Beginning in April 2004, the Company has
calculated pro forma compensation expense for any stock options
granted since that time using the accelerated amortization
method prescribed in FASB Interpretation No. 28,
Accounting for Stock Appreciation Rights and Other Variable
Stock Option or Award Plans, because it was more
representative of the Companys expected exercising
behavior. This change in accounting policy was not material to
the results of the pro forma disclosure.
Use of Estimates: The preparation of financial statements
in conformity with accounting principles generally accepted in
the United States of America requires management 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.
Reclassifications: Certain prior year items have been
reclassified to conform to the current year presentation, with
no effect on previously reported net income or
stockholders equity.
New Accounting Pronouncements: In March 2004, the
Emerging Issues Task Force (EITF) reached a
consensus on Issue No. 03-1, The Meaning of Other-Than
Temporary Impairment and Its Application to Certain
Investments. This Issue establishes impairment models for
determining whether to record impairment losses associated with
investments in certain equity and debt securities. In September
2004, the Financial Accounting Standards Board
(FASB) issued FASB Staff Position (FSP)
EITF 03-1-1, which defers the effective date of a
substantial portion of EITF 03-1 until such time as the
FASB issues further implementation guidance. Adoption of this
pronouncement is not expected to have a material impact on the
Companys consolidated financial statements.
In November 2004, the FASB issued SFAS No. 151,
Inventory Costs an amendment of ARB No. 43,
Chapter 4. SFAS No. 151 amends the guidance
in ARB No. 43, Chapter 4, Inventory Pricing, to
clarify the accounting for abnormal amounts of idle facility
expense, freight, handling costs, and wasted material
(spoilage). Among other provisions, the new rule requires that
items such as idle facility expense, excessive spoilage, double
freight, and re-handling costs be recognized as current-period
charges regardless of whether they meet the criterion of
so abnormal as stated in ARB No. 43.
Additionally, SFAS No. 151 requires that the
allocation of fixed production overheads to the costs of
conversion be based on the normal capacity of the production
facilities. SFAS No. 151 is effective for fiscal years
beginning after June 15, 2005. The Company is currently
evaluating the effect of SFAS No. 151 on its
consolidated financial statements.
In December 2004, the FASB issued FSP No. 109-2,
Accounting and Disclosure Guidance for the Foreign Earnings
Repatriation Provision within the American Jobs Creation Act of
2004. The American Jobs Creation Act of 2004 (the Jobs
Creation Act) was enacted on October 22, 2004. FSP
109-2 states that an enterprise is allowed time beyond the
financial reporting period of enactment to evaluate the effect
of the Jobs Creation Act on its plan for reinvestment or
repatriation of foreign earnings for purposes of applying
SFAS No. 109. The Company has not yet completed
evaluating the impact of the repatriation provisions.
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment
(SFAS No. 123R), which replaces
SFAS No. 123 and supersedes APB Opinion No. 25,
Accounting for Stock Issued to Employees.
SFAS No. 123R requires all share-based payments to
employees, including grants of employee stock options, to be
recognized in the financial statements based on their fair
values beginning with the first interim or annual period after
June 15, 2005. The pro forma disclosures previously
permitted under SFAS No. 123 will no longer be an
alternative to financial statement recognition. In April 2005,
the Securities and Exchange Commission issued a Final
Rule Release, Amendment to Rule 4-01(a) of
Regulation S-X Regarding the Compliance Date for Statement
of Financial Accounting Standards No. 123 (Revised 2004),
Share-Based Payment. This rule extends the date for
compliance with SFAS No. 123R until
8
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
the first interim or annual reporting period of the first fiscal
year beginning on or after June 15, 2005. The Company is
required to adopt SFAS No. 123R in the first quarter
of fiscal 2006, beginning January 1, 2006. The Company is
evaluating the requirements of SFAS No. 123R and
expects that the adoption of SFAS No. 123R will have a
material impact on its consolidated results of operations and
earnings per share.
Xcel Pharmaceuticals, Inc.: On March 1, 2005, the
Company acquired Xcel Pharmaceuticals, Inc. (Xcel),
a specialty pharmaceutical company focused on the treatment of
disorders of the central nervous system for $280,000,000 in
cash, plus expenses of $5,435,000. Under the terms of the
purchase agreement, the Company paid an additional $7,470,000 as
a post-closing working capital adjustment. The Xcel acquisition
adds to the Companys existing neurology product portfolio
with 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. Xcels products and sales organization have
synergies with the Companys existing neurology products
and adds retigabine to its pipeline of product candidates. These
factors contribute to the recognition of goodwill in the
purchase price. Approximately $44,000,000 of the cash
consideration was used to retire Xcels outstanding
long-term debt.
In connection with the Xcel acquisition, the Company completed
an offering of 8,280,000 shares of its common stock in
February 2005. The Company received net proceeds, after
underwriting discounts and commissions, 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
available cash on hand.
The Xcel acquisition has been accounted for using the purchase
method of accounting, and Xcels results of operations have
been included in the Companys consolidated condensed
statement of operations as of the date of acquisition.
Allocation of the purchase price is based on estimates of the
fair value of the assets acquired and liabilities assumed at the
date of acquisition. However, these estimates may be incomplete,
and unanticipated events and circumstances may occur. Estimates
for the purchase price allocation may change as subsequent
information becomes available.
The components of the purchase price allocation for the Xcel
acquisition is as follows (in thousands):
|
|
|
|
|
|
Purchase price:
|
|
|
|
|
|
Cash paid
|
|
$ |
280,000 |
|
|
Working capital adjustment
|
|
|
7,470 |
|
|
Transaction costs
|
|
|
5,435 |
|
|
|
|
|
|
|
$ |
292,905 |
|
|
|
|
|
Allocation:
|
|
|
|
|
|
Xcel net book value of assets acquired tangible
assets
|
|
$ |
9,488 |
|
|
In-process research and development
|
|
|
126,399 |
|
|
Product rights
|
|
|
103,500 |
|
|
Goodwill
|
|
|
53,518 |
|
|
|
|
|
|
|
$ |
292,905 |
|
|
|
|
|
The aggregate purchase price was allocated to tangible and
identifiable intangible assets acquired based on estimates of
fair value using a discounted cash flow model. The discount
rates used take into account the stage of completion and the
risks surrounding the successful development and
commercialization of each of the acquired in-process research
and development projects. The allocation of the purchase price
includes $126,399,000 of in-process research and development,
which was expensed in the three months ended
9
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
March 31, 2005, and goodwill of $53,518,000, which is
deductible for tax purposes and has been allocated to the
Companys United States pharmaceutical reporting unit.
The following unaudited pro forma financial information presents
the combined results of operations of the Company and Xcel as if
the acquisition had occurred as of the beginning of the period
presented (in thousands except per share information). 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 acquisition been completed as of the date
presented, and should not be taken as representative of the
Companys future consolidated results of operations or
financial condition.
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net revenues
|
|
$ |
192,721 |
|
|
$ |
170,289 |
|
Loss from continuing operations
|
|
|
(138,857 |
) |
|
|
(95,556 |
) |
Net loss
|
|
|
(140,360 |
) |
|
|
(98,617 |
) |
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(1.56 |
) |
|
$ |
(1.09 |
) |
|
Net loss
|
|
$ |
(1.58 |
) |
|
$ |
(1.12 |
) |
The above pro forma financial information includes the acquired
in-process research and development charge of $126,399,000 noted
above and adjustments for amortization of identifiable
intangible assets.
|
|
3. |
Discontinued Operations |
In the second half of 2002, the Company made a strategic
decision to divest certain assets, including certain raw
materials businesses and manufacturing facilities in Central
Europe. As of March 31, 2005, all of these businesses were
disposed of except the Companys remaining raw materials
business and manufacturing facility in Central Europe, which the
Company is actively working toward disposing.
Summarized selected financial information for discontinued
operations for the three months ended March 31, 2005 and
2004 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Revenue
|
|
$ |
2,092 |
|
|
$ |
5,522 |
|
|
|
|
|
|
|
|
Loss from discontinued operations
|
|
$ |
(1,285 |
) |
|
$ |
(2,413 |
) |
Loss on disposal of discontinued operations
|
|
|
(218 |
) |
|
|
(648 |
) |
|
|
|
|
|
|
|
|
Loss from discontinued operations
|
|
$ |
(1,503 |
) |
|
$ |
(3,061 |
) |
|
|
|
|
|
|
|
10
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
The assets and liabilities of discontinued operations are stated
separately as of March 31, 2005 and December 31, 2004
on the accompanying consolidated condensed balance sheets. The
major assets and liabilities categories of discontinued
operations are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
March 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Cash
|
|
$ |
132 |
|
|
$ |
129 |
|
Accounts receivable, net
|
|
|
2,654 |
|
|
|
3,352 |
|
Inventories, net
|
|
|
9,192 |
|
|
|
12,624 |
|
Property, plant and equipment, net
|
|
|
2,261 |
|
|
|
3,659 |
|
Other assets
|
|
|
2,370 |
|
|
|
4,130 |
|
|
|
|
|
|
|
|
|
Assets of discontinued operations
|
|
$ |
16,609 |
|
|
$ |
23,894 |
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
1,758 |
|
|
$ |
2,042 |
|
Accrued liabilities
|
|
|
22,118 |
|
|
|
22,932 |
|
Other liabilities
|
|
|
7,072 |
|
|
|
7,082 |
|
|
|
|
|
|
|
|
|
Liabilities of discontinued operations
|
|
$ |
30,948 |
|
|
$ |
32,056 |
|
|
|
|
|
|
|
|
Environmental contamination has been identified in the soil
under a facility built by the Company which housed operations of
its discontinued Biomedicals division and is currently vacant.
Remediation of the site will likely involve excavation and
disposal of the waste at appropriately licensed sites some
distance from the facility. Environmental reserves have been
provided for remediation and related costs that the Company 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
$21,183,000 and $21,475,000 as of March 31, 2005 and
December 31, 2004, respectively, and are included in the
liabilities of discontinued operations. Although the Company
believes that its reserves are adequate, there can 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 the Companys consolidated financial
condition, results of operations or cash flows. Any possible
loss that may be incurred in excess of amounts provided for as
of March 31, 2005 cannot be reasonably estimated by the
Company.
|
|
4. |
Manufacturing Restructuring |
During the third quarter of 2003, the Company approved a
restructuring plan to increase its capital utilization and
improve its operating efficiencies (the Manufacturing
Restructuring Plan). The Manufacturing Restructuring Plan
originally contemplated the disposal of ten manufacturing sites.
During the first quarter of 2005, the Company made the decision
to dispose of an additional manufacturing site in China and
wrote the net assets down to their fair value, which resulted in
an impairment charge of $2,220,000. The Company has made
significant progress in disposing of the manufacturing sites. As
of March 31, 2005, the Company has sold three of the
manufacturing sites and two additional sites were sold
subsequent to quarter end. The Company is currently actively
marketing the remaining six sites to prospective buyers. The
completion of the Companys Manufacturing Restructuring
Plan will result in a global manufacturing and supply chain
network of four manufacturing sites by the end of 2006.
11
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
The following table sets forth the computation of basic and
diluted earnings per share (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Income:
|
|
|
|
|
|
|
|
|
|
Numerator for basic and dilutive earnings per share
income available to stockholders
|
|
$ |
(139,259 |
) |
|
$ |
(13,573 |
) |
|
|
|
|
|
|
|
Shares:
|
|
|
|
|
|
|
|
|
|
Denominator for basic earnings per share
weighted-average shares outstanding
|
|
|
88,836 |
|
|
|
83,447 |
|
|
|
|
|
|
|
|
Basic and diluted loss per share:
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(1.55 |
) |
|
$ |
(0.12 |
) |
|
Loss from discontinued operations
|
|
|
(0.02 |
) |
|
|
(0.04 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(1.57 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
For the three months ended March 31, 2005, options to
purchase 2,868,000 weighted average shares of common stock,
respectively, were not included in the computation of earnings
per share because the Company incurred a loss and the effect
would have been anti-dilutive.
For the three months ended March 31, 2005, options to
purchase 1,901,000 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.
|
|
6. |
Detail of Certain Accounts |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Accounts receivable, net:
|
|
|
|
|
|
|
|
|
|
Trade accounts receivable
|
|
$ |
143,064 |
|
|
$ |
142,925 |
|
|
Royalties receivable
|
|
|
17,567 |
|
|
|
17,329 |
|
|
Other receivables
|
|
|
15,018 |
|
|
|
17,620 |
|
|
|
|
|
|
|
|
|
|
|
175,649 |
|
|
|
177,874 |
|
|
Allowance for doubtful accounts
|
|
|
(5,998 |
) |
|
|
(6,014 |
) |
|
|
|
|
|
|
|
|
|
$ |
169,651 |
|
|
$ |
171,860 |
|
|
|
|
|
|
|
|
Inventories, net:
|
|
|
|
|
|
|
|
|
|
Raw materials and supplies
|
|
$ |
42,490 |
|
|
$ |
42,568 |
|
|
Work-in-process
|
|
|
29,462 |
|
|
|
24,002 |
|
|
Finished goods
|
|
|
67,750 |
|
|
|
59,612 |
|
|
|
|
|
|
|
|
|
|
|
139,702 |
|
|
|
126,182 |
|
|
Allowance for inventory obsolescence
|
|
|
(13,843 |
) |
|
|
(13,932 |
) |
|
|
|
|
|
|
|
|
|
$ |
125,859 |
|
|
$ |
112,250 |
|
|
|
|
|
|
|
|
Property, plant and equipment, net:
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, at cost
|
|
$ |
413,048 |
|
|
$ |
416,398 |
|
|
Accumulated depreciation and amortization
|
|
|
(186,946 |
) |
|
|
(183,140 |
) |
|
|
|
|
|
|
|
|
|
$ |
226,102 |
|
|
$ |
233,258 |
|
|
|
|
|
|
|
|
12
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
Intangible assets: As of March 31, 2005 and
December 31, 2004, intangible assets were as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2005 | |
|
December 31, 2004 | |
|
|
| |
|
| |
|
|
Gross | |
|
Accumulated | |
|
Gross | |
|
Accumulated | |
|
|
Amount | |
|
Amortization | |
|
Amount | |
|
Amortization | |
|
|
| |
|
| |
|
| |
|
| |
Intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights
|
|
$ |
695,750 |
|
|
$ |
(215,757 |
) |
|
$ |
595,699 |
|
|
$ |
(206,367 |
) |
|
License agreement
|
|
|
67,376 |
|
|
|
(27,690 |
) |
|
|
67,376 |
|
|
|
(24,431 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$ |
763,126 |
|
|
$ |
(243,447 |
) |
|
$ |
663,075 |
|
|
$ |
(230,798 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense for the three months ended March 31,
2005 and 2004 were $13,968,000 and $13,287,000, respectively, of
which $10,709,000 and $8,311,000 were related to amortization of
acquired product rights. Estimated amortization expenses for the
years ending December 31, 2005, 2006, 2007, 2008, 2009 and
2010 are $61,300,000, $63,100,000, $61,900,000, $55,700,000,
$48,200,000 and $46,900,000, respectively.
For the three months ended March 31, 2005, the Company
recorded a tax provision of $16,367,000 on a pre-tax loss of
$121,218,000. The recording of a tax provision while recording a
pre-tax loss was the result of the Company not receiving a tax
benefit for either i) the charge of $126,399,000 as a result of
recognizing acquired in-process research and development or ii)
the restructuring charge of $2,220,000 resulting from the
impairment of the Companys manufacturing site in China.
The actual tax provision was impacted by additional items as
noted in the following table:
|
|
|
|
|
|
Increase in reserves due to IRS audit for tax years 1997 to 2001
|
|
$ |
56,389,000 |
|
Reversal of valuation allowance for losses that would be
recognized if IRS adjustments above are realized
|
|
|
(34,939,000 |
) |
|
|
|
|
|
Net impact to tax provision from U.S. tax adjustments
|
|
|
21,450,000 |
|
Reversal of valuation allowance on deferred tax assets on
foreign operations
|
|
|
(11,122,000 |
) |
|
|
|
|
|
Net impact to tax provision from all adjustments
|
|
$ |
10,328,000 |
|
|
|
|
|
The Companys U.S. tax returns for the period from 1997 to
2001 have been reviewed by the Internal Revenue Service and the
Company has received proposed adjustments, and associated
interest and penalties, resulting from the review. The Company
has recorded $56,389,000 as its estimate of the additional tax
expense from these reviews. The net impact to the tax provision
from U.S. tax adjustments of $21,450,000 referred to above
reflects the cash payments that could arise from the estimated
additional tax. The cash payments would be required even though
the Company has additional unutilized net operating losses due
to the net operating losses being subject to annual limitations,
expiring or being completely utilized for the periods impacted
by the specific adjustments.
In 1999, the Company restructured its operations by contributing
the stock of several non-United States subsidiaries to a wholly
owned Dutch company. At the time of the restructuring, the
Company intended to avail itself of the non-recognition
provisions of the Internal Revenue Code to avoid generating
taxable income on the intercompany transfer. One of the
requirements under the non-recognition provisions was to file
Gain Recognition Agreements with the Companys timely filed
1999 United States Corporate Income Tax Return. The Company
discovered and voluntarily informed the IRS that the Gain
Recognition Agreements had been inadvertently omitted from the
1999 tax return. The IRS has denied the Companys request
to rule that reasonable cause existed for the failure to provide
the agreements, the result of which is additional taxable
13
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
income in that year of approximately $120,000,000. The Company
will pursue resolution through the formal appeals process. The
impact of the IRS position on this issue is considered in the
adjustments noted above.
At December 31, 2004, the Company established a valuation
allowance to offset its deferred tax assets. For the three
months ended March 31, 2005, the Company incurred losses in
the U.S. tax jurisdiction, which includes the Companys
research and development operations, for which no tax benefit is
recorded. Losses are expected to continue in the United States
until tax strategies or product launches eliminate them. Until
these events occur, no benefit for the U.S. tax losses will be
recorded. A $3,449,000 benefit associated with U.S. tax losses
or the three months ended March 31, 2005 has not been
recorded in calculating the Companys effective tax rate
due to the insufficient objective evidence at this time to
recognize those assets for financial reporting purposes. The
Company believes the tax assets will be realized through the
successful commercialization of products in its pipeline,
including Viramidine. Ultimate realization of the benefit of the
U.S. net operating losses and research credits is dependent upon
the Company generating sufficient taxable income prior to their
expiration.
The Company reversed a valuation allowance of $11,122,000 on net
operating losses for certain foreign operations and recorded a
corresponding tax benefit due to additional evidence supporting
the ability to realize these net operating losses.
During the fourth quarter of 2004, legislation was passed that
provides for a special one-time tax deduction of 85 percent
of certain foreign earnings that are repatriated to the United
States (The American Jobs Creation Act of 2004). The range of
reasonably possible amounts of unremitted earnings that is being
considered for repatriation and the related potential range of
income tax effects of such repatriation cannot be reasonably
estimated at this time. We are evaluating the effects of this
law, and are expecting to complete the evaluation and develop an
appropriate plan of action during 2005.
|
|
8. |
Commitments and Contingencies |
We are involved in several legal proceedings, including the
following matters:
Ribapharm Tender Offer Litigation: In June 2003, seven
purported class actions were filed against the Company,
Ribapharm and certain directors and officers of Ribapharm in the
Delaware Court of Chancery. Six of these complaints were
consolidated under the caption In re Ribapharm Inc.
Shareholders Litigation, Consol. C.A. No. 20337 and the
seventh suit proceeded in coordination with the consolidated
case in which the plaintiffs alleged, among other things, that
the Company breached its fiduciary duties as a controlling
stockholder of Ribapharm in connection with its tender offer for
the shares of Ribapharm it did not already own. On
August 4, 2003, the Company and the plaintiffs reached an
agreement in principle to settle these lawsuits for a nominal
amount.
In June 2003, a purported class action on behalf of certain
stockholders of Ribapharm was filed against the Company in the
Delaware Court of Chancery seeking a declaration that the
shareholders rights plan is valid and enforceable. The Company
and the plaintiffs reached an agreement in principle to settle
this lawsuit which will be completed in combination with the
settlement In re Ribapharm Inc. Shareholders Litigation,
Consol. C.A. No. 20337.
In June 2003, a purported class action was filed in the Superior
Court of Orange County, California, against the Company,
Ribapharm and certain of Ribapharms officers and directors
asserting the same claims, on behalf of the same class of
plaintiffs and against the same defendants as in the seven
lawsuits filed in Delaware that are described above. The
settlement of the Delaware tender offer litigation has been
designed to release the claims brought in this lawsuit, although
the decision as to the effect of that release will be subject to
the discretion of the California court.
14
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
At a hearing held on December 2, 2004, the Delaware Court
entered an order approving the settlement and awarded
plaintiffs counsel $375,000 in fees and expenses. Pursuant
to the terms of the Delaware settlement, on January 18,
2005, the plaintiff in the California action filed a notice of
request for voluntary dismissal of the case, seeking to dismiss
the case with prejudice. On January 20, 2005, the
California court entered an order dismissing the California
action with prejudice.
|
|
|
Securities Class Actions: |
Section 10b-5 Litigation: Since July 25, 2002,
multiple class actions have been filed against the Company and
some of its 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 the Companys stock. The lawsuits
generally claim that the Company issued false and misleading
statements regarding its earnings prospects and sales figures
(based upon channel stuffing allegations), its
operations in Russia, the marketing of Efudex®, and the
earnings and sales of its Photonics division. The plaintiffs
generally seek 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 the Company. The plaintiffs have filed a notice of
appeal to the United States Court of Appeals for the Ninth
Circuit seeking review of the dismissal of the claims against
the Company. The plaintiffs filed their opening brief in the
Ninth Circuit on February 7, 2005. Although a schedule for
deciding the appeal has not yet been set by the court, the
Company expects a ruling on this matter by late fall 2005.
Valuepoint Bondholders Litigation: On May 9,
2003, a bondholder filed a class action lawsuit in Orange County
Superior Court against the Company and some of its current and
former directors and former executive officers. The lawsuit
alleges that the defendants violated Sections 11 and 15 of
the Securities Act of 1933 by making false and misleading
statements in connection with an offering of
61/2% Convertible
Subordinated Notes due 2008 in November 2001, thereby
artificially inflating the market price of the notes. The
plaintiffs generally sought to recover compensatory damages,
including interest. On February 28, 2005, the case was
dismissed upon the Companys payment of a previously agreed
upon settlement to the plaintiffs of $3,200,000.
Derivative Actions: The Company is 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
behalf of the Company against certain current and/or former
officers and directors of the Company. 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, or the Ribapharm Bonuses.
On October 1, 2002, several former and current directors of
the Company, as individuals, as well as the Company, 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 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 the 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.
15
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
The Company 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 the Companys 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 arising from the initial public offering of
Ribapharm. The Court granted the Companys motion to stay
the California proceedings in favor of the similar Delaware
proceedings. On June 27, 2003, the Company filed a motion
in the Delaware derivative action to (a) realign itself as
plaintiff in the Delaware proceedings, (b) pursue the
primary derivative claims relating to the Ribapharm Bonuses,
(c) seek dismissal of the secondary derivative claims, and
(d) settle certain claims with respect to certain of the
defendants. The Court granted the Companys motion for
realignment on October 27, 2003; additional aspects of the
Companys motion are still pending. The Company filed an
amended complaint in the Delaware action on September 17,
2003.
The Company has agreed to settle 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. Three of the settling defendants were first elected to
the Companys Board of Directors in 2001 (the
2001 Directors), only one of whom currently
serves on the Board of Directors. The 2001 Directors have
entered into settlement agreements, as amended, whereby they
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 further provides that, in the event the Company
negotiates a settlement with certain defendants on financial
terms that are materially better than those set forth in the
settlement agreements with the 2001 Directors, the Company
agrees to adjust the 2001 Directors settlement
payment by a comparable proportion. Following court-sponsored
mediation in the Delaware Court of Chancery, the Company entered
into settlement agreements with seven other defendants, which
have been executed by the parties and the mediator. Pursuant to
these settlements, six of these defendants (the Outside
Director Defendants) will each pay to the Company
$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 the Companys
stock options that were not issued to them in 2002. The terms of
the mediated settlement with the other settling former director
requires that he pay $80,000 to the Company in exchange for a
release from further liability in the lawsuit. None of the
settlements will be effective unless approved by the Delaware
Court of Chancery. Following the mediated settlement agreements,
counsel for the 2001 Directors notified the Company 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
the Company pay to the 2001 Directors the sum of $50,000
each. The Company has 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. Mediation was unsuccessful and has
terminated with respect to defendants Milan Panic and Adam
Jerney, who received Ribapharm Bonuses of $33,000,000 and
$3,000,000, respectively. Discovery in the case is proceeding.
Patent Oppositions: Various parties are opposing our
ribavirin patents in actions before the European Patent Office,
and the Company is responding to these oppositions. These
patents currently benefit from patent extensions in the major
European countries, that provide market protection until 2009.
Should the opponents prevail, the combination therapies marketed
by Schering-Plough would lose patent protection in Europe, but
the Company believes that these products will continue to enjoy
data exclusivity until 2009. Regardless of the outcome of the
oppositions, the Company believes the combination therapies
marketed by Roche will continue to benefit from a period of data
and marketing protection in the major markets of the European
Union until 2012.
16
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
Serbia & Montenegro: In March 1999, arbitration
was initiated in the following matters before the International
Chamber of Commerce International Court of Arbitration:
(a) State Health Fund of Serbia v. ICN
Pharmaceuticals, Inc., Case No. 10 373/ AMW/ BDW/ SPB/ JNK,
and (b) ICN Pharmaceuticals, Inc. v. Federal Republic
of Yugoslavia and Republic of Serbia, Case No. 10 439/ BWD/
SPB/ JNK. At issue in these matters were the parties
respective rights and obligations with respect to ICN
Yugoslavia, a joint venture formed by the parties
predecessors-in-interest in 1990. In these proceedings, the
Company asserted claims against the Federal Republic of
Yugoslavia (FRY) and the Republic of Serbia, and
counterclaims against the State Health Fund of Serbia
(Health Fund) for, inter alia, unlawful seizure of
the Companys majority interest in the joint venture and
failure to pay obligations to the joint venture in excess of
$176,000,000. The Company sought damages in excess of
$277,000,000. The Health Fund asserted claims against the
Company for breach of the joint venture agreement based on the
Companys alleged failure to make its required capital
contributions, and the Companys alleged mismanagement of
the joint venture. The Health Fund sought damages in excess of
$270,000,000. Early in the proceedings the arbitral tribunal
dismissed the FRY from these proceedings for lack of
jurisdiction. In November 2004 the arbitral tribunal issued a
final award in the case. The tribunal ruled that the Company had
complied with its capital contribution obligations, that the
Health Fund and Republic of Serbia had committed a de facto
expropriation of the Companys interest in the joint
venture, and that the Company was entitled to a return of its
capital contributions, including rights to certain
pharmaceutical compounds and $50,000,000 in cash. The tribunal
dismissed the remaining claims by the Company and by the Health
Fund for lack of jurisdiction. The tribunal ordered the Health
Fund and Republic of Serbia to liquidate the joint venture
within three months to repay Valeants $50,000,000 in cash,
and held that if such liquidation was not initiated in timely
fashion the Health Fund and the Republic of Serbia would be
jointly and severally liable for the return of these funds. The
deadline to liquidate the joint venture passed in February 2005,
but it appears that no liquidation of the joint venture has been
initiated. The Company accordingly intends to press forward with
enforcement efforts. The Company has seen press reports in
Serbia that the Republic of Serbia and the Health Fund have
filed one or more court actions in Serbia seeking to annul the
arbitral awards, but the Company has not been formally served
with process in such actions. The Health Fund has also
threatened to reassert in court some or all of the claims that
the tribunal did not reach on the merits. The Company intends to
vigorously contest such claims if they are asserted.
Argentina Antitrust Matter: In July 2004, the Company was
advised that the Argentine Antitrust Agency had issued a notice
unfavorable to the Company in a proceeding against its 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: In February 2004, the
Company purchased the shares of Amarin Pharmaceuticals Inc. At
that time a case captioned Debra Ann Blackstone v.
Amarin Pharmaceuticals, Inc., Amarin International Company, Eli
Lilly & Company, Health Net, Inc., Blue Shield of
California, Inc., Walgreen Co., Gaye Swenn, R.Ph., and John
Lowhon, R.Ph. Case No. 017 201332 03 was already
pending in the District Court of Tarrant County, Texas. On
February 15, 2005, the Company was served in a case
captioned Jerry G. Miller and Karren M. Miller v. Eli
Lilly and Company, Elan Pharmaceuticals, Inc., Valeant
Pharmaceuticals International, Amarin Corporation PLC, Amarin
Pharmaceuticals, Inc., Reasors, Inc., Reasors LLC
and Athena Neurosciences, Inc., Case No. CJ-2004-6757 in the
District Court of Tulsa County, Oklahoma. On February 23,
2005, Valeant was served in a case captioned Jimmy Ruth
Carson v. Eli Lilly and Company, Elan Pharmaceuticals,
Inc., and Valeant Pharmaceuticals International, Case No.,
17
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
05CV106 in the United States District Court for the
Northern District of Oklahoma. In general, these cases allege
that the use of Permax, a drug for the treatment of
Parkinsons Disease marketed and sold by Amarin, caused
valvular heart disease. The Company has also received from time
to time other claims alleging that the use of Permax caused
congestive heart failure and other coronary-related damage,
including a letter from an attorney purporting to represent five
persons with such claims. Eli Lilly, holder of the right granted
by the U.S. Food and Drug Administration (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 the Company and Eli Lilly, Eli Lilly will bear a portion
of the liability associated with these claims. Many of these
cases are in preliminary stages and it is difficult to assess
whether the Company will have any liability as to any particular
case or, if such liability exists, what the extent of the
liability would be. Product liability insurance exists with
respect to these claims. There can be no assurance that the
insurance will be sufficient to cover claims of which we have
been notified, 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 the Companys 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 infringement
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. Discovery is proceeding. The pretrial conference is
set for November 15, 2005. 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. 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, then the FDA may approve Kalis
ANDA at such time, even if prior to the expiration of the
thirty-month stay period.
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 the Company in
certain jurisdictions, including Argentina, Australia, Chile,
Colombia, Czech Republic, France, Germany, New Zealand, Spain,
Switzerland, Turkey, Venezuela and the United States. Valent
Biosciences oppositions in France and Spain have been
denied. While Valent Biosciences opposition in Chile has
been sustained, the Company has appealed that decision. The
Company has responded or will respond to the opposition
proceedings that have been filed and discovery is ongoing in the
opposition proceeding in the United States. If any of the
opposition proceedings are successful, the Company 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 those particular jurisdictions.
Other: The Company is 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 the Company,
at this
18
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
time in the opinion of management, the ultimate resolution of
these matters will not have a material effect on the
Companys consolidated financial position, results of
operations or liquidity.
The Companys four reportable specialty pharmaceutical
segments are comprised of its pharmaceutical operations in North
America, Latin America, Europe and Asia, Africa and Australia
(AAA). In addition, the Company has a research and
development division. The segment reporting has been
reclassified to conform to discontinued operations presentation
for all periods presented. See Note 3 for discussion of
discontinued operations.
The following table sets forth the amounts of segment revenues
and operating income of the Company for the three months ended
March 31, 2005 and 2004 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Revenues
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
48,943 |
|
|
$ |
27,629 |
|
|
Latin America
|
|
|
32,060 |
|
|
|
29,153 |
|
|
Europe
|
|
|
65,875 |
|
|
|
63,119 |
|
|
AAA
|
|
|
14,925 |
|
|
|
12,424 |
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
161,803 |
|
|
|
132,325 |
|
Ribavirin royalties
|
|
|
19,335 |
|
|
|
25,377 |
|
|
|
|
|
|
|
|
|
|
Consolidated revenues
|
|
$ |
181,138 |
|
|
$ |
157,702 |
|
|
|
|
|
|
|
|
Operating Income (Loss)
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
16,694 |
|
|
$ |
6,884 |
|
|
Latin America
|
|
|
10,343 |
|
|
|
5,813 |
|
|
Europe
|
|
|
11,734 |
|
|
|
8,614 |
|
|
AAA
|
|
|
790 |
|
|
|
(123 |
) |
|
|
|
|
|
|
|
|
|
|
39,561 |
|
|
|
21,188 |
|
|
Restructuring charges(1)
|
|
|
(2,220 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
37,341 |
|
|
|
21,188 |
|
Research and development
|
|
|
(9,336 |
) |
|
|
(972 |
) |
IPR&D(1)
|
|
|
(126,399 |
) |
|
|
(11,386 |
) |
|
|
|
|
|
|
|
Consolidated segment operating income
|
|
|
(98,394 |
) |
|
|
8,830 |
|
Corporate expenses
|
|
|
(14,367 |
) |
|
|
(12,593 |
) |
Interest income
|
|
|
3,015 |
|
|
|
3,060 |
|
Interest expense
|
|
|
(9,681 |
) |
|
|
(14,959 |
) |
Other, net
|
|
|
(1,791 |
) |
|
|
(1,046 |
) |
|
|
|
|
|
|
|
Loss from continuing operations before provision for income
taxes and provision for income taxes and minority interest
|
|
$ |
(121,218 |
) |
|
$ |
(16,708 |
) |
|
|
|
|
|
|
|
19
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
|
|
(1) |
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. For the three months ended
March 31, 2005, restructuring charges and IPR&D were
incurred in the AAA and North America pharmaceutical segments,
respectively. |
The following table sets forth the segment total assets of the
Company as of March 31, 2005 and December 31, 2004 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets | |
|
|
| |
|
|
March 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
603,139 |
|
|
$ |
439,084 |
|
|
Latin America
|
|
|
160,948 |
|
|
|
153,050 |
|
|
Europe
|
|
|
380,370 |
|
|
|
375,086 |
|
|
AAA
|
|
|
58,989 |
|
|
|
60,221 |
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
1,203,446 |
|
|
|
1,027,441 |
|
Corporate
|
|
|
181,600 |
|
|
|
270,777 |
|
Research and development division
|
|
|
159,766 |
|
|
|
199,763 |
|
Discontinued operations
|
|
|
16,609 |
|
|
|
23,894 |
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,561,421 |
|
|
$ |
1,521,875 |
|
|
|
|
|
|
|
|
The following table sets forth the segment goodwill of the
Company as of March 31, 2005 and December 31, 2004 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill | |
|
|
| |
|
|
March 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
60,917 |
|
|
$ |
7,398 |
|
Research and development division
|
|
|
13,101 |
|
|
|
13,101 |
|
|
|
|
|
|
|
|
Total
|
|
$ |
74,018 |
|
|
$ |
20,499 |
|
|
|
|
|
|
|
|
Goodwill increased $53,519,000 for the three months ended
March 31, 2005 primarily due to the acquisition of Xcel
Pharmaceuticals, Inc.
20
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the Companys ten largest
products and seven global brands by therapeutic class based on
sales for the three months ended March 31, 2005 and 2004
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Neurology
|
|
|
|
|
|
|
|
|
Mestinon®(G)(T)
|
|
$ |
9,860 |
|
|
$ |
8,911 |
|
Diastat(T)
|
|
|
5,177 |
|
|
|
|
|
Librax®(T)
|
|
|
4,080 |
|
|
|
3,697 |
|
TASMAR®(G)
|
|
|
939 |
|
|
|
|
|
Other Neurology
|
|
|
14,856 |
|
|
|
(a) |
|
Infectious Disease
|
|
|
|
|
|
|
|
|
Virazole®(G)(T)
|
|
|
4,195 |
|
|
|
4,817 |
|
Other Infectious Disease
|
|
|
3,957 |
|
|
|
(a) |
|
Dermatology
|
|
|
|
|
|
|
|
|
Efudix/ Efudex®(G)(T)
|
|
|
19,276 |
|
|
|
11,922 |
|
Kinerase®(G)(T)
|
|
|
4,435 |
|
|
|
3,937 |
|
Oxsoralen-Ultra®(G)(T)
|
|
|
2,968 |
|
|
|
1,388 |
|
Dermatix®(G)
|
|
|
1,896 |
|
|
|
1,377 |
|
Other Dermatology
|
|
|
7,600 |
|
|
|
(a) |
|
Other Therapeutic Classes
|
|
|
|
|
|
|
|
|
Bedoyecta®(T)
|
|
|
9,244 |
|
|
|
5,523 |
|
Solcoseryl(T)
|
|
|
4,194 |
|
|
|
4,053 |
|
Vision Care(T)
|
|
|
3,835 |
|
|
|
2,906 |
|
Other Products
|
|
|
65,291 |
|
|
|
83,794 |
|
|
|
|
|
|
|
|
Total product sales
|
|
$ |
161,803 |
|
|
$ |
132,325 |
|
|
|
|
|
|
|
|
Total top ten product sales(T)
|
|
$ |
67,264 |
|
|
$ |
47,154 |
|
|
|
|
|
|
|
|
Total global product sales(G)
|
|
$ |
43,569 |
|
|
$ |
32,352 |
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
In 2004, the Company tracked other products by three therapeutic
classes, but not by other classes; therefore, its ability to
provide additional data by therapeutic classes is not
practicable at this time. |
|
(T) |
|
Indicates ten largest product |
|
(G) |
|
Indicates global brand |
21
|
|
Item 2. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
In its discussion of the material changes in the Companys
financial condition and results of operations between the
reporting periods in the consolidated condensed financial
statements, management has sought to identify and, in some
cases, quantify, the factors that contributed to such material
changes. However, quantifying these factors may involve the
presentation of numerical measures that exclude amounts that are
included in the most directly comparable measure calculated and
presented in accordance with accounting principles generally
accepted in the United States (GAAP). Management
uses this information to assess material changes in the
Companys financial condition and results of operations and
is providing it to enable investors and potential investors to
understand these assessments. In each instance, such information
is presented immediately following (and in connection with an
explanation of) the most directly comparable financial measure
calculated in accordance with GAAP, and includes other material
information necessary to reconcile the information with the
comparable GAAP financial measure.
Overview
The Company is a global, research-based specialty pharmaceutical
company that discovers, develops, manufactures and markets a
broad range of pharmaceutical products. The Company focuses its
greatest resources and attention principally on ten global
brands in the therapeutic areas of neurology, infectious disease
and dermatology. The Companys products are currently sold
in more than 100 markets around the world, with its primary
focus on ten key geographic regions: the United States, Canada,
Mexico, the United Kingdom, France, Italy, Poland, Germany,
Spain and China.
The Company has a specialty pharmaceutical business with a
global platform, and a research and development infrastructure
with strong discovery, clinical development and regulatory
capabilities. In addition, the Company receives royalties from
the sale of ribavirin by Schering-Plough and Roche, although
such royalties represent a much smaller contribution to its
revenues than they have in the past.
|
|
|
Specialty Pharmaceuticals |
Product sales from the Companys specialty pharmaceutical
segments accounted for 89% and 84% of the Companys total
revenues from continuing operations for the three months ended
March 31, 2005 and 2004, respectively, and increased
$29,478,000 (22%) in the three months ended March 31, 2005
compared to the similar period in 2004. The increase in product
sales was due to approximately an 8% increase in volume, a 9%
increase due to changes in selling prices and a 6% favorable
impact from foreign exchange rate fluctuations.
The Companys specialty pharmaceutical business focuses its
efforts on ten global brands in three therapeutic areas. Seven
of these global brands are currently being marketed and
accounted for 27% and 24% of the Companys product sales
for the three months ended March 31, 2005 and 2004,
respectively. Global brand sales increased $11,217,000 (35%) in
the three months ended March 31, 2005 compared to the
similar period in 2004. The Company has experienced generic
challenges and other competition to its products, as well as
pricing challenges through government imposed price controls and
reductions, and expect these challenges to continue.
The Company seeks to discover, develop and commercialize
innovative products for the treatment of significant unmet
medical needs, principally in the areas of infectious diseases
and cancer. The Companys research and development
activities are based upon accumulated expertise developed
through 30 years of research focused on the internal
generation of novel molecules. These efforts led to the
discovery and development of ribavirin, an antiviral drug that
Schering-Plough and Roche market under separate licenses from
the Company, and which is the source of the Companys
royalty income.
The Company is also developing a pipeline of product candidates,
including three product candidates with clinical stage programs
which target large market opportunities: Viramidine, pradefovir
and retigabine. Viramidine is a pro-drug of ribavirin, for the
treatment of chronic hepatitis C in treatment-naïve
patients in
22
conjunction with a pegylated interferon. The Company is
developing pradefovir as an oral once-a-day monotherapy for
patients with chronic hepatitis B infection. With the
acquisition of Xcel Pharmaceuticals, Inc. (Xcel) in
March 2005, another product candidate, retigabine, was added to
the Companys pipeline. Retigabine is being developed as an
adjunctive treatment for partial-onset seizures in patients with
epilepsy.
Ribavirin royalty revenues decreased $6,042,000 (24%) and
accounted for 11% of the Companys total revenues from
continuing operations for the three months ended March 31,
2005 as compared to 16% for the similar period in 2004. The
decline in ribavirin royalty revenues, and the decreasing
contribution of royalties to the Companys revenues, had
been expected with the entry of generic ribavirin in the United
States. The Company expects ribavirin royalties to be relatively
stable for several years since generics are unlikely to enter
the major European and Japanese markets due to certain
protections in those markets through 2009 and 2010,
respectively. The Company could expect to see declines as a
result of alternative therapies, such as Viramidine, when and if
approved.
Company Strategy
The Companys strategic plan focuses on transforming the
business and growing through innovation. The Company has
developed a growth strategy by leveraging its current products,
rationalizing its supply chain and employing other measures to
obtain significant efficiencies. Additionally, the Company will
continue to increase investment in research and development
activities and continue to evaluate potential acquisition
opportunities. The key elements of the Companys strategy
are discussed below.
|
|
|
Targeted Growth of Existing Products |
The Company focuses its business on ten key geographic regions,
across three core therapeutic areas and ten global brands. The
Company believes that its core therapeutic areas are positioned
for further growth and that it is possible for a mid-sized
company to attain a leadership position within these categories.
Furthermore, the Company believes that its global brands have
the potential for further worldwide penetration and above
industry average growth rates. In addition, the Company intends
to continue to market and sell, and selectively pursue life
cycle management strategies for its regional and local brands.
|
|
|
Efficient Manufacturing and Supply Chain Organization |
Under its global manufacturing strategy announced in October
2003, the Company plans to reduce the number of manufacturing
facilities in order to increase capacity utilization and improve
efficiencies. The Company has also undertaken a major process
improvement initiative, affecting all phases of its operations,
from raw material and supply logistics to manufacturing,
warehousing and distribution. During the first quarter of 2005,
the Company made the decision to dispose of an additional
manufacturing site in China and wrote the net assets down to
their fair value, which resulted in an impairment charge of
$2,220,000. The Company has made significant progress in
disposing of the manufacturing sites and is currently actively
marketing the sites to prospective buyers. As of March 31,
2005, the Company has sold three of the manufacturing sites and
two additional sites were sold subsequent to quarter end. The
completion of the global manufacturing strategy will result in
four manufacturing sites worldwide by the end of 2006.
|
|
|
Development of New Products via Internal Research and
Development Activities |
The Company seeks to discover, develop and commercialize
innovative products for the treatment of significant unmet
medical needs, principally in the areas of infectious disease
and cancer. The Company intends to combine its scientific
expertise with advanced drug screening techniques in order to
discover and develop new product candidates.
23
The Company plans to selectively license or acquire product
candidates, technologies and businesses from third parties which
complement its existing business and provide for effective life
cycle management of key products. The Company believes that its
drug development expertise may allow it to recognize licensing
opportunities and to capitalize on research initially conducted
and funded by others.
On March 1, 2005, the Company acquired Xcel, a specialty
pharmaceutical company focused on the treatment of disorders of
the central nervous system, for $280,000,000 in cash, plus
expenses of $5,435,000. Under the terms of the purchase
agreement, the Company paid an additional $7,470,000 as a
post-closing working capital adjustment. Xcels portfolio
consists of four products that are sold within the United
States, and a late-state clinical product candidate, retigabine,
being developed for commercialization in all major markets. See
Note 2 of notes to consolidated condensed financial
statements for a discussion of this acquisition.
Results of Operations
The Companys four reportable specialty pharmaceutical
segments are comprised of its pharmaceuticals operations in
North America, Latin America, Europe and Asia, Africa and
Australia. In addition, the Company has a research and
development division. Certain financial information for the
Companys business segments is set forth below. This
discussion of the Companys results of operations should be
read in conjunction with the consolidated condensed financial
statements of the Company included elsewhere in this quarterly
report. For additional financial information by business
segment, see Note 9 of notes to consolidated condensed
financial statements included elsewhere in this quarterly report.
The following table compares 2005 and 2004 revenues by
reportable segments and operating expenses for the three months
ended March 31, 2005 and 2004 (in thousands, except
percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
|
|
|
|
March 31, | |
|
|
|
|
|
|
| |
|
|
|
Percent | |
|
|
2005 | |
|
2004 | |
|
Increase/(Decrease) | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
48,943 |
|
|
$ |
27,629 |
|
|
$ |
21,314 |
|
|
|
77 |
% |
|
Latin America
|
|
|
32,060 |
|
|
|
29,153 |
|
|
|
2,907 |
|
|
|
10 |
|
|
Europe
|
|
|
65,875 |
|
|
|
63,119 |
|
|
|
2,756 |
|
|
|
4 |
|
|
AAA
|
|
|
14,925 |
|
|
|
12,424 |
|
|
|
2,501 |
|
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
161,803 |
|
|
|
132,325 |
|
|
|
29,478 |
|
|
|
22 |
|
Ribavirin royalties
|
|
|
19,335 |
|
|
|
25,377 |
|
|
|
(6,042 |
) |
|
|
(24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
181,138 |
|
|
|
157,702 |
|
|
|
23,436 |
|
|
|
15 |
|
Costs and Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization)
|
|
|
48,721 |
|
|
|
46,712 |
|
|
|
2,009 |
|
|
|
4 |
|
Selling expenses
|
|
|
52,815 |
|
|
|
47,742 |
|
|
|
5,073 |
|
|
|
11 |
|
General and administrative expenses
|
|
|
24,052 |
|
|
|
23,875 |
|
|
|
177 |
|
|
|
1 |
|
Research and development costs
|
|
|
25,724 |
|
|
|
18,463 |
|
|
|
7,261 |
|
|
|
39 |
|
Acquired IPR&D
|
|
|
126,399 |
|
|
|
11,386 |
|
|
|
115,013 |
|
|
|
1,010 |
|
Restructuring charges
|
|
|
2,220 |
|
|
|
|
|
|
|
2,220 |
|
|
|
|
|
Amortization expense
|
|
|
13,968 |
|
|
|
13,287 |
|
|
|
681 |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
$ |
(112,761 |
) |
|
$ |
(3,763 |
) |
|
$ |
(108,998 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit on product sales (excluding amortization)
|
|
$ |
113,082 |
|
|
$ |
85,613 |
|
|
$ |
27,469 |
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit margin on product sales
|
|
|
70 |
% |
|
|
65 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Pharmaceutical Revenues: Product sales from the
Companys specialty pharmaceutical segments increased
$29,478,000 (22%) for the three months ended March 31, 2005
over 2004. The increase in product sales was led by the
Companys global brands, which increased $11,217,000 (35%),
as well as
24
increased sales of other key products. In addition, sales from
newly acquired products related to the acquisition of Xcel,
Amarin and TASMAR contributed $10,547,000 to product sales in
the three months ended March 31, 2005. Excluding sales from
products acquired, product sales increased $18,931,000 (14%) for
the three months ended March 31, 2005 over 2004. The
Company also benefited from favorable foreign currency exchange
rates, which contributed $7,303,000 on a net basis to the
increase in overall product sales primarily due to the increase
in the value of the Euro over the U.S. dollar.
In the North America pharmaceuticals segment, revenues for the
three months ended March 31, 2005 were $48,943,000 compared
to $27,629,000 for 2004, an increase of $21,314,000 (77%). The
increase was primarily driven by higher sales of Efudex,
Oxsoralens® and Cesamet of $10,377,000, along with sales of
products related to the acquisition of Xcel, Amarin and TASMAR
of $9,837,000. Revenues for the North America pharmaceuticals
segment will continue to benefit from the Xcel acquisition for
2005 compared to 2004.
In the Latin America pharmaceuticals segment, revenues for the
three months ended March 31, 2005 were $32,060,000 compared
to $29,153,000 for 2004, an increase of $2,907,000 (10%). The
increase was primarily due to higher sales of Bedoyecta® of
$3,721,000 resulting from a successful direct-to-consumer
campaign, partially offset by lower demand at the wholesalers
due to tax legislation changes.
In the Europe pharmaceuticals segment, revenues for the three
months ended March 31, 2005 were $65,875,000 compared to
$63,119,000 for 2004, an increase of $2,756,000 (4%). The
increase in the value of currencies in the region as compared to
the U.S. dollar contributed $6,382,000 to the increase in
revenues in the region, partially offset by lower sales volume
of $3,979,000 as a result of lower sales of non-promoted
products.
In the Asia, Africa and Australia (AAA)
pharmaceuticals segment, revenues for the three months ended
March 31, 2005 were $14,925,000 compared to $12,424,000 for
2004, an increase of $2,501,000 (20%). The increase was
primarily due to higher sales of Reptilase of $1,119,000 as a
result of supply chain issues in 2004 and higher sales of
Coracten of $956,000.
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. We receive 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
months ended March 31, 2005 were $19,335,000 compared to
$25,377,000 for 2004, a decrease of $6,042,000 (24%). The
decrease in ribavirin royalties includes the effects of the
launch of generic ribavirin in the United States and increasing
competition between Schering-Plough and Roche, partially offset
by increased royalties in Japan and a $2,948,000 payment from
Schering-Plough in the first quarter of 2005 on sales of
Rebetol® in 2004. Approval of a generic form of oral
ribavirin by the U.S. Food and Drug Administration
(FDA) in the United States was announced on
April 7, 2004. Competition from generic pharmaceutical
companies has had, and is expected to continue to have, a
material negative impact on the Companys royalty revenue.
With respect to Schering-Plough, royalty rates increase in tiers
based on increased sales levels in the United States. As a
result of reduced sales, the likelihood of achieving the maximum
effective royalty rate in the United States is diminished. With
respect to Roche, under the license agreement, the introduction
of generics in any market eliminates the obligation of Roche to
pay royalties for sales in that market. Upon the entry of
generics into the United States on April 7, 2004, Roche
ceased paying royalties on sales in the United States.
Schering-Plough announced its launch of a generic version of
ribavirin. Under the license and supply agreement,
Schering-Plough is obligated to pay the Company royalties for
sales of their generic ribavirin.
Gross Profit Margin: Gross profit margin on product sales
for the three months ended March 31, 2005 was 70% compared
to 65% in 2004. The increase in gross profit margin is primarily
due to an increase in sales in the North America region, which
generates higher profit margins, and greater efficiencies in the
Companys manufacturing and supply chain operations.
25
Selling Expenses: Selling expenses were $52,815,000 for
the three months ended March 31, 2005 compared to
$47,742,000 for 2004, an increase of $5,073,000 (11%). As a
percent of product sales, selling expenses were 33% for the
three months ended March 31, 2005 compared to 36% for 2004.
The increase in selling expenses reflects the Companys
increased promotional efforts primarily in North America and
includes costs related to the launch of line extensions and new
products. The Company expects selling expenses to increase in
subsequent quarters of 2005.
General and Administrative Expenses: General and
administrative expenses were $24,052,000 for the three months
ended March 31, 2005 compared to $23,875,000 for 2004, an
increase of $177,000 (1%). As a percent of product sales,
general and administrative expenses were 15% for the three
months ended March 31, 2005 compared to 18% for 2004. The
decrease in general and administrative expenses as a percentage
of product sales reflects the Companys ongoing efforts to
effectively manage costs.
Research and Development: Research and development
expenses were $25,724,000 for the three months ended
March 31, 2005 compared to $18,463,000 for 2004, an
increase of $7,261,000 (39%). The increase in research and
development expenses continues to reflect the acceleration of
clinical trials for Viramidine and pradefovir. Research and
development costs are expected to increase in 2005 compared to
2004 as progress continues with the clinical trials of
Viramidine, pradefovir and retigabine.
Acquired In-Process Research and Development: In the
three months ended March 31, 2005 and 2004, the Company
incurred an expense of $126,399,000 and $11,386,000,
respectively, associated with IPR&D related to the
acquisition of Xcel Pharmaceuticals, Inc. and Amarin
Pharmaceuticals, Inc., respectively. 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 months ended
March 31, 2005, the Company incurred an impairment charge
of $2,220,000 related to the manufacturing and rationalization
plan. The Company made the decision to dispose of an additional
manufacturing site in China in the first quarter of 2005.
Amortization: Amortization expense was $13,968,000 for
the three months ended March 31, 2005 compared to
$13,287,000 for 2004, an increase of $681,000 (5%). The increase
was primarily due to amortization of intangibles acquired with
the acquisition of Xcel partially offset by a decrease in
amortization on the royalty license intangible of $1,717,000,
which was acquired in the Ribapharm acquisition and is being
amortized on an accelerated basis.
Other Loss, Net, Including Translation and Exchange:
Other loss, net, including translation and exchange was
$1,791,000 for the three months ended March 31, 2005
compared to $1,046,000 for 2004. In the three months ended
March 31, 2005, translation losses principally consisted of
translation and exchange losses in Europe of $2,165,000,
partially offset by translation and exchange gains in Latin
America and North America of $461,000. Translation and exchange
losses are primarily related to U.S dollar denominated assets
and liabilities at the Companys foreign currency
denominated subsidiaries.
Interest Expense: Interest expense decreased $5,278,000
during the three months ended March 31, 2005 compared to
2004. The decrease was due to repurchases of the Companys
61/2% Convertible
Subordinated Notes due 2008 in June and July of 2004.
Income Taxes: For the three months ended March 31,
2005, the Company recorded a tax provision of $16,367,000 on a
pre-tax loss of $121,218,000. The recording of a tax provision
while recording a pre-tax loss was the result of the Company not
receiving a tax benefit for either i) the charge of $126,399,000
as a result of recognizing acquired in-process research and
development or ii) the restructuring charge of $2,220,000
26
resulting from the impairment of the Companys
manufacturing site in China. The actual tax provision was
impacted by additional items as noted in the following table:
|
|
|
|
|
|
Increase in reserves due to IRS audit for tax years 1997 to 2001
|
|
$ |
56,389,000 |
|
Reversal of valuation allowance for losses that would be
recognized if adjustments above are realized
|
|
|
(34,939,000 |
) |
|
|
|
|
|
Net impact to tax provision from U.S. tax adjustments
|
|
|
21,450,000 |
|
Reversal of valuation allowance on deferred tax assets on
foreign operations
|
|
|
(11,122,000 |
) |
|
|
|
|
|
Net impact to tax provision from all adjustments
|
|
$ |
10,328,000 |
|
|
|
|
|
A $3,449,000 benefit associated with U.S. tax losses for the
three months ended March 31, 2005 has not been recorded in
calculating the Companys effective tax rate due to the
insufficient objective evidence at this time to recognize these
assets for financial reporting purposes. Excluding the effect of
the items noted above, the effective tax rate for the three
months ended March 31, 2005 would have been 35%, which is
compared to a 37% effective tax rate for 2004. The decrease in
the effective tax rate is due to higher expected profits in
lower tax rate jurisdictions.
Loss from Discontinued Operations, Net of Taxes: Loss
from discontinued operations was $1,503,000 for the three months
ended March 31, 2005 compared to $3,061,000 for 2004. The
losses in the three months ended March 31, 2005 and 2004
relate to the Companys sales of products manufactured in
its facilities in Central Europe. The Company is actively
marketing for sale the remaining raw materials business and
manufacturing facility in Central Europe and is working toward
disposing of these assets.
Liquidity and Capital Resources
Cash and marketable securities totaled $361,565,000 at
March 31, 2005 compared to $461,508,000 at
December 31, 2004. Working capital was $465,667,000 at
March 31, 2005 compared to $578,462,000 at
December 31, 2004. The decrease in working capital of
$112,795,000 was primarily attributable to the use of cash in
the Xcel acquisition, net of cash received, of $281,778,000,
partially offset by cash generated from the Companys stock
offering in connection with the Xcel acquisition of $189,393,000.
Cash provided by operating activities is expected to be the
Companys primary recurring source of funds in 2005. During
the three months ended March 31, 2005, cash provided by
operating activities totaled $8,191,000 compared to $18,874,000
for 2004. The decrease in cash provided by operating activities
of $10,683,000 is primarily due to a decrease in the change in
working capital, excluding income taxes, of $20,237,000 and
higher tax payments of $2,750,000, partially offset by lower
interest expense of $8,187,000. Additionally, the Company
expects to see the effects of lower royalty revenues and
increased research and development expenses for the remainder of
the year and in 2006, which would negatively impact its
operating cash flows.
Cash used in investing activities was $83,476,000 for the three
months ended March 31, 2005 compared to $42,992,000 for
2004. For the three months ended March 31, 2005, net cash
used in investing activities consisted of payments for the
acquisition of Xcel of $281,778,000 (net of cash received) and
capital expenditures of $4,848,000, partially offset by net
proceeds from investments of $202,387,000 and proceeds from the
sale of assets of $762,000. The Company expects to update its
information technology infrastructure, which will result in
higher capital expenditures during the remainder of 2005. For
the three months ended March 31, 2004, net cash used in
investing activities consisted of payments for the Amarin
acquisition and various other product rights of $44,358,000,
purchase of investments of $5,894,000 related to the interest
rate swap on the 7% Senior Notes due 2011 and foreign
currency hedge and capital expenditures of $3,971,000, partially
offset by proceeds from the sale of assets of $11,208,000
primarily related to the sale of investments.
Cash provided by financing activities was $182,938,000 for the
three months ended March 31, 2005, including proceeds from
the Companys stock offering in connection with the Xcel
acquisition of $189,393,000 after underwriting commissions and
discounts and proceeds received from the exercise of stock
options of $640,000, partially offset by cash dividends paid on
common stock of $6,502,000 and payments on long-term
27
debt and notes payable of $593,000. In February 2005, the
Company sold 8,280,000 shares of its common stock in a
public offering to fund in part the Xcel acquisition. The
remainder of the funds required for the Xcel transaction was
provided by available cash on hand. Cash used in financing
activities was $2,062,000 for the three months ended
March 31, 2004, including cash dividends paid on common
stock of $6,432,000 and payments on long-term debt and notes
payable of $568,000, partially offset by proceeds received from
the exercise of stock options of $4,938,000.
In January 2004, 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
is to initially lower the Companys 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 the Companys
cash held. The Company continues to expect to retain minimum
cash levels of between $100,000,000 and $150,000,000.
The Company has collateral requirements on an interest rate swap
agreement and foreign currency hedges. The amount of collateral
varies monthly depending on the fair value of the underlying
swap contracts. As of March 31, 2005, the Company has
collateral of $8,495,000 included in marketable securities and
$8,624,000 included in other assets related to these instruments.
In the first quarter of 2005, investors in auction rate
securities were advised that under a recent interpretation of
SFAS No. 95, Statement of Cash Flows, all
auction rate securities should be classified as marketable
securities and not cash and cash equivalents. As a result, the
Company reviewed its investments in auction rate securities and
concluded that it was in technical non-compliance with a
covenant in the indenture governing its 7.0% Senior Notes
due 2011. As a result, the Company liquidated its holdings of
auction rate securities at approximately the carrying value and
cured the technical non-compliance.
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 March 31, 2006,
and to provide cash needed to fund acquisitions, capital
expenditures and its research and development program. While the
Company has no current intent to issue additional debt or equity
securities, it may seek additional debt financing or issue
additional equity securities to finance future acquisitions or
for other purposes. The Company funds its cash requirements
primarily from cash provided by its operating activities. The
Companys sources of liquidity are its cash and cash
equivalent balances and its cash flow from operations.
While the Company has historically paid quarterly cash
dividends, there can be no assurance that it will continue to do
so in the future.
In 1999, the Company restructured its operations by contributing
the stock of several non-United States subsidiaries to a wholly
owned Dutch company. At the time of the restructuring, the
Company intended to avail itself of the non-recognition
provisions of the Internal Revenue Code to avoid generating
taxable income on the inter-company transfer. One of the
requirements under the non-recognition provisions was to file
Gain Recognition Agreements with the Companys timely filed
1999 U.S. Corporate Income Tax Return. The Company discovered
and voluntarily informed the IRS that the Gain Recognition
Agreements had been inadvertently omitted from the 1999 Tax
Return. The IRS has denied the Companys request to rule
that reasonable cause existed for the failure to provide the
agreements and the Company will pursue resolution through the
formal appeals process.
The Companys U.S. tax returns for the period from
1997 to 2001 have been reviewed by the Internal Revenue Service
and the Company has received proposed adjustments resulting from
the review. The Company has recorded its estimate of the
additional tax expense from these reviews. In the three months
ended March 31, 2005, an adjustment of $34,939,000 has been
recorded to the deferred tax asset with an offsetting adjustment
to the valuation allowance for this matter, resulting in no
effect to the income statement. The Company recorded a tax
provision of $21,450,000 in the three months ended
March 31, 2005 which relates to cash payments that could
arise due to the net operating losses being subject to an annual
limitation, expiring or being completely utilized.
28
In March 2005, the Company purchased additional products
liability insurance to cover damages resulting from the use of
its products where such coverage was not already in place.
Historically, the Company had product liability insurance only
on certain products. No individual claim has been paid to date
in excess of the coverages now in place. Notwithstanding this
new coverage, a substantial claim, if successful, could have a
material adverse effect on the Companys liquidity and
financial performance. The Company maintains clinical trial
insurance in major markets in which it conducts clinical trials.
Products in Development
The Company expects its research and development expenses to
increase throughout 2005, of which a large percentage will be to
support the continuing product development programs for
Viramidine, pradefovir and retigabine. The Company expects that
for 2005, it will spend approximately $60,000,000 on external
research and development costs related to these product
development programs.
For Viramidine, the final analyses of all Phase 2 data were
presented at the European Association for the Study of the Liver
Conference in April 2005. The Phase 2 trial met its design
objective by confirming the selection of the 600 mg BID
dose used in the two pivotal Phase 3 trials, VISER 1 and
VISER 2. The results validated the study design by continuing to
show that Viramidine demonstrates statistical comparable
efficacy to ribavirin in SVR and a significantly reduced
incidence of anemia. On January 20, 2005, the Company
announced that it had completed enrollment in VISER 2. The
Company expects to complete its VISER 1 Phase 3 trial
by the end of this year and report VISER 1 results sometime
in the first half of 2006. The VISER 2 trial is about six
months behind VISER 1. The Companys external research
and development expenses for Viramidine were $9,794,000 for the
three months ended March 31, 2005 and $59,820,000 from
inception through March 31, 2005.
For pradefovir, which is being developed for the treatment of
hepatitis B, the Company has completed three Phase 1
clinical trials in a total of 87 healthy volunteers. A 48-week
dose-ranging Phase 2 study in Asia and the United States
began enrollment in July 2004 and completed enrollment in
November 2004. The Companys external research and
development expenses for pradefovir were $789,000 for the three
months ended March 31, 2005 and $20,646,000 (including a
milestone payment of $2,100,000) from inception through
March 31, 2005.
The Company acquired the rights to Zelapar, a late-stage
candidate being developed as an adjunctive therapy in the
treatment of Parkinsons disease, in the Amarin acquisition
in February 2004. In late 2004, the Company submitted a complete
response to an approvable letter from the FDA, following the
completion of two safety studies. The Company received a
response to its submission from the FDA that requires the
Company to provide them with additional information. A revised
submission for Zelapar was recently sent to the FDA, and the
Company expects to receive a Prescription Drug User Fee Act
(PDUFA) date soon. The Company expects to launch Zelapar in
2005. The Companys external research and development
expenses for Zelapar were $76,000 for the three months ended
March 31, 2005 and $4,908,000 from inception through
March 31, 2005.
The Company acquired the rights to retigabine, an adjunctive
treatment for partial-onset seizures in patients with epilepsy,
in the acquisition of Xcel Pharmaceuticals, Inc. on
March 1, 2005. For retigabine, the Company is scheduled to
commence Phase 3 trials in 2005. Retigabine is believed to
have a unique, dual-acting mechanism and has undergone several
Phase 2 clinical trials in over 600 patients. The
Company plans to hold a Special Protocol Assessment meeting for
retigabine with the FDA in the next few weeks. We expect to
begin clinical trials for retigabine by the end of the year.
Foreign Operations
Approximately 75% and 80% of the Companys revenues from
continuing operations, which includes royalties, for the three
months ended March 31, 2005 and 2004, respectively, were
generated from operations outside the United States. All of the
Companys 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.
29
Changes in the relative values of currencies occur and may
materially affect the Companys results of operations. The
effect of these risks remains difficult to predict.
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 the
Company 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, the Company
evaluates its 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.
The Company believes the following critical accounting policies
affect its more significant judgments and estimates used in the
preparation of its consolidated condensed financial statements.
The Company recognizes 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 established at the time of sale. Allowances for future
returns of products sold to the Companys 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. The Company uses third-party data to estimate the level
of product inventories, expiration dating, and product demand at
its major wholesalers. Based upon this information, adjustments
are made to the accrual if deemed necessary. Actual results
could be materially different from the Companys estimates,
resulting in future adjustments to revenue. For the three months
ended March 31, 2005, returns received and the provision
for sales returns were less than 2% of product sales. The
Company conducts a review of the current methodology and
assesses the adequacy of the allowance for returns on a
quarterly basis, adjusting for changes in assumptions,
historical results and business practices, as necessary.
The Company may offer sales incentives primarily in
international markets, where typically no right of return exists
for goods damaged in transit, product recalls or for replacement
of existing products due to packaging or labeling changes. In
the United States market, the Companys 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. The Company monitors and restricts
sales in the United States market in order to limit wholesaler
purchases in excess of their ordinary-course-of-business
inventory levels. However, specific events such as the case of
sales incentives described above or seasonal demand (e.g.
antivirals during an outbreak) may justify purchases by
wholesalers in excess of their ordinary course of business. The
Companys revenues recognition policy on these types of
purchases and on incentives in international markets is
consistent with the policies described in the revenue
recognition critical accounting policy.
The Company operates in numerous countries where its income tax
returns are subject to audit. Internal and external tax
professional are employed to minimize tax audit adjustments
where possible. The Company considers the expected outcome of
these audits in the calculation of its tax provision. See
Note 7 of notes to consolidated condensed financial
statements for a discussion of tax issues affecting the Company.
The Company assesses whether it is more likely than not that it
will realize the tax benefit associated with its deferred tax
assets and establishes valuation allowances 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 the Company revises these
30
forecasts or determines 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 |
The Company evaluates the carrying value of property, plant and
equipment in accordance with guidelines. In evaluating property,
plant and equipment, the Company determines 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 is less than the carrying value, the amount of the
impairment, if any, will be determined 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 |
The Company periodically reviews intangible assets for
impairment using an undiscounted net cash flows approach. The
Company determines whether there has been impairment by
comparing the anticipated undiscounted future operating income
of the products acquired with their 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.
The Company uses a discounted cash flow model to value
intangible assets acquired 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
Company evaluated the businesses included in discontinued
operations by comparing the carrying value of each intangible
asset to their fair value, as determined using discounted cash
flows analysis, appraisals, and purchase offers.
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 estimate 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.
|
|
|
Purchase Price Allocation Including Acquired In-Process
Research and Development |
The purchase price for the Xcel acquisition was 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. The Company
believes 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 allocation may change as
subsequent information becomes available.
The Company values 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 amount
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. For the Xcel
acquisition in March 2005, the estimated fair value was based on
the Companys use of a discounted cash flow model (based on
an estimate
31
of future sales and an average gross profit margin of 80%). The
estimated after-tax cash flows (using a tax rate of 35%) were
then discounted to a present value using a discount rate of 17%
to 18%. See Note 2 of notes to consolidated condensed
financial statements for discussion of the Xcel acquisition.
The major risks and uncertainties associated with the timely and
successful completion of these projects include the uncertainty
of the Companys ability to confirm the safety and efficacy
of the technology based on the data from clinical trials and of
obtaining necessary regulatory approvals. In addition, no
assurance can be given that the underlying assumptions the
Company 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.
The Company is 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 accordance, with SFAS No. 5,
Accounting for Contingencies, the Company records
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 8 of
notes to consolidated condensed financial statements for a
discussion of contingencies.
32
|
|
Item 3. |
Quantitative and Qualitative Disclosures About Market
Risk |
The Companys business and financial results are effected
by fluctuations in world financial markets. The Company
evaluates its exposure to such risks on an ongoing basis, and
seeks ways to manage these risks to an acceptable level, based
on managements judgment of the appropriate trade-off
between risk, opportunity and cost. The Company does not hold
any significant amount of market risk sensitive instruments
whose value is subject to market price risk. The Companys
significant foreign currency exposure relates to the Euro, the
Mexican Peso, the Polish Zloty, the Swiss Franc and the Canadian
Dollar. The Company seeks to manage its foreign currency
exposure by maintaining the majority of cash balances at foreign
subsidiaries in U.S. dollars and through operational means
by managing local currency revenues in relation to local
currency costs. The Company is currently taking steps to
mitigate the impact of foreign currency on the income statement,
which include hedging its foreign currency exposure.
In the normal course of business, the Company also faces 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
March 31, 2005, the fair values of the Companys
financial instruments were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets (Liabilities) | |
|
|
Notional/ | |
|
| |
|
|
Contract | |
|
Carrying | |
|
|
Description |
|
Amount | |
|
Value | |
|
Fair Value | |
|
|
| |
|
| |
|
| |
Forward contracts
|
|
$ |
33,415 |
|
|
$ |
(2,610 |
) |
|
$ |
(2,610 |
) |
Interest rate swaps
|
|
|
150,000 |
|
|
|
(3,969 |
) |
|
|
(3,969 |
) |
Outstanding debt
|
|
|
780,000 |
|
|
|
(780,000 |
) |
|
|
(770,556 |
) |
The Company currently does not hold financial instruments for
trading or speculative purposes. The financial assets of the
Company are not subject to significant interest rate risk due to
their short duration. At March 31, 2005, the Company had
$13,707,000 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 the
Companys financial instruments would not have had a
material effect on the Companys first quarter 2005 pretax
earnings. In addition, the Company has $780,000,000 of fixed
rate debt as of March 31, 2005, that requires
U.S. dollar repayment. To the extent that the Company
requires, as a source of debt repayment, earnings and cash flow
from some of its units located in foreign countries, the Company
is subject to risk of changes in the value of certain currencies
relative to the U.S. dollar. However, the increase of a 100
basis-points in interest rates would have reduced the fair value
of the Companys remaining fixed-rate debt instruments by
approximately $43,000,000 as of March 31, 2005.
The Company estimated the sensitivity of the fair value of its
derivative foreign exchange contracts to a hypothetical 10%
strengthening and 10% weakening of the spot exchange rates for
the U.S. dollar against the Euro at March 31, 2005.
The analysis showed that a 10% strengthening of the
U.S. dollar would have resulted in a gain from a fair value
change of $648,000 and a 10% weakening of the U.S. dollar
would have resulted in a loss from a fair value change of
$6,593,000 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.
33
|
|
Item 4. |
Controls and Procedures |
The Company maintains disclosure controls and procedures that
are designed to ensure that information required to be disclosed
in the Companys reports under the Securities Exchange Act
of 1934, as amended, 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 the Companys management, including its
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, management recognizes that any controls and
procedures, no matter how well designed and operated, can
provide only reasonable assurance of achieving the desired
control objectives, and management necessarily is required to
apply its judgment in evaluating the cost-benefit relationship
of possible controls and procedures.
As of March 31, 2005, the Company conducted an evaluation
of the effectiveness of the design and operation of the
Companys disclosure controls and procedures. This
evaluation was carried out under the supervision and with the
participation of the Companys management, including the
Companys Chief Executive Officer and Chief Financial
Officer. Based upon the foregoing, the Companys Chief
Executive Officer and Chief Financial Officer concluded that the
Companys disclosure controls and procedures were effective
in making known to them material information relating to the
Company (including its consolidated subsidiaries) required to be
included in this report.
There has been no change in the Companys internal controls
over financial reporting, known to the Chief Executive Officer
or the Chief Financial Officer, that occurred during the three
months ended March 31, 2005 that has materially affected,
or is reasonably likely to materially affect, the Companys
internal control over financial reporting.
34
FORWARD LOOKING STATEMENTS
Except for the historical information contained herein, the
matters addressed in this quarterly report on Form 10-Q
constitute forward-looking statements.
Forward-looking statements may be identified by the use of the
words anticipates, expects,
intends, plans, and variations or
similar expressions. 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 the Companys
management. In addition, the information set forth in the
Companys Form 10-K for the fiscal year ended
December 31, 2004, 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. The Company undertakes 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.
RISK FACTORS
The short and long-term success of the Company is subject to a
variety of risks and uncertainties, many of which are beyond the
Companys control. Stockholders and prospective
stockholders of the Company should consider carefully the
following risk factors, in addition to other information
contained in this report and in the Companys annual report
on Form 10-K. The Companys 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 the Companys business depends on the
development and approval of new products, including Viramidine,
pradefovir and retigabine. The process of developing new drugs
has an inherent risk of failure. Although certain of the
Companys research compounds show promise at their current
stages of development, the Company may fail to commercialize
them for various reasons. For example, they may turn out to be
ineffective or unsafe in clinical or pre-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. The
Companys inability to successfully develop its products
due to these or other factors could have a material adverse
effect on future revenues. |
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The Company can protect its products from generic substitution
by third parties only to the extent that its technologies are
covered by valid and enforceable patents, are effectively
maintained as trade secrets or are protected by data
exclusivity. However, the Companys presently pending or
future patent applications may not issue as patents. Any patent
issued may be challenged, invalidated, held unenforceable or
circumvented. Furthermore, the Companys 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. |
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Trade secret protection is less effective than patent protection
because competitors may discover the Companys technology
or develop parallel technology. |
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The scope of protection afforded by a patent can be highly
uncertain. A pending claim or a result unfavorable to the
Company in a patent dispute may preclude development or
commercialization of products or impact sales of existing
products, and 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 the Companys products. |
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The Companys current business plan includes expansion
through acquisitions, in addition to the development of new
products. If the Company is unable to successfully execute on
its expansion plans to find attractive acquisition candidates at
appropriate prices, and to integrate successfully any acquired
companies or products, the expected growth of the Companys
business may be negatively effected. |
35
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The Company and its competitors are always striving to develop
products that are more effective, safer, more easily tolerated
or less costly. If the Companys competitors succeed in
developing better alternatives to the Companys current
products before it does, the Company will lose sales and
revenues to their alternative products. If vaccines are
introduced to prevent the diseases treated by the Companys
products, the Companys 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 is high, and
failure to comply could result in fines or interruption in our
business. |
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The Company collects and pays a substantial portion of its sales
and expenditures in currencies other than the U.S. dollar.
As a result, fluctuations in foreign currency exchange rates
affect the Companys operating results. Additionally,
future exchange rate movements, inflation or other related
factors may have a material adverse effect on the Companys
sales, gross profit or operating expenses. The Company entered
into foreign currency hedge transactions to reduce its exposure
to variability in the Euro. The Company continues to evaluate
the possibility of entering into additional hedge arrangements. |
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A significant part of the Companys revenue is derived from
products manufactured by third parties. The Company relies on
their quality level, compliance with the FDA regulations and
continuity of supply. Any failure by them in these areas could
disrupt the Companys product supply and negatively impact
its revenues. |
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The Companys flexibility in maximizing commercialization
opportunities for its compounds may be limited by its
obligations to Schering-Plough. In November 2000, the Company
entered into an agreement that provides Schering-Plough with an
option to acquire the rights to up to three of its products that
they designate at an early stage of product development and a
right for first/last refusal to license various compounds the
Company may develop and elect to license to others. Viramidine
was not subject to the option of Schering-Plough, but it would
be subject to their right of first/last refusal if the Company
elected to license it to a third party. The interest of
potential collaborators in obtaining rights to the
Companys compounds or the terms of any agreement it
ultimately enters into for these rights may be hindered by its
agreement with Schering-Plough. |
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To purchase the Companys 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 the Company to realize an
appropriate return on its investment in product development. |
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Some of the Companys development programs are based on the
library of nucleoside compounds it has developed. It is not
practicable to create backups for the Companys nucleoside
library, and accordingly it is at risk of loss in earthquakes,
fire and other natural disasters. |
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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 the Companys products is found to have
harmed an individual or individuals, it may be responsible for
paying all or substantially all damages awarded. A successful
product liability claim against the Company could have a
material negative impact on its financial position and results
of operations. |
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The Company is allowed by its senior note indenture to borrow
money from third parties, subject to certain restrictions, but
there is no guaranty that it will actually be able to borrow any
money should the need for it arise. |
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The Company is involved in several legal proceedings, including
those described in Note 8 to notes to consolidated
condensed financial statements. |
36
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Dependence on key personnel leaves the Company vulnerable to a
negative impact if they leave. The Companys 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 the Company. |
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The Companys research and development activities involve
the controlled use of potentially harmful biological materials
as wells as hazardous materials, chemicals and various
radioactive compounds. The Company 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, the Company could be held liable for
damages that result. Any liability could exceed the
Companys resources. |
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The Companys stockholder rights plan, provisions of its
certificate of incorporation and provisions of the Delaware
General Corporation Law could provide its Board of Directors
with the ability to deter hostile takeovers or delay, deter or
prevent a change in control of the Company, including
transactions in which stockholders might otherwise receive a
premium for their shares over then current market prices. |
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The Company is authorized to issue, without stockholder
approval, 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 the Company issues additional equity securities, the
price of its 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 the Company. |
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The Company is subject to a Consent Order with the Securities
and Exchange Commission, which permanently enjoins the Company
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. The existence of the permanent
injunction under the Consent Order, and the lack of protection
under the Safe Harbor may limit the Companys ability to
defend against future allegations. |
37
PART II OTHER INFORMATION
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|
Item 1. |
Legal Proceedings |
See Note 8 of notes to consolidated condensed financial
statements in Item 1 of Part I of this quarterly
report, which is incorporated herein by reference.
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Item 5. |
Other Information |
None.
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3 |
.1 |
|
Restated Certificate of Incorporation of the Company, as amended
to date, previously filed as Exhibit 3.2 to the
Companys Current Report on Form 8-K dated
November 12, 2003, and incorporated herein by reference. |
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3 |
.2 |
|
Amended and Restated Bylaws of the Company, previously filed as
Exhibit 4.2 to the Companys registration statement on Form
S-3 (file number 333-88040), and incorporated herein by
reference. |
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10 |
.1* |
|
Executive Employment Agreement between Ribapharm Inc. and Kim D.
Lamon, M.D., Ph.D., dated as of February 21, 2003. |
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10 |
.2 |
|
Amended and Restated Employment Agreement, dated March 21,
2005 and effective as of January 1, 2005, between Valeant
Pharmaceuticals International and Timothy C. Tyson, previously
filed as Exhibit 10.1 to the Companys Current Report
on Form 8-K/A dated March 25, 2005, and incorporated herein
by reference. |
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10 |
.3 |
|
Amended and Restated Employment Agreement, dated March 21,
2005 and effective as of January 1, 2005, between Valeant
Pharmaceuticals International and Robert OLeary,
previously filed as Exhibit 10.2 to the Companys
Current Report on Form 8-K/A dated March 25, 2005, and
incorporated herein by reference. |
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10 |
.4 |
|
Executive Incentive Plan of Valeant Pharmaceuticals
International, previously filed as Exhibit 10.1 to the
Companys Current Report on Form 8-K dated
February 25, 2005, and incorporated herein by reference. |
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10 |
.5 |
|
Executive Severance Agreement, dated as of April 22, 2005,
between Valeant Pharmaceuticals International and Eileen C.
Pruette, previously filed as Exhibit 10.1 to the
Companys Current Report on Form 8-K dated April 27,
2005, and incorporated herein by reference. |
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10 |
.6 |
|
Agreement and Plan of Merger, dated February 2, 2005, by
and between Valeant Pharmaceuticals International and Xcel
Pharmaceuticals, Inc., previously filed as Exhibit 99.1 to
the Companys Current Report on Form 8-K dated
February 2, 2005, and incorporated herein by reference. |
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10 |
.7* |
|
Asset Purchase Agreement, dated as of January 22, 2004, by
and between Xcel Pharmaceuticals, Inc. and VIATRIS GmbH and Co.
KG. |
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10 |
.8* |
|
Amended and Restated Diastat Asset Purchase Agreement, dated
March 31, 2001, by and among Xcel Pharmaceuticals, Inc.,
Elan Pharmaceuticals, Inc. and Elan Pharma International Limited. |
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15 |
.1* |
|
Review Report of Independent Registered Public Accounting Firm. |
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15 |
.2* |
|
Awareness Letter of Independent Registered Public Accounting
Firm. |
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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. |
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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. |
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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. |
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|
|
Portions of this exhibit have been omitted pursuant to an
application for confidential treatment pursuant to
Rule 24b-2 of the Securities Exhange Act of 1934, as
amended. |
38
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.
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Valeant Pharmaceuticals
International
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Registrant |
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/s/ Timothy C. Tyson
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Timothy C. Tyson |
|
President and Chief Executive Officer |
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(Principal Executive Officer) |
Date: May 10, 2005
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/s/ Bary G. Bailey
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Bary G. Bailey |
|
Executive Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
Date: May 10, 2005
39
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
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|
|
|
|
3 |
.1 |
|
Restated Certificate of Incorporation of the Company, as amended
to date, previously filed as Exhibit 3.2 to the
Companys Current Report on Form 8-K dated
November 12, 2003, and incorporated herein by reference. |
|
|
3 |
.2 |
|
Amended and Restated Bylaws of the Company, previously filed as
Exhibit 4.2 to the Companys registration statement on Form
S-3 (file number 333-88040), and incorporated herein by
reference. |
|
|
10 |
.1* |
|
Executive Employment Agreement between Ribapharm Inc. and Kim D.
Lamon, M.D., Ph.D., dated as of February 21, 2003. |
|
|
10 |
.2 |
|
Amended and Restated Employment Agreement, dated March 21,
2005 and effective as of January 1, 2005, between Valeant
Pharmaceuticals International and Timothy C. Tyson, previously
filed as Exhibit 10.1 to the Companys Current Report
on Form 8-K/A dated March 25, 2005, and incorporated
herein by reference. |
|
|
10 |
.3 |
|
Amended and Restated Employment Agreement, dated March 21,
2005 and effective as of January 1, 2005, between Valeant
Pharmaceuticals International and Robert OLeary,
previously filed as Exhibit 10.2 to the Companys
Current Report on Form 8-K/A dated March 25, 2005, and
incorporated herein by reference. |
|
|
10 |
.4 |
|
Executive Incentive Plan of Valeant Pharmaceuticals
International, previously filed as Exhibit 10.1 to the
Companys Current Report on Form 8-K dated
February 25, 2005, and incorporated herein by reference. |
|
|
10 |
.5 |
|
Executive Severance Agreement, dated as of April 22, 2005,
between Valeant Pharmaceuticals International and Eileen C.
Pruette, previously filed as Exhibit 10.1 to the
Companys Current Report on Form 8-K dated April 27,
2005, and incorporated herein by reference. |
|
|
10 |
.6 |
|
Agreement and Plan of Merger, dated February 2, 2005, by
and between Valeant Pharmaceuticals International and Xcel
Pharmaceuticals, Inc., previously filed as Exhibit 99.1 to
the Companys Current Report on Form 8-K dated
February 2, 2005, and incorporated herein by reference. |
|
|
10 |
.7* |
|
Asset Purchase Agreement, dated as of January 22, 2004, by
and between Xcel Pharmaceuticals, Inc. and VIATRIS GmbH and Co.
KG. |
|
|
10 |
.8* |
|
Amended and Restated Diastat Asset Purchase Agreement, dated
March 31, 2001, by and among Xcel Pharmaceuticals, Inc.,
Elan Pharmaceuticals, Inc. and Elan Pharma International Limited. |
|
|
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. |
|
|
|
Portions of this exhibit have been omitted pursuant to an
application for confidential treatment pursuant to
Rule 24b-2 of the Securities Exhange Act of 1934, as
amended. |