e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2009
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 1-11397
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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One Enterprise
Aliso Viejo, California
(Address of principal executive offices)
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92656
(Zip Code) |
(949) 461-6000
(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 has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
The number of shares outstanding of the registrants Common Stock, $0.01 par value, as of July
31, 2009 was 81,229,290.
VALEANT PHARMACEUTICALS INTERNATIONAL
INDEX
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Page |
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Number |
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2 |
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2 |
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3 |
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4 |
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5 |
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6 |
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33 |
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50 |
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50 |
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51 |
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51 |
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53 |
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54 |
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55 |
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57 |
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1
PART I FINANCIAL INFORMATION
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Item 1. |
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Financial Statements |
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED CONDENSED BALANCE SHEETS
As of June 30, 2009 and December 31, 2008 (unaudited)
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June 30, |
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December 31, |
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2009 |
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2008 |
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(In thousands, except par value data) |
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ASSETS
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Current Assets: |
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Cash and cash equivalents |
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$ |
345,620 |
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$ |
199,582 |
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Marketable securities |
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107,359 |
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19,193 |
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Accounts receivable, net |
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145,622 |
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144,509 |
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Inventories, net |
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85,159 |
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72,972 |
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Prepaid expenses and other current assets |
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14,178 |
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17,605 |
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Current deferred tax assets, net |
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19,029 |
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16,179 |
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Income taxes |
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3,638 |
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Total current assets |
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720,605 |
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470,040 |
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Property, plant and equipment, net |
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95,435 |
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90,228 |
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Deferred tax assets, net |
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2,151 |
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14,850 |
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Goodwill |
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108,585 |
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114,634 |
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Intangible assets, net |
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452,015 |
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467,795 |
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Other assets |
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16,488 |
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28,385 |
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Total non-current assets |
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674,674 |
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715,892 |
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$ |
1,395,279 |
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$ |
1,185,932 |
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current Liabilities: |
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Trade payables |
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$ |
31,608 |
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$ |
41,638 |
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Accrued liabilities |
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198,734 |
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231,450 |
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Notes payable and current portion of long-term debt |
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766 |
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666 |
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Deferred revenue |
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11,599 |
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15,415 |
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Income taxes payable |
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8,354 |
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2,497 |
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Current deferred tax liabilities, net |
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2,446 |
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Current liabilities for uncertain tax positions |
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478 |
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Total current liabilities |
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251,061 |
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294,590 |
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Long-term debt, less current portion |
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649,447 |
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398,136 |
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Deferred revenue |
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10,389 |
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11,841 |
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Deferred tax liabilities, net |
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14,430 |
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812 |
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Liabilities for uncertain tax positions |
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13,652 |
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53,425 |
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Other liabilities |
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139,287 |
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175,380 |
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Total non-current liabilities |
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827,205 |
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639,594 |
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Total liabilities |
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1,078,266 |
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934,184 |
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Commitments and contingencies |
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Stockholders Equity: |
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Common stock, $0.01 par value; 200,000 shares authorized; 82,332 (June 30, 2009)
and 81,753 (December 31, 2008) shares outstanding (after deducting shares in
treasury of 19,787 as of June 30, 2009 and 18,688 as of December 31, 2008) |
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824 |
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818 |
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Additional capital |
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1,143,037 |
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1,138,575 |
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Accumulated deficit |
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(841,729 |
) |
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(905,784 |
) |
Accumulated other comprehensive income |
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14,862 |
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18,122 |
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Total Valeant stockholders equity |
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316,994 |
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251,732 |
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Noncontrolling interest |
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19 |
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17 |
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Total stockholders equity |
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317,013 |
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251,748 |
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$ |
1,395,279 |
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$ |
1,185,932 |
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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 and six months ended June 30, 2009 and 2008
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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(Unaudited, in thousands, except per share data) |
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Revenues: |
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Product sales |
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$ |
166,865 |
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$ |
138,751 |
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$ |
319,698 |
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$ |
277,961 |
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Service revenue |
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5,606 |
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12,344 |
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Alliances (including ribavirin royalties) |
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19,227 |
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14,805 |
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37,579 |
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27,578 |
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Total revenues |
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191,698 |
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153,556 |
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369,621 |
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305,539 |
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Costs and expenses: |
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Cost of goods sold (excluding amortization) |
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42,750 |
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47,874 |
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82,447 |
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83,629 |
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Cost of services |
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5,337 |
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9,663 |
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Selling, general and administrative |
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62,535 |
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70,772 |
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126,751 |
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140,211 |
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Research and development costs, net |
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9,145 |
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22,567 |
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17,880 |
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51,861 |
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Special charges and credits including acquired in-process research and
development |
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1,974 |
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1,974 |
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Restructuring, asset impairments and dispositions |
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1,694 |
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13,957 |
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2,905 |
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767 |
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Amortization expense |
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17,105 |
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12,799 |
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34,109 |
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26,128 |
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Total costs and expenses |
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140,540 |
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167,969 |
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275,729 |
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302,596 |
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Income (loss) from operations |
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51,158 |
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(14,413 |
) |
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93,892 |
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2,943 |
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Other income (expense), net including translation and exchange |
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(646 |
) |
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(298 |
) |
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566 |
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(1,829 |
) |
Gain on early extinguishment of debt |
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2,777 |
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7,376 |
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Interest income |
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725 |
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5,236 |
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2,560 |
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9,960 |
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Interest expense |
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(8,551 |
) |
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(13,325 |
) |
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(16,564 |
) |
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(26,709 |
) |
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Income (loss) from continuing operations before income taxes |
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45,463 |
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(22,800 |
) |
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87,830 |
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(15,635 |
) |
Provision for income taxes |
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12,427 |
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29,215 |
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23,996 |
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33,874 |
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Income (loss) from continuing operations |
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33,036 |
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(52,015 |
) |
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63,834 |
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(49,509 |
) |
Income (loss) from discontinued operations, net of tax |
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(175 |
) |
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(26,313 |
) |
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223 |
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(23,020 |
) |
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Net income (loss) |
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32,861 |
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(78,328 |
) |
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64,057 |
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(72,529 |
) |
Less: Net income attributable to noncontrolling interest |
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1 |
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2 |
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2 |
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4 |
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Net income (loss) attributable to Valeant |
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$ |
32,860 |
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$ |
(78,330 |
) |
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$ |
64,055 |
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$ |
(72,533 |
) |
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Basic income (loss) per share attributable to Valeant: |
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Income (loss) from continuing operations attributable to Valeant |
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$ |
0.40 |
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|
$ |
(0.58 |
) |
|
$ |
0.77 |
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$ |
(0.55 |
) |
Loss from discontinued operations attributable to Valeant |
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(0.29 |
) |
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(0.26 |
) |
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Net income (loss) per share attributable to Valeant |
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$ |
0.40 |
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$ |
(0.87 |
) |
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$ |
0.77 |
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$ |
(0.81 |
) |
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Diluted income (loss) per share attributable to Valeant: |
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Income (loss) from continuing operations attributable to Valeant |
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$ |
0.39 |
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|
$ |
(0.58 |
) |
|
$ |
0.76 |
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|
$ |
(0.55 |
) |
Income (loss) from discontinued operations attributable to Valeant |
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(0.29 |
) |
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|
0.01 |
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(0.26 |
) |
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Net income (loss) per share attributable to Valeant |
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$ |
0.39 |
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$ |
(0.87 |
) |
|
$ |
0.77 |
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$ |
(0.81 |
) |
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Shares used
in per share computation - Basic |
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|
82,794 |
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|
89,802 |
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|
82,733 |
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|
89,696 |
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Shares used
in per share computation - Diluted |
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83,673 |
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89,802 |
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83,566 |
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89,696 |
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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 INCOME
For the three and six months ended June 30, 2009 and 2008
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Three Months Ended |
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Six Months Ended |
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June 30, |
|
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June 30, |
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2009 |
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2008 |
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|
2009 |
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2008 |
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|
(Unaudited, in thousands) |
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|
|
Net income (loss) |
|
$ |
32,861 |
|
|
$ |
(78,328 |
) |
|
$ |
64,057 |
|
|
$ |
(72,529 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
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|
|
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|
Foreign currency translation adjustments |
|
|
26,011 |
|
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|
16,970 |
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|
(3,474 |
) |
|
|
70,539 |
|
Unrealized gain on marketable equity
securities |
|
|
172 |
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|
2,958 |
|
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|
172 |
|
|
|
1,084 |
|
Unrealized gain (loss) on hedges |
|
|
(155 |
) |
|
|
622 |
|
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|
56 |
|
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|
27 |
|
Pension liability adjustment |
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|
(83 |
) |
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|
147 |
|
|
|
(14 |
) |
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|
161 |
|
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|
|
Comprehensive income (loss) |
|
$ |
58,806 |
|
|
$ |
(57,631 |
) |
|
$ |
60,797 |
|
|
$ |
(718 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 six months ended June 30, 2009 and 2008
|
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|
|
|
|
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|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(Unaudited, in thousands) |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
64,057 |
|
|
$ |
(72,529 |
) |
Income (loss) from discontinued operations |
|
|
223 |
|
|
|
(23,020 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
63,834 |
|
|
|
(49,509 |
) |
Adjustments to reconcile income (loss) from continuing operations to net cash provided
by operating activities in continuing operations: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
41,753 |
|
|
|
35,686 |
|
Provision for losses on accounts receivable and inventory |
|
|
1,505 |
|
|
|
16,152 |
|
Stock compensation expense |
|
|
7,703 |
|
|
|
(1,687 |
) |
Excess tax deduction from stock options exercised |
|
|
(734 |
) |
|
|
|
|
Translation and exchange (gains) losses, net |
|
|
(625 |
) |
|
|
1,829 |
|
Impairment charges and other non-cash items |
|
|
8,320 |
|
|
|
(21,045 |
) |
Payments of accreted interest on long-term debt |
|
|
(22,987 |
) |
|
|
|
|
Deferred income taxes |
|
|
(501 |
) |
|
|
27,436 |
|
Gain on extinguishment of debt |
|
|
(7,376 |
) |
|
|
|
|
Change in assets and liabilities, net of effects of acquisitions: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
11,850 |
|
|
|
37,566 |
|
Inventories |
|
|
(9,662 |
) |
|
|
(16,565 |
) |
Prepaid expenses and other assets |
|
|
4,603 |
|
|
|
677 |
|
Trade payables and accrued liabilities |
|
|
4,965 |
|
|
|
12,838 |
|
Income taxes |
|
|
2,790 |
|
|
|
12,769 |
|
Other liabilities |
|
|
(23,155 |
) |
|
|
(90 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from operating activities in continuing operations |
|
|
82,283 |
|
|
|
56,057 |
|
Cash flow from operating activities in discontinued operations |
|
|
(2,434 |
) |
|
|
(4,354 |
) |
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
79,849 |
|
|
|
51,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(9,108 |
) |
|
|
(5,769 |
) |
Proceeds from sale of assets |
|
|
484 |
|
|
|
418 |
|
Proceeds from sale of businesses |
|
|
3,342 |
|
|
|
48,575 |
|
Proceeds from investments |
|
|
20,408 |
|
|
|
77,904 |
|
Purchase of investments |
|
|
(108,012 |
) |
|
|
(100,172 |
) |
Acquisition of businesses, license rights and product lines |
|
|
(84,098 |
) |
|
|
(980 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from investing activities in continuing operations |
|
|
(176,984 |
) |
|
|
19,976 |
|
Cash flow from investing activities in discontinued operations |
|
|
(10,610 |
) |
|
|
67,741 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
(187,594 |
) |
|
|
87,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments on long-term debt and notes payable |
|
|
(94,301 |
) |
|
|
(595 |
) |
Proceeds from capitalized lease financing, long-term debt and notes payable |
|
|
349,603 |
|
|
|
101 |
|
Stock option exercises and employee stock purchases |
|
|
31,445 |
|
|
|
7,867 |
|
Excess tax deduction from stock options exercised |
|
|
734 |
|
|
|
|
|
Purchase of treasury stock |
|
|
(25,706 |
) |
|
|
(6,819 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from financing activities in continuing operations |
|
|
261,775 |
|
|
|
554 |
|
Cash flow from financing activities in discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
261,775 |
|
|
|
554 |
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(7,992 |
) |
|
|
16,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
146,038 |
|
|
|
156,935 |
|
Cash and cash equivalents at beginning of period |
|
|
199,582 |
|
|
|
309,365 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
|
345,620 |
|
|
|
466,300 |
|
|
|
|
|
|
|
|
Cash and cash equivalents classified as part of discontinued operations |
|
|
|
|
|
|
(127,263 |
) |
|
|
|
|
|
|
|
Cash and cash equivalents of continuing operations |
|
$ |
345,620 |
|
|
$ |
339,037 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated condensed financial statements.
5
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
(all amounts in thousands, except share and per share amounts, unless otherwise indicated)
In the consolidated condensed financial statements included herein, we, us, our,
Valeant and the Company refer to Valeant Pharmaceuticals International and its subsidiaries.
The consolidated condensed financial statements have been prepared by us, without audit, pursuant
to the rules and regulations of the Securities and Exchange Commission (the SEC). Certain
information and footnote disclosures normally included in financial statements prepared on the
basis of accounting principles generally accepted in the United States of America have been
condensed or omitted pursuant to such rules and regulations. The results of operations presented
herein are not necessarily indicative of the results to be expected for a full year. Although we
believe that all adjustments (consisting only of normal, recurring adjustments) necessary for a
fair presentation of the interim periods presented are included and that the disclosures are
adequate to make the information presented not misleading, these consolidated condensed financial
statements should be read in conjunction with the consolidated financial statements and notes
thereto included in our Current Report on Form 8-K filed on May 28, 2009 (the 2008 Annual Report
8-K). The year-end condensed balance sheet data presented here was derived from audited financial
statements, but does not include all disclosures required by accounting principles generally
accepted in the United States of America.
1. Organization and Summary of Significant Accounting Policies
Organization: We are a multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products. Additionally, we generate
alliance revenue, including royalties from the sale of ribavirin by Schering-Plough Ltd.
(Schering-Plough) and revenues associated with the Collaboration and License Agreement with GSK
(as defined in Note 3 below). We also generate alliance revenue and service revenue from the
development of dermatological products by Dow Pharmaceutical Sciences, Inc. (Dow).
Principles of Consolidation: The accompanying consolidated financial statements include the
accounts of Valeant Pharmaceuticals International, its wholly owned subsidiaries and its
majority-owned subsidiary in Poland. All significant intercompany account balances and transactions
have been eliminated.
Marketable Securities: Marketable securities include short-term commercial paper, bank
certificates of deposit and corporate bonds which, at the time of purchase, have maturities of
greater than three months. Marketable securities are generally categorized as held-to-maturity and
are thus carried at amortized cost, because we have both the intent and the ability to hold these
investments until they mature. As of June 30, 2009 and December 31, 2008, the fair value of these
marketable securities approximated cost. As of December 31, 2008, corporate bonds are categorized
as available-for-sale and are carried at fair value.
Accumulated Other Comprehensive Income: The components of accumulated other comprehensive
income consists of accumulated foreign currency translation adjustments, unrealized gains on
marketable equity securities, pension funded status and changes in the fair value of derivative
instruments.
Discontinued Operations: The results of operations related to our product rights in Infergen
and our business operations located in Western and Eastern Europe, Middle East and Africa (the
WEEMEA business) have been reflected as discontinued operations in our consolidated financial
statements in accordance with Statement of Financial Accounting Standards (SFAS) No. 144,
Accounting for the Disposal and Impairment of Long-Lived Assets (SFAS 144) and Emerging Issues
Task Force (EITF) Issue No. 03-13, Applying the Conditions in Paragraph 42 of FASB Statement No. 144 in Determining Whether to Report Discontinued
Operations (EITF 03-13). For more details regarding our discontinued operations, see Note 5.
Derivative Financial Instruments: We account for derivative financial instruments based on
whether they meet our criteria for designation as hedging transactions, either as cash flow, net
investment or fair value hedges. Our derivative instruments are recorded at fair value and are
included in other assets or accrued liabilities. Depending on the nature of the hedge, changes in
the fair value of a 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.
6
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
Use of Estimates: The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires us to make estimates and
assumptions that affect the reported amount of assets and liabilities, the disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting periods. Actual results could differ materially from those
estimates.
Recently Adopted Accounting Standards:
Effective January 1, 2009, we adopted SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements-an amendment of ARB No. 51 (SFAS 160). The adoption of SFAS 160 changed the
presentation format of our consolidated statements of operations and consolidated balance sheets
but did not have an impact on net income or equity attributable to Valeant stockholders. SFAS 160
establishes accounting and reporting standards for the noncontrolling interest in a subsidiary and
for the deconsolidation of a subsidiary. It clarifies that a noncontrolling interest in a
subsidiary is an ownership interest in the consolidated entity that should be reported as a
separate component of equity in the consolidated financial statements. In addition, SFAS 160
changes the way the consolidated statement of operations is presented and requires consolidated net
income to be reported at amounts that include the amount attributable to both Valeant and the
noncontrolling interest.
In February 2008, the Financial Accounting Standards Board (FASB) issued Staff Position No.
FAS 157-2, Effective Date of FASB Statement No. 157 (FSP FAS 157-2), which delayed the effective
date of SFAS No. 157, Fair Value Measurements (SFAS 157), for certain nonfinancial assets and
nonfinancial liabilities until interim periods for fiscal years beginning after November 15, 2008.
SFAS 157 changed the underlying methodology of determining fair value when fair value measurements
are required in accounting principles generally accepted in the United States. SFAS 157 also
expanded the disclosure requirements about fair value measurements. The adoption of FSP FAS 157-2
in the first quarter of 2009 did not have a material impact on our financial position, cash flows
or results of operations.
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS
141(R)). SFAS 141(R) establishes principles and requirements for how the acquirer of a business
recognizes and measures in its financial statements the identifiable assets acquired, the
liabilities assumed and any noncontrolling interest in the acquiree. SFAS 141(R) also provides
guidance for recognizing and measuring goodwill acquired in the business combination and determines
what information to disclose to enable users of the financial statements to evaluate the nature and
financial effects of the business combination. Among other requirements, SFAS 141(R) expands the
definition of a business combination, requires acquisitions to be accounted for at fair value, and
requires transaction costs and restructuring charges to be expensed. SFAS 141(R) is effective for
fiscal years beginning on or after December 15, 2008. SFAS 141(R) requires that any reduction to a
tax valuation allowance established in purchase accounting that does not qualify as a measurement
period adjustment will be accounted for as a reduction to income tax expense, rather than a
reduction of goodwill. We adopted SFAS 141(R) as of January 1, 2009. The adoption did
not have a material effect on our consolidated financial statements. SFAS 141(R) is required
to be adopted concurrently with SFAS 160.
In December 2007, the FASB ratified the consensus reached by the EITF in EITF Issue No. 07-1,
Accounting for Collaborative Arrangements (EITF 07-1). EITF 07-1 defines collaborative
arrangements and establishes reporting requirements for transactions between participants in a
collaborative arrangement and between participants in the arrangement and third parties. EITF 07-1
also establishes the appropriate income statement presentation and classification for joint
operating activities and payments between participants, as well as the sufficiency of the
disclosures related to these arrangements. EITF 07-1 is effective for fiscal years beginning after
December 15, 2008, and interim periods within those fiscal years. Retrospective application to all
prior periods presented is required for all collaborative arrangements existing as of the effective
date. We adopted EITF 07-1 on January 1, 2009. The adoption of EITF 07-1 did not have a material
impact on our consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities an amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 requires
enhanced disclosures about an entitys derivative and hedging activities, including (i) how and why
an entity uses derivative instruments,
7
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(ii) how derivative instruments and related hedged items are accounted for under SFAS 133, and
(iii) how derivative instruments and related hedged items affect an entitys financial position,
financial performance and cash flows. We adopted SFAS 161 on January 1, 2009. The adoption of SFAS
161 did not have a material impact on our consolidated financial statements.
In April 2008, the FASB issued Staff Position No. FAS 142-3, Determination of the Useful Life
of Intangible Assets (FSP FAS 142-3). FSP FAS 142-3 amends the factors that should be considered
in developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets, (SFAS 142) in order to
improve the consistency between the useful life of a recognized intangible asset under SFAS 142 and
the period of expected cash flows used to measure the fair value of the asset under SFAS 141(R). We
adopted FSP FAS 142-3 on January 1, 2009. The adoption of FSP FAS 142-3 did not have a material
effect on our consolidated financial statements.
In May 2008, the FASB issued Staff Position No. APB 14-1, Accounting for Convertible Debt
Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (FSP
APB 14-1). FSP APB 14-1 requires the liability and equity components of convertible debt
instruments that may be settled in cash upon conversion (including partial cash settlement) to be
separately accounted for in a manner that reflects the issuers nonconvertible debt borrowing rate.
FSP APB 14-1 requires bifurcation of a component of the debt instruments, classification of that
component in equity and the accretion of the resulting discount on the debt to be recognized as
interest expense.
We adopted FSP APB 14-1 on January 1, 2009. The guidance in FSP APB 14-1 was applied
retrospectively to all periods presented. FSP APB 14-1 is effective for our 3.0% Convertible
Subordinated Notes (the 3.0% Notes) and our 4.0% Convertible Subordinated Notes (the 4.0%
Notes) issued in 2003, each of which had an original principal amount of $240.0 million. The
adoption of FSP APB 14-1 resulted in an increase in interest expense and decrease in net income
from continuing operations of $2.7 million and $6.1 million for the three and six months ended June
30, 2009, respectively. The impact on basic and diluted earnings per share was a reduction of $0.03
and $0.07 in the three and six months ended June 30, 2009. The adoption resulted in an increase in
interest expense and net loss from continuing operations of $3.7 million and $7.4 million for the
three and six months ended June 30, 2008, respectively. Basic and diluted loss per share increased
$0.04 and $0.08 for the three and six months ended June 30, 2008 as a result of the adoption. The
adoption also resulted in a decrease in additional capital of $70.0 million as of January 1, 2009.
See Note 9 for additional information regarding our implementation of FSP APB 14-1.
In April 2009, the FASB issued Staff Position No. FAS 115-2 and FAS 124-2, Recognition and
Presentation of Other-Than-Temporary Impairments (FSP FAS 115-2), which provides new guidance on
the recognition of other-than-temporary impairments of investments in debt securities and provides
new presentation and disclosure requirements for other-than-temporary impairments of investments in
debt and equity securities. FSP FAS 115-2 is effective for interim reporting periods ending after
June 15, 2009. We adopted FSP FAS 115-2 in the second quarter of 2009. The adoption did not have a
material impact on our consolidated financial statements.
In April 2009, the FASB issued Staff Position No. FAS 107-1 and APB 28-1, Interim Disclosures
about Fair Value of Financial Instruments (FSP FAS 107-1). FSP FAS 107-1 amends SFAS No. 107,
Disclosures about Fair Value of Financial Instruments (SFAS 107) to require disclosures about
fair value of financial instruments in interim reporting periods. Such disclosures were previously
required only in annual financial statements. FSP FAS 107-1 is effective for interim reporting
periods ending after June 15, 2009. We adopted FSP FAS 107-1 in the second quarter of 2009 and have
provided the additional disclosures required in Note 9.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events (SFAS 165). SFAS 165
establishes general standards of accounting for and disclosure of events that occur after the
balance sheet date but before financial statements are issued or are available to be issued. In
particular, SFAS 165 sets forth the following: (i) the period after the balance sheet date during
which management of a reporting entity should evaluate events or transactions that may occur for
potential recognition or disclosure in the financial statements; (ii) the circumstances under which
an entity should recognize events or transactions occurring after the balance sheet date in its
financial statements; and (iii) the disclosures that an entity should make about events or
transactions that occurred after the balance sheet
8
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
date. SFAS 165 does not apply to subsequent events or transactions that are within the scope
of other applicable U.S. generally accepted accounting principles (GAAP) that provide different
guidance on the accounting treatment for subsequent events or transactions. SFAS 165 is effective
for interim or annual reporting periods ending after June 15, 2009. We adopted SFAS 165 in the
second quarter of 2009. In accordance with SFAS 165, we evaluated subsequent events through August
4, 2009, the issuance date of these financial statements.
New Accounting Standards Not Yet Adopted:
In December 2008, the FASB issued Staff Position No. FAS 132(R)-1, Employers Disclosures
about Postretirement Benefit Plan Assets (FSP FAS 132(R)-1). FSP FAS 132(R)-1 provides additional
guidance regarding an employers disclosures about plan assets of a defined benefit pension or
other postretirement plan. FSP FAS 132(R)-1 requires an employer to disclose information about how
investment allocation decisions are made and the investment policies and strategies that support
those decisions, major categories of plan assets, the inputs and valuation techniques used to
develop fair value measurements of plan assets and significant concentrations of credit risk within
plan assets. The disclosures about plan assets are to be provided for fiscal years ending after
December 15, 2009. We do not expect the adoption of FSP FAS 132(R)-1 to have a material impact on
our financial statements.
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R) (SFAS
167). SFAS 167 amends FASB Interpretation No. 46(R), Consolidation of Variable Interest Entities,
(FIN 46(R)) and changes the consolidation guidance applicable to a variable interest entity
(VIE). It also amends the guidance governing the determination of whether an enterprise is the
primary beneficiary of a VIE, and is, therefore, required to consolidate an entity, by requiring a
qualitative analysis rather than a quantitative analysis. The qualitative analysis will include,
among other things, consideration of who has the power to direct the activities of the entity that
most significantly impact the entitys economic performance and who has the obligation to absorb
losses or the right to receive benefits of the VIE that could potentially be significant to the
VIE. This standard also requires continuous reassessments of whether an enterprise is the primary
beneficiary of a VIE. Previously, FIN 46(R) required reconsideration of whether an enterprise was
the primary beneficiary of a VIE only when specific events had occurred. SFAS 167 also requires
enhanced disclosures about an enterprises involvement with a VIE. SFAS 167 will be effective as of the beginning of interim and annual reporting periods beginning
after November 15, 2009. We are currently assessing the impact that SFAS 167 may have on our
financial statements.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards CodificationTM
and the Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168
establishes the FASB Accounting Standards Codification as the source of authoritative accounting
principles recognized by the FASB to be applied by non-governmental entities in the preparation of
financial statements in conformity with GAAP in the United States. SFAS 168 is effective for
financial statements issued for interim and annual periods ending after September 15, 2009. We do
not expect the adoption of SFAS 168 to have a material impact on our financial statements.
2. Restructuring
Our restructuring charges include severance costs, contract cancellation costs, the
abandonment of capitalized assets, the impairment of manufacturing facilities, and other associated
costs, including legal and professional fees. We have accounted for statutory and contractual
severance obligations when they are estimable and probable, pursuant to SFAS No. 112, Employers
Accounting for Postemployment Benefits. For one-time severance arrangements, we have applied the
methodology defined in SFAS No. 146, Accounting for Costs Associated with Exit or Disposal
Activities (SFAS 146). Pursuant to these requirements, these benefits are detailed in an approved
severance plan, which is specific as to number, position, location and timing. In addition, the
benefits are communicated in specific detail to affected employees and it is unlikely that the plan
will change when the costs are recorded. If service requirements exceed a minimum retention period,
the costs are spread over the service period; otherwise they are recognized when they are
communicated to the employees. Contract cancellation costs are recorded in accordance with SFAS
146. We have followed the requirements of SFAS No. 144, Accounting for the Impairment or Disposal
of Long-lived Assets (SFAS 144), in recognizing the abandonment of capitalized assets and the
impairment of manufacturing facilities. For a further description of the accounting for impairment
of long-lived assets under SFAS 144, see Note 1, Organization and Summary of Significant Accounting
Policies, in our
9
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
2008 Annual Report 8-K. Other associated costs, such as legal and professional fees, have been
expensed as incurred, pursuant to SFAS 146.
2008 Restructuring
In October 2007, our board of directors initiated a strategic review of our business
direction, geographic operations, product portfolio, growth opportunities and acquisition strategy.
In March 2008, we completed this strategic review and announced a strategic plan designed to
streamline our business, align our infrastructure to the scale of our operations, maximize our
pipeline assets and deploy our cash assets to maximize shareholder value. The strategic plan
included a restructuring program (the 2008 Restructuring), which reduced our geographic footprint
and product focus by restructuring our business in order to focus on the pharmaceutical markets in
our core geographies of the United States, Canada and Australia and on the branded generics markets
in Europe (Poland, Hungary, the Czech Republic and Slovakia) and Latin America (Mexico and Brazil).
The 2008 Restructuring plan included actions to divest our operations in markets outside of these
core geographic areas through sales of subsidiaries or assets and other strategic alternatives.
In March 2008, we closed the sale to Invida Pharmaceutical Holdings Pte. Ltd. (Invida) of
certain assets in Asia that included certain of our subsidiaries, branch offices and commercial
rights in Singapore, the Philippines, Thailand, Indonesia, Vietnam, Taiwan, Korea, China, Hong
Kong, Malaysia and Macau. This transaction also included the sale of certain product rights in
Japan. During the three months ended March 31, 2008, we received initial proceeds of $37.9 million
and recorded a gain of $36.9 million in this transaction. During the three months ended June 30,
2008, we recorded net asset adjustments and additional closing costs aggregating $1.0 million,
which resulted in a reduced gain of $35.9 million as of June 30, 2008. During the three months
ended March 31, 2009, we received substantially all of the remaining additional proceeds of $3.4
million from the sale in accordance with net asset settlement provisions of the sale.
In June 2008, we sold our subsidiaries in Argentina and Uruguay and recorded a loss on the
sale of $2.7 million, in addition to a $7.9 million impairment charge recorded in the first quarter
of 2008 related to the anticipated sale.
In December 2008, as part of our efforts to align our infrastructure to the scale of our
operations, we exercised our option to terminate the lease of our Aliso Viejo, California corporate
headquarters as of December 2011 and, as a result, recorded a restructuring charge of $3.8 million
for the year ended December 31, 2008. The charge consisted of a lease termination penalty of $3.2
million, which will be payable in October 2011, and $0.6 million for certain fixed assets.
The net restructuring, asset impairments and dispositions charge of $1.7 million in the three
months ended June 30, 2009 included $0.9 million of severance charges for a total of 8 affected
employees. The charge also included $0.8 million of contract cancellation costs and other cash
costs. The net restructuring, asset impairments and dispositions charge of $2.9 million in the six
months ended June 30, 2009 included $1.8 million of severance charges for a total of 30 affected
employees. The charge also included $1.1 million of contract cancellation costs and other cash
costs.
The following table summarizes the restructuring costs recorded in the three and six months
ended June 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
Severance costs (422 employees, cumulatively) |
|
$ |
847 |
|
|
$ |
1,775 |
|
Contract cancellation costs, legal and professional fees and other associated costs |
|
|
839 |
|
|
|
1,094 |
|
|
|
|
|
|
|
|
Subtotal: cash charges |
|
|
1,686 |
|
|
|
2,869 |
|
Non-cash charges |
|
|
8 |
|
|
|
36 |
|
|
|
|
|
|
|
|
Restructurings, asset impairments and dispositions |
|
$ |
1,694 |
|
|
$ |
2,905 |
|
|
|
|
|
|
|
|
10
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
The net restructuring, asset impairments and disposition charge of $14.0 million in the three
months ended June 30, 2008 included the $1.0 million of additional costs and net asset adjustments
recorded as reductions of the gain originally recorded in the first quarter of 2008 in the Invida
transaction, $5.9 million of severance charges for a total of 126 affected employees, professional
service fees and other cash costs of $3.7 million, a $0.7 million impairment charge related to
certain fixed assets in Mexico and the $2.7 million loss on the sale of our subsidiaries in
Argentina and Uruguay.
The net restructuring, asset impairments and disposition charge of $0.8 million in the six
months ended June 30, 2008 included $12.1 million of severance costs for a total of 141 affected
employees who were part of the supply, selling, general and administrative and research and
development workforce in the United States, Mexico and Brazil. The charge also included $6.9
million for professional service fees related to the strategic review of our business and other
cash costs of $1.7 million. Additional amounts incurred included a stock compensation charge for
the accelerated vesting of the stock options of our former chief executive officer of $4.8 million,
impairment charges relating to the sale of our subsidiaries in Argentina and Uruguay and certain
fixed assets in Mexico of $8.5 million and the $2.7 million loss on the sale of our subsidiaries in
Argentina and Uruguay, offset in part by the gain of $35.9 million in the transaction with Invida.
The following table summarizes the restructuring costs and gains recorded in the three and six
months ended June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2008 |
|
Severance costs (144 employees, cumulatively) |
|
$ |
5,854 |
|
|
$ |
12,069 |
|
Legal and professional fees and other associated costs |
|
|
3,666 |
|
|
|
8,552 |
|
|
|
|
|
|
|
|
Subtotal: cash charges |
|
|
9,520 |
|
|
|
20,621 |
|
Stock compensation |
|
|
|
|
|
|
4,778 |
|
Impairment of long-lived assets |
|
|
684 |
|
|
|
8,537 |
|
Loss on sale of long-lived assets |
|
|
2,736 |
|
|
|
2,736 |
|
|
|
|
|
|
|
|
Subtotal: restructuring expenses |
|
|
12,940 |
|
|
|
36,672 |
|
Gain on Invida transaction |
|
|
1,017 |
|
|
|
(35,905 |
) |
|
|
|
|
|
|
|
Restructurings, asset impairments and dispositions |
|
$ |
13,957 |
|
|
$ |
767 |
|
|
|
|
|
|
|
|
In the three and six months ended June 30, 2008, we recorded inventory obsolescence
charges of $11.5 million and $18.0 million, respectively, resulting primarily from decisions to
cease promotion of or discontinue certain products, decisions to discontinue certain manufacturing
transfers, and product quality failures. These inventory obsolescence charges were recorded in
costs of goods sold, in accordance with EITF Issue No. 96-9, Classification of Inventory Markdowns
and Other Costs Associated with a Restructuring.
Reconciliation of Cash Restructuring Payments with Restructuring Accrual
As of June 30, 2009, the restructuring accrual includes $7.2 million related to the 2008
restructuring plan for severance costs, lease termination penalty costs, contract cancellation
costs, legal and professional fees and other associated costs expected to be paid primarily during
the remainder of 2009, except for the lease termination penalty which will be paid in 2011. A
summary of accruals and expenditures of restructuring costs which will be paid in cash is as
follows:
Reconciliation of Cash Payments and Accruals
|
|
|
|
|
Restructuring accrual, March 31, 2009 |
|
$ |
8,404 |
|
Charges to earnings |
|
|
1,686 |
|
Cash paid |
|
|
(2,896 |
) |
|
|
|
|
Restructuring accrual, June 30, 2009 |
|
$ |
7,194 |
|
|
|
|
|
11
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
We expect the 2008 restructuring initiatives to be substantially completed by the end of the
third quarter of 2009. We expect to continue to recognize costs in 2009 including one-time employee
severance costs of $0.2 million related to severance plans already approved for which the costs are
spread over the service period in accordance with SFAS 146, and through 2011, related to the
accretion of lease termination penalty costs.
3. Acquisitions and Collaboration Agreement
Asset Purchase in Australia
On May 1, 2009, we acquired assets related to certain dermatology products in Australia from a
private company for cash of approximately $7.0 million, including transaction costs. We acquired
title and rights to the intellectual property, trademarks and inventory related to products which
are approved for sale in Australia and New Zealand. We accounted for the acquisition as a purchase
of assets. The purchase price was allocated to product rights of $6.2 million and inventories of
$0.8 million. The weighted-average useful life of the product rights was determined to be
approximately 15.7 years.
Emo-Farm Acquisition
On April 29, 2009, we acquired all of the outstanding stock of EMO-FARM sp. z o.o.
(Emo-Farm), a privately held Polish company, for a purchase price of $28.6 million, net of cash
acquired. Emo-Farm specializes in gel-based over-the-counter and cosmetic products. The acquisition
of Emo-Farm expands our base in Poland into multiple therapeutic categories and includes the
acquisition of a manufacturing facility. The results of operations of Emo-Farm are included in the
Consolidated Condensed Statements of Operations since the acquisition date.
We accounted for the acquisition as a business combination. The purchase price was allocated
to tangible and intangible assets acquired and liabilities assumed based upon their estimated fair
value as of the date of acquisition. Amortizing intangible assets aggregating $11.2 million consist
primarily of developed technology and customer relationships with weighted-average amortization
periods of 9.2 years and 6.8 years, respectively. The excess of the purchase price over the
estimated fair value of net assets acquired was allocated to goodwill totaling $9.0 million, which
is not deductible for tax purposes. The effects of this acquisition are not considered material.
Accordingly, pro forma information reflecting this acquisition has been omitted. The following
table summarizes the estimated fair value of the net assets acquired:
|
|
|
|
|
Current and long-term assets |
|
$ |
14,364 |
|
Identifiable intangible assets |
|
|
11,227 |
|
Goodwill |
|
|
8,995 |
|
Current and long-term liabilities |
|
|
(6,001 |
) |
|
|
|
|
Net assets acquired |
|
$ |
28,585 |
|
|
|
|
|
Dow Acquisition
On December 31, 2008, we completed the purchase of all of the outstanding common stock of Dow,
a privately held healthcare company that provides biopharmaceutical development services primarily
in the United States.
We acquired Dow for an agreed price of $285.0 million, subject to certain closing adjustments,
plus transaction costs. Pursuant to the terms of the acquisition, in the first half of 2009 we paid
$35.0 million into an escrow account for the benefit of the Dow common stockholders, subject to any
indemnification claims made by us for a period of eighteen months following the acquisition
closing.
The accounting treatment for the Dow acquisition requires the recognition of an additional
$85.1 million of conditional purchase consideration because the fair value of the net assets
acquired exceeded the total amount of the acquisition price. Contingent consideration of up to
$235.0 million may be incurred for future milestones related to certain pipeline products still in
development. Over 85% of this contingent consideration is dependent upon the
12
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
achievement of approval and commercial targets. Future contingent consideration paid in excess
of the $85.1 million will be treated as an additional cost of the acquisition and result in the
recognition of goodwill.
During the first quarter of 2009, we completed our evaluation of the fair value of assets
acquired and liabilities assumed. The conditional purchase consideration was reduced from $95.9
million recorded as of December 31, 2008 to $85.1 million as of June 30, 2009, due to the reduction
in the estimated fair value of the intangible assets acquired from the preliminary appraisal,
reduction in deferred tax assets and other closing adjustments.
The acquired intangible assets consisted of outlicensed technology, customer relationships and
developed formulations. Developed formulations include Dows U.S. Food and Drug Administration
(FDA) approved product, Acanya, a topical treatment for acne which was launched in the first
quarter of 2009. Outlicensed technology has been licensed to third parties and will generate future
royalty revenue. Customer relationships are from Dows contract research services. The
weighted-average amortization period for such intangible assets acquired is outlined in the table
below:
|
|
|
|
|
|
|
|
|
|
|
Value of |
|
|
|
|
|
|
Intangible |
|
|
Weighted-Average |
|
|
|
Assets |
|
|
Amortization |
|
|
|
Acquired |
|
|
Period |
|
Developed formulations |
|
$ |
104,500 |
|
|
6.1 years |
Outlicensed technology |
|
|
70,000 |
|
|
9.5 years |
Customer relationships |
|
|
6,600 |
|
|
7.0 years |
|
|
|
|
|
|
|
Total identifiable intangible assets |
|
$ |
181,100 |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration Agreement with GSK
In October 2008, we closed the worldwide License and Collaboration Agreement (the
Collaboration Agreement) with Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline
plc (GSK) to develop and commercialize retigabine and its backup compounds and received $125.0
million in upfront fees from GSK upon the closing.
We agreed to share equally with GSK the development and pre-commercialization expenses of
retigabine in the United States, Australia, New Zealand, Canada and Puerto Rico (the Collaboration
Territory) and GSK will develop and commercialize retigabine in the rest of the world. Our share
of such expenses in the Collaboration Territory is limited to $100.0 million, provided that GSK
will be entitled to credit our share of any such expenses in excess of such amount against future
payments owed to us under the Collaboration Agreement. To the extent that our expected development
and pre-commercialization expenses under the Collaboration Agreement are less than $100.0 million,
the difference will be recognized as alliance revenue over the period prior to the launch of a
retigabine product (the Pre-Launch Period). We will recognize alliance revenue during the
Pre-Launch Period as we complete our performance obligations using the proportional performance
model, which requires us to determine and measure the completion of our expected development and
pre-commercialization costs during the Pre-Launch Period, in addition to our participation in the
joint steering committee. We expect to complete our research and development and
pre-commercialization obligations in effect during the Pre-Launch Period by the first quarter of
2011.
GSK has the right to terminate the Collaboration Agreement at any time prior to the receipt of
the approval by the FDA of a new drug application (NDA) for a retigabine product, which right may
be irrevocably waived at any time by GSK. The period of time prior to such termination or waiver is
referred to as the Review Period. In February 2009, the Collaboration Agreement was amended to,
among other matters, reduce the maximum amount that we would be required to refund to GSK to $40.0
million through March 31, 2010, with additional reductions in the amount of the required refund
over the time the Collaboration Agreement is in effect. During the three and six months ended June
30, 2009, the combined research and development expenses and pre-commercialization expenses
incurred under the Collaboration Agreement by us and GSK were $13.5 million and $26.9 million,
respectively, as outlined in the table below. We recorded a charge of $1.2 million and a credit of
$0.2 million in the three and six
13
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
months ended June 30, 2009, respectively, against our share of the expenses to equalize
our expenses with GSK, pursuant to the terms of the Collaboration Agreement.
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
Valeant research and development costs |
|
$ |
5,477 |
|
|
$ |
13,424 |
|
Valeant selling, general and administrative |
|
|
56 |
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
5,533 |
|
|
|
13,629 |
|
|
|
|
|
|
|
|
|
|
GSK expenses |
|
|
7,976 |
|
|
|
13,279 |
|
|
|
|
|
|
|
|
Total spending for Collaboration Agreement |
|
$ |
13,509 |
|
|
$ |
26,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equalization charge (credit) |
|
$ |
1,222 |
|
|
$ |
(175 |
) |
|
|
|
|
|
|
|
The table below outlines the alliance revenue, expenses incurred, associated credits
against the expenses incurred, and remaining upfront payment for the Collaboration Agreement during
the following period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
Selling, |
|
|
Research |
|
|
|
Balance |
|
|
Alliance |
|
|
General and |
|
|
and |
|
Collaboration Accounting Impact |
|
Sheet |
|
|
Revenue |
|
|
Administrative |
|
|
Development |
|
Upfront payment from GSK |
|
$ |
125,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Release from upfront payment in 2008 |
|
|
(10,909 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Incurred cost in 2009 |
|
|
|
|
|
|
|
|
|
|
205 |
|
|
|
13,424 |
|
Incurred cost offset in 2009 |
|
|
(13,454 |
) |
|
|
|
|
|
|
(682 |
) |
|
|
(12,772 |
) |
Recognize alliance revenue |
|
|
(6,118 |
) |
|
|
(6,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Release from upfront payment |
|
|
(19,572 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining upfront payment from GSK |
|
$ |
94,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equalization receivable from GSK |
|
$ |
175 |
|
|
|
|
|
|
|
477 |
|
|
|
(652 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expense and revenue |
|
|
|
|
|
$ |
(6,118 |
) |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
$ |
36,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
36,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue short-term |
|
|
10,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue long-term |
|
|
10,373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining upfront payment from GSK |
|
$ |
94,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total combined expenses by us and GSK for the Collaboration Agreement through June 30,
2009 were $40.0 million.
4. Special Charges and Credits Including Acquired In-process Research and Development
In June 2009, we entered into an exclusive license agreement with Endo Pharmaceuticals Inc.
that grants us an exclusive license to develop and commercialize Opana® and Opana® ER in Canada,
Australia and New Zealand (the Opana Territory). Regulatory approval must be received prior to
any sale of the licensed products. We recorded a $1.8 million charge related to the initial license
fee in the three months ended June 30, 2009. Under the terms of the license agreement, we will pay
royalties from 10% to 20% of net sales, as well as milestone payments upon achievement of certain
sales levels of licensed products in the Opana Territory.
During the three months ended June 30, 2009, we acquired rights to other products in Mexico
that are not currently approved for sale, for an aggregate price of $0.2 million.
14
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
5. Discontinued Operations
In September 2008, we sold our WEEMEA business to Meda, AB, an international specialty
pharmaceutical company located in Stockholm, Sweden (Meda). Meda acquired our operating
subsidiaries in those markets, and the rights to all products and licenses marketed by us in those
divested regions as of the divestiture date. Excluded from this transaction are our Central
European operations, defined as the business in Poland, Hungary, the Czech Republic and Slovakia.
Under the terms of the agreement, we received initial cash proceeds of $428.4 million, which was
reduced by $11.8 million paid to Meda in January 2009, based upon the estimated levels of cash,
indebtedness and working capital as of the closing date. We recorded a net gain on this sale of
$158.9 million after deducting the carrying value of the net assets sold, transaction-related
expenses and income taxes. During the three and six months ended June 30, 2009, we recorded an
additional gain on this sale of $0.1 million and $0.6 million, respectively.
In January 2008, we sold our Infergen product rights to Three Rivers Pharmaceuticals, LLC. We
received $70.8 million as the initial payment for our Infergen product rights, with additional
payments due of up to $20.5 million. We recorded a net gain from this transaction of $39.4 million
after deducting the carrying value of the net assets sold from the proceeds received.
As a result of these dispositions, the results of the WEEMEA business and the Infergen
operations have been reflected as discontinued operations in our consolidated condensed statement
of operations for all periods, in accordance with SFAS 144 and EITF 03-13. In addition, any cash
flows related to these discontinued operations are presented separately in the consolidated
condensed statements of cash flows.
Summarized selected financial information for discontinued operations for the three and six
months ended June 30, 2009 and 2008 is as follows:
15
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
WEEMEA Business: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
|
|
|
$ |
53,208 |
|
|
$ |
|
|
|
$ |
95,911 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization) |
|
|
|
|
|
|
21,605 |
|
|
|
|
|
|
|
40,740 |
|
Selling, general and administrative |
|
|
|
|
|
|
30,315 |
|
|
|
|
|
|
|
50,772 |
|
Research and development costs, net |
|
|
|
|
|
|
125 |
|
|
|
|
|
|
|
223 |
|
Restructuring, asset impairments and dispositions |
|
|
|
|
|
|
734 |
|
|
|
|
|
|
|
1,260 |
|
Amortization expense |
|
|
|
|
|
|
5,314 |
|
|
|
|
|
|
|
10,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
|
|
|
|
58,093 |
|
|
|
|
|
|
|
103,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
249 |
|
|
|
|
|
|
|
(1,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations before income taxes, WEEMEA |
|
|
|
|
|
|
(4,636 |
) |
|
|
|
|
|
|
(8,373 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infergen: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
|
|
|
|
|
(50 |
) |
|
|
|
|
|
|
1,000 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization) |
|
|
|
|
|
|
(69 |
) |
|
|
|
|
|
|
2,007 |
|
Selling, general and administrative |
|
|
|
|
|
|
(741 |
) |
|
|
|
|
|
|
624 |
|
Research and development costs, net |
|
|
|
|
|
|
68 |
|
|
|
|
|
|
|
9,752 |
|
Amortization expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
|
|
|
|
(742 |
) |
|
|
|
|
|
|
12,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations, Infergen |
|
|
|
|
|
|
692 |
|
|
|
|
|
|
|
(11,383 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
(240 |
) |
|
|
792 |
|
|
|
(360 |
) |
|
|
792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations before income taxes |
|
|
(240 |
) |
|
|
(3,152 |
) |
|
|
(360 |
) |
|
|
(18,964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
|
|
|
|
17,873 |
|
|
|
|
|
|
|
22,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
(240 |
) |
|
|
(21,025 |
) |
|
|
(360 |
) |
|
|
(41,128 |
) |
Disposal of discontinued operations, net |
|
|
65 |
|
|
|
(5,288 |
) |
|
|
583 |
|
|
|
18,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations, net |
|
$ |
(175 |
) |
|
$ |
(26,313 |
) |
|
$ |
223 |
|
|
$ |
(23,020 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Fair Value Measurements
SFAS 157 defines fair value, establishes a consistent framework for measuring fair value and
expands disclosure requirements for each major asset and liability category measured at fair value
on either a recurring or nonrecurring basis. SFAS 157 clarifies that fair value is an exit price,
representing the amount that would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market participants would use in
pricing an asset or liability. SFAS 157 requires us to use valuation techniques to measure fair
value that maximize the use of observable inputs and minimize the use of unobservable inputs. These
inputs are prioritized as follows:
Level 1 Quoted market prices in active markets for identical assets or liabilities.
Level 2 Inputs, other than quoted prices in active markets, that are observable, either
directly or indirectly.
Level 3 Unobservable inputs that are not corroborated by market data.
16
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
The following table provides the assets and liabilities carried at fair value measured on a
recurring basis as of June 30, 2009 and December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets (Liabilities) |
|
Assets (Liabilities) |
|
|
June 30, 2009 |
|
December 31, 2008 |
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Available-for-sale securities |
|
$ |
889 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
6,646 |
|
|
$ |
|
|
|
$ |
|
|
Undesignated hedges |
|
|
|
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
157 |
|
|
|
|
|
Net investment derivative contracts |
|
|
|
|
|
|
(1,652 |
) |
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
|
|
Fair value hedges |
|
|
|
|
|
|
(1,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow derivative contracts |
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap |
|
|
|
|
|
|
(8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities are measured at fair value using quoted market prices and
are classified within Level 1 of the valuation hierarchy and consist of an investment in a publicly
traded investment fund, which is included in other assets and is carried at fair value. We
recognize impairments in accordance with SFAS No. 115, Accounting for Certain Investments in Debt
and Equity Securities. Under this guidance we recorded in selling, general and administrative
expenses an other-than-temporary impairment charge of $1.5 million in the first quarter of 2009 due
to sustained declines in the value of the publicly traded investment fund. No impairment charges
were recognized through earnings related to available-for-sale securities during the three months
ended June 30, 2009.
Available-for-sale securities as of December 31, 2008, consist of corporate bonds
classified as marketable securities and an investment in a publicly traded investment fund, which
is included in other assets, carried at fair value of $3.3 million and $3.3 million, respectively.
In the three and six months ended June 30, 2008, we recognized $3.2 million in charges for the
other-than-temporary impairment of the investment in a publicly traded investment fund.
Derivative contracts used as hedges are valued based on observable inputs such as changes
in interest rates and currency fluctuations and are classified within Level 2 of the valuation
hierarchy. For a derivative instrument in an asset position, we analyze the credit standing of the
counterparty and factor it into the fair value measurement. SFAS 157 states that the fair value
measurement of a liability must reflect the nonperformance risk of the reporting entity. Therefore,
the impact of our creditworthiness has also been factored into the fair value measurement of the
derivative instruments in a liability position.
7. Earnings Per Share
The following table sets forth the computation of basic and diluted earnings per share for the
three and six months ended June 30, 2009 and 2008:
17
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for basic and diluted earnings per share attributable to Valeant: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations attributable to Valeant |
|
$ |
33,035 |
|
|
$ |
(52,017 |
) |
|
$ |
63,832 |
|
|
$ |
(49,513 |
) |
Income (loss) from discontinued operations |
|
|
(175 |
) |
|
|
(26,313 |
) |
|
|
223 |
|
|
|
(23,020 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to Valeant |
|
$ |
32,860 |
|
|
$ |
(78,330 |
) |
|
$ |
64,055 |
|
|
$ |
(72,533 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic earnings per share attributable to Valeant: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
82,225 |
|
|
|
89,424 |
|
|
|
82,165 |
|
|
|
89,355 |
|
Vested stock equivalents (not issued) |
|
|
569 |
|
|
|
378 |
|
|
|
568 |
|
|
|
341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic earnings per share attributable to Valeant |
|
|
82,794 |
|
|
|
89,802 |
|
|
|
82,733 |
|
|
|
89,696 |
|
Denominator for diluted earnings per share attributable to Valeant: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee stock options |
|
|
622 |
|
|
|
|
|
|
|
589 |
|
|
|
|
|
Other dilutive securities |
|
|
257 |
|
|
|
|
|
|
|
244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares |
|
|
879 |
|
|
|
|
|
|
|
833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for diluted earnings per share attributable to Valeant |
|
|
83,673 |
|
|
|
89,802 |
|
|
|
83,566 |
|
|
|
89,696 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income per share attributable to Valeant: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations attributable to Valeant |
|
$ |
0.40 |
|
|
$ |
(0.58 |
) |
|
$ |
0.77 |
|
|
$ |
(0.55 |
) |
Loss from discontinued operations |
|
|
|
|
|
|
(0.29 |
) |
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to Valeant |
|
$ |
0.40 |
|
|
$ |
(0.87 |
) |
|
$ |
0.77 |
|
|
$ |
(0.81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per share attributable to Valeant: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations attributable to Valeant |
|
$ |
0.39 |
|
|
$ |
(0.58 |
) |
|
$ |
0.76 |
|
|
$ |
(0.55 |
) |
Income (loss) from discontinued operations |
|
|
|
|
|
|
(0.29 |
) |
|
|
0.01 |
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to Valeant |
|
$ |
0.39 |
|
|
$ |
(0.87 |
) |
|
$ |
0.77 |
|
|
$ |
(0.81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The 3.0% Notes and the 4.0% Notes, discussed in Note 9, allow us to settle any conversion
by remitting to the note holder the principal amount of the note in cash, while settling the
conversion spread (the excess conversion value over the accreted value) in shares of our common
stock. Only the conversion spread, which will be settled in stock, results in potential dilution in
our earnings-per-share computations as the accreted value of the notes will be settled for cash
upon the conversion. The calculation of diluted earnings per share was not affected by the
conversion spread in the three and six months ended June 30, 2009 and 2008.
For the three months ended June 30, 2009 and 2008, options to purchase 2,017,460 and 7,590,381
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
our common stock and, therefore, the effect would have been anti-dilutive. For the six months ended
June 30, 2009 and 2008, options to purchase 2,038,234 and 8,553,347 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 our common stock and,
therefore, the effect would have been anti-dilutive.
8. Detail of Certain Accounts
The following tables present the details of certain amounts included in our consolidated
balance sheet as of June 30, 2009 and December 31, 2008:
18
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Accounts receivable, net: |
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
$ |
94,138 |
|
|
$ |
93,796 |
|
Royalties receivable |
|
|
18,210 |
|
|
|
21,774 |
|
Other receivables |
|
|
36,969 |
|
|
|
33,038 |
|
|
|
|
|
|
|
|
|
|
|
149,317 |
|
|
|
148,608 |
|
Allowance for doubtful accounts |
|
|
(3,695 |
) |
|
|
(4,099 |
) |
|
|
|
|
|
|
|
|
|
$ |
145,622 |
|
|
$ |
144,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories, net: |
|
|
|
|
|
|
|
|
Raw materials and supplies |
|
$ |
21,783 |
|
|
$ |
16,742 |
|
Work-in-process |
|
|
11,235 |
|
|
|
8,506 |
|
Finished goods |
|
|
64,408 |
|
|
|
61,641 |
|
|
|
|
|
|
|
|
|
|
|
97,426 |
|
|
|
86,889 |
|
Allowance for inventory obsolescence |
|
|
(12,267 |
) |
|
|
(13,917 |
) |
|
|
|
|
|
|
|
|
|
$ |
85,159 |
|
|
$ |
72,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net: |
|
|
|
|
|
|
|
|
Property, plant and equipment, at cost |
|
$ |
186,836 |
|
|
$ |
178,156 |
|
Accumulated depreciation and amortization |
|
|
(91,401 |
) |
|
|
(87,928 |
) |
|
|
|
|
|
|
|
|
|
$ |
95,435 |
|
|
$ |
90,228 |
|
|
|
|
|
|
|
|
Intangible assets: As of June 30, 2009 and December 31, 2008, the components of intangible
assets were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
June 30, 2009 |
|
|
December 31, 2008 |
|
|
|
Average |
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|
|
Lives (years) |
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
Product rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neurology |
|
|
12 |
|
|
$ |
277,612 |
|
|
$ |
(161,083 |
) |
|
$ |
116,529 |
|
|
$ |
276,229 |
|
|
$ |
(147,745 |
) |
|
$ |
128,484 |
|
Dermatology |
|
|
13 |
|
|
|
281,781 |
|
|
|
(69,578 |
) |
|
|
212,203 |
|
|
|
275,032 |
|
|
|
(54,906 |
) |
|
|
220,126 |
|
Other |
|
|
11 |
|
|
|
86,845 |
|
|
|
(44,910 |
) |
|
|
41,935 |
|
|
|
72,956 |
|
|
|
(41,970 |
) |
|
|
30,986 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product rights |
|
|
13 |
|
|
|
646,238 |
|
|
|
(275,571 |
) |
|
|
370,667 |
|
|
|
624,217 |
|
|
|
(244,621 |
) |
|
|
379,596 |
|
Outlicensed technology |
|
|
10 |
|
|
|
70,000 |
|
|
|
(3,813 |
) |
|
|
66,187 |
|
|
|
74,000 |
|
|
|
|
|
|
|
74,000 |
|
Customer relationships |
|
|
8 |
|
|
|
9,282 |
|
|
|
(992 |
) |
|
|
8,290 |
|
|
|
8,242 |
|
|
|
(30 |
) |
|
|
8,212 |
|
Trade names |
|
Indefinite |
|
|
6,871 |
|
|
|
|
|
|
|
6,871 |
|
|
|
5,987 |
|
|
|
|
|
|
|
5,987 |
|
License agreement |
|
|
5 |
|
|
|
67,376 |
|
|
|
(67,376 |
) |
|
|
|
|
|
|
67,376 |
|
|
|
(67,376 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets |
|
|
|
|
|
$ |
799,767 |
|
|
$ |
(347,752 |
) |
|
$ |
452,015 |
|
|
$ |
779,822 |
|
|
$ |
(312,027 |
) |
|
$ |
467,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Future amortization of intangible assets at June 30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scheduled Future Amortization Expense |
|
|
|
2009 |
|
|
2010 |
|
|
2011 |
|
|
2012 |
|
|
2013 |
|
|
Thereafter |
|
|
Total |
|
|
|
|
Product rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neurology |
|
$ |
12,480 |
|
|
$ |
24,534 |
|
|
$ |
18,970 |
|
|
$ |
17,876 |
|
|
$ |
16,825 |
|
|
$ |
25,844 |
|
|
$ |
116,529 |
|
Dermatology |
|
|
14,566 |
|
|
|
28,937 |
|
|
|
28,937 |
|
|
|
28,937 |
|
|
|
27,315 |
|
|
|
83,511 |
|
|
|
212,203 |
|
Other |
|
|
2,717 |
|
|
|
5,578 |
|
|
|
5,875 |
|
|
|
5,916 |
|
|
|
5,824 |
|
|
|
16,026 |
|
|
|
41,936 |
|
Outlicensed technology |
|
|
3,813 |
|
|
|
7,626 |
|
|
|
8,234 |
|
|
|
7,690 |
|
|
|
7,689 |
|
|
|
31,135 |
|
|
|
66,187 |
|
Customer relationships |
|
|
936 |
|
|
|
1,651 |
|
|
|
1,416 |
|
|
|
1,180 |
|
|
|
944 |
|
|
|
2,162 |
|
|
|
8,289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
34,512 |
|
|
$ |
68,326 |
|
|
$ |
63,432 |
|
|
$ |
61,599 |
|
|
$ |
58,597 |
|
|
$ |
158,678 |
|
|
$ |
445,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
Amortization expense for the three and six months ended June 30, 2009 was $17.1 million and
$34.1 million, respectively, of which $14.8 million and $29.5 million, respectively, related to
amortization of acquired product rights. Amortization expense for the three and six months ended
June 30, 2008 was $12.8 million and $26.1 million, respectively, of which $10.4 million and $21.4
million, respectively, related to amortization of acquired product rights.
In the six months ended June 30, 2009, we acquired product rights in Poland for $0.7 million
in cash and $1.0 million in other consideration. In the six months ended June 30, 2008, we acquired
product rights in Poland for $1.3 million in cash and $0.3 million in other consideration.
Goodwill: Goodwill decreased $6.0 million in the six months ended June 30, 2009. Goodwill
decreased $16.7 million due to the reversal of a deferred tax liability recorded in the initial
allocation of purchase price for the acquisition of Coria Laboratories, Ltd. (Coria). This
decrease was partially offset by $9.0 million allocated to goodwill in the Emo-Farm acquisition and
$1.7 million primarily related to the effect of changes in foreign currency exchange rates.
9. Long-term Debt
Senior Notes
In June 2009, we issued $365.0 million aggregate principal amount of senior notes (Senior
Notes), which bear a coupon interest rate of 8.375% and are due June 15, 2016. The Senior Notes
were issued at a discounted price of 96.797%, resulting in an effective annual yield of 9.0%.
Interest is payable in arrears semi-annually on each June 15 and December 15, commencing on
December 15, 2009. We may redeem some or all of the Senior Notes on or after June 15, 2012 at fixed
redemption prices as set forth in the indenture. In addition, prior to June 15, 2012, we may redeem
up to 35% of the aggregate principal amount of the Senior Notes with the proceeds from certain
equity offerings at a redemption price of 108.375% of the principal amount, plus accrued and unpaid
interest, plus liquidated damages, if any, to the redemption date; provided that at least 65% of
the aggregate principal amount of the Senior Notes remain outstanding immediately after such
redemption.
The Senior Notes are guaranteed on a senior unsecured basis by each of our present and future
U.S. subsidiaries that qualify as restricted subsidiaries under the indenture. If we experience a
change of control, we may be required to offer to purchase the Senior Notes at a purchase price
equal to 101% of the principal amount, plus accrued and unpaid interest, plus liquidated damages,
if any, to the redemption date. The indenture governing the Senior Notes contains covenants that
will limit our ability and the ability of our restricted subsidiaries to, among other things: incur
additional debt; pay dividends or make other distributions, repurchase capital stock, repurchase
subordinated debt and make certain investments; create liens; create restrictions on the payment of
dividends and other amounts to us from restricted subsidiaries; sell assets or merge or consolidate
with or into other companies; and engage in transactions with affiliates. As of June 30, 2009, we
were in compliance with these covenants.
The Senior Notes were sold in accordance with Rule 144A of the Securities Act of 1933, as
amended (the Securities Act) and Regulation S of the Securities Act, and we are obligated, within
365 days after June 9, 2009, to file a registration statement with the Securities and Exchange
Commission that will enable the holders of the Senior Notes to exchange them for publicly
registered notes having substantially the same terms. In the event we do not file a registration
statement within 365 days after June 9, 2009, we will be obligated to pay liquidated damages
consisting of additional interest, up to a maximum additional interest rate of 1.0% per year. We
have not recorded a liability for any potential additional interest as of June 30, 2009.
3.0% and 4.0% Convertible Subordinated Notes
FSP APB 14-1 requires the issuer of convertible debt instruments with cash settlement features
to separately account for the liability and equity components of the convertible debt instruments
in a manner that reflects the issuers borrowing rate at the date of issuance for a similar debt
instrument without the conversion feature. FSP APB 14-1 requires bifurcation of a component of the
convertible debt instruments, classification of that component in equity and the accretion of the
resulting discount on the debt to be recognized as interest expense. Upon adoption of
20
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
FSP APB 14-1, we were required to separately account for the debt and equity components of our
3.0% Notes and our 4.0% Notes, both of which were issued in 2003 for a principal amount of $240.0
million each.
The equity component associated with the 3.0% Notes and the 4.0% Notes was $58.0 million and
$62.2 million, respectively, at the time of issuance and was applied as debt discount and as
additional capital. Transaction costs related to the issuance of the 3.0% Notes and the 4.0% Notes
were allocated to the liability component and equity component in proportion to the allocation of
proceeds and were accounted for as debt issuance costs and equity issuance costs, respectively.
The unamortized discount for the 3.0% Notes and 4.0% Notes will be amortized through the debt
maturity date of August 16, 2010 and November 15, 2013, respectively. The effective interest rate
on the liability component of the 3.0% Notes and 4.0% Notes is 7.74% and 7.78%, respectively.
Interest expense for the three and six months ended June 30, 2009 and 2008 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
3.0% Notes: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount amortization |
|
$ |
1,189 |
|
|
$ |
2,376 |
|
|
$ |
3,221 |
|
|
$ |
4,708 |
|
Contractual coupon rate |
|
$ |
922 |
|
|
$ |
1,800 |
|
|
$ |
2,341 |
|
|
$ |
3,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.0% Notes: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount amortization |
|
$ |
1,558 |
|
|
$ |
1,462 |
|
|
$ |
3,105 |
|
|
$ |
2,896 |
|
Contractual coupon rate |
|
$ |
2,366 |
|
|
$ |
2,400 |
|
|
$ |
4,766 |
|
|
$ |
4,800 |
|
During the six months ended June 30, 2009, we purchased an aggregate of $117.6 million
principal amount of the 3.0% Notes and 4.0% Notes at a purchase price of $115.2 million. The
carrying amount, net of unamortized debt issuance costs, of the 3.0% Notes and 4.0% Notes purchased
was $109.2 million and the estimated fair value of the Notes exclusive of the conversion feature
was $101.8 million. The difference between the carrying amount and the estimated fair value was
recognized as a gain of $7.4 million upon early extinguishment of debt. The difference between the
estimated fair value of $101.8 million and the purchase price of $115.2 million was $13.4 million
and was charged to additional capital. Upon adoption of FSP APB 14-1, $23.0 million of the purchase
price was attributable to accreted interest on the debt discount and is presented in the statement
of cash flows for the six months ended June 30, 2009 as payments of accreted interest on long-term
debt in cash flow from operating activities in continuing operations.
The liability component and the equity component of the 3.0% Notes and the 4.0% Notes as of
June 30, 2009 and December 31, 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
3.0% Notes |
|
$ |
104,796 |
|
|
$ |
207,360 |
|
Unamortized discount |
|
|
(4,740 |
) |
|
|
(13,548 |
) |
|
|
|
|
|
|
|
Net carrying value of 3.0% Notes |
|
$ |
100,056 |
|
|
$ |
193,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.0% Notes |
|
$ |
224,960 |
|
|
$ |
240,000 |
|
Unamortized discount |
|
|
(30,996 |
) |
|
|
(36,179 |
) |
|
|
|
|
|
|
|
Net carrying value of 4.0% Notes |
|
$ |
193,964 |
|
|
$ |
203,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity component for 3.0% Notes |
|
$ |
47,675 |
|
|
$ |
57,190 |
|
Equity component for 4.0% Notes |
|
$ |
58,352 |
|
|
$ |
62,167 |
|
The conversion price is 31.6336 shares per $1,000 principal amount for the 3.0% Notes and the
4.0% Notes. The number of shares used to determine the aggregate consideration that will be
delivered upon conversion was
21
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
3,315,075 shares for the 3.0% Notes and 7,116,295 shares for the 4.0% Notes as of June 30,
2009. The if-converted value of the 3.0% Notes and that of the 4.0% Notes did not exceed their
respective principal amount as of June 30, 2009.
In connection with the offering of the 3.0% Notes and the 4.0% Notes, we entered into
convertible note hedge and written call option transactions with respect to our common stock (the
Convertible Note Hedge). The Convertible Note Hedge consisted of our purchasing a call option on
12,653,440 shares of our common stock at a strike price of $31.61 and selling a written call option
on the identical number of shares at $39.52. The number of shares covered by the Convertible Note
Hedge is the same number of shares underlying the conversion of $200.0 million principal amount of
the 3.0% Notes and $200.0 million principal amount of the 4.0% Notes. The Convertible Note Hedge is
expected to reduce the potential dilution from conversion of the 3.0% Notes and the 4.0% Notes. The
written call option sold offset, to some extent, the cost of the written call purchased. The net
cost of the Convertible Note Hedge of $42.9 million was recorded as the sale of a permanent equity
instrument pursuant to EITF Issue No. 00-19, Accounting for Derivative Financial Instruments
Indexed to, and Potentially Settled in, a Companys Own Stock. As a result of the cessation of
Valeants common dividend, the strike price on the Convertible Note Hedge was adjusted during 2007,
with the new strike prices becoming $34.61 and $35.36 for the 3.0% Notes and the 4.0% Notes,
respectively.
During the six months ended June 30, 2009, corresponding to the partial redemption of the 3.0%
Notes, we also effected a proportionate partial termination of the Convertible Note Hedge, reducing
the number of shares covered by the Convertible Note Hedge by 3,011,645 shares. As of June 30,
2009, the number of shares covered by the Convertible Note Hedge is 9,641,795, the same number of
shares underlying the conversion of the remaining balance of $104.8 million principal amount of the
3.0% Notes and $200.0 million principal amount of the 4.0% Notes.
The estimated fair value of our public debt, based on quoted market prices or on current
interest rates for similar obligations with like maturities, was approximately $695.9 million and
$409.4 million compared to its carrying value of $647.4 million and $397.6 million at June 30, 2009
and December 31, 2008, respectively.
10. Income Taxes
We have historically incurred losses in the United States, where our research and development
activities are conducted and our corporate offices are located. As of June 30, 2009, there is
insufficient objective evidence as to the timing and amount of future U.S. taxable income to allow
for the release of the remaining U.S. valuation allowance which is primarily offsetting future
benefits of net operating losses, foreign tax and research and development credits. The valuation
allowance was recorded because it is more likely than not that such benefits will not be utilized.
Ultimate realization of these tax benefits is dependent upon generating sufficient taxable income
in the United States. We maintain a valuation allowance offsetting our net U.S. deferred tax assets
of approximately $112.2 million as of June 30, 2009.
The income tax provision for the six months ended June 30, 2009 consists of $17.2 million
related to the expected taxes on earnings in tax jurisdictions outside the U.S. and $6.8 million
related to state and U.S. withholding taxes and utilization of approximately $4.2 million of U.S.
deferred tax assets for which the reversal of the related valuation allowance is required to be
credited to additional capital.
The benefit of U.S. losses and research credits are subject to a yearly limitation, because of
ownership changes in the stock of the Company as well as our acquisitions of Dow and Coria in 2008.
However, the limitation is sufficient to allow for utilization of all losses and research credits
during the carryforward period.
As of June 30, 2009, we had $15.0 million of unrecognized tax benefits (FASB interpretation
No. 48, Accounting for Uncertainty in Income Taxes- an interpretation of FASB Statement No. 109),
of which $9.3 million would reduce our effective tax rate, if recognized. Of the total unrecognized
tax benefits, $3.5 million was recorded as an offset against a valuation allowance. To the extent
such portion of unrecognized tax benefits is recognized at a time when a valuation allowance no
longer exists, the recognition would affect our tax rate.
22
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
During the second quarter of 2009, we settled the examination of our U.S. income tax returns
for the years 2005 and 2006 with the Internal Revenue Service. As a result of this settlement, the
related unrecognized tax benefits were reversed in this quarter. The provision for income taxes
increased by $0.2 million, which was the net effect of changes to tax, interest and penalties. We
have also reduced $1.4 million relating to state audits from uncertain tax position liabilities and
reclassified it as income taxes payable, as it is reasonably possible that such amounts will be
settled within the next 12 months. In addition, the following accounts were affected by the
settlement of the examination of our U.S. income tax returns for the years 2005 and 2006 with the
Internal Revenue Service: income taxes payable increased by $1.1 million, income tax liability for
uncertain tax positions decreased $40.8 million and net deferred tax assets decreased $39.9
million.
Our continuing practice is to recognize interest and penalties related to income tax matters
in income tax expense. As of June 30, 2009, we had accrued $3.5 million for interest and $1.3
million for penalties. We accrued additional interest and penalties of $0.2 million during the six
months ended June 30, 2009. One of our Mexican subsidiaries is under audit for the 2004 and 2005
tax years. Our significant subsidiaries are open to tax examinations for years ending in 2001 and
later.
11. Stock and Stock Incentive Programs
Stock and Securities Repurchase Programs: In June 2007, our board of directors authorized a
stock repurchase program. This program authorized us to repurchase up to $200.0 million of our
outstanding common stock in a 24-month period. In June 2008, our board of directors increased the
authorization to $300.0 million, over the original 24-month period. This program was completed in
November 2008. The total number of shares repurchased pursuant to this program was 17,618,920 at an
average price of $17.03 per share, including transaction costs.
In October 2008, our board of directors authorized us to repurchase up to $200.0 million of
our outstanding common stock or convertible subordinated notes in a 24-month period ending October
2010, unless earlier terminated or completed. In May 2009, our board of directors increased the
authorization to $500.0 million, over a period ending in May 2011. Under the program, purchases may
be made from time to time on the open market, in privately negotiated transactions, pursuant to
tender offers or otherwise, including pursuant to one or more trading plans, at times and in
amounts as we see appropriate. The number of securities to be purchased and the timing of such
purchases are subject to various factors, which may include the price of our common stock, general
market conditions, corporate and regulatory requirements and alternate investment opportunities.
The securities repurchase program may be modified or discontinued at any time. During the six
months ended June 30, 2009, we purchased $117.6 million aggregate principal amount of our 3.0%
Notes and 4.0% Notes for $115.2 million in cash (see Note 9). In total, we have purchased $150.2
million aggregate principal amount of our 3.0% Notes and 4.0% Notes at a purchase price of $144.2
million as of June 30, 2009. During the six months ended June 30, 2009, we purchased 1,108,970
shares of our common stock for a total of $25.7 million. As of June 30, 2009, we have repurchased
an aggregate 1,407,931 shares of our common stock for $31.8 million under this program.
Stock-based compensation: We recognize compensation expense for the estimated fair value of
all share-based awards made to our employees and directors, including employee stock options. In
order to estimate the fair value of stock options we use the Black-Scholes option valuation model.
Option valuation models such as Black-Scholes require the input of subjective assumptions which can
vary over time. The variables used in our share-based compensation expense calculations include our
estimation of the forfeiture rate related to share-based payments. In 2006, 2007 and continuing
into 2008, we experienced significant turnover at both the executive and management levels, which
affected our actual forfeiture rate. We increased the estimated forfeiture rate in the three months
ended December 31, 2007 from 5% to 35%. During the second quarter of 2008, we recorded a correction
to adjust our historical estimated forfeiture rate for actual forfeitures which took place in 2006,
2007 and the first quarter of 2008. The correction recorded in the second quarter of 2008 resulted
in a $3.9 million decrease in stock compensation expense. Also, during the second quarter of 2008,
we recognized a change in estimate related to our estimated forfeiture rate for share-based
payments of $3.0 million for forfeitures which occurred in the three months ended June 30, 2008.
A summary of stock compensation expense in continuing operations for our stock incentive plans
for the three and six months ended June 30, 2009 and 2008 is presented below:
23
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Employee stock options |
|
$ |
1,144 |
|
|
$ |
(5,443 |
) |
|
$ |
2,638 |
|
|
$ |
(4,204 |
) |
Restricted stock units |
|
|
1,408 |
|
|
|
961 |
|
|
|
3,354 |
|
|
|
1,805 |
|
Perfomance stock units |
|
|
829 |
|
|
|
356 |
|
|
|
1,711 |
|
|
|
579 |
|
Employee stock purchase plan |
|
|
|
|
|
|
67 |
|
|
|
|
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation |
|
$ |
3,381 |
|
|
$ |
(4,059 |
) |
|
$ |
7,703 |
|
|
$ |
(1,687 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
In addition to the above amounts, we recorded stock compensation expense in discontinued
operations related to employee stock options of $(0.3) million and $(0.2) million in the three and
six months ended June 30, 2008, respectively.
Future stock compensation expense for restricted stock units, performance stock units and
stock option incentive awards outstanding as of June 30, 2009 is as follows:
|
|
|
|
|
Remainder of 2009 |
|
$ |
6,376 |
|
2010 |
|
|
8,798 |
|
2011 |
|
|
3,122 |
|
2012 |
|
|
805 |
|
2013 |
|
|
102 |
|
|
|
|
|
|
|
|
$ |
19,203 |
|
|
|
|
|
|
12. Derivative Financial Instruments
Our business and financial results are affected by fluctuations in world financial markets. We
evaluate our exposure to such risks on an ongoing basis, and seek ways to manage these risks to an
acceptable level, based on managements judgment of the appropriate trade-off between risk,
opportunity and cost. We do not hold any significant amount of market risk sensitive instruments
whose value is subject to market price risk. We use derivative financial instruments to hedge
foreign currency and interest rate exposures. We do not speculate in derivative instruments in
order to profit from foreign currency exchange or interest rate fluctuations; nor do we enter into
trades for which there is no underlying exposure.
Our significant foreign currency exposure relates to the Polish Zloty, the Mexican Peso, and
the Canadian Dollar in 2009. We utilize cash flow, fair value and net investment hedges to reduce
our exposure to foreign currency risk. We have chosen not to seek hedge accounting treatment for
certain undesignated cash flow hedges as these contracts are short term (typically less than 30
days in duration) and offset matching intercompany exposures in selected Valeant subsidiaries. In
2008, we used an interest rate swap to lower our interest expense by exchanging fixed rate payments
for floating rate payments. This interest rate swap was terminated in July 2008 in connection with
the redemption of our 7.0% Senior Notes. In connection with our April 2009 acquisition of Emo-Farm,
we acquired an interest rate swap with a notional amount of 7.5 million Polish Zloty
(approximately $2.3 million).
The table below summarizes the fair value and balance sheet location of our outstanding
derivatives at June 30, 2009 and December 31, 2008:
24
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2009 |
|
|
|
|
|
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
Notional |
|
|
Sheet |
|
|
Fair |
|
|
Sheet |
|
|
Fair |
|
Description |
|
Amount |
|
|
Location |
|
|
Value |
|
|
Location |
|
|
Value |
|
Undesignated hedges |
|
$ |
4,024 |
|
|
|
|
|
|
$ |
|
|
|
Accrued liabilities |
|
$ |
(15 |
) |
Net investment derivative contracts |
|
|
20,379 |
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
|
(1,652 |
) |
Fair value hedges |
|
|
23,891 |
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
|
(1,076 |
) |
Interest rate swap |
|
|
2,264 |
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
|
(8 |
) |
Cash flow derivative contracts |
|
|
2,654 |
|
|
Other assets |
|
|
56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2008 |
|
|
|
|
|
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
Notional |
|
|
Sheet |
|
|
Fair |
|
|
Sheet |
|
|
Fair |
|
Description |
|
Amount |
|
|
Location |
|
|
Value |
|
|
Location |
|
|
Value |
|
Undesignated hedges |
|
$ |
3,916 |
|
|
Other assets |
|
$ |
192 |
|
|
Accrued liabilities |
|
$ |
(35 |
) |
Net investment derivative contracts |
|
|
18,779 |
|
|
Other assets |
|
|
13 |
|
|
|
|
|
|
|
|
|
A summary is set out below of the accounting treatment for our undesignated, net
investment, cash flow and fair value hedges and interest rate swaps:
|
|
|
Changes in the fair value of undesignated hedges are recorded in earnings in the
period of the change. |
|
|
|
|
Changes in the fair value of a derivative that is designated and qualifies as a
net investment hedge are recorded as translation adjustment in accumulated other
comprehensive income. |
|
|
|
|
Changes in the fair value of a derivative that is designated and qualifies as a
cash flow hedge are recorded in accumulated other comprehensive income and then
recognized in earnings when the hedged items affect earnings. |
|
|
|
|
Changes in the fair value of a derivative that is designated and qualifies as a
fair value hedge are recorded in exchange gains or loss in the period of the change. |
|
|
|
|
Changes in the fair value of the interest rate swap are recorded as interest
expense in the period of the change. |
The table below summarizes the information related the changes in the fair value of our
derivatives instruments for the three and six months ended June 30, 2009 and 2008:
25
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2009 |
|
|
|
|
|
|
Net |
|
Cash |
|
|
|
|
|
|
|
|
|
|
Investment |
|
Flow |
|
Fair |
|
Interest |
|
|
Undesignated |
|
Derivative |
|
Derivative |
|
Value |
|
Rate |
Description |
|
Hedges |
|
Contracts |
|
Contracts |
|
Hedges |
|
Swap |
Loss recognized in currency translation
adjustment in other comprehensive income |
|
$ |
|
|
|
$ |
(523 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gain recognized in royalty income |
|
|
|
|
|
|
|
|
|
|
111 |
|
|
|
|
|
|
|
|
|
Loss recognized in exchange gain / loss |
|
|
(84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2009 |
|
|
|
|
|
|
Net |
|
Cash |
|
|
|
|
|
|
|
|
|
|
Investment |
|
Flow |
|
Fair |
|
Interest |
|
|
Undesignated |
|
Derivative |
|
Derivative |
|
Value |
|
Rate |
Description |
|
Hedges |
|
Contracts |
|
Contracts |
|
Hedges |
|
Swap |
Gain recognized in currency translation
adjustment in other comprehensive income |
|
$ |
|
|
|
$ |
2,284 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gain recognized in royalty income |
|
|
|
|
|
|
|
|
|
|
111 |
|
|
|
|
|
|
|
|
|
Gain recognized in exchange gain / loss |
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2008 |
|
|
|
|
|
|
Net |
|
Cash |
|
|
|
|
|
|
|
|
|
|
Investment |
|
Flow |
|
Fair |
|
Interest |
|
|
Undesignated |
|
Derivative |
|
Derivative |
|
Value |
|
Rate |
Description |
|
Hedges |
|
Contracts |
|
Contracts |
|
Hedges |
|
Swap |
Loss recognized in currency translation
adjustment in other comprehensive income |
|
$ |
|
|
|
$ |
(4,980 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gain recognized in interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,140 |
|
Loss recognized in royalty income |
|
|
|
|
|
|
|
|
|
|
(584 |
) |
|
|
|
|
|
|
|
|
Loss recognized in exchange gain / loss |
|
|
(384 |
) |
|
|
|
|
|
|
|
|
|
|
(977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2008 |
|
|
|
|
|
|
Net |
|
Cash |
|
|
|
|
|
|
|
|
|
|
Investment |
|
Flow |
|
Fair |
|
Interest |
|
|
Undesignated |
|
Derivative |
|
Derivative |
|
Value |
|
Rate |
Description |
|
Hedges |
|
Contracts |
|
Contracts |
|
Hedges |
|
Swap |
Loss recognized in currency translation
adjustment in other comprehensive income |
|
$ |
|
|
|
$ |
(4,980 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gain recognized in interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,459 |
|
Loss recognized in royalty income |
|
|
|
|
|
|
|
|
|
|
(1,342 |
) |
|
|
|
|
|
|
|
|
Loss recognized in exchange gain / loss |
|
|
(96 |
) |
|
|
|
|
|
|
|
|
|
|
(321 |
) |
|
|
|
|
See Note 6 for additional information about the fair value of our derivatives.
13. Commitments and Contingencies
We are involved in several legal proceedings, including the following matters:
SEC Investigation: We are the subject of a Formal Order of Investigation with respect to
events and circumstances surrounding trading in our common stock, the public release of data from
our first pivotal Phase III trial for taribavirin in March 2006, statements made in connection with
the public release of data and matters regarding our stock option grants since January 1, 2000 and
our restatement of certain historical financial statements announced in March 2008. In September
2006, our board of directors established a Special Committee to review our historical stock option
practices and related accounting, and informed the SEC of these efforts. We have cooperated fully
and will continue to cooperate with the SEC in its investigation. We cannot predict the outcome of
the investigation.
Derivative Actions Related to Stock Options: We are a nominal defendant in two shareholder
derivative lawsuits pending in state court in Orange County, California, styled (i) Michael Pronko
v. Timothy C. Tyson et al., and (ii) Kenneth Lawson v. Timothy C. Tyson et al. These lawsuits,
which were filed on October 27, 2006 and November
26
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
16, 2006, respectively, purported to assert derivative claims on our behalf against certain of our
current and/or former officers and directors. The lawsuits asserted claims for breach of fiduciary
duties, abuse of control, gross mismanagement, waste of corporate assets, unjust enrichment, and
violations of the California Corporations Code related to the purported backdating of employee
stock options. The plaintiffs sought, among other things, damages, an accounting, the rescission of
stock options, and a constructive trust over amounts acquired by the defendants who have exercised
Valeant stock options. On January 16, 2007, the court issued an order consolidating the two cases.
On February 6, 2007, the court issued a further order abating the Lawson action due to a procedural
defect while the Pronko action proceeded. On March 23, 2009, the court approved a settlement that
resolved the claims raised in the Pronko and Lawson actions. The settlement and final judgment
required us to adopt certain corporate governance reforms aimed at improving our process for
granting stock options. It also provided for an award of fees to counsel for the plaintiffs of $1.2
million and reimbursement of expenses of approximately $33 thousand, which amounts were covered by
insurance. On March 25, 2009, the court entered a Final Order of Judgment and Dismissal. These
cases are now dismissed.
We are also a nominal defendant in a shareholder derivative action pending in the Court of
Chancery of the state of Delaware, styled Sherwood v. Tyson, et. al., filed on March 20, 2007. This
complaint also purports to assert derivative claims on the Companys behalf for breach of fiduciary
duties, gross mismanagement and waste, constructive fraud and unjust enrichment related to the
alleged backdating of employee stock options. The plaintiff seeks, among other things, damages, an
accounting, disgorgement, rescission and/or repricing of stock options, and imposition of a
constructive trust for the benefit of the Company on amounts by which the defendants were unjustly
enriched. The plaintiff has agreed to a stay pending resolution of the Pronko action in California.
We intend to seek the dismissal of this action, whether by agreement of the plaintiff or by motion,
based on the final judgment entered in the Pronko and Lawson actions.
Permax Product Liability Cases: On August 27, 2008, we were served complaints in six separate
cases by plaintiffs Prentiss and Carol Harvey; Robert and Barbara Branson; Dan and Mary Ellen
Leach; Eugene and Bertha Nelson; Beverly Polin; and Ira and Michael Price against Eli Lilly and
Company and Valeant Pharmaceuticals International in Superior Court, Orange County, California (the
California Actions). The California Actions were consolidated under the heading of Branson v. Eli
Lilly and Company, et al. On September 15, 2008, we were served a complaint in a case captioned
Linda R. OBrien v. Eli Lilly and Company, Valeant Pharmaceuticals International, Amarin
Corporation, plc, Amarin Pharmaceuticals, Inc., Elan Pharmaceuticals, Inc., Athena Neurosciences,
Inc., Teva Pharmaceutical Industries, Ltd., Par Pharmaceutical Companies, Inc., and Ivax
Corporation in the Circuit Court of the 11th Judicial Circuit, Miami-Dade County, Florida. On March
24, 2009, we were named as a defendant in the following cases: Richard Andrew Baker v. Eli Lilly
and Company, Valeant Pharmaceuticals International, Amarin Corporation, plc, Amarin
Pharmaceuticals, Inc., Elan Pharmaceuticals, Inc., Athena Neurosciences, Inc., Par Pharmaceutical
Companies, Inc., Pfizer, Inc. and Pharmacia Corporation in the United States District Court for the
Northern District of Ohio, Eastern Division; Edwin Elling v. Eli Lilly and Company, Valeant
Pharmaceuticals International, Amarin Corporation, plc, Amarin Pharmaceuticals, Inc., Elan
Pharmaceuticals, Inc. and Athena Neurosciences, Inc. in the United Stated District Court for the
Northern District of Texas, Ft. Worth Division; and Judith LaVois v. Eli Lilly and Company, Valeant
Pharmaceuticals International, Amarin Corporation, plc, Amarin Pharmaceuticals, Inc., Elan
Pharmaceuticals, Inc., Athena Neurosciences, Inc. and Teva Pharmaceuticals USA, Inc. in the United
States District Court for the Southern District of Texas, Houston Division. On March 25, 2009, we
were named as a defendant in a case captioned Penny M. Hagerman v. Eli Lilly and Company, Valeant
Pharmaceuticals International, Amarin Corporation, plc, Amarin Pharmaceuticals, Inc., Elan
Pharmaceuticals, Inc., and Athena Neurosciences, Inc. in the United States District Court for the
District of Colorado. We are in the process of defending these matters. Eli Lilly, initial holder
of the right granted by the FDA to market and sell Permax in the United States, which right was
licensed to Amarin and assigned to Valeant, and the source of the manufactured product, has also
been named in the suits. In addition to the lawsuits described above, we have received, and from
time to time receive, communications from third parties relating to potential claims that may be
asserted with respect to Permax.
Eli Lilly: On January 12, 2009, we were served a complaint in an action captioned Eli Lilly
and Company v. Valeant Pharmaceuticals International, Case No. 1:08-cv-1720DFH-TAB in the U.S.
District Court for the Southern District of Indiana, Indianapolis Division (the Lilly Action). In
the Lilly Action, Lilly brings a claim for breach of contract and seeks a declaratory judgment
arising out of a February 25, 2004 letter agreement between and among
27
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
Lilly, Valeant and Amarin
Corporation, plc related to cost-sharing for product liability claims related to the pharmaceutical Permax. On March 2, 2009, we filed counterclaims against Eli Lilly for
declaratory judgment and indemnification.
Spear Pharmaceuticals, Inc.: On December 17, 2007, Spear Pharmaceuticals, Inc. and Spear
Dermatology Products, Inc. filed a complaint in federal court for the District of Delaware, Case
No. 07-821, against Valeant and investment firm William Blair & Company, LLC. Plaintiffs allege
that while William Blair was engaged in connection with the possible sale of plaintiffs generic
tretinoin business, plaintiffs disclosed to William Blair the development of generic Efudex in
their product pipeline. Plaintiffs further allege that William Blair, while under confidentiality
obligations to plaintiffs, shared such information with Valeant and that Valeant then filed a
Citizen Petition with the FDA requesting that any abbreviated new drug application for generic
Efudex include a study on superficial basal cell carcinoma. Arguing that Valeants Citizen Petition
caused the FDA to delay approval of their generic Efudex, plaintiffs seek damages for Valeants
alleged breach of contract, trade secret misappropriation and unjust enrichment, in addition to
other causes of action against William Blair. We believe this case is without merit and are
vigorously defending ourselves in this matter.
On April 11, 2008, the FDA approved an Abbreviated New Drug Application (ANDA) for a 5%
fluorouracil cream sponsored by Spear Pharmaceuticals. On April 11, 2008, the FDA also responded to
our Citizen Petition that was filed on December 21, 2004 and denied our request that the FDA
refrain from approving any ANDA for a generic version of Efudex unless the application contains
data from an adequately designed comparative clinical study conducted in patients with superficial
basal cell carcinoma. On April 25, 2008, Valeant filed an application for a temporary restraining
order (TRO) against Michael O. Leavitt and Andrew C. Von Eschenbach, in their official capacities
at the FDA, in the United States District Court for the Central District of California, seeking to
suspend the FDAs approval of Spears ANDA. On May 1, 2008, the Court granted the FDAs request to
stay proceedings on Valeants application for a TRO until May 14, 2008. On May 14, 2008, the FDA
entered an administrative order staying the approval of the Spear ANDA and initiating a process for
reconsidering the approval of the Spear ANDA. Spear Pharmaceuticals agreed to the stay and to the
prohibition on marketing, sale and shipment of its product until May 30, 2008. On May 31, 2008, the
Court granted our application for a TRO suspending approval of the Spear ANDA. On June 18, 2008 the
Court denied our request for a preliminary injunction to continue the suspension of the Spear ANDA
and extinguished the TRO. The stay on the Spear ANDA has been removed and the Spear product may be
marketed, sold and shipped. On September 23, 2008, we filed an Amended Complaint under the
Administrative Procedure Act challenging the FDAs initial decision to approve Spears ANDA, the
FDAs re-affirmance of Spears ANDA and the FDAs denial of Valeants Citizens Petition. Valeant,
the FDA and Spear (as an intervening party) have each filed motions for summary judgment which will
likely be heard by the Court in the next sixty days. The matter is currently set for trial on
September 15, 2009. However, the parties plan to file a stipulation to continue the trial date
because they believe the case will be resolved through the summary judgment process and that a
trial will not be necessary.
Paddock Litigation: On or around November 24, 2008, Paddock Laboratories, Inc. (Paddock)
notified Galderma Laboratories L.P. (Galderma), Dermalogix Partners, Inc. (Dermalogix), Panda
Pharmaceuticals, L.L.C. (Panda), and The University of Tennessee Research Foundation (UT) that
it had submitted ANDA No. 90-898 with the FDA seeking approval for a generic version of Clobex® (a
clobetasol propionate spray, .05%) prior to expiration of U.S. Patent Nos. 5,972,920 (the 920
patent) and 5,990,100 (the 100 patent). The Paddock ANDA contains a Paragraph IV certification
by Paddock that the claims of the 920 and 100 patents will not be infringed by Paddocks proposed
formulation and that the 920 and 100 patents are invalid and/or unenforceable. On January 7,
2009, Galderma, Galderma S.A., and Dermalogix (collectively, Plaintiffs) filed a complaint
against Paddock for the infringement of the 920 patent Civil Case No. 4-09CV-002-Y pending in
the United States District Court for the Northern District of Texas, Fort Worth Division.
Plaintiffs complaint alleges that Paddocks filing of ANDA No. 90-898 is an act of infringement of
the 920 patent under 35 U.S.C. § 271(e)(2). On January 29, 2009, Paddock filed an answer and
counterclaims against not only Plaintiffs, but also Panda, UT, and Dow for a declaratory judgment
of non-infringement, invalidity and unenforceability of the 920 patent and of the 100 patent. The
920 patent is owned by Dermalogix. The 100 patent is owned by Panda and The University of
Tennessee Research Corporation (now known as The University of Tennessee Research Foundation, which
we have abbreviated UT). Dow is a party to licenses involving the 920 patent and the 100
patent. On April 6, 2009, Paddock voluntarily dismissed its counterclaims involving the 100
patent, resulting in the dismissal of Panda and
28
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
UT from the lawsuit. On April 23, 2009, Dow filed a Motion to Dismiss as we believe that Dow is
improperly joined to the case. At the same time, Dow also filed a Motion to Stay Discovery to place any Dow
discovery obligations on hold. On June 18, 2009, the court granted Dows Motion to Dismiss.
Tolmar Matter: On or around January 19, 2009, Tolmar, Inc. (Tolmar) notified Galderma
Laboratories, L.P. and us that it had submitted an ANDA, No. 090-903, with the FDA seeking approval
for the commercial manufacture, use and sale of its Metronidazole Topical Gel, 1% (the Tolmar
Product) prior to the expiration of U.S. Patent Nos. 6,881,726 (the 726 patent) and 7,348,317
(the 317 patent). The 726 and 317 patents are owned by Dow, and licensed to Galderma. The ANDA
contains a Paragraph IV certification alleging that the claims of the 726 and 317 patents will
not be infringed by the manufacture, use, importation, sale or offer for sale of the Tolmar
Product.
On March 3, 2009, Galderma Laboratories, L.P., Galderma S.A., and Dow filed a complaint
against Tolmar for the patent infringement of the 726 and 317 patents, pending in the United
States District Court for the Northern District of Texas, Dallas Division. On April 20, 2009,
Tolmar filed an answer and counterclaims that included declaratory judgment actions for
non-infringement and invalidity. No trial date has been set.
This lawsuit was filed within forty-five days of Tolmars Paragraph IV certification. As a
result, The Hatch-Waxman Act provides an automatic stay on the FDAs final approval of Tolmars
ANDA for thirty months, which will expire in July 2011, or until a decision by the district,
whichever is earlier.
Novel ANDA Patent Certification Notice : On or around June 12, 2009, we received a notice
from Novel Laboratories, Inc. (Novel) advising us that Novel had filed with the FDA an ANDA for
Diastat AcuDial, 5 mg/mL, 2 mL pre-filled syringe and 4 mL pre-filled syringe. This ANDA contained
a Paragraph IV certification against our Orange Book listed patent, U.S. Patent No. 5,462,740 (the
"'740 Patent).
The 45-day period after the receipt of the notice, during which period we may file a
Hatch-Waxman suit against Novel, has expired.
Other: We are a party to other pending lawsuits and subject to a number of threatened
lawsuits. While the ultimate outcome of pending and threatened lawsuits or pending violations
cannot be predicted with certainty, and an unfavorable outcome could have a negative impact on us,
at this time in the opinion of management, the ultimate resolution of these matters will not have a
material effect on our consolidated financial position, results of operations or liquidity.
There can be no assurance that defending against any of the above claims or any future similar
claims and any resulting settlements or judgments will not, individually or in the aggregate, have
a material adverse effect on our consolidated financial position, results of operation or
liquidity.
14. Business Segments
Our products are sold through three segments comprising Specialty Pharmaceuticals, Branded
Generics Europe and Branded Generics Latin America. The Specialty Pharmaceuticals segment
revenues include product revenues primarily from the U.S., Canada, Australia and New Zealand and
divested businesses located in Argentina, Uruguay and Asia. The Branded Generics Europe segment
revenues include product revenues from branded generic pharmaceutical products primarily in Poland,
Hungary, the Czech Republic and Slovakia. The Branded Generics Latin America segment revenues
include product revenues from branded generic pharmaceutical products primarily in Mexico and
Brazil.
Additionally, we generate alliance revenue, including royalties from the sale of ribavirin by
Schering-Plough and revenues associated with the Collaboration Agreement with GSK. We also generate
alliance revenue and service revenue from the development of dermatological products resulting from
the acquisition of Dow.
The following table sets forth the amounts of our segment revenues and operating income for
the three and six months ended June 30, 2009 and 2008:
29
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals product sales |
|
$ |
96,633 |
|
|
$ |
64,413 |
|
|
$ |
182,946 |
|
|
$ |
144,427 |
|
Specialty pharmaceuticals services and alliance revenue (1) |
|
|
12,196 |
|
|
|
|
|
|
|
24,101 |
|
|
|
|
|
Branded
generics - Europe product sales |
|
|
34,032 |
|
|
|
38,500 |
|
|
|
69,370 |
|
|
|
76,453 |
|
Branded
generics - Latin America product sales |
|
|
36,200 |
|
|
|
35,838 |
|
|
|
67,382 |
|
|
|
57,081 |
|
Alliances (ribavirin royalties) |
|
|
12,637 |
|
|
|
14,805 |
|
|
|
25,822 |
|
|
|
27,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated revenues |
|
$ |
191,698 |
|
|
$ |
153,556 |
|
|
$ |
369,621 |
|
|
$ |
305,539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Income (Loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
34,089 |
|
|
$ |
(12,017 |
) |
|
$ |
62,339 |
|
|
$ |
(15,705 |
) |
Branded
generics - Europe |
|
|
6,791 |
|
|
|
3,106 |
|
|
|
15,655 |
|
|
|
15,847 |
|
Branded
generics - Latin America |
|
|
13,772 |
|
|
|
5,244 |
|
|
|
25,980 |
|
|
|
2,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
54,652 |
|
|
|
(3,667 |
) |
|
|
103,974 |
|
|
|
3,011 |
|
Alliances |
|
|
12,637 |
|
|
|
14,805 |
|
|
|
25,822 |
|
|
|
27,578 |
|
Corporate (2) |
|
|
(12,463 |
) |
|
|
(11,594 |
) |
|
|
(31,025 |
) |
|
|
(26,879 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subtotal |
|
|
54,826 |
|
|
|
(456 |
) |
|
|
98,771 |
|
|
|
3,710 |
|
Special charges and credits including acquired in-process research
and development |
|
|
(1,974 |
) |
|
|
|
|
|
|
(1,974 |
) |
|
|
|
|
Restructuring, asset impairments and dispositions |
|
|
(1,694 |
) |
|
|
(13,957 |
) |
|
|
(2,905 |
) |
|
|
(767 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated segment operating income (loss) |
|
|
51,158 |
|
|
|
(14,413 |
) |
|
|
93,892 |
|
|
|
2,943 |
|
Interest income |
|
|
725 |
|
|
|
5,236 |
|
|
|
2,560 |
|
|
|
9,960 |
|
Interest expense |
|
|
(8,551 |
) |
|
|
(13,325 |
) |
|
|
(16,564 |
) |
|
|
(26,709 |
) |
Gain on early extinguishment of debt |
|
|
2,777 |
|
|
|
|
|
|
|
7,376 |
|
|
|
|
|
Other, net |
|
|
(646 |
) |
|
|
(298 |
) |
|
|
566 |
|
|
|
(1,829 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations before income taxes |
|
$ |
45,463 |
|
|
$ |
(22,800 |
) |
|
$ |
87,830 |
|
|
$ |
(15,635 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Specialty pharmaceuticals services and alliance revenue consists of: |
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
Service revenue |
|
$ |
5,606 |
|
|
$ |
12,344 |
|
Dow dermatology royalties |
|
|
3,790 |
|
|
|
5,639 |
|
GSK Collaboration |
|
|
2,800 |
|
|
|
6,118 |
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals services and alliance revenue |
|
$ |
12,196 |
|
|
$ |
24,101 |
|
|
|
|
|
|
|
|
|
|
|
(2) |
|
Stock-based compensation expense has been considered a corporate cost as management
excludes this item in assessing the financial performance of individual business segments and
considers it a function of valuation factors that pertain to overall corporate stock
performance. |
The following table sets forth our total assets by segment as of June 30, 2009 and December
31, 2008:
30
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Total Assets |
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
599,925 |
|
|
$ |
692,734 |
|
Branded generics - Europe |
|
|
159,096 |
|
|
|
219,234 |
|
Branded generics - Latin America |
|
|
119,154 |
|
|
|
103,573 |
|
Alliances |
|
|
13,877 |
|
|
|
16,436 |
|
Corporate |
|
|
503,227 |
|
|
|
153,955 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,395,279 |
|
|
$ |
1,185,932 |
|
|
|
|
|
|
|
|
During the three and six months ended June 30, 2009 and 2008, two customers each accounted for
more than 10% of consolidated product sales. Sales to McKesson Corporation and its affiliates and
to Cardinal Health in the United States, Canada and Mexico are detailed in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
McKesson |
|
$ |
37,525 |
|
|
$ |
19,565 |
|
|
$ |
70,784 |
|
|
$ |
49,393 |
|
Cardinal |
|
|
24,187 |
|
|
|
13,943 |
|
|
|
45,433 |
|
|
|
32,085 |
|
Percentage of total product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
McKesson |
|
|
22 |
% |
|
|
14 |
% |
|
|
22 |
% |
|
|
18 |
% |
Cardinal |
|
|
14 |
% |
|
|
10 |
% |
|
|
14 |
% |
|
|
12 |
% |
15. Alliance Revenue
We report the royalties received from the sale of ribavirin by Schering-Plough separately from
our pharmaceuticals product sales revenue. Beginning in January 2009, we earn royalty income from
patent protected formulations developed by Dow and licensed to third parties. The following table
provides the details of our alliance revenue in the three and six months ended June 30, 2009 and
2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Ribavirin royalty |
|
$ |
12,637 |
|
|
$ |
14,805 |
|
|
$ |
25,822 |
|
|
$ |
27,578 |
|
Dermatology royalties |
|
|
3,790 |
|
|
|
|
|
|
|
5,639 |
|
|
|
|
|
GSK Collaboration |
|
|
2,800 |
|
|
|
|
|
|
|
6,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total alliance revenue |
|
$ |
19,227 |
|
|
$ |
14,805 |
|
|
$ |
37,579 |
|
|
$ |
27,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16. Related Parties
Robert A. Ingram has been the Vice Chairman Pharmaceuticals of GSK. Mr. Ingram has been
elected to our board of directors since 2003. In 2008, Mr. Ingram became the boards lead director.
Stephan F. Stefano has been Senior Vice President of GSKs Payor Markets Division since January
2001. Effective March 25, 2009, Mr. Stefano was elected by our board of directors to fill an open
board position in the class expiring in 2010. See Note 3 for further discussion of the
Collaboration Agreement with GSK.
31
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
Anders Lönner has been the Group President and Chief Executive Officer of Meda since 1999, and
serves on Medas board of directors. Effective January 7, 2009, Mr. Lönner was elected by our board
of directors to fill an open board position in the class expiring in 2011. See Note 5 for further
discussion of transactions with Meda.
17. Subsequent Events
On July 31, 2009, we acquired Tecnofarma S.A. de C.V. (Tecnofarma), a privately held company
located in Mexico for approximately one times sales. Tecnofarma is a producer of generic
pharmaceuticals with approximately $33 million in annual sales primarily to the government and
private label markets.
32
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
This discussion of our results of operations should be read in conjunction with our
consolidated condensed financial statements included elsewhere in this quarterly report.
Company Overview
Introduction
We are a multinational specialty pharmaceutical company that develops, manufactures and
markets a broad range of pharmaceutical products. Our specialty pharmaceutical and OTC products are
marketed under brand names or as OTC products and are sold in the United States, Canada, Australia,
and New Zealand, where we focus most of our efforts on the dermatology and neurology therapeutic
classes. We also have branded generic operations in Europe and Latin America which focus on
pharmaceutical products that are bioequivalent to original products and are marketed under company
brand names.
Our products are sold through three segments comprising Specialty Pharmaceuticals, Branded
Generics Europe and Branded Generics Latin America. The Specialty Pharmaceuticals segment
generates product revenues primarily from the United States, Canada, Australia and New Zealand. The
Branded Generics Europe segment generates product revenues from branded generic pharmaceutical
products primarily in Poland, Hungary, the Czech Republic and Slovakia. The Branded Generics
Latin America segment generates product revenues from branded generic pharmaceutical products
primarily in Mexico and Brazil.
Additionally, we generate alliance revenue, including royalties from the sale of ribavirin by
Schering-Plough Ltd. (Schering-Plough) and revenues associated with the Collaboration Agreement
with GSK (as defined below). We also generate alliance revenue and service revenue from the
development of dermatological products resulting from the acquisition of Dow Pharmaceutical
Sciences, Inc. (Dow).
Business Strategy
In March 2008, we announced a new company-wide restructuring effort and new strategic
initiatives (the 2008 Strategic Plan). The restructuring was designed to streamline our business,
align our infrastructure to the scale of our operations, maximize our pipeline assets and deploy
our cash assets to maximize shareholder value, while highlighting key opportunities for growth.
We have built our current business infrastructure by executing our multi-faceted strategy: 1)
focus the business on core geographies and therapeutic classes; 2) maximize pipeline assets through
strategic partnerships with other pharmaceutical companies; and 3) deploy cash with an appropriate
mix of debt purchases, share buybacks and selective acquisitions. We believe our
multi-faceted strategy will allow us to expand our product offerings and upgrade our product
portfolio with higher growth and higher margin assets.
Our leveraged research and development (R&D) model is a key element to our business
strategy. It allows us to progress development programs to drive future commercial growth, while
minimizing the R&D expense in our income statement. This is achieved in 4 ways: (1) we structure
partnerships and collaborations so that our partner partially or fully funds development work, e.g.
GSK collaboration on retigabine, (2) we bring products already developed for other markets to our
territories, e.g. our joint venture relationship with Meda AB, (3) we acquire dossiers and
registrations for branded generic products, which require limited and low risk formulation and
development activities, and (4) we have a dermatology service business that works with external
customers as well as progressing our internal development programs. This service business model
brings invaluable scientific experience and allows higher utilization and infrastructure cost
absorption.
Prior to the start of the 2008 Strategic Plan, we reviewed our portfolio for products and
geographies that did not meet our growth and profitability expectations and, as a result, divested
or discontinued certain non-strategic products and regional operations. In January 2008, we sold
our rights in Infergen to Three Rivers Pharmaceuticals, LLC. In March 2008, we sold certain assets
in Asia to Invida Pharmaceutical Holdings Pte. Ltd. (Invida) that included certain of our
subsidiaries, branch offices and commercial rights in Singapore, the Philippines, Thailand,
33
Indonesia, Vietnam, Korea, China, Hong Kong, Malaysia and Macau. This transaction also included the
sale of certain product rights in Japan. In June 2008, we sold our subsidiaries in Argentina and
Uruguay. In September 2008, we sold our business operations located in Western and Eastern Europe,
Middle East and Africa (the WEEMEA business) to Meda AB, an international specialty
pharmaceutical company located in Stockholm, Sweden (Meda).
The results of operations for the three and six months ended June 30, 2008 have been adjusted
in this quarterly report to exclude the results of operations for Infergen and the WEEMEA business,
whose results are presented as discontinued operations.
In October 2008, we closed the worldwide License and Collaboration Agreement (the
Collaboration Agreement) with Glaxo Group Limited, a wholly owned subsidiary of GlaxoSmithKline
plc, (GSK), to develop and commercialize retigabine, a first-in-class neuronal potassium channel
opener for the treatment of adult epilepsy patients with refractory partial onset seizures.
In October 2008, we acquired Coria Laboratories Ltd. (Coria), a privately-held specialty
pharmaceutical company focused on dermatology products in the United States. In November 2008, we
acquired DermaTech Pty Ltd (DermaTech), an Australian specialty pharmaceutical company focused on
dermatology products marketed in Australia. In December 2008, we acquired Dow, a privately-held
dermatology company that specializes in the development of topical products on a proprietary basis,
as well as for pharmaceutical and biotechnology companies. In April 2009, we acquired EMO-FARM sp.
z o.o. (Emo-Farm), a privately held Polish company that specializes in gel-based over-the-counter
and cosmetic products.
In May 2009, we entered into an exclusive option agreement with Schering Corporation and
Schering-Plough (together with Schering Corporation, SP) for taribavirin in Japan. Under the
terms of the option agreement, we granted SP an option to enter into an exclusive license agreement
for the development and commercialization of taribavirin in Japan. In exchange for the exclusive
option, SP agreed to waive and release its right of last refusal on taribavirin under a 2000
agreement. Upon exercising the option and entering into the exclusive license agreement, SP would
provide us with a $2 million upfront payment and pay mid-single digit royalties on net sales of
taribavirin in Japan.
Pharmaceutical Products
Product sales from our pharmaceutical segments accounted for 87% and 86% of our total revenues
from continuing operations for the three and six months ended June 30, 2009, respectively, compared
with 90% and 91% for the corresponding periods in 2008. Product sales increased $28.1 million (20%)
and $41.7 million (15%) for the three and six months ended June 30, 2009, respectively, compared
with the corresponding periods in 2008. The 20% increase in pharmaceutical product sales for the
three months ended June 30, 2009 was due to a 35% increase in volume and a 6% increase in price
offset by a 21% reduction due to currency fluctuations. The 15% increase in pharmaceutical product
sales for the six months ended June 30, 2009 was due to a 33% increase in volume and a 3% increase
in price offset by a 21% reduction due to currency fluctuations.
We have experienced generic challenges and other competition to our products, as well as price
and currency challenges, and expect these challenges to continue in 2009 and beyond.
Alliance Revenue
Our royalties have historically been derived from sales of ribavirin, a nucleoside analog that
we discovered. In 1995, Schering-Plough licensed from us all oral forms of ribavirin for the
treatment of chronic hepatitis C. We also licensed ribavirin to Roche in 2003. Roche discontinued
royalty payments to us in June 2007.
Ribavirin royalties were $12.6 million and $25.8 million for the three and six months ended
June 30, 2009, respectively, compared with $14.8 million and $27.6 million in the corresponding
periods in 2008. We expect ribavirin royalties to continue to decline in 2009 as royalty payments
from Schering-Plough will continue for European sales only until the ten-year anniversary of the
launch of the product, which varied by European country and started in May 1999. We expect that
royalties from Schering-Plough in Japan will continue after 2009.
34
Alliance revenue also includes $2.8 million and $6.1 million for the three and six months
ended June 30, 2009, respectively, related to the GSK Collaboration Agreement.
Beginning in January 2009, we receive royalties from patent protected formulations developed
by Dow and licensed to third parties. These royalties were $3.8 million and $5.6 million for the
three and six months ended June 30, 2009, respectively.
Beginning in January 2009, we also receive revenue from contract research services performed
by Dow in the areas of dermatology and topical medication. These services are primarily focused on
contract research for external development and clinical research in areas such as formulations
development, in vitro drug penetration studies, analytical sciences and consulting in the areas of
labeling and regulatory affairs. This service revenue was $5.5 million and $12.2 million for the
three and six months ended June 30, 2009, respectively. Other service revenue totaled $0.1 million
in the three and six months ended June 30, 2009.
Research and Development
We are developing product candidates, including two clinical stage programs, retigabine and
taribavirin, which target large market opportunities. Retigabine is being developed in partnership
with GSK as a first-in-class neuronal potassium channel opener for the treatment of adult epilepsy
patients with refractory partial onset seizures. Taribavirin is a pro-drug of ribavirin for the
treatment of chronic hepatitis C in treatment-naive patients in conjunction with a pegylated
interferon. We are looking for potential partnering opportunities for taribavirin.
Collaboration Agreement
In October 2008, we closed the Collaboration Agreement with GSK to develop and commercialize
retigabine and its back up compounds and received $125.0 million in upfront fees from GSK upon the
closing.
We agreed to share equally with GSK the development and pre-commercialization expenses of
retigabine in the United States, Australia, New Zealand, Canada and Puerto Rico (the Collaboration
Territory) and GSK will develop and commercialize retigabine in the rest of the world. Our share
of such expenses in the Collaboration Territory is limited to $100.0 million, provided that GSK
will be entitled to credit our share of any such expenses in excess of such amount against future
payments owed to us under the Collaboration Agreement. To the extent that our expected development
and pre-commercialization expenses under the Collaboration Agreement are less than $100.0 million,
the difference will be recognized as alliance revenue over the period prior to launch of a
retigabine product (the Pre-Launch Period). We will recognize alliance revenue during the
Pre-Launch Period as we complete our performance obligations using the proportional performance
model, which requires us to determine and measure the completion of our expected development and
pre-commercialization costs during the Pre-Launch Period, in addition to our participation in the
joint steering committee. We expect to complete our research and development and
pre-commercialization obligations in effect during the Pre-Launch Period by the first quarter of
2011.
GSK has the right to terminate the Collaboration Agreement at any time prior to the receipt of
the approval by the United States Food and Drug Administration (FDA) of a new drug application
(NDA) for a retigabine product, which right may be irrevocably waived at any time by GSK. The
period of time prior to such termination or waiver is referred to as the Review Period. In
February 2009, the Collaboration Agreement was amended to, among other matters, reduce the maximum
amount that we would be required to refund to GSK to $40.0 million through March 31, 2010, with
additional reductions in the amount of the required refund over the time the Collaboration Agreement is in effect. During the three and six months ended June 30,
2009, the combined research and development expenses and pre-commercialization expenses incurred
under the Collaboration Agreement by us and GSK were $13.5 million and $26.9 million, respectively,
as outlined in the table below. We recorded a charge of $1.2 million and a credit of $0.2 million
in the three and six months ended June 30, 2009, respectively, against our share of the expenses to
equalize our expenses with GSK, pursuant to the terms of the Collaboration Agreement.
35
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
|
|
(in thousands) |
|
Valeant research and development costs |
|
$ |
5,477 |
|
|
$ |
13,424 |
|
Valeant selling, general and administrative |
|
|
56 |
|
|
|
205 |
|
|
|
|
|
|
|
|
|
|
|
5,533 |
|
|
|
13,629 |
|
|
|
|
|
|
|
|
|
|
GSK expenses |
|
|
7,976 |
|
|
|
13,279 |
|
|
|
|
|
|
|
|
Total spending for Collaboration Agreement |
|
$ |
13,509 |
|
|
$ |
26,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equalization charge (credit) |
|
$ |
1,222 |
|
|
$ |
(175 |
) |
|
|
|
|
|
|
|
The table below outlines the alliance revenue, expenses incurred, associated credits
against the expenses incurred, and the remaining upfront payment for the Collaboration Agreement
during the following period (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
Selling, |
|
|
Research |
|
|
|
Balance |
|
|
Alliance |
|
|
General and |
|
|
and |
|
Collaboration Accounting Impact |
|
Sheet |
|
|
Revenue |
|
|
Administrative |
|
|
Development |
|
Upfront payment from GSK |
|
$ |
125,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Release from upfront payment in 2008 |
|
|
(10,909 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Incurred cost in 2009 |
|
|
|
|
|
|
|
|
|
|
205 |
|
|
|
13,424 |
|
Incurred cost offset in 2009 |
|
|
(13,454 |
) |
|
|
|
|
|
|
(682 |
) |
|
|
(12,772 |
) |
Recognize alliance revenue |
|
|
(6,118 |
) |
|
|
(6,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Release from upfront payment |
|
|
(19,572 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining upfront payment from GSK |
|
$ |
94,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equalization receivable from GSK |
|
$ |
175 |
|
|
|
|
|
|
|
477 |
|
|
|
(652 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expense and revenue |
|
|
|
|
|
$ |
(6,118 |
) |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued liabilities |
|
$ |
36,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
36,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue short-term |
|
|
10,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue long-term |
|
|
10,373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining upfront payment from GSK |
|
$ |
94,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total combined expenses by us and GSK for the Collaboration Agreement to date through
June 30, 2009 were $40.0 million.
Results of Operations
In connection with the 2008 Strategic Plan and resulting acquisitions and dispositions in
2008, we realigned our organization in the fourth quarter of 2008 to improve our execution and
align our resources and product development efforts in the markets in which we operate. We have
realigned segment financial data for the three and six months ended June 30, 2008 to reflect these
changes in our organizational structure.
Certain financial information for our business segments is set forth below. This discussion of
our results of operations should be read in conjunction with the consolidated condensed financial
statements included elsewhere in this quarterly report. For additional financial information by
business segment, see Note 14 of notes to consolidated condensed financial statements included
elsewhere in this quarterly report.
36
The following table summarizes revenues by reportable segments and operating expenses for the
three and six months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals product sales |
|
$ |
96,633 |
|
|
$ |
64,413 |
|
|
$ |
182,946 |
|
|
$ |
144,427 |
|
Specialty pharmaceuticals services and alliance revenue |
|
|
12,196 |
|
|
|
|
|
|
|
24,101 |
|
|
|
|
|
Branded generics - Europe |
|
|
34,032 |
|
|
|
38,500 |
|
|
|
69,370 |
|
|
|
76,453 |
|
Branded generics - Latin America |
|
|
36,200 |
|
|
|
35,838 |
|
|
|
67,382 |
|
|
|
57,081 |
|
Alliances (ribavirin royalties) |
|
|
12,637 |
|
|
|
14,805 |
|
|
|
25,822 |
|
|
|
27,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated revenues |
|
|
191,698 |
|
|
|
153,556 |
|
|
|
369,621 |
|
|
|
305,539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization) |
|
|
42,750 |
|
|
|
47,874 |
|
|
|
82,447 |
|
|
|
83,629 |
|
Cost of services |
|
|
5,337 |
|
|
|
|
|
|
|
9,663 |
|
|
|
|
|
Selling, general and administrative |
|
|
62,535 |
|
|
|
70,772 |
|
|
|
126,751 |
|
|
|
140,211 |
|
Research and development costs, net |
|
|
9,145 |
|
|
|
22,567 |
|
|
|
17,880 |
|
|
|
51,861 |
|
Special charges and credits including acquired in-process research and
development |
|
|
1,974 |
|
|
|
|
|
|
|
1,974 |
|
|
|
|
|
Restructuring, asset impairments and dispositions |
|
|
1,694 |
|
|
|
13,957 |
|
|
|
2,905 |
|
|
|
767 |
|
Amortization expense |
|
|
17,105 |
|
|
|
12,799 |
|
|
|
34,109 |
|
|
|
26,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
$ |
51,158 |
|
|
$ |
(14,413 |
) |
|
$ |
93,892 |
|
|
$ |
2,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Computations of percentage change period over period are based upon our results, as rounded
and presented herein.
Product Sales Revenues: In the Specialty Pharmaceuticals segment, revenues from product sales
for the three months ended June 30, 2009 were $96.6 million, compared with $64.4 million for the
corresponding period in 2008, representing an increase of $32.2 million (50%). Revenues from
product sales for the six months ended June 30, 2009 were $182.9 million, compared with $144.4
million for the corresponding period in 2008, representing an increase of $38.5 million (27%). The
increase in product sales in the three months ended June 30, 2009 was primarily driven by growth in
existing products. In the three months ended June 30, 2008, as part of our restructuring efforts,
we reduced shipments to wholesaler customers aggregating approximately $17.4 million to reduce the
amount of inventory in the wholesale channel. Revenues from product sales include sales of products
acquired in late 2008 as part of the Coria and DermaTech acquisitions, which contributed an
additional $11.5 million and $22.9 million in the three and six months ended June 30, 2009,
respectively. In the three months ended June 30, 2009, these increases were partly offset by a $4.7
million reduction from the depreciation of the Canadian Dollar and Australian Dollar relative to
the U.S. Dollar. Sales increases in the six months ended June 30 were partly offset by a $7.1
million reduction in sales of Efudex as a result of generic competition, a reduction of $5.8
million due to the sale of business operations in Argentina, Uruguay and Asia and $9.9 million from
the depreciation of the Canadian Dollar and Australian Dollar relative to the U.S. Dollar.
In the Branded Generics Europe segment, revenues for the three months ended June 30, 2009
were $34.0 million compared with $38.5 million for the corresponding period in 2008, a decrease of
$4.5 million (12%). Revenues for the six months ended June 30, 2009 were $69.4 million, compared
with $76.5 million for the corresponding period in 2008, representing a decrease of $7.1 million
(9%). The depreciation of foreign currencies, particularly the Polish Zloty, relative to the U.S.
Dollar resulted in decreases of $15.0 million and $29.0 million in product sales revenue in the
three and six months ended June 30, 2009, respectively. This reduction was partly offset by growth
in existing products, increased revenue from a distribution contract and $2.3 million from the
acquisition of Emo-Farm in April 2009.
In the Branded Generics Latin America segment, revenues for the three months ended June 30,
2009 were $36.2 million compared with $35.8 million for the corresponding period in 2008, an
increase of $0.4 million (1%).
37
Revenues for the six months ended June 30, 2009 were $67.4 million, compared with $57.1
million for the corresponding period in 2008, representing an increase of $10.3 million (18%). The
increase in product sales is across all products primarily from the improvement of trading
relationships with the major wholesalers in Mexico that impacted product sales for the previous two
years. This increase was partly offset by decreases of $9.3 million and $19.4 million due to the
depreciation of foreign currencies, particularly the Mexican Peso, relative to the U.S. Dollar in
the three and six months ended June 30, 2009, respectively.
Alliance Revenue: Alliance revenue for the three months ended June 30, 2009 and 2008 was $19.2
million and $14.8 million, respectively. Alliance revenue for the six months ended June 30, 2009
and 2008 was $37.6 million and $27.6 million, respectively. Alliance revenue in the three and six
months ended June 30, 2008 consisted exclusively of ribavirin royalty revenue. Ribavirin royalty
revenue was $12.6 million and $25.8 million for the three and six months ended June 30, 2009,
respectively.
We expect ribavirin royalties to continue to decline in 2009 as royalty payments from
Schering-Plough will continue for European sales only until the ten-year anniversary of the launch
of the product, which varied by European country and started in May 1999. We expect that royalties
from Schering-Plough in Japan will continue after 2009.
Beginning in January 2009, we receive royalties from patent protected formulations developed
by Dow and licensed to third parties. These royalties were $3.8 million and $5.6 million for the
three and six months ended June 30, 2009, respectively.
Beginning in January 2009, we also receive revenue from contract research services performed
by Dow in the areas of dermatology and topical medication. The services are primarily focused on
contract research for external development and clinical research in areas such as formulations
development, in vitro drug penetration studies, analytical sciences and consulting in the areas of
labeling, and regulatory affairs. This service revenue was $5.5 million and $12.2 million for the
three and six months ended June 30, 2009, respectively. Other service revenue totaled $0.1 million
in the three and six months ended June 30, 2009.
We also earned $2.8 million and $6.1 million under the GSK Collaboration Agreement for the
three and six months ended June 30, 2009, respectively.
Services and alliance revenue in the Specialty Pharmaceuticals segment consists of (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
Service revenue |
|
$ |
5,606 |
|
|
$ |
12,344 |
|
Dow dermatology royalties |
|
|
3,790 |
|
|
|
5,639 |
|
GSK Collaboration |
|
|
2,800 |
|
|
|
6,118 |
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals services and alliance revenue |
|
$ |
12,196 |
|
|
$ |
24,101 |
|
|
|
|
|
|
|
|
Gross Profit Margin: Gross profit margin on product sales, net of pharmaceutical product
amortization, was 66% and 65% for the three and six months ended June 30, 2009, respectively,
compared with 58% and 62% for the corresponding periods in 2008, respectively. Product amortization
expense was $14.8 million and $10.4 million for the three months ended June 30, 2009 and 2008,
respectively. Product amortization expense was $29.5 million and $21.4 million for the six months
ended June 30, 2009 and 2008, respectively. The increase in product amortization expense in the
three and six month periods is primarily attributable to products acquired within the Specialty
Pharmaceuticals segment in the U.S. in late 2008. The gross profit margin improvement in the
Branded Generics Latin America segment was primarily due to the negative impact of inventory
reserve provisions of $5.6 million and $10.4 million in the three and six months ended June 30,
2008, respectively. The gross profit margin improvement in the Branded Generics Europe segment
in the three months ended June 30, 2009 is primarily attributable to the negative impact of
inventory reserve provisions of $3.6 million in the three months ended June 30, 2008. The
38
decline in the gross profit margin in the Branded Generics Europe segment in the six
months ended June 30, 2009 is primarily due to mix of products and low margin revenue from a
distribution contract.
Gross profit margin on product sales (excluding pharmaceutical product amortization) was 74%
for the three and six months ended June 30, 2009, respectively, compared to 65% and 70% in the
corresponding periods in 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
Percent |
|
|
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
|
|
|
Gross Profit (excluding product amortization) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
78,453 |
|
|
$ |
48,245 |
|
|
$ |
30,208 |
|
|
|
63 |
% |
% of product sales |
|
|
81 |
% |
|
|
75 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Europe |
|
|
19,048 |
|
|
|
20,364 |
|
|
|
(1,316 |
) |
|
|
(6 |
)% |
% of product sales |
|
|
56 |
% |
|
|
53 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Latin America |
|
|
26,601 |
|
|
|
21,321 |
|
|
|
5,280 |
|
|
|
25 |
% |
% of product sales |
|
|
73 |
% |
|
|
59 |
% |
|
|
|
|
|
|
|
|
Corporate |
|
|
13 |
|
|
|
947 |
|
|
|
(934 |
) |
|
|
|
|
% of product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated gross profit |
|
$ |
124,115 |
|
|
$ |
90,877 |
|
|
$ |
33,238 |
|
|
|
37 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
% of product sales |
|
|
74 |
% |
|
|
65 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
13,443 |
|
|
$ |
9,101 |
|
|
$ |
4,342 |
|
|
|
48 |
% |
Branded
generics - Europe |
|
|
497 |
|
|
|
313 |
|
|
|
184 |
|
|
|
59 |
% |
Branded
generics - Latin America |
|
|
855 |
|
|
|
1,021 |
|
|
|
(166 |
) |
|
|
(16 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product amortization |
|
$ |
14,795 |
|
|
$ |
10,435 |
|
|
$ |
4,360 |
|
|
|
42 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit (including product amortization) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
65,010 |
|
|
$ |
39,144 |
|
|
$ |
25,866 |
|
|
|
66 |
% |
% of product sales |
|
|
67 |
% |
|
|
61 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Europe |
|
|
18,551 |
|
|
|
20,051 |
|
|
|
(1,500 |
) |
|
|
(7 |
)% |
% of product sales |
|
|
55 |
% |
|
|
52 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Latin America |
|
|
25,746 |
|
|
|
20,300 |
|
|
|
5,446 |
|
|
|
27 |
% |
% of product sales |
|
|
71 |
% |
|
|
57 |
% |
|
|
|
|
|
|
|
|
Corporate |
|
|
13 |
|
|
|
947 |
|
|
|
(934 |
) |
|
|
|
|
% of product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated gross profit |
|
$ |
109,320 |
|
|
$ |
80,442 |
|
|
$ |
28,878 |
|
|
|
36 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
% of product sales |
|
|
66 |
% |
|
|
58 |
% |
|
|
|
|
|
|
|
|
39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
Percent |
|
|
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
|
|
|
Gross Profit (excluding product amortization) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
149,402 |
|
|
$ |
114,760 |
|
|
$ |
34,642 |
|
|
|
30 |
% |
% of product sales |
|
|
82 |
% |
|
|
79 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Europe |
|
|
37,969 |
|
|
|
45,155 |
|
|
|
(7,186 |
) |
|
|
(16 |
)% |
% of product sales |
|
|
55 |
% |
|
|
59 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Latin America |
|
|
49,886 |
|
|
|
33,536 |
|
|
|
16,350 |
|
|
|
49 |
% |
% of product sales |
|
|
74 |
% |
|
|
59 |
% |
|
|
|
|
|
|
|
|
Corporate |
|
|
(6 |
) |
|
|
881 |
|
|
|
(887 |
) |
|
|
|
|
% of product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated gross profit |
|
$ |
237,251 |
|
|
$ |
194,332 |
|
|
$ |
42,919 |
|
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
% of product sales |
|
|
74 |
% |
|
|
70 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
27,114 |
|
|
$ |
18,803 |
|
|
$ |
8,311 |
|
|
|
44 |
% |
Branded
generics - Europe |
|
|
731 |
|
|
|
591 |
|
|
|
140 |
|
|
|
24 |
% |
Branded
generics - Latin America |
|
|
1,634 |
|
|
|
2,007 |
|
|
|
(373 |
) |
|
|
(19 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product amortization |
|
$ |
29,479 |
|
|
$ |
21,401 |
|
|
$ |
8,078 |
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit (including product amortization) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals |
|
$ |
122,288 |
|
|
$ |
95,957 |
|
|
$ |
26,331 |
|
|
|
27 |
% |
% of product sales |
|
|
67 |
% |
|
|
66 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Europe |
|
|
37,238 |
|
|
|
44,564 |
|
|
|
(7,326 |
) |
|
|
(16 |
)% |
% of product sales |
|
|
54 |
% |
|
|
58 |
% |
|
|
|
|
|
|
|
|
Branded
generics - Latin America |
|
|
48,252 |
|
|
|
31,529 |
|
|
|
16,723 |
|
|
|
53 |
% |
% of product sales |
|
|
72 |
% |
|
|
55 |
% |
|
|
|
|
|
|
|
|
Corporate |
|
|
(6 |
) |
|
|
881 |
|
|
|
(887 |
) |
|
|
|
|
% of product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated gross profit |
|
$ |
207,772 |
|
|
$ |
172,931 |
|
|
$ |
34,841 |
|
|
|
20 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
% of product sales |
|
|
65 |
% |
|
|
62 |
% |
|
|
|
|
|
|
|
|
Selling, General and Administrative Expenses: Selling, general and administrative (SG&A)
expenses were $62.5 million and $126.8 million for the three and six months ended June 30, 2009,
respectively, compared to $70.8 million and $140.2 million in the corresponding periods in 2008,
reflecting decreases of $8.3 million (12%) and $13.4 million (10%), respectively. As a percentage
of product sales, SG&A expenses were 37% and 40% in the three and six months ended June 30, 2009,
respectively, compared to 51% and 50% in the corresponding periods in 2008. The decrease in SG&A
expenses for the three and six months ended June 30, 2009 primarily reflects savings from our
restructuring initiatives partially offset by increased costs attributable to the acquisition of
Dow and Coria, as well as increased stock-based compensation expense. SG&A expenses had $9.5
million and $18.0 million of favorable currency impact in the three and six month periods ended
June 30, 2009, respectively. SG&A expenses in the three months ended June 30, 2009 included $0.9
million of transaction costs related to the April 2009 acquisition of Emo-Farm. SG&A expenses in
the six months ended June 30, 2009 also included the recognition of an other-than-temporary
impairment of $1.5 million on an investment in a publicly traded investment fund and $1.6 million
of transfer taxes on an intercompany return of capital.
Research and Development Costs: Research and development expenses were $9.1 million and $17.9
million for the three and six months ended June 30, 2009, respectively, compared to $22.6 million
and $51.9 million in the corresponding periods in 2008, reflecting decreases of $13.5 million (60%)
and $34.0 million (66%), respectively. The decrease in research and development expenses was
largely related to the expenditures of $12.2 million and $27.4 million for the retigabine clinical
development program in the three and six month periods ended June 30, 2008, respectively. Our
research and development expenses for the retigabine clinical development program in the
40
three and six month periods ended June 30, 2009 were $5.5 million and $13.4 million,
respectively, but were reduced to zero by the credit resulting from the upfront fee from GSK under
the Collaboration Agreement. Research and development expenses also decreased $2.9 million and $7.7
million in the three and six months ended June 30, 2009, respectively, from the effects of our
restructuring actions. In addition, spending for other products in development, primarily Diastat
Intranasal and taribavirin, decreased by $2.9 million and $6.1 million in the three and six months
ended June 30, 2009, respectively. These decreases in research and development expenses were
partially offset by increases of $3.9 million and $8.8 million in the three and six months ended
June 30, 2009, respectively, due to the acquisition of Dow in December 2008. Research and
development costs are expected to increase as certain dermatology compounds enter Phase III
clinical trial activity.
Special Charges and Credits Including Acquired In-process Research and Development:
In June 2009, we entered into a license agreement with Endo Pharmaceuticals Inc. that grants
us an exclusive license to develop and commercialize Opana® and Opana® ER in Canada, Australia and
New Zealand. Regulatory approval must be received prior to any sale of the licensed products. We
recorded a $1.8 million charge related to the initial license fee in the three months ended June
30, 2009. During the three months ended June 30, 2009, we acquired rights to additional products in
Mexico that are not currently approved for sale, for an aggregate price of $0.2 million.
Restructuring, Asset Impairments and Dispositions: Our restructuring charges include severance
costs, contract cancellation costs, the abandonment of capitalized assets, the impairment of
manufacturing facilities, and other associated costs, including legal and professional fees. We
have accounted for statutory and contractual severance obligations when they are estimable and
probable, pursuant to SFAS No. 112, Employers Accounting for Postemployment Benefits. For one-time
severance arrangements, we have applied the methodology defined in SFAS No. 146, Accounting for
Costs Associated with Exit or Disposal Activities (SFAS 146). Pursuant to these requirements,
these benefits are detailed in an approved severance plan, which is specific as to number,
position, location and timing. In addition, the benefits are communicated in specific detail to
affected employees and it is unlikely that the plan will change when the costs are recorded. If
service requirements exceed a minimum retention period, the costs are spread over the service
period; otherwise they are recognized when they are communicated to the employees. Contract
cancellation costs are recorded in accordance with SFAS 146. We have followed the requirements of
SFAS No. 144, Accounting for the Impairment or Disposal of Long-lived Assets (SFAS 144), in
recognizing the abandonment of capitalized assets and the impairment of manufacturing facilities.
For a further description of the accounting for impairment of long-lived assets under SFAS 144, see
Note 1, Organization and Summary of Significant Accounting Policies, in our Current Report on Form
8-K filed on May 28, 2009 (the 2008 Annual Report 8-K). Other associated costs, such as legal and
professional fees, have been expensed as incurred, pursuant to SFAS 146.
2008 Restructuring
In October 2007, our board of directors initiated a strategic review of our business
direction, geographic operations, product portfolio, growth opportunities and acquisition strategy.
In March 2008, we completed this strategic review and announced a strategic plan designed to
streamline our business, align our infrastructure to the scale of our operations, maximize our
pipeline assets and deploy our cash assets to maximize shareholder value. The strategic plan
included a restructuring program (the 2008 Restructuring), which reduced our geographic footprint
and product focus by restructuring our business in order to focus on the pharmaceutical markets in
our core geographies of the United States, Canada and Australia and on the branded generics markets
in Europe (Poland, Hungary, the Czech Republic and Slovakia) and Latin America (Mexico and Brazil).
The 2008 Restructuring plan included actions to divest our operations in markets outside of these
core geographic areas through sales of subsidiaries or assets and other strategic alternatives.
In March 2008, we closed the sale to Invida Pharmaceutical Holdings Pte. Ltd. (Invida) of
certain assets in Asia in a transaction that included certain of our subsidiaries, branch offices
and commercial rights in Singapore, the Philippines, Thailand, Indonesia, Vietnam, Taiwan, Korea,
China, Hong Kong, Malaysia and Macau. This transaction also included the sale of certain product
rights in Japan. During the three months ended March 31, 2008, we received initial proceeds of
$37.9 million and recorded a gain of $36.9 million in this transaction. During the three months
ended June 30, 2008, we recorded net asset adjustments and additional closing costs aggregating
$1.0 million, which resulted in a reduced gain of $35.9 million as of June 30, 2008. During the
three months ended
41
March 31, 2009, we received substantially all of the remaining additional proceeds of $3.4
million from the sale in accordance with net asset settlement provisions of the sale.
In June 2008, we sold our subsidiaries in Argentina and Uruguay and recorded a loss on the
sale of $2.7 million, in addition to a $7.9 million impairment charge recorded in the first quarter
of 2008 related to the anticipated sale.
In December 2008, as part of our efforts to align our infrastructure to the scale of our
operations, we exercised our option to terminate the lease of our Aliso Viejo, California corporate
headquarters as of December 2011 and, as a result, recorded a restructuring charge of $3.8 million
for the year ended December 31, 2008. The charge consisted of a lease termination penalty of $3.2
million, which will be payable in October 2011, and $0.6 million for certain fixed assets.
The net restructuring, asset impairments and dispositions charge of $1.7 million in the three
months ended June 30, 2009 included $0.9 million of severance charges for a total of 8 affected
employees. The charge also included $0.8 million of contract cancellation costs and other cash
costs. The net restructuring, asset impairments and dispositions charge of $2.9 million in the six
months ended June 30, 2009 included $1.8 million of severance charges for a total of 30 affected
employees. The charge also included $1.1 million of contract cancellation costs and other cash
costs.
The following table summarizes the restructuring costs recorded in the three and six months
ended June 30, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
Severance costs (422 employees, cumulatively) |
|
$ |
847 |
|
|
$ |
1,775 |
|
Contract cancellation costs, legal and professional fees and other associated costs |
|
|
839 |
|
|
|
1,094 |
|
|
|
|
|
|
|
|
Subtotal: cash charges |
|
|
1,686 |
|
|
|
2,869 |
|
Non-cash charges |
|
|
8 |
|
|
|
36 |
|
|
|
|
|
|
|
|
Restructurings, asset impairments and dispositions |
|
$ |
1,694 |
|
|
$ |
2,905 |
|
|
|
|
|
|
|
|
The net restructuring, asset impairments and disposition charge of $14.0 million in the
three months ended June 30, 2008 included the $1.0 million of additional costs and net asset
adjustments recorded as reductions of the gain originally recorded in the first quarter of 2008 in
the Invida transaction, $5.9 million of severance charges for a total of 126 affected employees,
professional service fees and other cash costs of $3.7 million, a $0.7 million impairment charge
related to certain fixed assets in Mexico and the $2.7 million loss on the sale of our subsidiaries
in Argentina and Uruguay.
The net restructuring, asset impairments and disposition charge of $0.8 million in the six
months ended June 30, 2008 included $12.1 million of severance costs for a total of 141 affected
employees who were part of the supply, selling, general and administrative and research and
development workforce in the United States, Mexico and Brazil. The charge also included $6.9
million for professional service fees related to the strategic review of our business and other
cash costs of $1.7 million. Additional amounts incurred included a stock compensation charge for
the accelerated vesting of the stock options of our former chief executive officer of $4.8 million,
impairment charges relating to the sale of our subsidiaries in Argentina and Uruguay and certain
fixed assets in Mexico of $8.5 million and the $2.7 million loss on the sale of our subsidiaries in
Argentina and Uruguay, offset in part by the gain of $35.9 million in the transaction with Invida.
The following table summarizes the restructuring costs and gains recorded in the three and six
months ended June 30, 2008 (in thousands):
42
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2008 |
|
Severance costs (144 employees, cumulatively) |
|
$ |
5,854 |
|
|
$ |
12,069 |
|
Legal and professional fees and other associated costs |
|
|
3,666 |
|
|
|
8,552 |
|
|
|
|
|
|
|
|
Subtotal: cash charges |
|
|
9,520 |
|
|
|
20,621 |
|
Stock compensation |
|
|
|
|
|
|
4,778 |
|
Impairment of long-lived assets |
|
|
684 |
|
|
|
8,537 |
|
Loss on sale of long-lived assets |
|
|
2,736 |
|
|
|
2,736 |
|
|
|
|
|
|
|
|
Subtotal: restructuring expenses |
|
|
12,940 |
|
|
|
36,672 |
|
Gain on Invida transaction |
|
|
1,017 |
|
|
|
(35,905 |
) |
|
|
|
|
|
|
|
Restructurings, asset impairments and dispositions |
|
$ |
13,957 |
|
|
$ |
767 |
|
|
|
|
|
|
|
|
In the three and six months ended June 30, 2008, we recorded inventory obsolescence
charges of $11.5 million and $18.0 million, respectively, resulting primarily from decisions to
cease promotion of or discontinue certain products, decisions to discontinue certain manufacturing
transfers, and product quality failures. These inventory obsolescence charges were recorded in
costs of goods sold, in accordance with EITF Issue No. 96-9, Classification of Inventory Markdowns
and Other Costs Associated with a Restructuring.
Reconciliation of Cash Restructuring Payments with Restructuring Accrual
As of June 30, 2009, the restructuring accrual includes $7.2 million related to the 2008
restructuring plan for severance costs, lease termination penalty costs, contract cancellation
costs, legal and professional fees and other associated costs expected to be paid primarily during
the remainder of 2009, except for the lease termination penalty which will be paid in 2011. A
summary of accruals and expenditures of restructuring costs which will be paid in cash is as
follows (in thousands):
Reconciliation of Cash Payments and Accruals
|
|
|
|
|
Restructuring accrual, March 31, 2009 |
|
$ |
8,404 |
|
Charges to earnings |
|
|
1,686 |
|
Cash paid |
|
|
(2,896 |
) |
|
|
|
|
Restructuring accrual, June 30, 2009 |
|
$ |
7,194 |
|
|
|
|
|
We expect the 2008 restructuring initiatives to be substantially completed by the end of the
third quarter of 2009. We expect to continue to recognize costs in 2009, including one-time
employee severance costs of $0.2 million related to severance plans already approved for which the
costs are spread over the service period in accordance with SFAS 146, and through 2011, related to
the accretion of lease termination penalty costs.
Amortization: Amortization expense was $17.1 million and $34.1 million for the three and six
months ended June 30, 2009, respectively, compared to $12.8 million and $26.1 million in the
corresponding periods of 2008, reflecting an increase of $4.3 million (34%) and $8.0 million (31%),
respectively. Amortization increased by $4.0 million and $8.3 million in the three and six months
ended June 30, 2009, respectively, related to the intangible assets obtained in our acquisition of
Dow and Coria, partially offset by the declining amortization of the rights to the ribavirin
royalty intangible, which has been amortized using an accelerated method and was fully amortized as
of September 30, 2008 and lower amortization from the divestiture of our operations in Asia,
Uruguay and Argentina.
Interest Expense and Income: Interest expense was $8.6 million and $16.6 million for the three
and six months ended June 30, 2009, respectively, compared to $13.3 million and $26.7 million in
the corresponding periods in 2008, reflecting decreases of $4.7 million (35%) and $10.1 million
(38%), respectively. The decrease was primarily due to the purchase of our $300.0 million 7.0%
Senior Notes, which occurred in July 2008, offset in part by interest expense on our $365.0 million
8.375% Senior Notes issued in June 2009.
Interest income was $0.7 million and $2.6 million for the three and six months ended June 30,
2009, respectively, compared to $5.2 million and $10.0 million in the corresponding periods in
2008, reflecting decreases
43
of $4.5 million (87%) and $7.4 million (74%), respectively. The decrease was due to lower cash
balances resulting from our acquisitions, the purchase of our $300.0 million 7.0% Senior Notes,
purchase of a portion of our 3.0% Notes and 4.0% Notes, repurchases of our common stock and lower
average interest rates.
On January 1, 2009, we adopted Financial Accounting Standards Board Staff Position No. APB
14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion
(Including Partial Cash Settlement) (FSP APB 14-1). FSP APB 14-1 requires the liability and
equity components of convertible debt instruments that may be settled in cash upon conversion
(including partial cash settlement) to be separately accounted for in a manner that reflects the
issuers nonconvertible debt borrowing rate. FSP APB 14-1 requires bifurcation of a component of
the debt instruments, classification of that component in equity and the accretion of the resulting
discount on the debt to be recognized as interest expense. FSP APB 14-1 is applicable to our 3.0%
Convertible Subordinated Notes (the 3.0% Notes) and our 4.0% Convertible Subordinated Notes (the
4.0% Notes) issued in 2003. FSP APB 14-1 requires retrospective application upon adoption to
prior periods presented. Interest expense attributable to the adoption of FSP APB 14-1 was $2.7
million and $6.1 million for the three and six months ended June 30, 2009, respectively, compared
with $3.7 million and $7.4 million in the corresponding periods in 2008. See Note 9 to our
condensed consolidated financial statements contained elsewhere in this quarterly report for
additional information regarding our implementation of FSP APB 14-1.
Gain on Early Extinguishment of Debt: During the six months ended June 30, 2009, we purchased
an aggregate of $117.6 million principal amount of the 3.0% Notes and 4.0% Notes at a purchase
price of $115.2 million. The carrying amount, net of unamortized debt issuance costs, of the 3.0%
Notes and 4.0% Notes purchased was $109.2 million and the estimated fair value of the Notes
exclusive of the conversion feature was $101.8 million. The difference between the carrying amount
and the estimated fair value was recognized as a gain of $7.4 million upon early extinguishment of
debt.
Other Income (Expense), Net, Including Translation and Exchange: Other income (expense), net,
including translation and exchange was expense of $0.6 million and income of $0.6 million for the
three and six months ended June 30, 2009, respectively, compared to expense of $0.3 million and
$1.8 million in the corresponding periods of 2008. The expense for the three months ended June 30,
2009 primarily related to the weakening of the U.S. Dollar relative to the Euro, the Swiss Franc
and the British Pound resulting in translation and exchange losses on foreign currency denominated
liabilities in our U.S. Dollar denominated subsidiaries. The income in the six months ended June
30, 2009 resulted primarily from the weakening of the Polish Zloty against the U.S. Dollar
denominated cash and receivables balances in non-U.S. Dollar denominated subsidiaries. The expense
in the six months ended June 30, 2008 resulted primarily from the strengthening of the Polish Zloty
against the U.S. Dollar denominated cash and receivable balances in non-U.S. Dollar denominated
subsidiaries.
Income Taxes: The income tax provisions in the three and six months ended June 30, 2009 and
2008 relate to the profits of our foreign operations, foreign withholding taxes, the income tax
effects on interest paid on our integrated debt, penalties and interest associated with U.S.
liabilities and state and local taxes in the United States. We continue to provide residual U.S.
tax on the unremitted earnings of our foreign subsidiaries including applicable withholding taxes
due upon repatriation.
Because of our losses in prior periods, we are required to maintain a valuation allowance
offsetting our net U.S. deferred tax assets of approximately $112.2 million as of June 30, 2009.
See Note 10 to our consolidated condensed financial statements contained elsewhere in this
quarterly report for a discussion of this valuation allowance.
The valuation allowance is reviewed quarterly and is maintained until sufficient positive
evidence exists to support the reversal. The exact timing of the valuation allowance release is
subject to change based on the level of profitability that we are able to achieve and our
visibility into future period results. Because evidence, such as our historical operating results
during the most recent three-year period, is afforded more weight than forecasted results for
future periods, our historical losses during this three-year period represent sufficient negative
evidence regarding the need for a full valuation allowance under SFAS No. 109, Accounting for
Income Taxes. At this time, there is insufficient objective evidence as to the timing and amount of
future U.S. taxable income to allow for the release of the remaining U.S. valuation allowance which
is primarily offsetting future benefits of foreign tax and research and development credits. We
will release this valuation allowance when management determines that it is more likely
44
than not that our deferred tax assets will be realized. Any release of valuation allowance
will be recorded as a tax benefit increasing net income.
It
is reasonably possible that if we continue to generate taxable profits
in the U.S. over the near term that management may evaluate that it
is more likely than not that the deferred tax assets will be
realized.
Income (loss) from Discontinued Operations, Net: The results from discontinued operations were
a loss of $0.2 million and income of $0.2 million for the three and six months ended June 30, 2009,
respectively, compared to losses of $26.3 million and $23.0 million in the corresponding periods in
2008, and relate primarily to the WEEMEA business and our Infergen operations.
Liquidity and Capital Resources
Cash and cash equivalents and marketable securities totaled $453.0 million at June 30, 2009
compared with $218.8 million at December 31, 2008. The increase of $234.2 million resulted
primarily from net proceeds of $346.0 million from the issuance of the 8.375% Senior Notes due June
15, 2016 (the Senior Notes) (comprised of $365.0 million gross proceeds, less $11.7 million
original issue discount and $7.3 million underwriters fees), $79.8 million of cash from operations
and proceeds from stock option exercises and employee stock purchases of $31.4 million offset by
$115.2 million paid to purchase a portion of the 3.0% Notes and 4.0% Notes. Upon adoption of FSP
APB 14-1, $23.0 million of the $115.2 million was attributable to accreted interest on the debt
discount and deferred loan costs. The $23.0 million has been reflected as payments of accreted
interest on long-term debt in cash flow from operating activities in continuing operations. The
remaining $92.2 million has been reflected as payments on long-term debt and notes payable in cash
flows from financing activities in continuing operations. In addition to the $115.2 million paid to
purchase a portion of the 3.0% Notes and 4.0% Notes, the offsetting decrease related to $46.5
million paid for liabilities for the acquisition of Dow, $28.6 million, net of cash acquired, paid
for the acquisition of Emo-Farm, $25.7 million for the purchase of treasury stock, $13.4 million
paid for liabilities related to the sale of the WEEMEA business, $9.1 million of capital
expenditures, $8.0 million related to the effect of exchange rate changes and $6.2 million for the
acquisition of product rights in Australia and New Zealand. Working capital was $469.5 million at
June 30, 2009 compared with $175.5 million at December 31, 2008. The increase in working capital of
$294.0 million primarily resulted from the increase in cash and cash equivalents and marketable
securities and a decrease in trade payables and accrued liabilities.
Cash provided by operating activities in continuing operations is expected to be our primary
source of funds for operations in 2009. During the six months ended June 30, 2009, cash provided by
operating activities in continuing operations totaled $82.3 million, compared with $56.1 million
for the corresponding period in 2008. The cash provided by operating activities in continuing
operations was primarily a result of net income adjusted for non-cash charges and a decrease in
accounts receivable, offset in part by a decrease in other liabilities. The cash provided by
operating activities in continuing operations for 2008 was primarily a result of the reduction in
accounts receivable, the increase in trade payables and accrued liabilities and the reduction in
income taxes receivable, offset by the increase in inventories.
Cash used in investing activities in continuing operations was $177.0 million for the six
months ended June 30, 2009, compared with cash provided by investing activities in continuing
operations of $20.0 million in 2008. In 2009, cash used in investing activities in continuing
operations consisted primarily of the purchase of investments of $108.0 million, $46.5 million paid
for liabilities for the acquisition of Dow, $28.6 million, net of cash acquired, paid for the
acquisition of Emo-Farm, capital expenditures of $9.1 million and $6.2 million for the acquisition
of product rights in Australia and New Zealand, offset in part by proceeds from investments of
$20.4 million. Cash used in investing activities in discontinued operations in 2009 of $10.6
million consisted primarily of $13.4 million paid for liabilities related to the sale of the WEEMEA
business, offset by $2.8 million received from Meda for proceeds from a legal settlement. In 2008,
cash provided by investing activities in continuing operations consisted primarily of proceeds from
investments of $77.9 million, proceeds of $37.9 million received from the Invida transaction and
$13.5 million received from the sale of our subsidiaries in Argentina and Uruguay, offset by $100.2
million for the purchase of investments. Cash provided by investing activities in discontinued
operations in 2008 of $67.7 million consisted primarily of $70.8 million of cash proceeds received
as the initial payment in the sale of our Infergen operations to Three Rivers Pharmaceuticals.
Cash provided by financing activities in continuing operations was $261.8 million for the six
months ended June 30, 2009, compared with $0.6 million in 2008 and primarily consisted of the net
proceeds of $346.0 million for the issuance of the Senior Notes, proceeds from stock option
exercises and employee stock purchases of $31.5 million
45
offset in part by the payments on long-term debt and notes payable of $94.3 million and $25.7
million for the purchase of treasury stock.
The Senior Notes are guaranteed on a senior unsecured basis by each of our present and future
U.S. subsidiaries that qualify as restricted subsidiaries under the indenture. As of June 30, 2009,
our non-guarantor subsidiaries had total assets of $491.1 million, total liabilities of $317.0
million, net revenues of $184.9 million, and income from
operations of $55.1 million for the six months ended June 30, 2009.
If GSK terminates the Collaboration Agreement prior to the expiration of the Review Period, we
would be required to refund to GSK up to $40.0 million of the upfront fee through June 30, 2010,
with additional reductions in the amount of the required refund over the time the Collaboration
Agreement is in effect.
We believe that our existing cash and cash equivalents and funds generated from operations
will be sufficient to meet our operating requirements at least through June 30, 2010, and to
provide cash needed to fund capital expenditures and our clinical development program. While we
have no current intent to issue additional debt or equity securities, we may seek additional debt
financing or issue additional equity securities to finance future acquisitions or for other
purposes. There can be no assurance we would be able to secure such financing on acceptable terms,
if at all, especially in light of current economic and market conditions. We fund our operating
cash requirements primarily from cash provided by operating activities. Our sources of liquidity
are cash and cash equivalent balances, cash flow from operations, and cash provided by investing
activities.
We did not pay dividends for either the six months ended June 30, 2009 or the twelve months
ended December 31, 2008.
Off-Balance Sheet Arrangements
We do not use special purpose entities or other off-balance sheet financing techniques except
for operating leases disclosed in our 2008 Annual Report 8-K. Our 3.0% and 4.0% Convertible
Subordinated Notes include conversion features that are considered off-balance sheet arrangements
under SEC requirements.
Products in Development
Retigabine
Subject to the terms of the Collaboration Agreement with GSK, we are developing retigabine as
an adjunctive treatment for partial-onset seizures in patients with epilepsy. Retigabine stabilizes
hyper-excited neurons primarily by opening neuronal potassium channels. The results of the key
Phase II study indicated that the compound is potentially efficacious with a demonstrated
statistically significant reduction in monthly seizure rates of 23% to 35% as adjunctive therapy in
patients with partial seizures.
Following a Special Protocol Assessment by the FDA, two Phase III trials of retigabine were
initiated in 2005. One Phase III trial (RESTORE 1; RESTORE stands for Retigabine Efficacy and
Safety Trial for partial Onset Epilepsy) was conducted at approximately 50 sites, mainly in the
Americas (U.S., Central/South America); the second Phase III trial (RESTORE 2) was conducted at
approximately 70 sites, mainly in Europe.
We announced clinical data results for RESTORE 1 on February 12, 2008. RESTORE 1 evaluated the
1200 mg daily dose of retigabine (the highest dose in the RESTORE program) versus placebo in
patients taking stable doses of one to three additional anti-epileptic drugs (AEDs). Retigabine
demonstrated statistically significant (p< 0.001) results on the primary efficacy endpoints
important for regulatory review by both the FDA and the European Medicines Evaluation Agency
(EMEA).
The intent-to-treat (ITT) median reduction in 28-day total partial seizure frequency from
baseline to the end of the double-blind period (the FDA primary efficacy endpoint), was 44.3%
(n=153) and 17.5% (n=152) for the retigabine arm and placebo arm of the trial, respectively. The
responder rate, defined as > 50% reduction in 28-day total partial seizure frequency
compared with the baseline period, during maintenance (the dual primary efficacy endpoint required
for the EMEA submission) was 55.5% (n=119) and 22.6% (n=137) for the retigabine arm and the placebo
arm of the trial, respectively.
46
During RESTORE 1, 26.8% of patients in the retigabine arm and 8.6% of patients in the placebo
arm withdrew due to adverse events. The most common side effects associated with retigabine in
RESTORE 1 included dizziness, somnolence, fatigue, confusion, dysarthria (slurring of speech),
ataxia (loss of muscle coordination), blurred vision, tremor, and nausea. Results of the study were
presented at the 8th European Congress on Epileptology, Berlin, Germany in September 2008.
On May, 13, 2008, we announced clinical data results for RESTORE 2. RESTORE 2 evaluated the
600 and 900 mg daily doses of retigabine versus placebo in patients taking stable doses of one to
three additional AEDs. Retigabine at both the 600 mg and 900 mg doses demonstrated highly
statistically significant results on the primary efficacy endpoints important for regulatory review
by both the FDA and the EMEA.
The ITT median reduction in 28-day total partial seizure frequency from baseline to the end of
the double-blind period (the FDA primary efficacy endpoint), was 15.9% (n=179), 27.9% (n=181) and
39.9% (n=178) for the placebo, retigabine 600 mg and retigabine 900 mg arms of the trial,
respectively. The responder rate, defined as > 50% reduction in 28-day total partial
seizure frequency compared with the baseline period, during maintenance (the dual primary efficacy
endpoint required for the EMEA submission) was 18.9% (n=164), 38.6% (n=158) and 47.0% (n=149) for
the placebo, retigabine 600 mg and retigabine 900 mg and placebo arms of the trial, respectively.
During RESTORE 2, 14.4% and 25.8% of patients in the retigabine 600 mg and 900 mg arms,
respectively, and 7.8% of patients in the placebo arm withdrew due to adverse events. As expected,
the most common side effects associated with retigabine in RESTORE 2 included dizziness,
somnolence, and fatigue and were generally seen at lower rates than at a 1200 mg dose in the
RESTORE 1 trial. Results of the study were presented at the 62nd American Epilepsy Society annual
meeting in Seattle, Washington in December 2008. We, along with our collaboration partner GSK, are
currently targeting a third quarter 2009 New Drug Application
(NDA) submission and expect to complete this event in 2009.
In March 2007, we initiated development of a modified release formulation of retigabine. In
addition, in November 2007, we began enrolling patients into a randomized, double-blind,
placebo-controlled Phase IIa study to evaluate the efficacy and tolerability of retigabine as a
treatment for neuropathic pain resulting from post-herpetic neuralgia. We completed enrollment at
the end of 2008, and we expect that clinical results will be available in August 2009.
As discussed in more detail in the subsection Collaboration Agreement above, in October
2008, we closed the worldwide Collaboration Agreement with GSK to develop and commercialize
retigabine and its backup compounds and received $125.0 million in upfront fees from GSK upon the
closing.
External research and development expenses for retigabine were $3.9 million ($5.5 million
total research and development expenses) and $10.1 million ($13.4 million total research and
development expenses) prior to the credit from the GSK Collaboration Agreement for the three and
six months ended June 30, 2009, respectively, compared with $12.2 million and $27.4 million for the
corresponding periods in 2008.
Taribavirin
Taribavirin (formerly referred to as viramidine) is a nucleoside (guanosine) analog that is
converted into ribavirin by adenosine deaminase in the liver and intestine. We are developing
taribavirin in oral form for the treatment of hepatitis C.
Preclinical studies indicated that taribavirin, a prodrug of ribavirin, has antiviral and
immunological activities (properties) similar to ribavirin. In 2006, we reported the results of two
pivotal Phase III trials for taribavirin. The Viramidine Safety and Efficacy Versus Ribavirin
(VISER) trials included two co-primary endpoints: one for safety (superiority to ribavirin in
incidence of anemia) and one for efficacy (non-inferiority to ribavirin in sustained viral response
(SVR)). The results of the VISER trials met the safety endpoint of a reduced incidence of anemia
but did not meet the efficacy endpoint.
The studies demonstrated that 38-40% of patients treated with taribavirin achieved SVR and
that the drug has a safety advantage over ribavirin by significantly reducing the number of
subjects who developed anemia, but that it
47
was not comparable to ribavirin in efficacy at the fixed dose of 600 mg which was studied. We
believe that the results of the studies were significantly impacted by the dosing methodology which
employed a fixed dose of taribavirin for all patients and a variable dose of ribavirin based on a
patients weight. Our analysis of the study results led us to believe that the dosage of
taribavirin, like ribavirin, likely needs to be based on a patients weight to achieve efficacy
equal or superior to that of ribavirin. Additionally, we think that higher doses of taribavirin
than those studied in the VISER program may be necessary to achieve our efficacy objectives and to
deliver doses of taribavirin derived ribavirin comparable to the doses of ribavirin that are used
as standard of care.
Based on our analysis, we initiated a Phase IIb study to evaluate the efficacy of taribavirin
at 20, 25 and 30 mg/kg in combination with pegylated interferon, compared with ribavirin in
combination with pegylated interferon. In the VISER program, taribavirin was administered in a
fixed dose of 600 mg BID (approximately equivalent to 13-18 mg/kg).
The Phase IIb study was a U.S. multi-center, randomized, parallel, open-label study in 278
treatment naïve, genotype 1 patients evaluating taribavirin at 20 mg/kg, 25 mg/kg, and 30 mg/kg per
day in combination with pegylated interferon alfa-2b. The control group was administered
weight-based dosed ribavirin (800/1,000/1,200/1,400 mg daily) and pegylated interferon alfa-2b.
Overall treatment duration was 48 weeks with a post-treatment follow-up period of 24 weeks. The
primary endpoints for this study were viral load reduction at treatment week 12 and anemia rates
throughout the study.
On March 17, 2008, we reported the results of the 12-week analysis of the taribavirin Phase
IIb study. The 12-week early viral response (EVR) data from the Phase IIb study showed comparable
reductions in viral load for weight-based doses of taribavirin and ribavirin. The anemia rate was
statistically significantly lower for patients receiving taribavirin in the 20mg/kg and 25mg/kg
arms versus the ribavirin control arm. The most common adverse events were fatigue, nausea,
flu-like symptoms, headache and diarrhea. The incidence rates among treatment arms were generally
comparable except with respect to diarrhea. Diarrhea was approximately twice as common in
taribavirin patients as ribavirin patients. However, the diarrhea was not treatment limiting for
taribavirin or ribavirin patients.
We presented results from the week-60 analysis for the Phase IIb dose-finding clinical trial
on April 23, 2009 at the European Association for the Study of Liver (EASL) 44th Annual Meeting in
Copenhagen, Denmark. On June 1, 2009, we reported final results for its Phase IIb dose-finding
clinical trial. Throughout the 72-week trial, all doses of taribavirin demonstrated comparable
efficacy (sustained virologic response (SVR)) to ribavirin with consistently lower levels of
anemia. In addition, relapse rates in the 25 mg/kg and 30 mg/kg arms were comparable with the
ribavirin arm; supporting the premise that higher dose weight-based taribavirin may be as effective
as weight based ribavirin. We plan to present the full final data at the American Association for
the Study of Liver Disease later this year.
We are actively seeking potential partners for the taribavirin program. External research and
development expenses for taribavirin were $0.6 million and $1.4 million for the three and six
months ended June 30, 2009, respectively, compared with $2.3 million and $5.1 million for the
corresponding periods in 2008.
Dermatology Products
A number of late stage dermatology product candidates in development were acquired as part of
the acquisition of Dow in December 2008. These include, but are not limited to:
IDP-107: IDP-107 is an antibiotic for the treatment of moderate to severe acne vulgaris.
Acne is a disorder of the pilosebaceous unit characterized by the presence of inflammatory
(pimples) and non-inflammatory (whiteheads and blackheads) lesions, predominately on the face.
Acne vulgaris is a common skin disorder that affects about 85% of people at some point in their
lives.
IDP-108: IDP-108, a novel triazole compound, is an antifungal targeted to treat
onychomycosis, a fungal infection of the fingernails and toenails primarily in older adults. The
mechanism of antifungal activity appears similar to other antifungal triazoles, i.e. ergosterol
synthesis inhibition. IDP-108 is a non-lacquer formulation
48
designed for topical delivery into the nail.
IDP-113: IDP-113 has the same active pharmaceutical ingredient as IDP-108. IDP-113 is a
topical therapy for the treatment of tinea capitis, which is a fungal infection of the scalp
characterized by redness, scaling and bald patches, particularly in children. There are currently
no approved topical treatments for this scalp condition.
IDP-115: IDP-115 combines an established anti-rosacea active ingredient with sunscreen
agents to provide sun protection in the same topical treatment for rosacea patients. Rosacea is
common condition treated by dermatologists and characterized by multiple signs and symptoms
including papules, pustules and erythema, most commonly on the central area of the face.
Foreign Operations
Approximately 57% and 67% of our revenues from continuing operations, which includes
royalties, for the six months ended June 30, 2009 and 2008, respectively, were generated from
operations outside the United States. All of our foreign operations are subject to risks inherent
in conducting business abroad, including possible nationalization or expropriation, price and
currency exchange controls, fluctuations in the relative values of currencies, political
instability and restrictive governmental actions. Changes in the relative values of currencies may,
in some instances, materially affect our 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 us to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting periods. On an on-going basis, we evaluate our estimates, including
those related to product returns, alliance revenue and expense offsets recognized under the GSK
Collaboration Agreement, collectibility of receivables, inventories, intangible assets, income
taxes and contingencies and litigation. The actual results could differ materially from those
estimates. See Item 7, Managements Discussion and Analysis of Financial Condition and Results of
Operations in our 2008 Annual Report 8-K for a discussion of our critical accounting estimates.
Other Financial Information
With respect to the unaudited consolidated condensed financial information of Valeant
Pharmaceuticals International for the three and six months ended June 30, 2009 and 2008,
PricewaterhouseCoopers LLP reported that they have applied limited procedures in accordance with
professional standards for a review of such information. However, their separate report dated
August 4, 2009, appearing herein, states that they did not audit and they do not express an opinion
on that unaudited consolidated condensed financial information. Accordingly, the degree of reliance
on their report on such information should be restricted in light of the limited nature of the
review procedures applied. PricewaterhouseCoopers LLP is not subject to the liability provisions of
Section 11 of the Securities Act of 1933, as amended (the Act) for their report on the unaudited
consolidated condensed financial information because that report is not a report or a part of a
registration statement prepared or certified by PricewaterhouseCoopers LLP within the meaning of
Sections 7 and 11 of the Act.
Forward-Looking Statements
Except for the historical information contained herein, the matters addressed in Managements
Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this
quarterly report on Form 10-Q constitute forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements may be identified by the use of the words
anticipates, expects, intends, plans, should, could, would, may,
49
will, believes, estimates, potential, or continue and variations or similar
expressions. These forward-looking statements are subject to a variety of risks and uncertainties
that could cause actual results to differ materially from those anticipated by our management.
Factors that might cause or contribute to these differences include the factors discussed in Part
I, Item 1A Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2008,
as updated by Part II, Item 1A Risk Factors of this Quarterly Report on Form 10-Q. Readers are
cautioned not to place undue reliance on any of these forward-looking statements, which speak only
as of the date of this report. We undertake no obligation to update any of these forward-looking
statements to reflect events or circumstances after the date of this report or to reflect actual
outcomes.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures About Market Risk |
Our business and financial results are affected by fluctuations in world financial markets. We
evaluate our exposure to such risks on an ongoing basis, and seek ways to manage these risks to an
acceptable level, based on managements judgment of the appropriate trade-off between risk,
opportunity and cost. We do not hold any significant amount of market risk sensitive instruments
whose value is subject to market price risk. Our significant foreign currency exposure relates to
the Polish Zloty, the Mexican Peso and the Canadian Dollar. During 2009, we entered into various
forward foreign currency contracts to: a) reduce our exposure to forecasted 2009 Japanese Yen
denominated royalty revenue, b) hedge our net investment in our Polish and Brazilian subsidiaries,
and c) utilize fair value hedges to reduce our exposure to various currencies as a result of
repetitive short-term intercompany investments and obligations. In the normal course of business,
we also face risks that are either non-financial or non-quantifiable. Such risks principally
include country risk, credit risk and legal risk and are not discussed or quantified in the
following analysis. At June 30, 2009, the fair value of our derivatives was (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notional/ |
|
Assets (Liabilities) |
|
|
Contract |
|
Carrying |
|
Fair |
Description |
|
Amount |
|
Value |
|
Value |
Undesignated hedges |
|
$ |
4,024 |
|
|
$ |
(15 |
) |
|
$ |
(15 |
) |
Net investment derivative contracts |
|
|
20,379 |
|
|
|
(1,652 |
) |
|
|
(1,652 |
) |
Fair value hedges |
|
|
23,891 |
|
|
|
(1,076 |
) |
|
|
(1,076 |
) |
Cash flow derivative contracts |
|
|
2,654 |
|
|
|
56 |
|
|
|
56 |
|
Interest rate swap |
|
|
2,264 |
|
|
|
(8 |
) |
|
|
(8 |
) |
We currently do not hold financial instruments for trading or speculative purposes. Our
financial assets are not subject to significant interest rate risk due to their short duration. A
100 basis-point increase in interest rates affecting our financial instruments would not have had a
material effect on our 2009 pretax earnings. In addition, we had $694.8 million of fixed rate debt
as of June 30, 2009 that required U.S. Dollar repayment. To the extent that we require, as a source
of debt repayment, earnings and cash flow from some of our subsidiaries located in foreign
countries, we are subject to risk of changes in the value of certain currencies relative to the
U.S. Dollar.
|
|
|
Item 4. |
|
Controls and Procedures |
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms and that such information
is accumulated and communicated to our management, including the chief executive officer and chief
financial officer, as appropriate, to allow timely decisions regarding required disclosure. In
designing and evaluating the disclosure controls and procedures, we recognize that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and that we necessarily are required to apply our
judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As of June 30, 2009, we conducted an evaluation of the effectiveness of the design and
operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the
Securities Exchange Act of 1934). This evaluation was carried out under the supervision and with
the participation of our management, including the chief
50
executive officer and chief financial officer. Based on this evaluation, our chief executive
officer and chief financial officer have concluded that, as of the end of the period covered by
this report, our disclosure controls and procedures were effective to ensure that information we
are required to disclose in the reports that we file or submit under the Securities Exchange Act of
1934, is recorded, processed, summarized and reported within the time periods specified in the
Securities and Exchange Commissions rules and forms relating to us, including our consolidated
subsidiaries, and was accumulated and communicated to our management, including our chief executive
officer and chief financial officer, as appropriate, to allow timely decisions regarding required
disclosure.
Changes in Internal Control over Financial Reporting
There has been no change in our internal controls over financial reporting that occurred
during the quarter ended June 30, 2009 that has materially affected, or is reasonably likely to
materially affect, the internal controls over financial reporting.
PART II OTHER INFORMATION
|
|
|
Item 1. |
|
Legal Proceedings |
See Note 13, Commitments and Contingencies, of the notes to consolidated condensed financial
statements in Item 1 of Part I of this quarterly report, which is incorporated herein by reference.
In addition to the other information contained in this Quarterly Report on Form 10-Q, you
should carefully consider the factors discussed in Part I, Item 1A Risk Factors in our Annual
Report on Form 10-K for the year ended December 31, 2008 in evaluating our business, financial
position, future results, and prospects. The information presented below updates and supplements
those risk factors for events, changes and developments since the filing of that Form 10-K and
should be read in conjunction with the risks and other information contained in that Form 10-K. The
risks described in our Form 10-K, as updated below, are not the only risks we face. Additional
risks that we do not presently know or that we currently believe are not material could also
materially adversely affect our business, financial position, future results and prospects.
If we, our partners or licensees cannot successfully develop or obtain future products and
commercialize those products, our growth would be delayed.
Our future growth will depend, in large part, upon our ability or the ability of our partners
or licensees to develop or obtain and commercialize new products and new formulations of, or
indications for, current products. We are engaged in an active development program involving
compounds which we may commercially develop in the future. Partners or licensees may also help us
develop these and other product candidates in the future and are responsible for developing other
product candidates that have been licensed to or acquired by them. The process of successfully
commercializing products is time consuming, expensive and unpredictable. There can be no assurance
that we, our partners or our licensees will be able to develop or acquire new products,
successfully complete clinical trials, obtain regulatory approvals to use these products for
proposed or new clinical indications, manufacture the potential products in compliance with
regulatory requirements or in commercial volumes, or gain market acceptance for such products. Our
existing licensing arrangements contain, and future licensing arrangements are likely to contain,
various provisions, such as repayment upon termination rights, that, if exercised, could have a
negative impact on our efforts to commercialize the applicable products, or on our Company in
general. In addition, changes in regulatory policy for product approval during the period of
product development and regulatory agency review of each submitted new application may cause delays
or rejections. It may be necessary for us to enter into other licensing arrangements with other
pharmaceutical companies in order to market effectively any new products or new indications for
existing products. There can be no assurance that we will be successful in entering into such
licensing arrangements on terms favorable to us or at all.
Any future revenue we may obtain under our worldwide license and collaboration agreement with
GSK is subject to the risks and uncertainties described above. In addition, there can be no
assurance that the clinical trials of any of our product candidates, including retigabine and
taribavirin, will be successful, that the product candidates
51
will be granted approval to be marketed for any of the indications being sought or that any of
the product candidates will result in a commercially successful product.
Our business, financial condition and results of operations are subject to risks arising from the
international scope of our operations.
We conduct a significant portion of our business outside the United States. Including
ribavirin royalties, approximately 63% of our revenues from continuing operations were generated
outside the United States during the years ended December 31, 2008 and 2007. We sell our
pharmaceutical products in many countries around the world. All of our foreign operations are
subject to risks inherent in conducting business abroad, including possible nationalization or
expropriation, price and currency exchange controls, fluctuations in the relative values of
currencies, political instability and restrictive governmental actions. The international scope of
our operations may also lead to volatile financial results and difficulties in managing our
operations because of, but not limited to, the following:
|
|
|
difficulties and costs of staffing, severance and benefit payments and managing
international operations; |
|
|
|
|
exchange controls, currency restrictions and exchange rate fluctuations; |
|
|
|
|
unexpected changes in regulatory requirements; |
|
|
|
|
price controls restrictions on products sold in the relevant countries; |
|
|
|
|
the burden of complying with multiple and potentially conflicting laws; |
|
|
|
|
the geographic, time zone, language and cultural differences between personnel in
different areas of the world; |
|
|
|
|
market share and product sales in certain markets being dependent on actions by and
relationships with key distributors; |
|
|
|
|
greater difficulty in collecting accounts receivables in and moving cash out of certain
geographic regions; |
|
|
|
|
difficulties from repatriating earnings in our foreign subsidiaries to the Company in a
manner that is tax efficient, or at all; and |
|
|
|
|
the need for a significant amount of available cash from operations to fund our business
in a number of geographic and economically diverse locations; and political, social and
economic instability in emerging markets in which we currently operate. |
Legislative or regulatory reform of the healthcare system may affect our ability to sell our
products profitably.
In both the United States and certain foreign jurisdictions, there have been a number of
legislative and regulatory proposals to change the healthcare system in ways that could impact our
ability to sell our products profitably. In recent years, new legislation has been proposed in the
United States at the federal and state levels that would effect major changes in the healthcare
system, either nationally or at the state level.
These proposals have included prescription drug benefit proposals for Medicare beneficiaries
introduced in Congress. Legislation creating a prescription drug benefit and making certain changes
in Medicaid reimbursement has recently been enacted by Congress and signed by the President. Given
this legislations recent enactment, it is still too early to determine its impact on the
pharmaceutical industry and our business. Further federal and state proposals are likely. The
potential for adoption of these proposals affects or will affect our ability to raise capital,
obtain additional collaborators and market our products. We expect to experience pricing pressures
in connection with the sale of our products due to the trend toward managed health care, the
increasing influence of health maintenance organizations and additional legislative proposals. Our
results of operations could be adversely affected by future health care reforms.
Many of our key processes, opportunities and expenses are a function of existing national and/or
local government regulation. Significant changes in regulations could have a material adverse
impact on our business.
The process by which pharmaceutical products are approved is lengthy and highly regulated. Our
multi-year clinical trials programs are planned and executed to conform to these regulations, and
once begun, can be difficult and expensive to change should the regulations regarding approval of
pharmaceutical products significantly change.
52
Failures to comply with the applicable legal requirements at any time during the product
development process, approval process or after approval may result in administrative or judicial
sanctions. These sanctions could include the FDAs imposition of a hold on clinical trials, refusal
to approve pending applications, withdrawal of an approval, warning letters, product recalls,
product seizures, total or partial suspension of production or distribution, injunctions, fines,
civil penalties or criminal prosecution. Any agency or judicial enforcement action could have a
material adverse effect on us. In addition, newly discovered or developed safety or effectiveness
data may require changes to a products approved labeling, including the addition of new warnings,
precautions and contraindications.
Manufacturers of drug products are required to comply with manufacturing regulations,
including current good manufacturing regulations enforced by the FDA and similar regulations
enforced by regulatory agencies outside the United States. In addition, we are subject to price
control restrictions on our pharmaceutical products in many countries in which we operate. We are
also subject to extensive health care marketing and fraud and abuse regulation by the federal and
state governments and foreign countries in which we may conduct our business. If our operations are
found to be in violation of any of these laws, regulations, rules or policies or any other law or
governmental regulation, or if interpretations of the foregoing change, we may be subject to civil
and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the
curtailment or restructuring of our operations.
In addition, we depend on patent law and data exclusivity to keep generic products from
reaching the market in our evaluations of the development of our products. In assessing whether we
will invest in any development program, or license a product from a third party, we assess the
likelihood of patent and/or data exclusivity under the laws and regulations then in effect. If
those schemes significantly change in a large market, or across many smaller markets, our ability
to protect our investment may be adversely affected.
Appropriate tax planning requires that we consider the current and prevailing national and
local tax laws and regulations, as well as international tax treaties and arrangements that we
enter into with various government authorities. Changes in national/local tax regulations or
changes in political situations may limit or eliminate the effects of our tax planning and could
result in unanticipated tax expenses.
We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar
worldwide anti-bribery laws.
The U.S. Foreign Corrupt Practices Act, or FCPA, and similar worldwide anti-bribery laws
generally prohibit companies and their intermediaries from making improper payments to non-U.S.
officials for the purpose of obtaining or retaining business. Our policies mandate compliance with
these anti-bribery laws.
We operate in many parts of the world that have experienced governmental corruption to some
degree and in certain circumstances, strict compliance with anti-bribery laws may conflict with
local customs and practices or may require us to interact with doctors and hospitals, some of which
may be state controlled, in a manner that is different than in the United States. Despite our
training and compliance program, we cannot assure you that our internal control policies and
procedures always will protect us from reckless or criminal acts committed by our employees or
agents. Violations of these laws, or allegations of such violations, could disrupt our business and
result in a material adverse effect on our financial condition, results of operations and cash
flows.
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
In October 2008, our board of directors authorized us to repurchase up to $200.0 million of
our outstanding common stock or convertible subordinated notes in a 24-month period ending October
2010, unless earlier terminated or completed. In May 2009, our board of directors increased the
authorization to $500.0 million, over a period ending in May 2011. Under the program, purchases may
be made from time to time on the open market, in privately negotiated transactions, pursuant to
tender offers or otherwise, including pursuant to one or more trading plans, at times and in
amounts as we see appropriate. The number of securities to be purchased and the timing of such
purchases are subject to various factors, which may include the price of our common stock, general
market conditions, corporate requirements and alternate investment opportunities. The securities
repurchase program may be modified or discontinued at any time. During the six months ended June
30, 2009, we purchased $117.6 million aggregate principal amount of our 3.0% Notes and 4.0% Notes
for $115.2 million in cash. In total, we have
53
purchased $150.2 million aggregate principal amount of our 3.0% Notes and 4.0% Notes at a
purchase price of $144.2 million as of June 30, 2009. During the six months ended June 30, 2009, we
purchased 1,108,970 shares of our common stock for a total of $25.7 million. As of June 30, 2009,
we have repurchased an aggregate 1,407,931 shares of our common stock for $31.8 million under this
program.
Set forth below is the information regarding shares repurchased under the stock repurchase
program during the three months ended June 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate Dollar |
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
|
Value of Shares that |
|
|
|
Total Number of |
|
|
Average Price |
|
|
Shares Purchased |
|
|
May Yet Be |
|
|
|
Shares |
|
|
Paid Per |
|
|
as Part of Publicly |
|
|
Purchased under the |
|
Period |
|
Repurchased |
|
|
Share |
|
|
Announced Plan |
|
|
Plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
4/1/09 - 4/30/09 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
100,680 |
|
5/1/09 - 5/31/09 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
366,361 |
|
6/1/09 - 6/30/09 |
|
|
1,108,970 |
|
|
$ |
23.17 |
|
|
|
1,108,970 |
|
|
$ |
324,038 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,108,970 |
|
|
$ |
23.17 |
|
|
|
1,108,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Item 4. |
|
Submission of Matters to a Vote of Security Holders |
At our 2009 annual meeting of stockholders held on May 12, 2009 (the Annual Meeting), our
stockholders elected Robert A. Ingram, Lawrence N. Kugelman and Theo Melas-Kyriazi as directors to
serve until our 2012 annual meeting of stockholders or until such directors respective successor
is elected and qualified. The term of office for the following directors whose terms expire at our
2010 annual meeting continued after the Annual Meeting: J. Michael Pearson, Norma Ann Provencio and
Stephen F. Stefano. The term of office for the following directors whose terms expire at our 2011
annual meeting continued after the Annual Meeting: Richard H. Koppes, Anders Lönner and G. Mason
Morfit.
At the Annual Meeting, our stockholders voted to ratify the appointment of
PricewaterhouseCoopers LLP as our independent registered public accounting firm for our fiscal year
ending December 31, 2009.
Voting at the Annual Meeting was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Votes Cast |
|
Votes Cast |
|
Votes |
|
Votes |
Matter |
|
For |
|
Against |
|
Withheld |
|
Abstain |
Election of Robert A. Ingram |
|
|
67,797,965 |
|
|
|
|
|
|
|
2,582,912 |
|
|
|
14,682 |
|
Election of Lawrence N. Kugelman |
|
|
70,005,464 |
|
|
|
|
|
|
|
370,346 |
|
|
|
19,748 |
|
Election of Theo Melas-Kyriazi |
|
|
69,865,666 |
|
|
|
|
|
|
|
508,849 |
|
|
|
1,894 |
|
Ratification of appointment of PricewaterhouseCoopers LLP |
|
|
70,224,101 |
|
|
|
158,296 |
|
|
|
|
|
|
|
13,163 |
|
54
Item 6. Exhibits
|
|
|
|
|
Exhibit |
|
3.1 |
|
|
Restated Certificate of Incorporation, as amended to date,
previously filed as Exhibit 3.1 to the Registrants Form 10-Q for
the quarter ended September 30, 2003 (File No. 03995078), which
is incorporated herein by reference. |
|
|
|
|
|
|
3.2 |
|
|
Certificate of Designation, Preferences and Rights of Series A
Participating Preferred Stock previously filed as Exhibit 3.1 to
the Registrants Current Report on Form 8-K, dated October 6,
2004, which is incorporated herein by reference. |
|
|
|
|
|
|
3.3 |
|
|
Certificate of Correction to Restated Certificate of
Incorporation, dated April 3, 2006, previously filed as Exhibit
3.3 to the Registrants Form 10-Q for the quarter ended September
30, 2007, which is incorporated herein by reference. |
|
|
|
|
|
|
3.4 |
|
|
Amended and Restated Bylaws of the Registrant previously filed as
Exhibit 3.1 to the Registrants Current Report on Form 8-K, dated
February 25, 2008, which is incorporated herein by reference. |
|
|
|
|
|
|
4.1 |
|
|
Form of Rights Agreement, dated as of November 2, 1994, between
the Registrant and American Stock Transfer & Trust Company, as
trustee, previously filed as Exhibit 4.3 to the Registrants
Registration Statement on Form 8-A, dated November 10, 1994 (No.
94558814), which is incorporated herein by reference. |
|
|
|
|
|
|
4.2 |
|
|
Amendment No. 1 to Rights Agreement, dated as of October 5, 2004,
by and between Valeant Pharmaceuticals International and American
Transfer & Trust Company as Rights Agent, previously filed as
Exhibit 4.1 to the Registrants Current Report on Form 8-K, dated
October 6, 2004, which is incorporated herein by reference. |
|
|
|
|
|
|
4.3 |
|
|
Amendment No. 2 to Rights Agreement, dated as of June 5, 2008, by
and between Valeant Pharmaceuticals International and American
Transfer & Trust Company as Rights Agent, previously filed as
Exhibit 4.3 to the Registrants Amendment No. 4 to Form 8-A/A,
filed June 6, 2008, which is incorporated herein by reference. |
|
|
|
|
|
|
4.4 |
|
|
Amendment No. 3 to Rights Agreement, dated as of May 15, 2009, by
and between Valeant Pharmaceuticals International and American
Transfer & Trust Company as Rights Agent, previously filed as
Exhibit 4.4 to the Registrants Amendment No. 5 to Form 8-A/A,
filed May 15, 2009, which is incorporated herein by reference. |
|
|
|
|
|
|
10.1 |
|
|
Agreement and Plan of Merger, dated December 9, 2008, by and
among Valeant Pharmaceuticals International, Descartes
Acquisition Corp., Dow Pharmaceutical Sciences, Inc., and Harris
Goodman, as Stockholder Representative, previously filed as
Exhibit 2.1 to the Registrants Current Report on Form 8-K/A,
filed May 22, 2009, which is incorporated herein by reference. |
|
|
|
|
|
|
10.2 |
|
|
Waiver, Release and Option Agreement for Taribavirin, effective
as of May 29, 2009, by and between Valeant Pharmaceuticals
International, Schering Corporation and Schering-Plough Ltd. |
|
|
|
|
|
|
10.3 |
|
|
Exchange and Registration Rights Agreement, dated as of June 9,
2009, by and among the Company, Goldman, Sachs & Co. and UBS
Securities LLC as Representative of the several Initial
Purchasers named therein and the Guarantors (as defined therein),
relating to the 8.375% Senior Notes due 2016, previously filed as
Exhibit 99.1 to the Registrants Current Report on Form 8-K,
filed June 11, 2009, which is incorporated herein by reference. |
|
|
|
|
|
|
10.4 |
|
|
Indenture, dated as of June 9, 2009, by and among the Company,
the Guarantors named therein and The Bank of New York Mellon
Trust Company, N.A., as Trustee, relating to the 8.375% Senior
Notes due 2016, previously filed as Exhibit 99.2 to the
Registrants Current Report on Form 8-K, filed June 11, 2009,
which is incorporated herein by reference. |
|
|
|
|
|
|
10.5 |
|
|
Purchase Agreement, dated as of June 3, 2009, by and among the
Company, the Purchasers named in Schedule I thereto and the
Guarantors (as defined therein), relating to the 8.375% Senior
Notes due |
55
|
|
|
|
|
|
|
|
|
2016, previously filed as Exhibit 99.3 to the
Registrants Current Report on Form 8-K, filed June 11, 2009,
which is incorporated herein by reference. |
|
|
|
|
|
|
15.1 |
|
|
Review Report of Independent Registered Public Accounting Firm. |
|
|
|
|
|
|
15.2 |
|
|
Awareness Letter of Independent Registered Public Accounting Firm. |
|
|
|
|
|
|
31.1 |
|
|
Certification of Chief Executive Officer pursuant to Rule
13a-14(a) under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
31.2 |
|
|
Certification of Chief Financial Officer pursuant to Rule
13a-14(a) under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.1 |
|
|
Certification of Chief Executive Officer and Chief Financial
Officer of Periodic Financial Reports pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002, 18 U.S.C. § 1350. |
|
|
|
|
|
Portions of this exhibit have been omitted pursuant to an Order Granting Confidential Treatment
issued by the SEC or a request for confidential treatment filed with the SEC. Such information has
been omitted and filed separately with the Securities and Exchange Commission. |
56
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this quarterly report on Form 10-Q to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
|
|
|
Valeant Pharmaceuticals International
Registrant
|
|
|
/s/ J. Michael Pearson
|
|
|
J. Michael Pearson |
|
Date: August 4, 2009 |
Chairman and Chief Executive Officer
|
|
|
|
|
|
|
/s/ Peter J. Blott
|
|
|
Peter J. Blott |
|
Date: August 4, 2009 |
Executive Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
57
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
3.1 |
|
|
Restated Certificate of Incorporation, as amended to date,
previously filed as Exhibit 3.1 to the Registrants Form 10-Q for
the quarter ended September 30, 2003(No. 03995078), which is
incorporated herein by reference. |
|
|
|
|
|
|
3.2 |
|
|
Certificate of Designation, Preferences and Rights of Series A
Participating Preferred Stock previously filed as Exhibit 3.1 to
the Registrants Current Report on Form 8-K, dated October 6,
2004, which is incorporated herein by reference. |
|
|
|
|
|
|
3.3 |
|
|
Certificate of Correction to Restated Certificate of
Incorporation, dated April 3, 2006, previously filed as Exhibit
3.3 to the Registrants Form 10-Q for the quarter ended September
30, 2007, which is incorporated herein by reference. |
|
|
|
|
|
|
3.4 |
|
|
Amended and Restated Bylaws of the Registrant previously filed as
Exhibit 3.1 to the Registrants Current Report on Form 8-K, dated
February 25, 2008, which is incorporated herein by reference. |
|
|
|
|
|
|
4.1 |
|
|
Form of Rights Agreement, dated as of November 2, 1994, between
the Registrant and American Stock Transfer & Trust Company, as
trustee, previously filed as Exhibit 4.3 to the Registrants
Registration Statement on Form 8-A, dated November 10, 1994 (No.
94558814), which is incorporated herein by reference. |
|
|
|
|
|
|
4.2 |
|
|
Amendment No. 1 to Rights Agreement, dated as of October 5, 2004,
by and between Valeant Pharmaceuticals International and American
Transfer & Trust Company as Rights Agent, previously filed as
Exhibit 4.1 to the Registrants Current Report on Form 8-K, dated
October 6, 2004, which is incorporated herein by reference. |
|
|
|
|
|
|
4.3 |
|
|
Amendment No. 2 to Rights Agreement, dated as of June 5, 2008, by
and between Valeant Pharmaceuticals International and American
Transfer & Trust Company as Rights Agent, previously filed as
Exhibit 4.3 to the Registrants Amendment No. 4 to Form 8-A/A,
filed June 6, 2008, which is incorporated herein by reference. |
|
|
|
|
|
|
4.4 |
|
|
Amendment No. 3 to Rights Agreement, dated as of May 15, 2009, by
and between Valeant Pharmaceuticals International and American
Transfer & Trust Company as Rights Agent, previously filed as
Exhibit 4.4 to the Registrants Amendment No. 5 to Form 8-A/A,
filed May 15, 2009, which is incorporated herein by reference. |
|
|
|
|
|
|
10.1 |
|
|
Agreement and Plan of Merger, dated December 9, 2008, by and
among Valeant Pharmaceuticals International, Descartes
Acquisition Corp., Dow Pharmaceutical Sciences, Inc., and Harris
Goodman, as Stockholder Representative, previously filed as
Exhibit 2.1 to the Registrants Current Report on Form 8-K/A,
filed May 22, 2009, which is incorporated herein by reference. |
|
|
|
|
|
|
10.2 |
|
|
Waiver, Release and Option Agreement for Taribavirin, effective
as of May 29, 2009, by and between Valeant Pharmaceuticals
International, Schering Corporation and Schering-Plough Ltd. |
|
|
|
|
|
|
10.3 |
|
|
Exchange and Registration Rights Agreement, dated as of June 9,
2009, by and among the Company, Goldman, Sachs & Co. and UBS
Securities LLC as Representative of the several Initial
Purchasers named therein and the Guarantors (as defined therein),
relating to the 8.375% Senior Notes due 2016, previously filed as
Exhibit 99.1 to the Registrants Current Report on Form 8-K,
filed June 11, 2009, which is incorporated herein by reference. |
|
|
|
|
|
|
10.4 |
|
|
Indenture, dated as of June 9, 2009, by and among the Company,
the Guarantors named therein and The Bank of New York Mellon
Trust Company, N.A., as Trustee, relating to the 8.375% Senior
Notes due 2016, previously filed as Exhibit 99.2 to the
Registrants Current Report on Form 8-K, filed June 11, 2009,
which is incorporated herein by reference. |
|
|
|
|
|
|
10.5 |
|
|
Purchase Agreement, dated as of June 3, 2009, by and among the
Company, the Purchasers named in |
|
|
|
|
|
|
|
|
|
Schedule I thereto and the
Guarantors (as defined therein), relating to the 8.375% Senior
Notes due 2016, previously filed as Exhibit 99.3 to the
Registrants Current Report on Form 8-K, filed June 11, 2009,
which is incorporated herein by reference. |
|
|
|
|
|
|
15.1 |
|
|
Review Report of Independent Registered Public Accounting Firm. |
|
|
|
|
|
|
15.2 |
|
|
Awareness Letter of Independent Registered Public Accounting Firm. |
|
|
|
|
|
|
31.1 |
|
|
Certification of Chief Executive Officer pursuant to Rule
13a-14(a) under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
31.2 |
|
|
Certification of Chief Financial Officer pursuant to Rule
13a-14(a) under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.1 |
|
|
Certification of Chief Executive Officer and Chief Financial
Officer of Periodic Financial Reports pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002, 18 U.S.C. § 1350. |
|
|
|
|
|
Portions of this exhibit have been omitted pursuant to an Order Granting Confidential
Treatment issued by the SEC or a request for confidential treatment filed with the SEC. Such
information has been omitted and filed separately with the Securities and Exchange Commission. |