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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q


ý

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended September 30, 2010

OR

o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                                to                               

Commission File Number: 001-14956

VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)

Canada
(State or other jurisdiction of
incorporation or organization)
  98-0448205
(I.R.S. Employer Identification No.)

7150 Mississauga Road, Mississauga, Ontario
(Address of principal executive offices)

 

L5N 8M5
(Zip Code)

(905) 286-3000
(Registrant's 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 ý    No o

        Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, 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 ý    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 definition of "large accelerated filer", "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

  Large accelerated filer ý   Accelerated filer o   Non-accelerated filer o
(Do not check if a smaller
reporting company)
  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 ý

        Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

        Common shares, no par value — 299,988,521 shares issued and outstanding at November 2, 2010


VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2010
INDEX

Part I.   Financial Information        

Item 1.

 

Financial Statements (unaudited)

 

 

1

 

 

 

Consolidated Balance Sheets as at September 30, 2010 and December 31, 2009

 

 

1

 

 

 

Consolidated Statements of Income (Loss) for the three months and nine months ended September 30, 2010 and 2009

 

 

2

 

 

 

Consolidated Statements of Accumulated Deficit for the three months and nine months ended September 30, 2010 and 2009

 

 

3

 

 

 

Consolidated Statements of Cash Flows for the three months and nine months ended September 30, 2010 and 2009

 

 

4

 

 

 

Notes to the Consolidated Financial Statements

 

 

5

 

Item 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

 

50

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

 

88

 

Item 4.

 

Controls and Procedures

 

 

88

 

Part II.

 

Other Information

 

 

 

 

Item 1.

 

Legal Proceedings

 

 

89

 

Item 1A.

 

Risk Factors

 

 

89

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

 

104

 

Item 3.

 

Defaults Upon Senior Securities

 

 

104

 

Item 4.

 

(Removed and Reserved)

 

 

104

 

Item 5.

 

Other Information

 

 

104

 

Item 6.

 

Exhibits

 

 

104

 

Signature

 

 

107

 

i


VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2010
INTRODUCTORY NOTE

        On September 28, 2010, Biovail Corporation completed the acquisition of Valeant Pharmaceuticals International through a wholly-owned subsidiary, pursuant to an Agreement and Plan of Merger, dated as of June 20, 2010, with Valeant Pharmaceuticals International surviving as a wholly-owned subsidiary of Biovail Corporation (the "Merger"). In connection with the Merger, Biovail Corporation was renamed "Valeant Pharmaceuticals International, Inc."

        Except where the context otherwise requires, all references in this Quarterly Report on Form 10-Q (this "Form 10-Q") to the "Company", "we", "us", "our" or similar words or phrases are to Valeant Pharmaceuticals International, Inc. and its subsidiaries, taken together, after giving effect to completion of the Merger; references to "Biovail" are to Biovail Corporation prior to the completion of the Merger and "Valeant" are to Valeant Pharmaceuticals International.

        All dollar amounts in this report are expressed in United States ("U.S.") dollars.

FORWARD-LOOKING STATEMENTS

        Caution regarding forward-looking information and statements and "Safe Harbor" statements under the U.S. Private Securities Litigation Reform Act of 1995:

        To the extent any statements made in this Form 10-Q contain information that is not historical, these statements are 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, and may be forward-looking information within the meaning defined under applicable Canadian securities legislation (collectively, "forward-looking statements").

        These forward looking statements relate to, among other things: the expected benefits of the Merger, such as cost savings, operating synergies and growth potential of the Company; business plans and prospects, prospective products or product approvals, future performance or results of current and anticipated products; the impact of healthcare reform; exposure to foreign currency exchange rate changes and interest rate changes; the outcome of contingencies, such as certain litigation and regulatory proceedings; general market conditions; and financial results.

        Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "continue", "will", "may", "could", "would", "target", "potential" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements may not be appropriate for other purposes. Although we have indicated above certain of these statements set out herein, all of the statements in this Form 10-Q that contain forward-looking statements are qualified by these cautionary statements. Although we believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, including, but not limited to, factors and assumptions regarding the items outlined above. Actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things, the following:

ii


        Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found elsewhere in this Form 10-Q, under Item 1A. "Risk Factors" of Biovail's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 (the "Biovail 2009 Form 10-K"), and in the Company's other filings with the SEC and CSA. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to our Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement, except as may be required by law.

iii



PART I.    FINANCIAL INFORMATION

Item 1.    Financial Statements


VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

CONSOLIDATED BALANCE SHEETS

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)

 
  At
September 30
2010
  At
December 31
2009
 

ASSETS

             

Current

             

Cash and cash equivalents

  $ 592,654   $ 114,463  

Marketable securities

    5,591     9,566  

Accounts receivable

    291,118     119,919  

Inventories

    295,279     82,773  

Prepaid expenses and other current assets

    41,167     15,377  

Deferred tax assets, net of valuation allowance

    70,597      

Assets held for sale

    4,042     8,542  
           

    1,300,448     350,640  

Marketable securities

    3,645     11,516  

Property, plant and equipment, net

    280,161     103,848  

Intangible assets, net

    6,470,596     1,335,222  

Goodwill

    2,963,947     100,294  

Deferred tax assets, net of valuation allowance

    88,646     132,800  

Other long-term assets, net

    28,460     32,724  
           

  $ 11,135,903   $ 2,067,044  
           

LIABILITIES

             

Current

             

Accounts payable

  $ 175,993   $ 72,022  

Dividends payable

    15,078     14,246  

Accrued liabilities

    448,489     121,898  

Accrued legal settlements

    40,500     7,950  

Income taxes payable

    15,260     6,846  

Deferred revenue

    23,326     21,834  

Deferred tax liabilities

    5,686      

Current portion of long-term debt

    121,590     12,110  
           

    845,922     256,906  

Deferred revenue

    55,032     69,247  

Long-term debt

    3,113,960     313,975  

Income taxes payable

    93,655     66,200  

Deferred tax liabilities

    1,549,578      

Other long-term liabilities

    128,092     6,344  
           

    5,786,239     712,672  
           

SHAREHOLDERS' EQUITY

             

Common shares, no par value, unlimited shares authorized, 295,136,949 and 158,310,884 issued and outstanding at September 30, 2010 and December 31, 2009, respectively

    5,189,589     1,465,004  

Additional paid-in capital

    580,872     91,768  

Accumulated deficit

    (467,744 )   (245,974 )

Accumulated other comprehensive income

    46,947     43,574  
           

    5,349,664     1,354,372  
           

  $ 11,135,903   $ 2,067,044  
           

Commitments and contingencies (note 14)

The accompanying notes are an integral part of the consolidated financial statements.

1



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

CONSOLIDATED STATEMENTS OF INCOME (LOSS)

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

 
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
 
  2010   2009   2010   2009  

REVENUE

                         

Product sales

  $ 201,372   $ 204,291   $ 644,650   $ 557,400  

Research and development

    455     3,392     6,096     10,362  

Royalty and other

    6,440     4,840     15,927     11,615  
                   

    208,267     212,523     666,673     579,377  
                   

EXPENSES

                         

Cost of goods sold (exclusive of amortization of intangible assets shown separately below)

    62,142     50,669     184,947     145,566  

Research and development

    14,298     23,202     118,443     82,422  

Selling, general and administrative

    60,187     44,774     148,794     137,516  

Amortization of intangible assets

    35,499     33,121     102,098     70,402  

Restructuring and other costs

    95,916     2,413     99,410     15,128  

Acquisition-related costs

    28,037         35,614     5,596  

Legal settlements

    38,500         38,500     241  
                   

    334,579     154,179     727,806     456,871  
                   

Operating income (loss)

    (126,312 )   58,344     (61,133 )   122,506  

Interest income

    126     238     548     823  

Interest expense

    (11,218 )   (10,998 )   (30,997 )   (14,850 )

Write-down of deferred financing charges

    (5,774 )       (5,774 )   (537 )

Foreign exchange gain

    301     197     345     918  

Loss on auction rate securities

    (5,005 )   (385 )   (5,552 )   (4,709 )

Gain on disposal of investments

        466         804  

Gain on auction rate security settlement

                22,000  
                   

Income (loss) before provision for income taxes

    (147,882 )   47,862     (102,563 )   126,955  

Provision for income taxes

    60,000     7,500     74,500     23,500  
                   

Net income (loss)

  $ (207,882 ) $ 40,362   $ (177,063 ) $ 103,455  
                   

Basic and diluted earnings (loss) per share

  $ (1.27 ) $ 0.25   $ (1.11 ) $ 0.65  
                   

Weighted-average number of common shares outstanding (000s)

                         

Basic

    163,295     158,231     160,082     158,225  

Diluted

    163,295     158,652     160,082     158,418  
                   

Cash dividends declared per share

  $ 0.095   $ 0.090   $ 0.280   $ 0.555  
                   

The accompanying notes are an integral part of the consolidated financial statements.

2



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

CONSOLIDATED STATEMENTS OF ACCUMULATED DEFICIT

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)

 
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
 
  2010   2009   2010   2009  

Accumulated deficit, beginning of period

  $ (244,669 ) $ (330,509 ) $ (245,974 ) $ (319,909 )

Net income (loss)

    (207,882 )   40,362     (177,063 )   103,455  

Cash dividends declared and dividend equivalents

    (15,193 )   (14,479 )   (44,707 )   (88,172 )
                   

Accumulated deficit, end of period

  $ (467,744 ) $ (304,626 ) $ (467,744 ) $ (304,626 )
                   

The accompanying notes are an integral part of the consolidated financial statements.

3



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)

 
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
 
  2010   2009   2010   2009  

CASH FLOWS FROM OPERATING ACTIVITIES

                         

Net income (loss)

  $ (207,882 ) $ 40,362   $ (177,063 ) $ 103,455  

Adjustments to reconcile net income (loss) to net cash provided by operating activities

                         

Depreciation and amortization

    42,338     43,293     122,619     102,447  

Amortization of deferred revenue

    (4,775 )   (5,300 )   (14,326 )   (15,901 )

Amortization of discounts on long-term debt

    2,712     2,682     8,350     3,246  

Amortization and write-down of deferred financing costs

    6,854     1,228     9,498     2,326  

Acquired in-process research and development

        8,126     61,245     38,540  

Deferred income taxes

    59,500     3,800     64,500     12,000  

Payment of accrued legal settlements

        (24,648 )   (5,950 )   (30,806 )

Addition to accrued legal settlements

    38,500         38,500     241  

Share-based compensation

    68,284     1,126     71,836     4,217  

Impairment charges

    5,405     385     5,952     12,392  

Gain on disposal of investments

        (466 )       (804 )

Other

    (346 )   (89 )   (1,022 )   80  

Changes in operating assets and liabilities:

                         
 

Accounts receivable

    17,966     (1,938 )   21,628     (9,303 )
 

Insurance recoveries receivable

                770  
 

Inventories

    1,752     (2,392 )   (4,070 )   (11,126 )
 

Prepaid expenses and other current assets

    (2,164 )   (6,085 )   3,072     (105 )
 

Accounts payable

    22,277     6,773     (8,019 )   (3,338 )
 

Accrued liabilities

    63,450     18,681     66,450     30,417  
 

Income taxes payable

    (2,929 )   886     2,148     1,576  
 

Deferred revenue

    (18 )   2,773     (758 )   (7,074 )
                   

Net cash provided by operating activities

    110,924     89,197     264,590     233,250  
                   

CASH FLOWS FROM INVESTING ACTIVITIES

                         

Acquisition of Valeant, net cash acquired

    308,982         308,982      

Acquisition of intangible assets

    (1,000 )   (8,126 )   (61,245 )   (549,015 )

Proceeds from sale of property, plant and equipment and other assets

    6,422     5,189     14,964     5,189  

Additions to property, plant and equipment

    (1,037 )   (1,083 )   (7,531 )   (2,711 )

Proceeds from sales and maturities of marketable securities

    2,000     13     6,965     1,078  

Acquisition of business, net of cash acquired

                (200,000 )

Proceeds from sale and leaseback of assets

                5,300  

Transfer to restricted cash

                (5,250 )

Additions to marketable securities

        (1,060 )       (3,823 )

Other

        553         923  
                   

Net cash provided by (used in) investing activities

    315,367     (4,514 )   262,135     (748,309 )
                   

CASH FLOWS FROM FINANCING ACTIVITIES

                         

Cash dividends paid

    (15,064 )   (14,240 )   (43,566 )   (132,902 )

Repayment of other long-term debt

            (12,500 )    

Proceeds from exercise of stock options

    4,474     26     7,272     44  

Issuance of 5.375% Convertible Notes

                350,000  

Advances under credit facility

                130,000  

Repayments under credit facility

        (75,000 )       (75,000 )

Financing costs paid

                (26,274 )

Other

                (393 )
                   

Net cash provided by (used in) financing activities

    (10,590 )   (89,214 )   (48,794 )   245,475  
                   

Effect of exchange rate changes on cash and cash equivalents

    387     1,019     260     1,443  
                   

Net increase (decrease) in cash and cash equivalents

    416,088     (3,512 )   478,191     (268,141 )

Cash and cash equivalents, beginning of period

    176,566     52,918     114,463     317,547  
                   

Cash and cash equivalents, end of period

  $ 592,654   $ 49,406   $ 592,654   $ 49,406  
                   

NON-CASH INVESTING AND FINANCING ACTIVITIES

                         

Acquisition of Valeant, equity issued

  $ (3,880,301 ) $   $ (3,880,301 ) $  

Cash dividends declared but unpaid

    (15,078 )   (14,241 )   (15,078 )   (14,241 )

Long-term obligation related to acquisition of business

                (26,768 )

The accompanying notes are an integral part of the consolidated financial statements.

4



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

1.     DESCRIPTION OF BUSINESS

2.     SIGNIFICANT ACCOUNTING POLICIES

5



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

2.     SIGNIFICANT ACCOUNTING POLICIES (Continued)

3.     BIOVAIL MERGER WITH VALEANT

6



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

 
(Number of shares, stock options and restricted
share units in thousands)
  Conversion
Calculation
  Fair
Value
  Form of
Consideration
 

Number of common shares of Biovail issued in exchange for Valeant common stock outstanding as of the Merger Date

    139,137          
 

Multiplied by Biovail's stock price as of the Merger Date(a)

  $ 26.35   $ 3,666,245   Common shares
                 
 

Number of common shares of Biovail expected to be issued pursuant to vested Valeant restricted share units ("RSUs") as a result of the Merger

    1,694          
 

Multiplied by Biovail's stock price as of the Merger date(a)

  $ 26.35     44,643   Common shares
                 
 

Fair value of vested and partially vested Valeant stock options converted into Biovail stock options

          110,687   Stock options(b)
 

Fair value of vested and partially vested Valeant RSUs converted into Biovail RSUs

          58,726   RSUs(c)
 

Cash consideration

          39,655   Cash(d)
                 
 

Total fair value of consideration transferred

        $ 3,919,956    
                 
(a)
As the Merger was effective at 12:01 a.m. on September 28, 2010, the conversion calculation reflects the closing price of Biovail's common shares on the New York Stock Exchange ("NYSE") at September 27, 2010.

7



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

(b)
The fair value of the vested and partially vested portions of Valeant stock options that were converted into stock options of Biovail was recognized as a component of the consideration transferred, based on a weighted-average fair value of $17.63 per stock option, which was calculated using the Black-Scholes option pricing model. This calculation considered the closing price of Biovail's common shares of $26.35 per share as of the Merger Date and the following assumptions:

  Expected volatility     32.9%            
  Expected life       3.4 years      
  Risk-free interest rate     1.1%            
  Expected dividend yield     1.5%            
(c)
The fair value of the vested portion of Valeant time-based and performance-based RSUs converted into RSUs of Biovail was recognized as a component of the purchase price. The fair value of the vested portion of the Valeant time-based RSUs was determined based on the closing price of Biovail's common share of $26.35 per share as of the Merger Date. The fair value of Valeant performance-based RSUs was determined using a Monte Carlo simulation model, which utilizes multiple input variables to estimate the probability that the performance condition will be achieved.
(d)
Represents income tax withholdings paid by Biovail on behalf of employees of Valeant, in connection with the net share settlement of certain vested Valeant RSUs as of the Merger Date.

8



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

   
  Amounts
Recognized as of
Merger Date
 
 

Cash and cash equivalents

  $ 348,637  
 

Accounts receivable(a)

    194,930  
 

Inventories(b)

    208,874  
 

Other current assets(c)

    33,460  
 

Property, plant and equipment

    184,757  
 

Identifiable intangible assets, excluding in-process research and development ("IPR&D")(d)

    3,844,310  
 

IPR&D(e)

    1,399,956  
 

Other non-current assets

    5,905  
 

Current liabilities(f)

    (384,223 )
 

Long-term debt, including current portion(g)

    (3,167,585 )
 

Deferred income taxes, net(h)

    (1,472,321 )
 

Other non-current liabilities(i)

    (140,397 )
         
 

Total indentifiable net assets

    1,056,303  
 

Goodwill(j)

    2,863,653  
         
 

Net assets acquired

  $ 3,919,956  
         
(a)
The fair value of accounts receivable acquired was $194,930,000, which comprised trade receivables ($151,852,000) and royalty and other receivables ($43,078,000). The gross contractual amount of trade receivables was $158,990,000, of which the Company expects that $7,138,000 will be uncollectible.

(b)
Reflects a provisional adjustment of $72,096,000 to record Valeant's inventory at its estimated fair value.

(c)
Includes prepaid expenses and assets held for sale.

(d)
The following table summarizes the provisional amounts and useful lives assigned to identifiable intangible assets:

   
  Useful
Lives
(Years)
  Amounts
Recognized as of
Merger Date
 
 

Finite-lived intangible assets:

             
   

Product brands

    10-20   $ 3,114,689  
   

Product rights

    5-15     360,970  
   

Out-licensed technology and other

    7-10     200,049  
               
   

Total finite-lived intangible assets

          3,675,708  
 

Indefinite-lived intangible assets:

             
   

Corporate brands

    N/A     168,602  
               
 

Total identifiable intangible assets acquired

        $ 3,844,310  
               
(e)
Acquired IPR&D assets are initially recognized at fair value and are classified as indefinite-lived intangible assets until the successful completion or abandonment of the associated research and development efforts. The significant components of the

9



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

   
  Amounts
Recognized as of
Merger Date
 
  Ezogabine/retigabine   $ 891,461  
  Dermatology products     431,323  
  Other     77,172  
         
  Total IPR&D assets acquired   $ 1,399,956  
         
(f)
Includes accounts payable, accrued liabilities and income taxes payable.

(g)
As described in note 10, in connection with the Merger, Valeant secured financing of $125,000,000 under a senior secured revolving credit facility (the "Revolving Credit Facility"), $1,000,000,000 under a senior secured term loan A facility (the "Term Loan A Facility"), and $1,625,000,000 under a senior secured term loan B facility (the "Term Loan B Facility"), and used a portion of the proceeds to undertake the following transactions prior to the Merger Date:

fund the payment of the special dividend of $16.77 per share of Valeant common stock to Valeant stockholders of record;

fund the legal defeasance of Valeant's existing 8.375% and 7.625% senior unsecured notes, by depositing with the trustees amounts sufficient to pay 100% of the outstanding aggregate principal amount of the notes, plus applicable premium and accrued and unpaid interest, on October 27, 2010; and

fund the repayment in full of indebtedness under Valeant's existing senior secured term loan.

10



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

   
  Amounts
Recognized as of
Merger Date
 
 

Term Loan A Facility

  $ 1,000,000  
 

Term Loan B Facility

    500,000  
 

6.75% Senior Notes

    497,500  
 

7.00% Senior Notes

    695,625  
 

4.0% Convertible Notes

    474,460  
         
 

Total long-term debt assumed

  $ 3,167,585  
         
(h)
Comprises current deferred tax assets ($85,623,000), non-current deferred tax assets ($4,320,000), current deferred tax liabilities ($5,686,000) and non-current deferred tax liabilities ($1,556,578,000).

(i)
Includes the fair value of contingent consideration related to Valeant's acquisition of Princeton Pharma Holdings LLC, and its wholly-owned operating subsidiary, Aton Pharma, Inc., on May 26, 2010. The aggregate fair value of the contingent consideration was determined to be $21,583,000 as of the Merger Date. The contingent consideration consists of future milestones predominantly based upon the achievement of approval and commercial targets for certain pipeline products (which are included in the fair value ascribed to IPR&D assets acquired, as described above under (e)). The range of the undiscounted amounts the Company could be obligated to pay as contingent consideration ranges from nil to $390,000,000.

(j)
Goodwill is calculated as the difference between the Merger Date fair value of the consideration transferred and the provisional values assigned to the assets acquired and liabilities assumed. None of the goodwill is expected to be deductible for tax purposes. The goodwill recorded represents the following:

cost savings, operating synergies and other benefits expected to result from combining the operations of Valeant with those of Biovail;

the value of the going-concern element of Valeant's existing business (that is, the higher rate of return on the assembled net assets versus if Biovail had acquired all of the net assets separately); and

intangible assets that do not qualify for separate recognition (for instance, Valeant's assembled workforce), as well as future, as yet unidentified research and development projects.

11



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

 

Share-based compensation expense related to vested and partially vested Valeant stock options and RSUs

  $ 20,909  
 

Amortization expense related to acquired finite-lived intangible assets

    2,200  
 

Interest expense related to assumed long-term debt

    1,692  
         
 

Total

  $ 24,801  
         

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Revenue

  $ 467,499   $ 432,841   $ 1,413,470   $ 1,169,316  
 

Net income (loss)

    (111,518 )   23,190     (84,056 )   6,839  

12



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     BIOVAIL MERGER WITH VALEANT (Continued)

4.     ASSET ACQUISITIONS

13



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

4.     ASSET ACQUISITIONS (Continued)

5.     RESTRUCTURING AND INTEGRATION

   
  Employee Termination Costs    
   
 
   
  Severance and
Related Benefits
  Share-Based
Compensation
  Other Costs   Total  
  Costs incurred and charged to expense   $ 46,326   $ 45,665   $ 2,976   $ 94,967  
  Cash payments     (2,188 )           (2,188 )
  Non-cash adjustments         (45,665 )       (45,665 )
                     
  Balance, September 30, 2010   $ 44,138   $   $ 2,976   $ 47,114  
                     

14



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

5.     RESTRUCTURING AND INTEGRATION (Continued)

 
Program
  Counterparty   Compound   Contingent
Milestone
Obligations
Terminated(1)
  Termination
Payments
 
  AZ-004   Alexza   Staccato® loxapine   $ 90,000,000     Nil  
  BVF-007   Cortex   AMPAKINE®   $ 15,000,000     Nil  
  BVF-014   MedGenesis Therapeutix Inc.   GDNF   $ 20,000,000   $ 5,000,000 (2)
  BVF-025   Santhera Pharmaceuticals (Switzerland) Ltd.   Fipamezole   $ 200,000,000     Nil  
  BVF-036,
-040, -048
  ACADIA Pharmaceuticals Inc.   Pimavanserin   $ 365,000,000   $ 8,750,000 (2)
(1)
Represent the maximum amount of milestone payments the Company could have been required to make to the counterparty under each agreement. These milestone payments were contingent on the achievement of specific developmental, regulatory and commercial milestones. In addition, the Company could have been obligated to make royalty payments based on future net sales of the products if regulatory approval was obtained. As a consequence of the termination of these arrangements, the Company has no ongoing or future obligation in respect of these milestone or royalty payments.

(2)
Represents the amount of negotiated settlements with each counterparty, which will be recognized by the Company in the three-month period ended December 31, 2010.

15



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

5.     RESTRUCTURING AND INTEGRATION (Continued)

   
  Asset Impairments   Employee Termination Costs    
   
 
   
  Contract
Termination
and Other
Costs
   
 
   
  Manufacturing   Pharmaceutical
Sciences
  Manufacturing   Pharmaceutical
Sciences
  Total  
 

Balance, January 1, 2008

  $   $   $   $   $   $  
 

Costs incurred and charged to expense

    42,602     16,702     3,309     2,724     4,865     70,202  
 

Cash payments

                (2,724 )   (333 )   (3,057 )
 

Non-cash adjustments

    (42,602 )   (16,702 )           (1,186 )   (60,490 )
                             
 

Balance, December 31, 2008

            3,309         3,346     6,655  
                             
 

Costs incurred and charged to expense

    7,591     2,784     4,942     1,441     2,307     19,065  
 

Cash payments

            (2,041 )   (1,278 )   (1,321 )   (4,640 )
 

Non-cash adjustments

    (7,591 )   (2,784 )       71         (10,304 )
                             
 

Balance, December 31, 2009

            6,210     234     4,332     10,776  
                             
 

Costs incurred and charged to expense

            333         280     613  
 

Cash payments

            (2,703 )   (195 )   (429 )   (3,327 )
 

Non-cash adjustments

                6         6  
                             
 

Balance, March 31, 2010

            3,840     45     4,183     8,068  
                             
 

Costs incurred and charged to expense

            708     1,924     249     2,881  
 

Cash payments

            (820 )       (435 )   (1,255 )
 

Non-cash adjustments

                (46 )       (46 )
                             
 

Balance, June 30, 2010

            3,728     1,923     3,997     9,648  
                             
 

Costs incurred and charged to expense

    400         392         157     949  
 

Cash payments

            (1,240 )   (1,862 )   (331 )   (3,433 )
 

Non-cash adjustments

    (400 )                   (400 )
                             
 

Balance, September 30, 2010

  $   $   $ 2,880   $ 61   $ 3,823   $ 6,764  
                             

16



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

5.     RESTRUCTURING AND INTEGRATION (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
  Research and development revenue   $ 409   $ 2,835   $ 5,642   $ 9,090  
                     
  Research and development expenses     532     3,526     7,211     10,510  
  Selling, general and administrative expenses     650     746     2,328     2,507  
                     
  Total operating expenses     1,182     4,272     9,539     13,017  
                     
  Operating loss     (773 )   (1,437 )   (3,897 )   (3,927 )
  Foreign exchange gain (loss)     6     (51 )   (102 )   110  
                     
  Net loss   $ (767 ) $ (1,488 ) $ (3,999 ) $ (3,817 )
                     

17



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

6.     FAIR VALUE MEASUREMENTS

   
  At September 30, 2010  
   
  Carrying
Value
  Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 
 

Money market funds

  $ 221,293   $ 221,293   $   $  
 

Available-for-sale debt securities:

                         
   

Corporate bonds

    7,390         7,390      
   

Government-sponsored enterprise securities

    1,846         1,846      
                     
 

Total financial assets

  $ 230,529   $ 221,293   $ 9,236   $  
                     
 

Cash and cash equivalents

  $ 221,293   $ 221,293   $   $  
 

Marketable securities

    9,236         9,236      
                     
 

Total financial assets

  $ 230,529   $ 221,293   $ 9,236   $  
                     

 

   
  At December 31, 2009  
   
  Carrying
Value
  Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 
 

Money market funds

  $ 7,994   $ 7,994   $   $  
 

Available-for-sale debt securities:

                         
   

Corporate bonds

    10,880         10,880      
   

Government-sponsored enterprise securities

    4,193         4,193      
   

Auction rate securities

    6,009             6,009  
                     
 

Total financial assets

  $ 29,076   $ 7,994   $ 15,073   $ 6,009  
                     
 

Cash and cash equivalents

  $ 7,994   $ 7,994   $   $  
 

Marketable securities

    21,082         15,073     6,009  
                     
 

Total financial assets

  $ 29,076   $ 7,994   $ 15,073   $ 6,009  
                     

18



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

6.     FAIR VALUE MEASUREMENTS (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Balance, beginning of period

  $ 6,016   $ 6,604   $ 6,009   $ 10,333  
 

Total unrealized gains (losses):

                         
   

Included in net income (loss)(1):

                         
     

Arising during period

    (4,616 )   (156 )   (5,163 )   (3,978 )
     

Reclassification from other comprehensive income

    (389 )   (229 )   (389 )   (731 )
   

Included in other comprehensive income:

                         
     

Arising during period

        73     554     166  
     

Reclassification to net income (loss)

    389     229     389     731  
 

Settlement

    (1,400 )       (1,400 )    
                     
 

Balance, end of period

  $   $ 6,521   $   $ 6,521  
                     
   

Total amount of unrealized losses for the period included in net income relating to securities still held at end of period

  $   $ (385 ) $   $ (4,709 )
                     

19



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

7.     FAIR VALUE OF FINANCIAL INSTRUMENTS

   
  At September 30, 2010  
   
  Carrying
Value
  Fair
Value
 
 

Cash equivalents

  $ 221,293   $ 221,293  
 

Marketable securities

    9,236     9,236  
 

Long-term debt (as described in note 10)

    (3,235,550 )   (3,775,798 )

 

   
  At December 31, 2009  
   
  Carrying
Value
  Fair
Value
 
 

Cash equivalents

  $ 7,994   $ 7,994  
 

Marketable securities

    21,082     21,082  
 

Long-term debt (as described in note 10)

    (326,085 )   (434,518 )

   
  At September 30, 2010  
   
   
   
  Gross Unrealized  
   
  Cost
Basis
  Fair
Value
 
   
  Gains   Losses  
 

Corporate bonds

  $ 7,251   $ 7,390   $ 139   $  
 

Government-sponsored enterprise securities

    1,832     1,846     14      
                     
 

  $ 9,083   $ 9,236   $ 153   $  
                     

 

   
  At December 31, 2009  
   
   
   
  Gross Unrealized  
   
  Cost
Basis
  Fair
Value
 
   
  Gains   Losses  
 

Corporate bonds

  $ 10,626   $ 10,880   $ 254   $  
 

Government-sponsored enterprise securities

    4,100     4,193     93      
 

Auction rate securities

    26,775     6,009         (20,766 )
                     
 

  $ 41,501   $ 21,082   $ 347   $ (20,766 )
                     

   
  Carrying
Value
  Fair
Value
 
 

Within one year

  $ 5,591   $ 5,591  
 

One to two years

    3,645     3,645  
             
 

  $ 9,236   $ 9,236  
             

20



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

7.     FAIR VALUE OF FINANCIAL INSTRUMENTS (Continued)

8.     INVENTORIES

   
  At
September 30
2010
  At
December 31
2009
 
 

Raw materials

  $ 63,254   $ 14,290  
 

Work in process

    28,393     25,012  
 

Finished goods

    203,632     43,471  
             
 

  $ 295,279   $ 82,773  
             

9.     INTANGIBLE ASSETS

   
  At September 30, 2010   At December 31, 2009  
   
  Gross
Carrying
Value
  Accumulated
Amortization
  Net
Carrying
Value
  Gross
Carrying
Value
  Accumulated
Amortization
  Net
Carrying
Value
 
 

Finite-lived intangible assets:

                                     
   

Product brands

  $ 4,198,915   $ (329,115 ) $ 3,869,800   $ 1,084,226   $ (267,249 ) $ 816,977  
   

Product rights

    1,054,196     (249,827 )   804,369     693,126     (202,881 )   490,245  
   

Out-licensed technology and other

    200,049     (180 )   199,869              
                             
   

Total finite-lived intangible assets

    5,453,160     (579,122 )   4,874,038     1,777,352     (470,130 )   1,307,222  
                             
 

Indefinite-lived intangible assets:

                                     
   

IPR&D

    1,427,956         1,427,956     28,000         28,000  
   

Corporate brands

    168,602         168,602              
                             
   

Total indefinite-lived intangible assets

    1,596,558         1,596,558     28,000         28,000  
                             
 

Total intangible assets

  $ 7,049,718   $ (579,122 ) $ 6,470,596   $ 1,805,352   $ (470,130 ) $ 1,335,222  
                             

21



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

9.     INTANGIBLE ASSETS (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Royalty and other revenue

  $ 268   $ 268   $ 804   $ 804  
 

Cost of goods sold

    2,026     2,026     6,077     6,077  
 

Amortization expense

    35,499     33,121     102,098     70,402  
                     
 

  $ 37,793   $ 35,415   $ 108,979   $ 77,283  
                     

10.   LONG-TERM DEBT

   
  At
September 30
2010
  At
December 31
2009
 
 

Term Loan A Facility

  $ 1,000,000   $  
 

Term Loan B Facility

    500,000      
 

6.75% Senior Notes, net of unamortized debt discount of $2,500

    497,500      
 

7.00% Senior Notes, net of unamortized debt discount of $4,375

    695,625      
 

5.375% Convertible Notes, net of unamortized debt discount

           
   

(September 30, 2010 — $44,654; December 31, 2009 — $51,715)

    305,346     298,285  
 

4.0% Convertible Notes, net of unamortized debt discount of $4,471

    220,489      
 

Cambridge obligation, net of unamortized debt discount

             
   

(September 30, 2010 — $910; December 31, 2009 — $2,200)

    16,590     27,800  
             
 

    3,235,550     326,085  
 

Less current portion

    121,590     12,110  
             
 

  $ 3,113,960   $ 313,975  
             

22



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

10.   LONG-TERM DEBT (Continued)

 

2010

  $ 26,250  
 

2011

    122,500  
 

2012

    130,000  
 

2013

    429,960  
 

2014

    605,000  
 

Thereafter

    1,978,750  
         
 

Total gross maturities

    3,292,460  
 

Unamortized discounts

    (56,910 )
         
 

Total long-term debt

  $ 3,235,550  
         

23



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

10.   LONG-TERM DEBT (Continued)

24



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

10.   LONG-TERM DEBT (Continued)

25



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

10.   LONG-TERM DEBT (Continued)

26



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

10.   LONG-TERM DEBT (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Cash interest per contractual coupon rate

  $ 4,703   $ 4,703   $ 14,109   $ 5,800  
 

Non-cash amortization of debt discount

    2,408     2,199     7,062     2,705  
                     
 

  $ 7,111   $ 6,902   $ 21,171   $ 8,505  
                     

27



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

10.   LONG-TERM DEBT (Continued)

11.   SHAREHOLDERS' EQUITY

   
  Common Shares    
   
   
   
 
   
   
   
  Accumulated
Other
Comprehensive
Income
   
 
   
  Shares
(000s)(1)
  Amount   Paid-In
Additional
Capital
  Accumulated
Deficit
  Total  
 

Balance, January 1, 2010

    158,311   $ 1,465,004   $ 91,768   $ (245,974 ) $ 43,574   $ 1,354,372  
 

Acquisition of Valeant

    140,831     3,710,888     169,413             3,880,301  
 

Equity component of 4.0% Convertible Notes

            253,971             253,971  
 

Share-based compensation

            71,836             71,836  
   

Common shares issued under share-based compensation plans

    796     13,697     (6,425 )           7,272  
   

Cash dividends declared and dividend equivalents ($0.28 per share)

            309     (44,707 )       (44,398 )
                             
 

    299,938     5,189,589     580,872     (290,681 )   43,574     5,523,354  
                             
 

Comprehensive loss:

                                     
   

Net loss

                (177,063 )       (177,063 )
   

Other comprehensive income

                    3,373     3,373  
                             
 

Total comprehensive loss

                (177,063 )   3,373     (173,690 )
                             
 

Balance, September 30, 2010

    299,938   $ 5,189,589   $ 580,872   $ (467,744 ) $ 46,947   $ 5,349,664  
                             
(1)
Represents common shares issued and outstanding and common shares issuable in connection with the Merger.

28



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

11.   SHAREHOLDERS' EQUITY (Continued)

29



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

11.   SHAREHOLDERS' EQUITY (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
  Stock options   $ 41,082   $ 524   $ 42,264   $ 2,144  
  RSUs     27,202     602     29,572     2,073  
                     
  Stock-based compensation expense   $ 68,284   $ 1,126   $ 71,836   $ 4,217  
                     
  Cost of goods sold(1)   $ 536   $ 131   $ 797   $ 419  
  Research and development expenses(1)     648     151     1,107     591  
  Selling, general and administrative expenses(1)     21,435     844     24,267     3,207  
  Restructuring and other costs(2)     45,665         45,665      
                     
  Stock-based compensation expense   $ 68,284   $ 1,126   $ 71,836   $ 4,217  
                     
(1)
Includes the excess of the fair value of Biovail stock options and time-based RSUs over the fair value of the vested and partially vested Valeant stock options and time-based RSUs of $20,909,000 (as described in note 3), which was recognized immediately as post-Merger compensation expense and allocated as follows: cost of goods sold ($418,000), research and development expenses ($418,000), and selling, general and administrative expenses ($20,073,000).

(2)
As described below, the components of share-based compensation recorded in restructuring and other costs were as follows:

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Stock options and time-based RSUs held by Biovail employees with employment agreements

  $ 5,805   $   $ 5,805   $  
 

Stock options held by Biovail employees without employment agreements

    (492 )       (492 )    
 

Performance-based RSUs held by Biovail executive officers and selected employees

    20,287         20,287      
 

Stock options and RSUs held by former executive officers of Valeant

    20,065         20,065      
                     
 

  $ 45,665   $   $ 45,665   $  
                     

30



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

11.   SHAREHOLDERS' EQUITY (Continued)

   
  Stock
Options
  Time-
Based
RSUs
  Performance-
Based
RSUs
 
 

Number of awards issued (000s)

    12,464     2,217     1,212  
   

Total compensation cost related to unvested awards to be recognized

  $ 66,520   $ 30,558   $ 24,998  
   

Weighted-average service period over which compensation cost is expected to be recognized (months)

    18     25     34  

31



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

11.   SHAREHOLDERS' EQUITY (Continued)

   
  Options
(000s)
  Weighted-
Average
Exercise
Price
  Weighted-
Average
Remaining
Contractual
Term
(Years)
  Aggregate
Intrinsic
Value
 
  Outstanding, January 1, 2010     3,988   $ 17.02              
  Granted     905     15.33              
  Conversion of Valeant awards     12,464     8.59              
  Exercised     (490 )   14.73              
  Expired or forfeited     (802 )   20.44              
                           
  Outstanding, September 30, 2010     16,065   $ 10.28     6.4   $ 237,305  
                     
  Vested and exercisable, September 30, 2010     7,703   $ 9.80     4.7   $ 117,527  
                     

   
  Time-Based
RSUs
(000s)
  Weighted-
Average
Grant-Date
Fair Value
 
 

Non-vested, January 1, 2010

    379   $ 11.71  
 

Granted

    209     14.95  
 

Conversion of Valeant awards

    2,217     26.35  
 

Reinvested dividend equivalents

    7     16.85  
 

Vested

    (175 )   19.74  
 

Forfeited

    (43 )   12.94  
               
 

Non-vested, September 30, 2010

    2,594   $ 23.94  
             

32



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

11.   SHAREHOLDERS' EQUITY (Continued)

   
  Performance-
Based RSUs
(000s)
  Weighted-
Average
Grant-Date
Fair Value
 
  Non-vested, January 1, 2010     676   $ 18.94  
  Granted     107     22.29  
  Conversion of Valeant awards     1,212     52.72  
  Reinvested dividend equivalents     12     19.39  
  Vested and released     (219 )   20.28  
  Vested and to be released     (576 )   19.30  
               
  Non-vested, September 30, 2010     1,212   $ 52.72  
             

   
  DSUs
(000s)
  Weighted-
Average
Grant-Date
Fair Value
 
  Outstanding, January 1, 2010     343   $ 12.82  
  Granted     101     15.82  
  Reinvested dividend equivalents     6     16.81  
               
  Outstanding, September 30, 2010     450   $ 13.54  
             

33



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

11.   SHAREHOLDERS' EQUITY (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Net income (loss)

  $ (207,882 ) $ 40,362   $ (177,063 ) $ 103,455  
                     
 

Comprehensive income (loss)

                         
 

Foreign currency translation adjustment

    4,590     10,116     2,666     15,051  
 

Unrealized holding gain on auction rate securities:

                         
   

Arising in period

        73     554     166  
   

Reclassification to net income (loss)(1)

    389     229     389     731  
   

Net unrealized holding gain (loss) on available-for-sale securities

                         
   

Arising in period

    (69 )   46     (236 )   806  
   

Reclassification to net income (loss)(2)

        (622 )       (1,003 )
                     
 

Other comprehensive income

    4,910     9,842     3,373     15,751  
                     
 

Comprehensive income (loss)

  $ (202,972 ) $ 50,204   $ (173,690 ) $ 119,206  
                     
(1)
Included in loss on auction rate securities in the consolidated statements of income (loss).

(2)
Included in gain on disposal of investments in the consolidated statements of income (loss).

   
  Foreign
Currency
Translation
Adjustment
  Unrealized
Holding Loss
on Auction
Rate
Securities
  Net Unrealized
Holding
Gain (Loss)
on Available-
For-Sale
Securities
  Total  
  Balance, January 1, 2010   $ 44,286   $ (943 ) $ 231   $ 43,574  
  Foreign currency translation adjustment     2,666             2,666  
  Unrealized holding gain on auction rate securities         554         554  
  Net unrealized holding loss on available-for-sale securities             (236 )   (236 )
  Reclassification to net loss(1)         389         389  
                     
  Balance, September 30, 2010   $ 46,952   $   $ (5 ) $ 46,947  
                     
(1)
Included in loss on auction rate securities in the consolidated statement of loss.

34



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

12.   INCOME TAXES

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Current income tax expense

  $ 500   $ 3,700   $ 10,000   $ 11,500  
 

Deferred income tax expense

    59,500     3,800     64,500     12,000  
                     
 

Total provision for income taxes

  $ 60,000   $ 7,500   $ 74,500   $ 23,500  
                     

35



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

13.   EARNINGS (LOSS) PER SHARE

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2010   2009   2010   2009  
 

Net income (loss)

  $ (207,882 ) $ 40,362   $ (177,063 ) $ 103,455  
                     
   

Basic weighted-average number of common shares outstanding (000s)

    163,295     158,231     160,082     158,225  
 

Dilutive effect of stock options and RSUs (000s)

        421         193  
                     
   

Diluted weighted-average number of common shares outstanding (000s)

    163,295     158,652     160,082     158,418  
                     
 

Basic and diluted earnings (loss) per share

  $ (1.27 ) $ 0.25   $ (1.11 ) $ 0.65  
                     

   
  Three Months Ended
September 30
2010
  Nine Months Ended
September 30
2010
 
 

Basic weighted-average number of common shares outstanding (000s)

    163,295     160,082  
 

Dilutive effect of stock options and RSUs (000s)

    1,425     771  
 

Dilutive effect of 5.375% and 4.0% Convertible Notes (000s)

    8,527     4,292  
             
 

Diluted weighted-average number of common shares outstanding (000s)

    173,247     165,145  
             

14.   LEGAL PROCEEDINGS

36



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

37



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

38



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

39



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

40



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

41



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

42



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

43



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

44



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

45



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

46



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

47



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

48



VALEANT PHARMACEUTICALS INTERNATIONAL, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

14.   LEGAL PROCEEDINGS (Continued)

15.   SEGMENT INFORMATION

49


Item 2.    Management's Discussion and Analysis of Financial Condition and Results of Operations

INTRODUCTION

        On September 28, 2010 (the "Merger Date"), Biovail Corporation ("Biovail") completed the acquisition of Valeant Pharmaceuticals International ("Valeant") through a wholly-owned subsidiary pursuant to an Agreement and Plan of Merger, dated as of June 20, 2010, with Valeant surviving as a wholly-owned subsidiary of Biovail (the "Merger"). In connection with the Merger, Biovail was renamed "Valeant Pharmaceuticals International, Inc." ("we", "us" "our" or the "Company").

        The following Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") should be read in conjunction with the unaudited consolidated financial statements, and notes thereto, prepared in accordance with United States ("U.S.") generally accepted accounting principles ("GAAP") for the interim period ended September 30, 2010 (our "Consolidated Financial Statements"). This MD&A should also be read in conjunction with the annual MD&A and audited consolidated financial statements and notes thereto prepared in accordance with U.S. GAAP that are contained in Biovail's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, filed on February 26, 2010 with the U.S. Securities and Exchange Commission (the "SEC") and the Canadian Securities Administrators (the "CSA") (the "Biovail 2009 Form 10-K").

        Additional information relating to our Company, including the Biovail 2009 Form 10-K, is available on SEDAR at www.sedar.com and on the SEC's website at www.sec.gov.

        Unless otherwise indicated herein, the discussion and analysis contained in this MD&A is as of November 5, 2010.

        All dollar amounts are expressed in U.S. dollars.

FORWARD-LOOKING STATEMENTS

        Caution regarding forward-looking information and statements and "Safe-Harbor" statements under the U.S. Private Securities Litigation Reform Act of 1995:

        To the extent any statements made in this MD&A contain information that is not historical, these statements are 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, and may be forward-looking information within the meaning defined under applicable Canadian securities legislation (collectively, "forward-looking statements"). These forward looking statements relate to, among other things: the expected benefits of the Merger, such as cost savings, operating synergies and growth potential of the Company; business plans and prospects, prospective products or product approvals, future performance or results of current and anticipated products; the impact of healthcare reform; exposure to foreign currency exchange rate changes and interest rate changes; the outcome of contingencies, such as certain litigation and regulatory proceedings; general market conditions; and financial results.

        Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "continue", "will", "may", "could", "would", "target", "potential" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements may not be appropriate for other purposes. Although we have indicated above certain of these statements set out herein, all of the statements in this Form 10-Q that contain forward-looking statements are qualified by these cautionary statements. Although we believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, including, but not limited to, factors and assumptions regarding the items outlined above. Actual results may

50



differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things, the following:

51


        Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found elsewhere in this Form 10-Q, under Item 1A. "Risk Factors" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and in the Company's other filings with the SEC and CSA. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to our Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement, except as may be required by law.

BIOVAIL MERGER WITH VALEANT

Description of the Transaction

        On September 28, 2010, a wholly-owned subsidiary of Biovail acquired all of the outstanding equity of Valeant in a share transaction, in which each share of Valeant common stock was cancelled and converted into the right to receive 1.7809 Biovail common shares. The share consideration was valued at $26.35 per share based on the market price of Biovail's common shares as of the Merger Date. In addition, immediately preceding the effective time of the Merger, Valeant paid its stockholders a special dividend of $16.77 per share of Valeant common stock. As a result of the Merger, Valeant became a wholly-owned subsidiary of the Company.

        Valeant is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products. Valeant's specialty pharmaceutical and over-the-counter ("OTC") products are marketed under brand names and are sold in the U.S., Canada, Australia and New Zealand, where Valeant focuses most of its efforts on the dermatology and neurology therapeutic classes. Valeant also has branded generic and OTC operations in Europe and Latin America, which focus on pharmaceutical products that are bioequivalent to original products and are marketed under company brand names.

        The Merger is expected to result in significant strategic benefits to the Company by creating a larger, more globally diversified company with a broader and better diversified array of products and an expanded presence in North America and internationally. In addition, the anticipated market capitalization, strong balance sheet, free cash flow, liquidity and capital structure of the Company are expected to be stronger relative to either Biovail or Valeant on a stand-alone basis. The Company also expects to achieve significant operational cost savings, coming from, among other things, reductions in research and development, general and administrative expenses, and sales and marketing.

        For additional information regarding the potential risks and uncertainties associated with the Merger, please see Item 1A. "Risk Factors" of this Form 10-Q.

Basis of Presentation

        The transaction has been accounted for as a business combination under the acquisition method of accounting, which requires, among other things, the share consideration transferred be measured at the acquisition date based on the then-current market price and that most assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date. Biovail was both the legal and accounting acquirer in the Merger. Accordingly, the Company's consolidated financial statements reflect the assets, liabilities and results of operations of Valeant from the date of acquisition. Acquisition-related transaction costs and certain acquisition-related restructuring charges are not included as a component of the acquisition accounting, but are accounted for as expenses in the periods in which the costs are incurred.

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Fair Value of Consideration Transferred

($ in 000s, except per share data; Number of shares, stock
options and restricted share units in thousands)
  Conversion
Calculation
  Fair
Value
  Form of
Consideration

Number of common shares of Biovail issued in exchange for Valeant common stock outstanding as of the Merger Date

    139,137          

Multiplied by Biovail's stock price as of the Merger Date(a)

  $ 26.35   $ 3,666,245   Common shares
               

Number of common shares of Biovail expected to be issued pursuant to vested Valeant restricted share units ("RSUs") as a result of the Merger

    1,694          

Multiplied by Biovail's stock price as of the Merger date(a)

  $ 26.35     44,643   Common shares
               

Fair value of vested and partially vested Valeant stock options converted into Biovail stock options

          110,687   Stock options

Fair value of vested and partially vested Valeant RSUs converted into Biovail RSUs

          58,726   RSUs

Cash consideration

          39,655   Cash
               

Total fair value of consideration transferred

        $ 3,919,956    
               

(a)
As the Merger was effective at 12:01 a.m. on September 28, 2010, the conversion calculation reflects the closing price of Biovail's common shares on the New York Stock Exchange ("NYSE") at September 27, 2010.

Assets Acquired and Liabilities Assumed

        The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date. The following recognized amounts are provisional and subject to change:

        The Company will finalize these amounts as it obtains the information necessary to complete the measurement process. Any changes resulting from facts and circumstances that existed as of the acquisition date may result in retrospective adjustments to the provisional amounts recognized at the acquisition date. These

53



changes could be significant. The Company expects to finalize these amounts no later than one year from the acquisition date.

 
  Amounts
Recognized as of
Merger Date
 
($ in 000s)
  $  

Cash and cash equivalents

    348,637  

Accounts receivable

    194,930  

Inventories(a)

    208,874  

Other current assets

    33,460  

Property, plant and equipment

    184,757  

Identifiable intangible assets, excluding in-process research and development ("IPR&D")(b)

    3,844,310  

IPR&D(c)

    1,399,956  

Other non-current assets

    5,905  

Current liabilities

    (384,223 )

Long-term debt, including current portion(d)

    (3,167,585 )

Deferred income taxes, net

    (1,472,321 )

Other non-current liabilities(e)

    (140,397 )
       

Total indentifiable net assets

    1,056,303  

Goodwill(f)

    2,863,653  
       

Total consideration transferred

    3,919,956  
       

(a)
Reflects a provisional adjustment of $72.1 million to record Valeant's inventory at its estimated fair value, which will be recognized as a charge to cost of goods sold as the inventory acquired is subsequently sold.

(b)
The following table summarizes the provisional amounts and useful lives assigned to identifiable intangible assets:

   
  Useful
Lives
  Amounts
Recognized as of
Merger Date
 
 
($ in 000s)
  (Years)   $  
 

Finite-lived intangible assets:

             
   

Product brands

    10-20     3,114,689  
   

Product rights

    5-15     360,970  
   

Out-licensed technology and other

    7-10     200,049  
               
   

Total finite-lived intangible assets

          3,675,708  
 

Indefinite-lived intangible assets:

             
   

Corporate brands

    N/A     168,602  
               
 

Total identifiable intangible assets acquired

          3,844,310  
               
(c)
IPR&D assets are initially recognized at fair value and are classified as indefinite-lived intangible assets until the successful completion or abandonment of the associated research and development efforts. The significant components of the IPR&D assets relate to the development of ezogabine/retigabine in collaboration with Glaxo Group Limited, a subsidiary of GlaxoSmithKline plc ("GSK") and a number of dermatology products, which are described below under "— Products in Development". The following table summarizes the provisional amounts assigned to these assets:

   
  Amounts
Recognized as of
Merger Date
 
 
($ in 000s)
  $  
 

Ezogabine/retigabine

    891,461  
 

Dermatology products

    431,323  
 

Other

    77,172  
         
 

Total IPR&D assets acquired

    1,399,956  
         

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(d)
In connection with the Merger, Valeant secured financing of $125.0 million under a senior secured revolving credit facility (the "Revolving Credit Facility"), $1.0 billion under a senior secured term loan A facility (the "Term Loan A Facility"), and $1.625 billion under a senior secured term loan B facility (the "Term Loan B Facility"), and used a portion of the proceeds to undertake the following transactions prior to the Merger Date:

   
  Amounts
Recognized as of
Merger Date
 
 
($ in 000s)
  $  
 

Term Loan A Facility

    1,000,000  
 

Term Loan B Facility

    500,000  
 

6.75% Senior Notes

    497,500  
 

7.00% Senior Notes

    695,625  
 

4.0% Convertible Notes

    474,460  
         
 

Total long-term debt assumed

    3,167,585  
         

55


(e)
Includes the fair value of contingent consideration related to Valeant's acquisition of Princeton Pharma Holdings LLC, and its wholly-owned operating subsidiary, Aton Pharma, Inc., on May 26, 2010. The aggregate fair value of the contingent consideration was determined to be $21.6 million as of the Merger Date. The contingent consideration consists of future milestones predominantly based upon the achievement of approval and commercial targets for certain pipeline products (which are included in the fair value ascribed to IPR&D assets acquired, as described above under (c)). The range of the undiscounted amounts the Company could be obligated to pay as contingent consideration ranges from nil to $390.0 million.

(f)
Goodwill is calculated as the difference between the Merger Date fair value of the consideration transferred and the provisional values assigned to the assets acquired and liabilities assumed. None of the goodwill is expected to be deductible for tax purposes. The goodwill recorded represents the following:

    cost savings, operating synergies and other benefits expected to result from combining the operations of Valeant with those of Biovail;

    the value of the going-concern element of Valeant's existing business (that is, the higher rate of return on the assembled net assets versus if Biovail had acquired all of the net assets separately); and

    intangible assets that do not qualify for separate recognition (for instance, Valeant's assembled workforce), as well as future, as yet unidentified research and development projects.

Acquisition-Related Costs

        Biovail has incurred to date $35.6 million of transaction costs directly related to the Merger, which included expenditures for advisory, legal, valuation, accounting and other similar services. These costs have been expensed as acquisition-related costs in the Company's consolidated statements of income (loss) as of the Merger Date.

Post-Merger Revenue and Earnings of Valeant

        The revenue and earnings of Valeant for the period from the Merger Date to September 30, 2010 were not material to the Company's consolidated results of operations. The Company recorded the following acquisition accounting charges in the three-day period ended September 30, 2010:

 
($ in 000s)
  $  
 

Share-based compensation expense related to vested and partially vested Valeant stock options and RSUs

    20,909  
 

Amortization expense related to acquired finite-lived intangible assets

    2,200  
 

Interest expense related to assumed long-term debt

    1,692  
         
 

Total

    24,801  
         

Valeant Partial Third Quarter Revenue

        Valeant revenue in the third quarter of 2010 was $259.2 million, compared with $220.3 million in the corresponding period in 2009, representing an increase of $38.9 million (18%). Total revenue in the third quarter of 2010 is not comparable to the third quarter of 2009 due to various integration and cut-off activities performed in connection with the Merger, including the early cut-off of shipping in September 2010 to accommodate

56



physical inventory counts in some locations. Shipping cut-off dates varied by location and are outlined in the following table:

 
Location
  Last Shipping Date
 

U.S.

  September 25
 

Canada

  September 24
 

Mexico

  September 27
 

Brazil

  September 17
 

Central Europe

  September 27
 

Australia

  September 24

BUSINESS STRATEGY

        Our strategy will be to focus the newly combined Biovail and Valeant businesses on core geographies and therapeutic classes, manage pipeline assets through strategic partnerships with other pharmaceutical companies and deploy cash with an appropriate mix of selective acquisitions, share buybacks and debt repurchases. We believe this strategy will allow us to improve both our growth rates and profitability, while exploiting the benefits of the Merger.

        Our leveraged research and development model is one key element to this business strategy. It will allow us to progress development programs to drive future commercial growth, while minimizing our research and development expense. This will be achieved in four ways:

        We will be diverse not only in our sources of revenue from our broad drug portfolio, but also among the therapeutic classes and geographic segments we serve. We will have a focused geographic footprint aimed at retaining only those businesses that we view to have the potential for strong operating margins and solid growth, while providing natural balance across geographies. In addition, we will have an established portfolio of specialty pharmaceutical, branded generic and OTC products with a focus in the neurology and dermatology therapeutic areas.

        We will measure our success through shareholder returns and market capitalization.

SYNERGIES AND COST SAVINGS

        We believe the complementary nature of the Biovail and Valeant businesses presents an opportunity to capture significant operating synergies and cost savings. The Merger should provide the opportunity to realize cost savings from, among other things, reductions in general and administrative expenses, research and development and sales and marketing. In total, we have identified over $300 million of annual cost synergies that we expect to realize by the end of 2012. This amount does not include potential revenue synergies or the potential benefits of expanding the Biovail corporate structure to Valeant's operations. Further, we currently expect our combined cash tax rate to be approximately 15% by the end of 2012.

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Merger-Related Cost-Rationalization and Integration Initiatives

        We have initiated cost-rationalization and integration initiatives to capture operating synergies and generate cost savings across the Company. These measures include:

        We estimate that we will incur costs in the range of $135 million and $180 million (of which the non-cash component, including share-based compensation, is expected to be approximately $55 million) in connection with these cost-rationalization and integration initiatives. These costs include employee termination costs (including related share-based payments), costs to consolidate or close facilities and relocate employees, asset impairments, and contract termination and lease cancellation costs. The following costs were incurred in connection with these initiatives through September 30, 2010:

 
  Employee Termination Costs    
   
 
 
  Severance and
Related Benefits
  Share-Based
Compensation
  Other Costs   Total  
($ in 000s)
  $   $   $   $  

Costs incurred and charged to expense

    46,326     45,665     2,976     94,967  

Cash payments

    (2,188 )           (2,188 )

Non-cash adjustments

        (45,665 )       (45,665 )
                   

Balance, September 30, 2010

    44,138         2,976     47,114  
                   

        We recognized employee termination costs of $46.3 million for severance and related benefits payable to approximately 500 employees of Biovail and Valeant who have been, or will be, terminated as a result of the Merger. These reductions primarily reflect the elimination of redundancies and consolidation of staff in the sales and marketing, research and development, and general and administrative functions. As of September 30, 2010, $2.2 million of the termination costs had been paid, and we expect that a significant portion of the remaining costs will be paid prior to April 1, 2011, with the balance payable through to the first quarter of 2012.

        In addition, we recognized incremental share-based compensation expense of $45.7 million, related to the following stock options and RSUs held by terminated employees of Biovail and Valeant:

($ in 000s)
  $  

Stock options and time-based RSUs held by Biovail employees with employment agreements

    5,805  

Stock options held by Biovail employees without employment agreements

    (492 )

Performance-based RSUs held by Biovail executive officers and selected employees

    20,287  

Stock options and RSUs held by former executive officers of Valeant

    20,065  
       

    45,665  
       

Biovail Research and Development Pipeline Rationalization

        Prior to the Merger, Biovail's product development and business development efforts were focused on unmet medical needs in specialty central nervous system ("CNS") disorders. Following the Merger, we intend to employ a leveraged research and development model that will allow us to progress development programs, while

58



minimizing research and development expense, through partnerships and other means. In consideration of this model, we conducted a strategic and financial review of the Biovail product development pipeline and identified the programs that did not satisfy our hurdle rate, as outlined in the table below. In consideration of this model, subsequent to September 30, 2010, we conducted a strategic and financial review of the Biovail product development pipeline and identified the programs that did not satisfy the Company's hurdle rate, as outlined in the table below. In respect of the Staccato® loxapine, GDNF, fipamezole and pimavanserin programs, we provided notices of termination to, or entered into termination agreements with, the counterparty to each of the agreements. Regarding the AMPAKINE® program, we have suspended development of these compounds and are reviewing our options with Cortex and other potential parties.

 
Program
  Counterparty
  Compound
  Contingent
Milestone
Obligations
Terminated(1)

  Termination
Payment

 

AZ-004

  Alexza Pharmaceuticals, Inc. ("Alexza")   Staccato® loxapine   $ 90,000,000   Nil   
 

BVF-007

  Cortex Pharmaceuticals, Inc. ("Cortex")   AMPAKINE®   $ 15,000,000   Nil   
 

BVF-014

  MedGenesis Therapeutix Inc.   GDNF   $ 20,000,000   $5,000,000(2)
 

BVF-025

  Santhera Pharmaceuticals (Switzerland) Ltd.   Fipamezole   $ 200,000,000   Nil   
 

BVF-036, -040, -048

  ACADIA Pharmaceuticals Inc.   Pimavanserin   $ 365,000,000   $8,750,000(2)
 
(1)
Represent the maximum amount of milestone payments we could have been required to make to the counterparty under each agreement. These milestone payments were contingent on the achievement of specific developmental, regulatory and commercial milestones. In addition, we could have been obligated to make royalty payments based on future net sales of the products if regulatory approval was obtained. As a consequence of the termination of these arrangements, we have no ongoing or future obligation in respect of these milestone or royalty payments.

(2)
Represents the amount of negotiated settlements with each counterparty, which we will recognize in the fourth quarter of 2010.

PRODUCTS IN DEVELOPMENT

        We currently have the following products, among others, in clinical development:

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BIOVAIL PRE-MERGER 2010 BUSINESS DEVELOPMENT

Istradefylline

        On June 2, 2010, Biovail entered into a license agreement with Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") to acquire the U.S. and Canadian rights to develop and commercialize products containing istradefylline — a new chemical entity targeted for the treatment of Parkinson's disease. In April 2007, Kyowa Hakko Kirin filed an NDA for istradefylline, which received a Not Approvable letter from the FDA in February 2008. The FDA has requested a Complete Response to the Not Approvable letter before it will consider meeting with us to discuss the regulatory approval process for istradefylline.

        Under the terms of its license agreement, Biovail paid an upfront fee of $10.0 million, and we could pay up to $20.0 million in potential development milestones through FDA approval and up to an additional $35.0 million if certain sales-based milestones are met. We will also make tiered royalty payments of up to 30% on net commercial sales of products containing istradefylline. In connection with this acquisition, Biovail also entered into an agreement with Kyowa Hakko Kirin for the supply of the istradefylline compound.

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        This acquisition was accounted for as a purchase of IPR&D intangible assets with no alternative future use. Accordingly, the $10.0 million upfront payment, together with $0.2 million of acquisition costs, was charged to research and development expenses in the second quarter of 2010.

AMPAKINE®

        On March 25, 2010, Biovail acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex for use in the field of respiratory depression, a brain-mediated breathing disorder. The acquired compounds include the Phase 2 compound CX717 in an oral formulation, the pre-clinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739. This acquisition was accounted for as a purchase of IPR&D intangible assets with no alternative future use. Accordingly, the $9.0 million upfront payment and the $1.0 million transition payment made by Biovail to Cortex, together with $0.7 million of acquisition costs, were charged to research and development expenses in the first quarter of 2010.

        As described above under "Synergies and Cost Savings — Biovail Research and Development Rationalization", we have suspended development of the AMPAKINE® compounds and are reviewing our options with Cortex and other potential parties.

Staccato® Loxapine

        On February 9, 2010, Biovail entered into a collaboration and license agreement with Alexza to acquire the U.S. and Canadian development and commercialization rights to AZ-004 for the treatment of psychiatric and/or neurological indications and the symptoms associated with these indications, including the initial indication of treating agitation in schizophrenia and bipolar patients. AZ-004 combines Alexza's proprietary Staccato® drug-delivery system with the antipsychotic drug loxapine. This acquisition was accounted for as a purchase of IPR&D intangible assets with no alternative future use. Accordingly, the $40.0 million upfront payment made by Biovail to Alexza, together with $0.3 million of acquisition costs, was charged to research and development expenses at the acquisition date.

        On October 8, 2010, Alexza received a Complete Response letter from the FDA regarding the NDA for AZ-004, in which the FDA indicated that the NDA was not ready for approval.

        As described above under "Synergies and Cost Savings — Biovail Research and Development Rationalization", the Company has determined to terminate the agreement with Alexza.

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BIOVAIL PRE-MERGER COST-RATIONALIZATION INITIATIVES

        In May 2008, Biovail initiated restructuring measures that were intended to rationalize its manufacturing operations, pharmaceutical sciences operations, and general and administrative expenses. The following costs were incurred in connection with these initiatives through September 30, 2010:

 
  Asset Impairments   Employee Termination Costs    
   
 
 
  Contract
Termination
and Other
Costs
   
 
 
  Manufacturing   Pharmaceutical
Sciences
  Manufacturing   Pharmaceutical
Sciences
  Total  
($ in 000s)
  $   $   $   $   $   $  

Balance, January 1, 2008

                         

Costs incurred and charged to expense

    42,602     16,702     3,309     2,724     4,865     70,202  

Cash payments

                (2,724 )   (333 )   (3,057 )

Non-cash adjustments

    (42,602 )   (16,702 )           (1,186 )   (60,490 )
                           

Balance, December 31, 2008

            3,309         3,346     6,655  
                           

Costs incurred and charged to expense

    7,591     2,784     4,942     1,441     2,307     19,065  

Cash payments

            (2,041 )   (1,278 )   (1,321 )   (4,640 )

Non-cash adjustments

    (7,591 )   (2,784 )       71         (10,304 )
                           

Balance, December 31, 2009

            6,210     234     4,332     10,776  
                           

Costs incurred and charged to expense

            333         280     613  

Cash payments

            (2,703 )   (195 )   (429 )   (3,327 )

Non-cash adjustments

                6         6  
                           

Balance, March 31, 2010

            3,840     45     4,183     8,068  
                           

Costs incurred and charged to expense

            708     1,924     249     2,881  

Cash payments

            (820 )       (435 )   (1,255 )

Non-cash adjustments

                (46 )       (46 )
                           

Balance, June 30, 2010

            3,728     1,923     3,997     9,648  
                           

Costs incurred and charged to expense

    400         392         157     949  

Cash payments

            (1,240 )   (1,862 )   (331 )   (3,433 )

Non-cash adjustments

    (400 )                   (400 )
                           

Balance, September 30, 2010

            2,880     61     3,823     6,764  
                           

Manufacturing Operations

        On January 15, 2010, Biovail completed the sale of its Dorado, Puerto Rico manufacturing facility for net cash proceeds of $8.5 million. The related property, plant and equipment was classified as assets held for sale on the consolidated balance sheet at December 31, 2009. Biovail occupied the Dorado facility until March 31, 2010, pursuant to a short-term lease agreement with the buyer.

        As of September 30, 2010, we completed the transfer of remaining manufacturing processes from our Carolina, Puerto Rico manufacturing facility to our plant in Steinbach, Manitoba. We recorded an impairment charge of $0.4 million in the third quarter of 2010, to write-off the remaining carrying value of the Carolina facility after unsuccessful efforts to locate a buyer for the facility.

        Biovail expected to incur employee termination costs of approximately $9.8 million in total for severance and related benefits payable to the approximately 240 employees who have been, or will be, terminated as a

62


result of the closure of the Dorado and Carolina facilities. As these employees were required to provide service during the shutdown period in order to be eligible for termination benefits, Biovail was recognizing the cost of those termination benefits ratably over the estimated future service period. On a cumulative basis to September 30, 2010, we have recognized $9.7 million of these costs, of which $6.8 million have been paid. We will pay the remaining termination benefits prior to December 31, 2010.

Pharmaceutical Sciences Operations

        On April 30, 2010, Biovail entered into an asset purchase agreement to sell its contract research division ("CRD") to Lambda Therapeutic Research Inc. ("Lambda"). Biovail no longer considered CRD a strategic fit as a result of Biovail's pre-Merger transition from reformulation programs to the in-licensing, acquisition and development of specialty CNS products. CRD has not been treated as a discontinued operation for accounting purposes, on the basis that its operations were immaterial and incidental to Biovail's core specialty pharmaceutical business.

        On July 23, 2010, Biovail completed the sale of CRD to Lambda for net cash proceeds of $6.4 million. The carrying value of net assets of CRD at the date of disposal amounted to $6.4 million, which comprised net current assets and liabilities of $1.6 million and property, plant and equipment of $4.8 million.

        Biovail recognized employee termination costs of $1.9 million for the approximately 70 CRD employees not offered employment by Lambda.

        In the third quarter and first nine months of 2010 and 2009, the consolidated statements of income (loss) included the following revenue and expenses of CRD, which, as described above, have not been segregated from continuing operations:

 
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
 
  2010   2009   2010   2009  
($ in 000s)
  $   $   $   $  

Research and development revenue

    409     2,835     5,642     9,090  
                   

Research and development expenses

    532     3,526     7,211     10,510  

Selling, general and administrative expenses

    650     746     2,328     2,507  
                   

Total operating expenses

    1,182     4,272     9,539     13,017  
                   

Operating loss

    (773 )   (1,437 )   (3,897 )   (3,927 )

Foreign exchange gain (loss)

    6     (51 )   (102 )   110  
                   

Net loss

    (767 )   (1,488 )   (3,999 )   (3,817 )
                   

        Prior to December 31, 2009, Biovail completed the closure of its research and development facilities in Dublin, Ireland and Mississauga, Ontario, and the consolidation of its research and development operations in Chantilly, Virginia.

Results of Efficiency Initiatives

        Biovail's efficiency initiatives were substantively implemented prior to the Merger. These initiatives resulted in cumulative charges to earnings of $103.9 million recorded through September 30, 2010, of which the cash component amounted to $29.3 million incurred through September 30, 2010. With the sale of CRD, Biovail realized its target of $70 million in total gross proceeds from the divestiture and monetization of non-core assets.

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U.S. HEALTHCARE REFORM

        In March 2010, healthcare reform legislation was enacted in the U.S. This legislation contains several provisions that may impact our business.

        Although many provisions of the new legislation do not take effect immediately, several provisions became effective in the first nine months of 2010. These provisions include: (i) an increase in the minimum Medicaid rebate to states participating in the Medicaid program from 15.1% to 23.1% on branded prescription drugs; (ii) the extension of the Medicaid rebate to Managed Care Organizations that dispense drugs to Medicaid beneficiaries; and (iii) the expansion of the 340(B) Public Health Services drug pricing program, which provides outpatient drugs at reduced rates, to include additional hospitals, clinics, and healthcare centres.

        Beginning in 2011, the new legislation requires that drug manufacturers provide a 50% discount to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap. Also, beginning in 2011, a new fee will be assessed on prescription drug manufacturers and importers that sell branded prescription drugs to specified U.S. government programs (e.g., Medicare and Medicaid). This fee will be calculated based upon each entity's relative share of total applicable branded prescription drug sales to specified U.S. government programs for the preceding calendar year. The aggregate industry wide fee is expected to total $28.0 billion through 2019, ranging from $2.5 billion to $4.1 billion annually.

        Presently, uncertainty exists as many of the specific determinations necessary to implement this new legislation have yet to be decided and communicated to industry participants. For example, we do not yet know when discounts will be provided to the additional hospitals eligible to participate under the 340(B) program. In addition, determinations as to how the Medicare Part D coverage gap will operate and how the annual fee on branded prescription drugs will be calculated and allocated remain to be clarified, though, as noted above, these programs will not be effective until 2011. We have made several estimates with regard to important assumptions relevant to determining the financial impact of this legislation on our business due to the lack of availability of both certain information and complete understanding of how the process of applying the legislation will be implemented. Based on these estimates and assumptions, this new legislation did not have a material impact on our financial condition or results of operations in the third quarter or first nine months of 2010; however, the legislation could have a material adverse effect on our future business, cash flows, financial condition and results of operations.

        For additional information regarding the potential risks and uncertainties associated with the implementation of the U.S. healthcare reform legislation, please see Item 1A. "Risk Factors" of this Form 10-Q.

SELECTED FINANCIAL INFORMATION

        The following table provides selected financial information for the periods indicated:

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s, except per share data)
  $   $   $   %   $   $   $   %  

Revenue

    208,267     212,523     (4,256 )   (2 )   666,673     579,377     87,296     15  

Operating expenses

    334,579     154,179     180,400     117     727,806     456,871     270,935     59  

Net income (loss)

    (207,882 )   40,362     (248,244 )   (615 )   (177,063 )   103,455     (280,518 )   (271 )

Basic and diluted earnings (loss) per share

    (1.27 )   0.25     (1.52 )   (608 )   (1.11 )   0.65     (1.76 )   (271 )
                                   

Cash dividends declared per share

    0.095     0.090     0.005     6     0.280     0.555     (0.275 )   (50 )
                                   

64



 
  At
September 30
2010
  At
December 31
2009
  Change  
 
  $   $   $   %  

Total assets

    11,135,903     2,067,044     9,068,859     439  

Long-term debt, including current portion

    3,235,550     326,085     2,909,465     892  
                   

General Economic Conditions

        Beginning in late 2008 and continuing through the third quarter of 2010, foreign currency exchange rates between the U.S. dollar and the Canadian dollar have been experiencing significant volatility. Changes in foreign currency exchange rates increased total revenue by approximately $1.5 million, or 0.7%, and $9.6 million, or 1.4%, in the third quarter and first nine months of 2010, respectively, compared with the corresponding periods of 2009, due to a strengthening year-over-year of the Canadian dollar relative to the U.S. dollar on an average basis. A stronger Canadian dollar, while having a favourable impact on revenue, had a negative impact on our operating expenses. Where possible, we manage our exposure to foreign currency exchange rate changes through operational means, mainly by matching our cash flow exposures in foreign currencies. As a result, the positive impact of a stronger Canadian dollar on revenue generated in Canadian dollars, but reported in U.S. dollars, is largely counteracted by an opposing effect on operating expenses incurred in Canadian dollars. As our Canadian dollar-denominated expenses moderately exceeded our Canadian dollar-denominated revenues, the appreciation of the Canadian dollar in the third quarter and first nine months of 2010 had the overall effect of marginally decreasing our net income as reported in U.S. dollars. As a result of the Merger, our exposure to global economic and financial market conditions has substantially increased.

Financial Performance

Changes in Revenue

        Total revenue declined $4.3 million, or 2%, to $208.3 million in the third quarter of 2010, compared with $212.5 million in the third quarter of 2009, primarily due to:

        Those factors were partially offset by:

        Total revenue increased $87.3 million, or 15%, to $666.7 million in the first nine months of 2010, compared with $579.4 million in the first nine months of 2009, primarily due to:

65


        Those factors were partially offset by:

Changes in Net Income

        Net income declined $248.2 million to a net loss of $207.9 million (basic and diluted loss per share of $1.27) in the third quarter of 2010, compared with net income of $40.4 million (basic and diluted earnings per share ("EPS") of $0.25) in the third quarter of 2009, primarily due to:

        Net income declined $280.5 million to a net loss of $177.1 million (basic and diluted loss per share of $1.11) in the first nine months of 2010, compared with net income $103.5 million (basic and diluted EPS of $0.65) in the first nine months of 2009, primarily due to:

66


        Those factors were partially offset by:

Specific Items Impacting Net Income

        When assessing our financial performance, management utilizes an internal measure that excludes specific items from net income determined in accordance with U.S. GAAP. Management believes the identification of these items enhances an analysis of our financial performance when comparing our operating results between periods. These items consist of: acquisition-related costs (including IPR&D charges and transaction costs); restructuring costs; legal settlements; gains and losses on asset dispositions; investment gains and losses; and certain other unusual items that are evaluated on an individual basis based on their nature or size. The following are examples of how net income excluding specific items is utilized:

        We believe that investors' understanding of our financial performance is enhanced by disclosing the specific items identified by management. However, any measure of net income excluding any or all of these items is not, and should not be viewed as, a substitute for net income prepared under U.S. GAAP. These items are presented solely to allow investors to more fully understand how management assesses our financial performance.

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        The following table displays the specific items identified by management that impacted net income in the third quarters and first nine months of 2010 and 2009, and the impact of these items (individually and in the aggregate) on diluted EPS. EPS figures may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   2010   2009  
 
  Amount   Diluted
EPS Impact
  Amount   Diluted
EPS Impact
  Amount   Diluted
EPS Impact
  Amount   Diluted
EPS Impact
 
($ in 000s, except per share data; Income (Expense))
  $   $   $   $   $   $   $   $  

Restructuring and other costs

    (95,916 )   (0.55 )   (2,413 )   (0.02 )   (99,410 )   (0.60 )   (15,128 )   (0.10 )

IPR&D(1)

            (8,126 )   (0.05 )   (61,245 )   (0.37 )   (38,540 )   (0.24 )

Increase in valuation allowance on deferred tax assets(2)

    (48,000 )   (0.28 )           (48,000 )   (0.29 )        

Legal settlements

    (38,500 )   (0.22 )           (38,500 )   (0.23 )   (241 )    

Acquisition-related costs

    (28,037 )   (0.16 )           (35,614 )   (0.22 )   (5,596 )   (0.04 )
 

Share-based compensation expense related to vested and partially vested Valeant stock options and RSUs(3)

    (20,909 )   (0.12 )           (20,909 )   (0.13 )        

Write-down of deferred financing costs

    (5,774 )   (0.03 )           (5,774 )   (0.03 )   (537 )    

Loss on auction rate securities

    (5,005 )   (0.03 )   (385 )       (5,552 )   (0.03 )   (4,709 )   (0.03 )

SEC/OSC independent consultant and related costs(4)

    (680 )       169         (1,461 )   (0.01 )   (2,804 )   (0.02 )

Gain on auction rate security settlement

                            22,000     0.14  

Proxy contest costs(4)

            (399 )               (1,028 )   (0.01 )

Gain on disposal of investments

            466                 804     0.01  
                                   

Total

    (242,821 )   (1.40 )   (10,688 )   (0.07 )   (316,465 )   (1.92 )   (45,779 )   (0.29 )
                                   

(1)
Included in research and development expenses.

(2)
Included in provision for income taxes.

(3)
Allocated to cost of goods sold ($0.4 million), research and development expenses ($0.4 million), and selling general and administrative expenses ($20.1 million).

(4)
Included in selling, general and administrative expenses.

        In addition to the items noted in the table above, we recorded an adjustment of $12.0 million to the provision for income taxes in the third quarter of 2010, to reflect the impact of the increase in our annualized effective tax rate as a result of the Merger. With the exception of tax-specific items, the net impact of the preceding specific items on our provision for income taxes in each of the periods presented was not material.

Cash Dividends

        Pre-Merger cash dividends per share declared by Biovail were $0.095 and $0.28 in the third quarter and first nine months of 2010, respectively, compared with $0.09 and $0.555 in the corresponding periods of 2009. We will pay a post-Merger special dividend of $1.00 per share on December 22, 2010 (as described below under "Financial Condition, Liquidity and Capital Resources — Post-Merger Special Dividend"), after which we do not intend to pay dividends.

Changes in Financial Condition

        At September 30, 2010, we had cash and cash equivalents of $592.7 million and long-term debt of $3,235.6 million. In the first nine months of 2010, operating cash flows of $264.6 million were a significant source of liquidity, as well as net cash acquired on the acquisition of Valeant of $309.0 million. Prior to the Merger Date, Biovail paid total cash dividends of $43.6 million and made a payment of $12.5 million on account of the obligation to Cambridge Laboratories (Ireland) Limited ("Cambridge") in connection with the tetrabenazine acquisition in June 2009. In addition, Biovail paid $60.0 million (exclusive of acquisition costs) in the aggregate in connection with the istradefylline, AMPAKINE® and Staccato® loxapine acquisitions.

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RESULTS OF OPERATIONS

        Biovail operated its business on the basis of a single reportable segment — pharmaceutical products. This basis reflects how management reviewed the business, made investing and resource allocation decisions, and assessed operating performance. Effective with the Merger, our new management is reassessing the Company's internal reporting structure and composition of its operating segments for disclosure in succeeding interim and annual reporting periods.

Revenue

        The following table displays the dollar amounts of each source of revenue in the third quarters and first nine months of 2010 and 2009; the percentage of each source of revenue compared with total revenue in the respective period; and the dollar and percentage change in the dollar amount of each source of revenue. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s)
  $   %   $   %   $   %   $   %   $   %   $   %  

Product sales

    201,372     97     204,291     96     (2,919 )   (1 )   644,650     97     557,400     96     87,250     16  

Research and development

    455         3,392     2     (2,937 )   (87 )   6,096     1     10,362     2     (4,266 )   (41 )

Royalty and other

    6,440     3     4,840     2     1,600     33     15,927     2     11,615     2     4,312     37  
                                                       

Total revenue

    208,267     100     212,523     100     (4,256 )   (2 )   666,673     100     579,377     100     87,296     15  
                                                   

Product Sales

        The following table displays the dollar amounts of product sales by internal reporting category in the third quarters and first nine months of 2010 and 2009; the percentage of each category compared with total product sales in the respective period; and the dollar and percentage changes in the dollar amount of each category. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s)
  $   %   $   %   $   %   $   %   $   %   $   %  

Wellbutrin XL®

    52,136     26     58,606     29     (6,470 )   (11 )   155,910     24     115,861     21     40,049     35  

Aplenzin®

    4,823     2     2,660     1     2,163     81     10,963     2     8,151     1     2,812     34  

Xenazine®

    21,852     11     13,692     7     8,160     60     58,178     9     31,423     6     26,755     85  

Zovirax®

    34,720     17     30,824     15     3,896     13     115,112     18     100,013     18     15,099     15  

Biovail Pharmaceuticals Canada ("BPC")

    27,319     14     20,704     10     6,615     32     78,542     12     54,231     10     24,311     45  

Ultram® ER

    4,252     2     12,139     6     (7,887 )   (65 )   19,040     3     49,319     9     (30,279 )   (61 )

Cardizem® LA

    3,859     2     13,728     7     (9,869 )   (72 )   16,896     3     30,790     6     (13,894 )   (45 )

Legacy

    47,287     23     41,799     20     5,488     13     136,292     21     122,945     22     13,347     11  

Generic

    4,135     2     9,757     5     (5,622 )   (58 )   51,304     8     43,782     8     7,522     17  

Glumetza® (U.S.)

    989         382         607     159     2,413         885         1,528     173  
                                                       

Total product sales

    201,372     100     204,291     100     (2,919 )   (1 )   644,650     100     557,400     100     87,250     16  
                                                   

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Wholesaler Inventory Levels

        In the third quarter and first nine months of 2010 and 2009, three drug wholesale customers accounted for the majority of Biovail's Zovirax®, off-patent branded pharmaceutical ("Legacy") and, since May 14, 2009, Wellbutrin XL® product sales in the U.S. Biovail's distribution agreements with these wholesalers limited the amount of inventory they can own to between 1/2 and 11/2 months of supply of our products. As indicated in the following table, at September 30, 2010 and December 31, 2009, these wholesalers owned overall 0.8 months and 1.0 months of supply of Biovail products, respectively, of which only $0.4 million and $0.2 million of inventory had less than 12 months remaining shelf life as of those respective dates.

 
   
  At September 30, 2010   At December 31, 2009  
 
  Original
Shelf Life
  Total
Inventory
  Months
On Hand
  Inventory With
Less Than
12 Months
Remaining
Shelf Life
  Total
Inventory
  Months
On Hand
  Inventory With
Less Than
12 Months
Remaining
Shelf Life
 
($ in 000s)
  (In Months)   $   (In Months)   $   $   (In Months)   $  

Wellbutrin XL®

    18     19,731     0.8     210     15,389     1.0     34  

Zovirax®

    36-48     7,716     0.6     140     14,689     1.1     93  

Cardizem®

    36-48     4,649     0.7     35     8,380     1.1     21  

Vasotec® and Vaseretic®

    24     2,339     1.6     11     1,468     1.1     9  

Ativan®

    24     1,819     0.8     8     2,300     1.1     77  

Isordil®

    36-60     200     0.8     1     265     1.2     1  
                                     

Total

    18-60     36,454     0.8     405     42,491     1.0     235  
                               

Wellbutrin XL®

        Wellbutrin XL® product sales declined $6.5 million, or 11%, to $52.1 million in the third quarter of 2010, compared with $58.6 million in the third quarter of 2009, reflecting declines in prescription volumes due to the affects of generic competition and formulary placement. Wellbutrin XL® product sales increased $40.0 million, or 35%, to $155.9 million in the first nine months of 2010, compared with $115.9 million in the first nine months of 2009, reflecting incremental revenue of approximately $50.4 million following acquisition of the full U.S. commercialization rights in May 2009, and the positive effect of subsequent price increases, partially offset by the declines in prescription volumes.

Aplenzin®

        Aplenzin® product sales increased $2.2 million, or 81%, to $4.8 million in the third quarter of 2010, compared with $2.7 million in the third quarter of 2009, and increased $2.8 million, or 34%, to $11.0 million in the first nine months of 2010, compared with $8.2 million in the first nine months of 2009. Sanofi-aventis U.S. LLC ("sanofi-aventis") launched the 348mg and 522mg dosage strengths of Aplenzin® in the U.S. in April 2009 and the 174mg dosage strength in July 2009. In April 2010, sanofi-aventis advised us that it had engaged an independent contract sales organization to promote Aplenzin®.

Xenazine®

        Xenazine® product sales increased $8.2 million, or 60%, to $21.9 million in the third quarter of 2010, compared with $13.7 million in the third quarter of 2009, and increased $26.8 million, or 85%, to $58.2 million in the first nine months of 2010, compared with $31.4 million in the first nine months of 2009, reflecting year-over-year increases in patient enrollment in the U.S., following the product's launch in December 2008, as well as the inclusion of sales of the product in other countries in Europe and around the world, following the acquisition of the worldwide development and commercialization rights to tetrabenazine in June 2009.

70


Zovirax®

        Zovirax® product sales increased $3.9 million, or 13%, to $34.7 million in the third quarter of 2010, compared with $30.8 million in the third quarter of 2009, and increased $15.1 million, or 15%, to $115.1 million in the first nine months of 2010, compared with $100.0 million in the first nine months of 2009, reflecting price increases implemented for these products over the last 12 months, which more than offset lower prescription volumes.

BPC

        Sales of BPC products increased $6.6 million, or 32%, to $27.3 million in the third quarter of 2010, compared with $20.7 million in the third quarter of 2009, and increased $24.3 million, or 45%, to $78.5 million in the first nine months of 2010, compared with $54.2 million in the first nine months of 2009. Excluding the positive effect on BPC Canadian dollar-denominated revenue of the strengthening of the Canadian dollar relative to the U.S. dollar, BPC product sales increased 23% and 28% in the third quarter and first nine months of 2010, respectively, compared with the corresponding periods of 2009. The increases in BPC revenue reflected increased prescription volumes for our promoted Wellbutrin® XL and Tiazac® XC products, as well as increased demand for our branded Tiazac® product, which was attributable to competitors' manufacturing issues. In addition, sales of Glumetza® in the third quarter and first nine months of 2010 benefited from a delay in the introduction of a competing generic version of the 500mg dosage strength.

Ultram® ER

        Ultram® ER product sales declined $7.9 million, or 65%, to $4.3 million in the third quarter of 2010, compared with $12.1 million in the third quarter of 2009, and declined $30.3 million, or 61%, to $19.0 million in the first nine months of 2010, compared with $49.3 million in the first nine months of 2009, reflecting the impact on volumes due to the introduction of generic competition to the 100mg and 200mg dosage strengths in November 2009 (which also had some negative impact on sales of the 300mg product). In addition, upon generic entry, our contractual supply price to PriCara (a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.), for branded 100mg and 200mg product (which is determined based on a percentage of PriCara's net selling price) was reduced by 50%. As there is currently no generic equivalent to the 300mg product, our supply price to PriCara for that dosage strength remains unchanged. All of those factors were partially offset by revenue generated through our supply of 100mg and 200mg authorized generic versions of Ultram® ER to Patriot Pharmaceuticals LLC (an affiliate of PriCara).

Cardizem® LA

        Revenue from sales of Cardizem® LA declined $9.9 million, or 72%, to $3.9 million in the third quarter of 2010, compared with $13.7 million in the third quarter of 2009, and declined $13.9 million, or 45%, to $16.9 million in the first nine months of 2010, compared with $30.8 million in the first nine months of 2009, reflecting lower volumes as a result of the introduction of a generic version of Cardizem® LA (in all dosage strengths except 120mg) by a competitor in March 2010, and a resulting reduction in inventory levels by our distributor. We are entitled to a royalty based on net sales of the competitor's generic version of Cardizem® LA.

        Cardizem® LA product sales include the amortization of deferred revenue associated with the cash consideration received from the sale to Kos Pharmaceuticals, Inc. (now known as Abbott Laboratories) of the distribution rights to Cardizem® LA in May 2005, which is being amortized over seven years on a straight-line basis. This amortization amounted to $3.8 million and $11.3 million in each of the third quarters and first nine months, respectively, of 2010 and 2009.

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Legacy

        Sales of our Legacy products increased $5.5 million, or 13%, to $47.3 million in the third quarter of 2010, compared with $41.8 million in the third quarter of 2009, and increased $13.3 million, or 11%, to $136.3 million in the first nine months of 2010, compared with $122.9 million in the first nine months of 2009, reflecting higher sales of generic Tiazac®, which was attributable to competitors' manufacturing issues. In addition, declining prescription volumes for our other Legacy brands were largely offset by price increases implemented over the last 12 months.

        In March 2010, Biovail reached a settlement with Sun Pharmaceutical Industries Ltd., India ("Sun"), with respect to patent litigation related to Sun's Abbreviated New Drug Application for a generic version of Cardizem® CD. Under the terms of the settlement and license agreements, which were submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice pursuant to Section 1112(a) of the Medicare Prescription Drug Improvement and Modernization Act of 2003, Biovail granted Sun, and its subsidiary Sun Pharma Global FZE, a non-exclusive license (without right to sublicense) to distribute various dosage strengths of Sun's generic formulation of Cardizem® CD in the U.S., upon receipt of regulatory approval from the FDA, and subject to certain limitations on the sales quantities of the 360mg dosage strength. Nevertheless, the introduction of Sun's 360mg generic version (following FDA approval) could have a material adverse impact on our revenues and earnings. Sun will pay us a royalty based on net sales of the various dosage strengths of its generic formulation. The license term ends on August 8, 2012 — the date on which the last Cardizem® CD patent expires. No amount was paid to Sun under the terms of this settlement.

Generic

        Sales of our bioequivalent ("Generic") products declined $5.6 million, or 58%, to $4.1 million in the third quarter of 2010, compared with $9.8 million in the third quarter of 2009, reflecting the recognition in the third quarter of 2010 of a $10.6 million rebate charge, of which $8.1 million relates to the first half of 2010 and fourth quarter of 2009. Generic product sales increased $7.5 million, or 17%, to $51.3 million in the first nine months of 2010, compared with $43.8 million in the first nine months of 2009, reflecting higher sales of generic Cardizem® CD, which was attributable to competitors' manufacturing issues.

Research and Development Revenue

        Research and development revenue declined $2.9 million, or 87%, to $0.5 million in the third quarter of 2010, compared with $3.4 million in the third quarter of 2009, and declined $4.3 million, or 41%, to $6.1 million in the first nine months of 2010, compared with $10.4 million in the first nine months of 2009, reflecting the sale of CRD by Biovail in July 2010 (as described above under "Biovail Pre-Merger Cost-Rationalization Initiatives — Pharmaceutical Sciences Operations").

Royalty and Other Revenue

        Royalties from third parties on sales of products Biovail developed or acquired and other revenue increased $1.6 million, or 33%, to $6.4 million in the third quarter of 2010, compared with $4.8 million in the third quarter of 2009, and increased $4.3 million, or 37%, to $15.9 million in the first nine months of 2010, compared with $11.6 million in the first nine months of 2009, due mainly to royalties earned on sales of generic Cardizem® LA and generic Cardizem® CD by third parties.

Operating Expenses

        The following table displays the dollar amounts of each operating expense category in the third quarters and first nine months of 2010 and 2009; the percentage of each category compared with total revenue in the

72



respective period; and the dollar and percentage changes in the dollar amount of each category. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s)
  $   %   $   %   $   %   $   %   $   %   $   %  

Cost of goods sold (exclusive of amortization of intangible assets shown separately below)

    62,142     30     50,669     24     11,473     23     184,947     28     145,566     25     39,381     27  

Research and development

    14,298     7     23,202     11     (8,904 )   (38 )   118,443     18     82,422     14     36,021     44  

Selling, general and administrative

    60,187     29     44,774     21     15,413     34     148,794     22     137,516     24     11,278     8  

Amortization of intangible assets

    35,499     17     33,121     16     2,378     7     102,098     15     70,402     12     31,696     45  

Restructuring and other costs

    95,916     46     2,413     1     93,503     NM     99,410     15     15,128     3     84,282     557  

Acquisition-related costs

    28,037     13             28,037     NM     35,614     5     5,596     1     30,018     536  

Legal settlements

    38,500     18             38,500     NM     38,500     6     241         38,259     NM  
                                                       

Total operating expenses

    334,579     161     154,179     73     180,400     117     727,806     109     456,871     79     270,935     59  
                                                   


NM
— Not meaningful

Cost of Goods Sold

        Cost of goods sold, which excludes the amortization of intangible assets described separately below under "— Amortization of Intangible Assets", increased $11.5 million, or 23%, to $62.1 million in the third quarter of 2010, compared with $50.7 million in the third quarter of 2009, and increased $39.4 million, or 27%, to $184.9 million in the first nine months of 2010, compared with $145.6 million in the first nine months of 2009. The percentage increases in cost of goods sold were higher than the corresponding 1% decline and 16% increase in total product sales in the third quarter and first nine months of 2010, respectively, primarily due to:

        Those factors were partially offset by:

73


Research and Development Expenses

        The following table displays the dollar amounts of research and development expenses by internal reporting category in the third quarters and first nine months of 2010 and 2009; the percentage of each category compared with total revenue in the respective period; and the dollar and percentage changes in the dollar amount of each category. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s)
  $   %   $   %   $   %   $   %   $   %   $   %  

IPR&D

            8,126     4     (8,126 )   (100 )   61,245     9     38,540     7     22,705     59  

Internal research and development programs

    13,766     7     11,550     5     2,216     19     49,987     7     33,372     6     16,615     50  

Contract research services provided to external customers

    532         3,526     2     (2,994 )   (85 )   7,211     1     10,510     2     (3,299 )   (31 )
                                                       

Total research and development expenses

    14,298     7     23,202     11     (8,904 )   (38 )   118,443     18     82,422     14     36,021     44  
                                                   

        As described above under "Biovail Pre-Merger 2010 Business Development", we recorded total IPR&D charges of $61.2 million in the first nine months of 2010 related to the istradefylline acquisition in the second quarter of 2010, and the AMPAKINE® and Staccato® loxapine acquisitions in the first quarter of 2010. In the third quarter and first nine months of 2009, we recorded IPR&D charges of $8.1 million and $38.5 million, respectively, related to the fipamezole and pimavanserin acquisitions.

        Internal research and development expenses increased $2.2 million, or 19%, to $13.8 million in the third quarter of 2010, compared with $11.6 million in the third quarter of 2009, and increased $16.6 million, or 50%, to $50.0 million in the first nine months of 2010, compared with $33.4 million in the first nine months of 2009, reflecting higher direct project spending on Biovail's specialty CNS drug-development programs. As described above under "Products in Development", we have assessed Biovail's product development pipeline and have decided not to continue a number of these specialty CNS programs. Prior to the Merger, Biovail cancelled the Phase 3 clinical trials that were underway in Europe for BVF-324 (the use of non-commercially available doses of tramadol for the treatment of premature ejaculation), due to slower-than-anticipated enrolment in these studies and a lack of commercial interest in the product. In the second quarter of 2010, Biovail accrued $2.8 million for the estimated contractual obligations related to the termination of these studies.

        Costs associated with providing contract research services to external customers declined $3.0 million, or 85%, to $0.5 million in the third quarter of 2010, compared with $3.5 million in the third quarter of 2009, and declined $3.3 million, or 31%, to $7.2 million in the first nine months of 2010, compared with $10.5 million in the first nine months of 2009, reflecting the decline in activity levels at CRD prior to its disposal in July 2010 (as described above under "Biovail Pre-Merger Cost-Rationalization Initiatives — Pharmaceutical Sciences Operations").

Selling, General and Administrative Expenses

        Selling, general and administrative expenses increased $15.4 million, or 34%, to $60.2 million in the third quarter of 2010, compared with $44.8 million in the third quarter of 2009, and increased $11.3 million, or 8%, to $148.8 million in the first nine months of 2010, compared with $137.5 million in the first nine months of 2009, primarily due to:

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        Those factors were partially offset by:

Amortization of Intangible Assets

        Amortization expense increased $2.4 million, or 7%, to $35.5 million in the third quarter of 2010, compared with $33.1 million in the third quarter of 2009, due to the inclusion of amortization of the Valeant identifiable intangible assets, and increased $31.7 million, or 45%, to $102.1 million in the first nine months of 2010, compared with $70.4 million in the first nine months of 2009, due to the inclusion of the amortization of the Valeant identifiable intangible assets, as well as the Wellbutrin XL® trademark intangible asset acquired in May 2009 and the product rights intangible assets arising from the tetrabenazine acquisition in June 2009.

Restructuring and Other Costs

        As described above under "Synergies and Cost Savings — Merger-Related Cost-Rationalization and Integration Initiatives" and "Biovail Pre-Merger Cost-Rationalization Initiatives", restructuring charges of $95.9 million and $99.4 million were recognized in the third quarter and first nine months of 2010, respectively, compared with $2.4 million and $15.1 million in the corresponding periods of 2009.

Acquisition-Related Costs

        As described above under "Biovail Merger with Valeant — Acquisition-Related Costs", in the third quarter and first nine months of 2010, Biovail incurred $28.0 million and $35.6 million, respectively, of Merger-related transaction costs. In the third quarter of 2009, Biovail incurred transaction costs of $5.6 million in connection with the tetrabenazine acquisition.

Legal Settlements

        In the third quarter of 2010, we recorded a $38.5 million charge in connection with the agreements or agreements in principle to settle certain Biovail legacy litigation matters.

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Non-Operating Income (Expense)

        The following table displays the dollar amounts of each non-operating income or expense category in the third quarters and first nine months of 2010 and 2009; and the dollar and percentage changes in the dollar amount of each category.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s; Income (Expense))
  $   $   $   %   $   $   $   %  

Interest income

    126     238     (112 )   (47 )   548     823     (275 )   (33 )

Interest expense

    (11,218 )   (10,998 )   (220 )   2     (30,997 )   (14,850 )   (16,147 )   109  

Write-down of deferred financing costs

    (5,774 )       (5,774 )   NM     (5,774 )   (537 )   (5,237 )   975  

Foreign exchange gain

    301     197     104     53     345     918     (573 )   (62 )

Loss on auction rate securities

    (5,005 )   (385 )   (4,620 )   NM     (5,552 )   (4,709 )   (843 )   18  

Gain on auction rate security settlement

                        22,000     (22,000 )   (100 )

Gain on disposal of investments

        466     (466 )   (100 )       804     (804 )   (100 )
                                       

Total non-operating expense

    (21,570 )   (10,482 )   (11,088 )   106     (41,430 )   4,449     (45,879 )   NM  
                                   

NM — Not meaningful

Interest Expense

        Interest expense for the third quarter and first nine months of 2010 includes $1.7 million of interest on assumed long-term debt of Valeant. In addition, interest expense includes the non-cash amortization of debt discounts on the 5.375% Convertible Notes and the Cambridge obligation and the non-cash amortization of deferred financing costs on the 5.375% Convertible Notes and Biovail's former credit facility of $3.8 million and $12.1 million, in the aggregate, in the third quarter and first nine months of 2010, respectively, compared with $3.9 million and $5.0 million, in the aggregate, in the corresponding periods of 2009.

Loss on Auction Rate Securities

        In August 2010, Biovail disposed of its entire portfolio of auction rate securities for cash proceeds of $1.4 million and recorded losses related to other-than-temporary declines in the estimated fair value these securities of $5.0 million and $5.6 million in the third quarter and first nine months of 2010, respectively, compared with $0.4 million and $4.7 million in the corresponding periods of 2009.

Gain on Auction Rate Security Settlement

        In May 2009, Biovail received $22.0 million to settle an arbitration with the investment bank that invested its assets in auction rate securities.

Provision for Income Taxes

        The following table displays the dollar amounts of the current and deferred provisions for income taxes in the third quarters and first nine months of 2010 and 2009; and the dollar and percentage changes in the dollar amount of each provision. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s)]
  $   $   $   %   $   $   $   %  

Current income tax expense

    500     3,700     (3,200 )   (86 )   10,000     11,500     (1,500 )   (13 )

Deferred income tax expense

    59,500     3,800     55,700     NM     64,500     12,000     52,500     438  
                                       

Total provision for income taxes

    60,000     7,500     52,500     700     74,500     23,500     51,000     217  
                                   

NM — Not meaningful

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        In the third quarter of 2010, our effective tax rate was impacted by (i) the recording of a valuation allowance against a portion of the net deferred tax asset in respect of our U.S. tax loss carryforwards; (ii) the addition of Valeant's fourth quarter forecasted taxable income and associated tax expense at Valeant's higher effective tax rate to Biovail's annualized effective tax rate to be applied against our current quarter income; (iii) the non-deductible portion of the acquisition-related costs related to the Merger; and (iv) provisions for legal settlements in jurisdictions with lower statutory rates than those that apply in Canada, or where a full valuation allowance is recorded against tax loss carryforwards. The Merger resulted in tax loss carryforwards of Biovail's U.S. group becoming subject to the ownership change limitations of the U.S. Internal Revenue Code and similar state legislation. As of September 30, 2010, we concluded that it is not more likely than not that we will be able to utilize the full amount of our U.S. tax loss carryforwards and recorded a valuation allowance in the amount of $48.0 million against the related deferred tax asset.

        In the first nine months of 2010, our effective tax rate was impacted by (i) the recording of a valuation allowance against a portion of the net deferred tax asset in respect of our U.S. tax loss carryforwards; (ii) the effect of including Valeant's forecast taxable income for the balance of the year and the income tax provision on that income at Valeant's higher effective tax rate; (iii) the non-deductible portion of the acquisition-related costs related to the Merger; (iv) the non-deductible portion of the IPR&D charges associated with the istradefylline, AMPAKINE®, and Staccato® loxapine acquisitions (as described above under "Biovail Pre-Merger 2010 Business Development") recognized in a jurisdiction with lower statutory tax rates than those that apply in Canada; and (v) the provision for a legal settlement in a jurisdiction with lower statutory rates than those that apply in Canada.

        In the third quarter and first nine months of 2009, Biovail's effective tax rate was impacted by the non-deductible portion of an IPR&D charge associated with the acquisition of the U.S. and Canadian rights to develop, manufacture and commercialize pimavanserin, which was recognized in a jurisdiction with lower statutory tax rates than those that apply in Canada.

SUMMARY OF QUARTERLY RESULTS

        The following table displays a summary of our quarterly results of operations and operating cash flows for each of the eight most recently completed quarters:

 
  2010   2009   2008  
 
  Q3   Q2   Q1   Q4   Q3   Q2   Q1   Q4  
($ in 000s, except per share data)
  $   $   $   $   $   $   $   $  

Revenue

    208,267     238,771     219,635     241,053     212,523     193,535     173,319     181,496  

Expenses

    334,579     189,959     203,268     182,405     154,179     182,988     119,704     144,617  
                                   

Operating income (loss)

    (126,312 )   48,812     16,367     58,648     58,344     10,547     53,615     36,879  
                                   

Net income (loss)

    (207,882 )   33,969     (3,150 )   73,000     40,362     24,090     39,003     120,380  
                                   

Basic and diluted earnings (loss) per share

    (1.27 )   0.21     (0.02 )   0.46     0.25     0.15     0.25     0.76  
                                   

Net cash provided by operating activities

    110,924     108,913     44,753     127,647     89,197     97,081     46,972     106,963  
                                   

        The following table displays the specific items identified by management that impacted net income in each of the eight most recently completed quarters and the impact of these items in the aggregate on diluted EPS. As described above under "Selected Financial Information — Specific Items Impacting Net Income", management believes the identification of these items enhances an analysis of our financial performance when comparing

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operating results between periods; however, excluding some or all of these items should not be viewed as a substitute for net income under U.S. GAAP.

 
  2010   2009   2008  
 
  Q3   Q2   Q1   Q4   Q3   Q2   Q1   Q4  
($ in 000s, except per share data; Income (Expense))
  $   $   $   $   $   $   $   $  

Restructuring and other costs

    (95,916 )   (2,881 )   (613 )   (3,937 )   (2,413 )   (11,367 )   (1,348 )   (10,855 )

Decrease (increase) in valuation allowance on deferred tax assets(1)

    (48,000 )           26,000                 90,000  

Legal settlements

    (38,500 )           (5,950 )           (241 )   (5,917 )

Acquisition-related costs

    (28,037 )   (7,577 )               (5,596 )        

Share-based compensation expense related to vested and partially vested Valeant stock options and RSUs(2)

    (20,909 )                            

Write-down of deferred financing costs

    (5,774 )                   (537 )        

Losses on auction rate and equity securities

    (5,005 )   (392 )   (155 )   (501 )   (385 )   (1,617 )   (2,707 )   (4,541 )

SEC/OSC independent consultant and related costs(3)

    (680 )   (150 )   (631 )   (83 )   169     (1,546 )   (1,427 )    

IPR&D(4)

        (10,242 )   (51,003 )   (20,814 )   (8,126 )   (30,414 )        

Loss on sale and leaseback of assets

                (10,968 )                

Proxy contest costs(3)

                    (399 )   (629 )       (50 )

Gain (loss) on disposal of investments

                    466     344     (6 )   (1,083 )

Gain on auction rate security settlement

                        22,000          

Management succession costs(3)

                                (1,362 )
                                   

Total

    (242,821 )   (21,242 )   (52,402 )   (16,253 )   (10,688 )   (29,362 )   (5,729 )   66,192  
                                   

Diluted EPS impact

    (1.40 )   (0.13 )   (0.33 )   (0.10 )   (0.07 )   (0.19 )   (0.04 )   0.42  
                                   

(1)
Included in provision for income taxes.

(2)
Allocated to cost of goods sold ($0.4 million), research and development expenses ($0.4 million), and selling general and adminstrative expenses ($20.1 million).

(3)
Included in selling, general and administrative expenses.

(4)
Included in research and development expenses.

        In addition to the above noted items, we recorded an adjustment of $12.0 million to the provision for income taxes in the third quarter of 2010, to reflect the impact of the increase in Biovail's annualized effective tax rate as a result of the Merger (as described above under "Results of Operations — Income Taxes").

Third quarter of 2010 Compared To Second Quarter of 2010

Results of Operations

        Total revenue declined $30.5 million, or 13%, to $208.3 million in the third quarter of 2010, compared with $238.8 million in the second quarter of 2010, mainly due to lower sales of Generic products (as a result of the inclusion of the rebate charge) and Zovirax® (due to reduced wholesaler inventory levels, in advance of a planned introduction of a new product presentation), partially offset by higher generic Tiazac® product sales.

        Net income declined $241.9 million to a net loss of $207.9 million in the third quarter of 2010, compared with net income of $34.0 million in the second quarter of 2010, primarily due to:

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        Those factors were partially offset by:

Cash Flows

        Net cash provided by operating activities increased $2.0 million, or 2%, to $110.9 million in the third quarter of 2010, compared with $108.9 million in the second quarter of 2010, primarily due to:

FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES

Selected Measures of Financial Condition

        The following table displays a summary of our financial condition at September 30, 2010 and December 31, 2009:

 
  At
September 30
2010
  At
December 31
2009
  Change  
($ in 000s; Asset (Liability))
  $   $   $   %  

Working capital(1)

    454,526     93,734     360,792     385  

Long-lived assets(2)

    9,714,704     1,539,364     8,175,340     531  

Long-term debt, including current portion

    (3,235,550 )   (326,085 )   (2,909,465 )   892  

Shareholders' equity

    (5,349,664 )   (1,354,372 )   (3,995,292 )   295  
                   

(1)
Total current assets less total current liabilities.

(2)
Property, plant and equipment, intangible assets, and goodwill.

79


Working Capital

        Working capital increased $360.8 million, or 385%, to $454.5 million at September 30, 2010, compared with $93.7 million at December 31, 2009, primarily due to:

        Those factors were partially offset by:

Long-Lived Assets

        Long-lived assets increased $8,175.3 million, or 531%, to $9,714.7 million at September 30, 2010, compared with $1,539.4 million at December 31, 2009, primarily due to:

        Those factors were partially offset by:

Long-term Debt

        Long-term debt (including the current portion) increased $2,909.5 million, or 892%, to $3,235.6 million at September 30, 2010, compared with $326.1 million at December 31, 2009, primarily due to:

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        Those factors were partially offset by:

Shareholders' Equity

        Shareholders' equity increased $3,995.3 million, or 295%, to $5,349.7 million at September 30, 2010, compared with $1,354.4 million at December 31, 2009, primarily due to:

        That factor was partially offset by:

Cash Flows

        The following table displays cash flow information for the third quarters and first nine months of 2010 and 2009:

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2010   2009   Change   2010   2009   Change  
($ in 000s)
  $   $   $   %   $   $   $   %  

Net cash provided by operating activities

    110,924     89,197     21,727     24     264,590     233,250     31,340     13  

Net cash provided by (used in) investing activities

    315,367     (4,514 )   319,881     NM     262,135     (748,309 )   1,010,444     (135 )

Net cash provided by (used in) financing activities

    (10,590 )   (89,214 )   78,624     (88 )   (48,794 )   245,475     (294,269 )   (120 )

Effect of exchange rate changes on cash and cash equivalents

    387     1,019     (632 )   (62 )   260     1,443     (1,183 )   (82 )
                                       

Net increase (decrease) in cash and cash equivalents

    416,088     (3,512 )   419,600     NM     478,191     (268,141 )   746,332     (278 )

Cash and cash equivalents, beginning of period

    176,566     52,918     123,648     234     114,463     317,547     (203,084 )   (64 )
                                       

Cash and cash equivalents, end of period

    592,654     49,406     543,248     1,100     592,654     49,406     543,248     1,100  
                                   

NM — Not meaningful

Operating Activities

        Net cash provided by operating activities increased $21.7 million, or 24%, to $110.9 million in the third quarter of 2010, compared with $89.2 million in the third quarter of 2009, attributable to the net effect of the following factors:

81


        Net cash provided by operating activities increased $31.3 million, or 13%, to $264.6 million in the first nine months of 2010, compared with $233.3 million in the first nine months of 2009, attributable to the net effect of the following factors:

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Investing Activities

        Net cash provided by investing activities increased $319.9 million to $315.4 million in the third quarter of 2010, compared with cash used of $4.5 million in the third quarter of 2009, primarily due to net cash acquired on the acquisition of Valeant of $309.0 million.

        Net cash provided by investing activities increased $1,010.4 million to $262.1 million in the first nine months of 2010, compared with cash used of $748.3 million in the first nine months of 2009, primarily due to:

        Those factors were partially offset by:

Financing Activities

        Net cash used in financing activities declined $78.6 million, or 88%, to $10.6 million in the third quarter of 2010, compared with $89.2 million in the third quarter of 2009, primarily due to repayments of $75.0 million made under the former credit facility of Biovail in the first nine months of 2009.

        Net cash used in financing activities increased $294.3 million to $48.8 million in the first nine months of 2010, compared with cash provided of $245.5 million in the first nine months of 2009, primarily due to:

        Those factors were partially offset by:

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Net Financial Assets (Liabilities)

 
  At
September 30
2010
  At
December 31
2009
  Change  
($ in 000s; Asset (Liability))
  $   $   $   %  

Financial Assets

                         

Cash and cash equivalents

    592,654     114,463     478,191     418  

Marketable securities

    9,236     21,082     (11,846 )   (56 )
                     

Total financial assets

    601,890     135,545     466,345     344  
                   

Financial Liabilities

                         

Term Loan A Facility

    (1,000,000 )       (1,000,000 )   NM  

Term Loan B Facility

    (500,000 )       (500,000 )   NM  

6.75% Senior Notes

    (497,500 )       (497,500 )   NM  

7.00% Senior Notes

    (695,625 )       (695,625 )   NM  

5.375% Convertible Notes

    (305,346 )   (298,285 )   (7,061 )   2  

4.0% Convertible Notes

    (220,489 )       (220,489 )   NM  

Cambridge obligation

    (16,590 )   (27,800 )   11,210     (40 )
                     

Total financial liabilities

    (3,235,550 )   (326,085 )   (2,909,465 )   892  
                     

Net financial liabilities

    (2,633,660 )   (190,540 )   (2,443,120 )   NM  
                   

NM — Not meaningful

        Historically, our primary sources of liquidity have been our cash flow from operations and issuances of long-term debt securities. We believe that existing cash and cash generated from operations, funds available under the Credit Agreement (as defined below), supplemented with additional debt issuances as needed, will be sufficient to meet our liquidity needs, based on our current expectations. We have no material commitments for capital expenditures.

        Our short-term debt maturities consist of $105.0 million outstanding principal amount under the Credit Agreement, due in quarterly installments of $26.3 million commencing December 31, 2010. We believe our existing cash and cash generated from operations will be sufficient to cover these short-term debt maturities as they become due.

        Part of our business strategy is to expand through strategic acquisitions which may require us to seek additional debt financing, issue additional equity securities or sell assets, as necessary, to finance future acquisitions or for other general corporate purposes.

        On September 27, 2010, Valeant and certain of its subsidiaries entered into the Credit and Guaranty Agreement (the "Credit Agreement"), which consists of (1) a four-and-one half-year non-amortizing $125 million Revolving Credit Facility, which will include a sublimit for the issuance of standby and commercial letters of credit and a sublimit for swing line loans, (2) a five-year amortizing $1.0 billion Term Loan A Facility, and (3) a six-year amortizing $1.625 billion Term Loan B Facility, consisting of a $1.5 billion "initial draw" and a $125.0 million "delayed draw" (together the "Credit Facilities"). We may use the loans under the "delayed draw" Term Loan B Facility, together with cash of hand, for the payment of the post-Merger special dividend of $1.00 per share that will be payable on December 22, 2010 (as described below under "Post-Merger Special Dividend"). On September 28, 2010, we and certain of our subsidiaries (other than Valeant and its subsidiaries) entered into Counterpart Agreements to the Credit Agreement, each in substantially the same form.

        On September 28, 2010, Valeant issued $500.0 million aggregate principal amount of 6.75% Senior Notes and $700.0 million aggregate principal amount of 7.00% Senior Notes. The Senior Notes are the senior unsecured obligations of Valeant and are jointly and severally guaranteed by us and certain of our subsidiaries (other than Valeant), that are guarantors under the Credit Facilities. Certain of the future domestic subsidiaries of Valeant and certain of our future subsidiaries may be required to guarantee the Senior Notes. A portion of

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the proceeds of the Senior Notes offering was used to repay $1.0 billion of the Term Loan B Facility and the remaining portion will be used for general corporate purposes.

Post-Merger Special Dividend

        On November 4, 2010, our board of directors declared a special dividend of $1.00 (the "post-merger special dividend") per common share, no par value. Shareholders of record as of the close of business on November 15, 2010 (the "record date") will be entitled to receive the post-merger special dividend on December 22, 2010. In connection with the post-merger special dividend, we have established a special dividend reinvestment plan (the "special dividend reinvestment plan") under which eligible shareholders of record as of the record date may elect to reinvest the post-merger special dividend (net of any applicable withholding tax) in additional common shares of the Company.

        This Form 10-Q does not and will not constitute an offer to sell or the solicitation of an offer to buy common shares of the Company. We intend to file a registration statement (including a prospectus) with the SEC to register the common shares of the Company that will be offered pursuant to the special dividend reinvestment plan. You may also obtain these documents, free of charge, from the Company's website (www.valeant.com) under the tab "Investor Relations" and then under the heading "SEC Filings", or by directing a request to the Company, 7150 Mississauga Road, Mississauga, Ontario, Canada, L5N 8M5, Attention: Investor Relations. Information related to the special dividend reinvestment plan is being provided pursuant to and in accordance with Rule 135 under the Securities Act.

Securities Repurchase Program

        Our board of directors has approved a securities repurchase program (the "securities repurchase program"), pursuant to which we may make purchases of our common shares, 5.375% and 4.0% Convertible Notes and/or Senior Notes up to an aggregate maximum value of $1.5 billion, subject to any restrictions in the Company's financing agreements and applicable law.

        In connection with the securities repurchase program, the board of directors also approved a sub-limit of up to 16,000,000 common shares, representing approximately 10% of the Company's public float, to be purchased for cancellation under a normal course issuer bid through the facilities of the NYSE and Toronto Stock Exchange ("TSX"), subject to completion of the appropriate filings and receipt of applicable approvals.

Biovail Share Repurchase Program

        On August 5, 2009, Biovail's board of directors approved the purchase of up to 15,800,000 of its common shares on the open market under a share repurchase program, or normal course issuer bid, subject to a maximum of $75.0 million of common shares being repurchased during any fiscal year pursuant to a covenant in Biovail's former credit facility (unless such condition was waived or varied by the lenders). The share repurchase program terminated on August 11, 2010. Biovail did not repurchase any of its common shares under this program.

OFF-BALANCE SHEET ARRANGEMENTS AND CONTRACTUAL OBLIGATIONS

        We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our results of operations, financial condition, capital expenditures, liquidity, or capital resources.

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        The following table summarizes expected principal and interest payments on long-term debt as of September 30, 2010:

 
  Payments Due by Period  
 
  Total   2010   2011
and 2012
  2013
and 2014
  Thereafter  
($ in 000s)
  $   $   $   $   $  

Long-term debt(1)

    4,438,177     37,341     620,690     1,353,104     2,427,042  
                       

(1)
Expected interest payments assume repayment of the principal amount of the related debt obligations at maturity. Principal and interest payments on the Credit Facilities are calculated based on outstanding borrowings at September 30, 2010, using the effective interest rate on the facilities at that date.

        We have also assumed lease and purchase obligations of Valeant that individually and in the aggregate are not expected to have a material future effect on our liquidity or capital resources.

        We acquire and collaborate on products still in development and enter into research and development arrangements with third parties that often require milestone and royalty payments to the third party contingent upon the occurrence of certain future events linked to the success of the products in development. As described above under "Synergies and Cost Savings — Biovail Research and Development Pipeline Rationalization", we have determined not to continue a number of Biovail's specialty CNS programs, and have provided notices of termination to, or entered into termination agreements with, the counterparty to each of the related agreements. As a result, we will not be required to make the previously identified contingent milestone or royalty payments under those agreements. As described above under "Biovail Pre-Merger 2010 Business Development", we may be required to make milestone payments of up to $55.0 million in the aggregate in connection with the istradefylline acquisition, contingent on the achievement of specific developmental, regulatory and commercial milestones. In addition, we may have to make royalty payments based on net commercial sales of products containing istradefylline.

        There have been no other material changes outside the normal course of business to the items specified in the contractual obligations table and related disclosures under the heading "Off-Balance Sheet Arrangements and Contractual Obligations" in the annual MD&A contained in the Biovail 2009 Form 10-K.

OUTSTANDING SHARE DATA

        Our common shares are listed on the TSX and the NYSE under the ticker symbol "VRX".

        At November 2, 2010, we had 299,988,521 issued and outstanding common shares and 2,102,893 common shares issuable in connection with the Merger. In addition, we had 14,846,843 stock options and 2,535,336 time-based RSUs that each represent the right of a holder to receive one of the Company's common shares, and 1,211,833 performance-based RSUs that represent the right of a holder to receive up to 300% of the RSUs granted.

        Assuming full share settlement, 23,482,008 common shares are issuable upon the conversion of the 5.375% Convertible Notes (based on a current conversion rate of 67.09145 common shares per $1,000 principal amount of notes, subject to adjustment), and 17,118,286 common shares are issuable upon the conversion of the 4.0% Convertible Notes (based on a current conversion rate of 76.09483 common shares per $1,000 principal amount of notes, subject to adjustment); however, our intent and policy is to settle these notes using a net share settlement approach. Under the Valeant call options agreements assumed in connection with the Merger, the Company has the right but not the obligation to buy up to 15,218,960 of its common shares from the counterparties to these agreements, and the counterparties have the right but not the obligation to buy from the Company up to 18,937,405 common shares.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        Our business and financial results are affected by fluctuations in world financial markets, including the impacts of foreign currency exchange rate and interest rate movements. We evaluate our exposure to such risks

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on an ongoing basis, and seek ways to manage these risks to an acceptable level, based on management's judgment of the appropriate trade-off between risk, opportunity and cost. We use derivative financial instruments from time to time as a risk management tool and not for trading or speculative purposes. Currently, we do not hold any significant amount of market risk sensitive instruments whose value is subject to market price risk.

Foreign Currency Risk

        Historically, a majority of Biovail's revenue and expense activities and capital expenditures were denominated in U.S. dollars. Biovail also faced foreign currency exposure on the translation of its operations in Canada from Canadian dollars to U.S. dollars. Effective with the Merger, we have additional foreign currency exposure related to the Polish zloty (and other Eastern European currencies), the Mexican peso, the Brazilian real and the Australian dollar. Where possible, we manage foreign currency risk by managing same currency assets in relation to same currency liabilities, and same currency revenue in relation to same currency expenses.

Interest Rate Risk

        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. The primary objective of our policy for the investment of temporary cash surpluses is the protection of principal, and accordingly, we generally invest in investment-grade debt securities with varying maturities, but typically less than one year. As it is our intent and policy to hold these investments until maturity, we do not have a material exposure to interest rate risk.

        We had $1.775 billion and $1.5 billion principal amount of fixed rate debt and variable rate debt, respectively, as of September 30, 2010 that required U.S. dollar repayment. The estimated fair value of our fixed rate debt at September 30, 2010 was $2.259 billion. If interest rates were to increase or decrease by 100 basis-points the fair value of our long-term debt would increase or decrease by approximately $109 million. We are subject to interest rate risk on our variable rate debt as changes in interest rates could adversely affect earnings and cash flows. A 100 basis-points change in interest rates would have an annualized pre-tax effect of approximately $10 million in our consolidated statements of operations and cash flows, based on current outstanding borrowings and effective interest rates on our variable rate debt. While our variable-rate debt may impact earnings and cash flows as interest rates change, it is not subject to changes in fair value.

        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.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

        Critical accounting policies and estimates are those policies and estimates that are most important and material to the preparation of our consolidated financial statements, and which require management's most subjective and complex judgment due to the need to select policies from among alternatives available and make estimates about matters that are inherently uncertain. There have been no material changes to our critical accounting policies and estimates disclosed under the heading "Critical Accounting Policies and Estimates" in the annual MD&A contained in the Biovail 2009 Form 10-K.

RECENT ACCOUNTING GUIDANCE

Adoption of New Accounting Guidance

        Effective January 1, 2010, Biovail adopted the following new accounting guidance:

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Recently Issued Accounting Guidance, Not Adopted as of September 30, 2010

        In March 2010, new authoritative guidance was issued recognizing the milestone method of revenue recognition as a valid application of the proportional performance model when applied to research and development arrangements. An entity may make an accounting policy election to recognize the receipt of a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. The guidance is effective for fiscal years, and interim periods within those years, beginning on or after June 15, 2010. We are currently evaluating the effect that the adoption of this guidance will have on our financial condition and results of operations.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk

        Information relating to quantitative and qualitative disclosures about market risk is detailed in Item 2, and is incorporated herein by reference.

Item 4.    Controls and Procedures

        Our management, with the participation of our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO"), has evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2010. Based on this evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of September 30, 2010. In the period leading up to the Merger, there were no changes to either Biovail's or Valeant's internal controls over financial reporting that were reasonably likely to have a material effect. For the post-Merger period, management has maintained the operational integrity of each company's internal controls over financial reporting.

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PART II. OTHER INFORMATION

Item 1.    Legal Proceedings

        For information concerning legal proceedings, reference is made to note 14 to the condensed consolidated financial statements included under Part I, Item 1, of this Quarterly Report on Form 10-Q.

Item 1A.    Risk Factors

        The Company has reviewed and updated its risk factors as previously disclosed in the Biovail 2009 Form 10-K. Below are the updated risk factors set forth in their entirety.

        The Company's business, operations and financial condition are subject to various risks and uncertainties. You should carefully consider the risks and uncertainties described below, together with all of the other information in this Quarterly Report on Form 10-Q and the Biovail 2009 Annual Report, including those risks set forth under the heading entitled "Forward-Looking Statements", and in other documents that the Company files with the SEC and the CSA, before making any investment decision with respect to its securities. If any of the risks or uncertainties actually occur or develop, the Company's business, financial condition, results of operations and future growth prospects could change. Under these circumstances, the market value of the Company's securities could decline, and you could lose all or part of your investment in the Company's securities.

We operate in an extremely competitive industry. If competitors develop more effective or less costly drugs for our target indications, our business could be seriously harmed.

        Many of our competitors, particularly large pharmaceutical companies, have substantially greater financial, technical and human resources than we do. Many of our competitors spend significantly more on research and development related activities than we do. Others may succeed in developing products that are more effective than those currently marketed or proposed for development by us. Progress by other researchers in areas similar to those being explored by us may result in further competitive challenges. In addition, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products. They may also establish exclusive collaborative or licensing relationships with our competitors.

The failure to integrate successfully the businesses of Valeant and Biovail in the expected time frame could adversely affect the Company's future results.

        The success of the Merger will depend, in large part, on the ability of the Company to realize the anticipated benefits, including cost savings, from combining the businesses of Valeant and Biovail. To realize these anticipated benefits, the businesses of Valeant and Biovail must be successfully integrated. This integration will be complex and time-consuming. The failure to integrate successfully and to manage successfully the challenges presented by the integration process may result in the Company not achieving the anticipated benefits of the Merger.

        Potential difficulties that may be encountered in the integration process include the following:

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The Company's future results will suffer if it does not effectively manage its expanded operations following the Merger.

        The size of the Company's business will be dramatically larger than the size of each of Valeant's and Biovail's businesses prior to the Merger. The combined future success depends, in part, upon its ability to manage this expanded business, which will pose substantial challenges for management, including challenges related to the management and monitoring of new operations and associated increased costs and complexity. We cannot assure you that the Company will be successful or that the Company will realize the expected operating efficiencies, synergies, cost savings, revenue enhancements and other benefits currently anticipated from the Merger.

The Company's effective tax rates may increase.

        The Company has operations in various countries that have differing tax laws and rates. A significant portion of the Company's revenue and income is earned in Barbados, a country with a low domestic tax rate. Dividends from such after-tax business income are received tax-free in Canada. The Company's tax structure is supported by current domestic tax laws in the countries in which the Company operates and the application of tax treaties between the various countries in which the Company operates. The Company's income tax reporting will be, and the historic tax reporting of each of Valeant and Biovail is, subject to audit by domestic and foreign authorities. The Company's effective tax rate may change from year to year based on changes in the mix of activities and income allocated or earned among the different jurisdictions in which it operates; changes in tax laws in these jurisdictions; changes in the tax treaties between various countries in which it operates; changes in its eligibility for benefits under those tax treaties; and changes in the estimated values of deferred tax assets and liabilities. Such changes could result in an increase in the effective tax rate on all or a portion of the Company's income to a rate possibly exceeding the statutory income tax rate of Canada or the U.S.

        The Company's provision for income taxes is based on certain estimates and assumptions made by management. The Company's consolidated income tax rate is affected by the amount of net income earned in its various operating jurisdictions, the availability of benefits under tax treaties, and the rates of taxes payable in respect of that income. The Company enters into many transactions and arrangements in the ordinary course of business in respect of which the tax treatment is not entirely certain. The Company therefore makes estimates and judgments based on its knowledge and understanding of applicable tax laws and tax treaties, and the application of those tax laws and tax treaties to its business, in determining its consolidated tax provision. For example, certain countries could seek to tax a greater share of income than will be provided for by the Company. The final outcome of any audits of the Company by taxation authorities may differ from the estimates and assumptions the Company may use in determining its consolidated tax provisions and accruals. This could result in a material adverse effect on the Company's consolidated income tax provision, financial condition and the net income for the period in which such determinations are made.

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        The Company records a valuation allowance on deferred tax assets relating to a portion of the Company's Canadian and U.S. operating losses, Scientific Research and Experimental Development pool, investment tax credit carry-forward balances, provisions for legal settlements, and future tax depreciation. The Company has assumed that these deferred tax assets are more likely than not to remain unrealized by the Company.

        The Company's deferred tax liabilities, deferred tax assets and any related valuation allowances are affected by events and transactions arising in the ordinary course of business, acquisitions of assets and businesses, and non-recurring items. The assessment of the appropriate amount of a valuation allowance against the deferred tax assets is dependent upon several factors, including estimates of the realization of deferred income tax assets, which realization will be primarily based on forecasts of future taxable income. Significant judgment is applied to determine the appropriate amount of valuation allowance to record. Changes in the amount of any valuation allowance required could materially increase or decrease the Company's provision for income taxes in a given period.

The Company is expected to incur substantial expenses related to the Merger and the integration of Valeant and Biovail.

        The Company is expected to incur substantial expenses in connection with the Merger and the integration of Valeant and Biovail including certain restructuring actions that may be taken to achieve synergies. There are a large number of processes, policies, procedures, operations, technologies and systems that must be integrated, including purchasing, accounting and finance, sales, billing, payroll, manufacturing, marketing and benefits. While the Company has assumed that a certain level of expenses will be incurred, there are many factors beyond its control that could affect the total amount or the timing of the integration expenses. Moreover, many of the expenses that will be incurred are, by their nature, difficult to estimate accurately. These expenses could, particularly in the near term, exceed the savings that the Company expects to achieve from the elimination of duplicative expenses and the realization of economies of scale and cost savings. While management believes the estimated integration expense is reasonable, the amount of future integration expense is not certain and could result in the Company taking significant charges against earnings in future periods.

If goodwill or other intangible assets that the Company records in connection with the Merger become impaired, the Company could have to take significant charges against earnings.

        In connection with the accounting for the Merger, the Company recorded a significant amount of goodwill and other intangible assets. Under U.S. GAAP, the Company must assess, at least annually and potentially more frequently, whether the value of goodwill and other indefinite-lived intangible assets has been impaired. Amortizing intangible assets will be assessed for impairment in the event of an impairment indicator. Any reduction or impairment of the value of goodwill or other intangible assets will result in a charge against earnings, which could materially adversely affect the Company's results of operations and shareholders' equity in future periods.

The Company has incurred significant indebtedness in connection with the Merger, which indebtedness may restrict the manner in which the Company conducts business and limit the Company's ability to implement elements of its growth strategy.

        The Company has incurred significant indebtedness in connection with the Merger, which indebtedness may restrict the manner in which the Company conducts business and limit the Company's ability to implement elements of its growth strategy. As a result of the transactions entered into in connection with Merger, we have approximately $3.2 billion of indebtedness outstanding. We may also incur additional long-term debt and working capital lines of credit to meet future financing needs, subject to certain restrictions under our indebtedness, including the Credit Facilities and the Senior Notes, which would increase our total debt.

        The potential significant negative consequences on our financial condition and results of operations that could result from our substantial debt include:

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The Company must continue to retain, motivate and recruit executives and other key employees, and failure to do so could negatively affect the Combined Company.

        For the Merger to be successful, the Company must continue to retain, motivate and recruit executives and other key employees. Experienced employees in the pharmaceutical industry are in high demand and competition for their talents can be intense. A failure by the Company to retain and motivate executives and other key employees could have an adverse impact on the Company's business.

To service our debt, we will require a significant amount of cash. Our ability to generate cash depends on many factors beyond our control, and any failure to meet our debt service obligations could harm our business, financial condition and results of operations.

        Our ability to satisfy our debt obligations will depend principally upon our future operating performance. As a result, prevailing economic conditions and financial, business and other factors, many of which are beyond our control, will affect our ability to make payments on our debt. If we do not generate sufficient cash flow from operations to satisfy our debt service obligations, we may have to undertake alternative financing plans, such as refinancing or restructuring our debt, selling assets, reducing or delaying capital investments or seeking to raise additional capital. Our ability to restructure or refinance our debt will depend on the capital markets and our financial condition at such time. Any refinancing of our debt could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. Our inability to generate sufficient cash flow to satisfy our debt service obligations or to refinance our obligations on commercially reasonable terms would have an adverse effect, which could be material, on our business, financial position, results of operations and cash flows.

        Repayment of our indebtedness is dependent on the generation of cash flow by our subsidiaries and their ability to make such cash available to us, by dividend, debt repayment or otherwise. Our subsidiaries may not be able to, or may not be permitted to, make distributions to enable us to make payments in respect of our indebtedness. Each subsidiary is a distinct legal entity and, under certain circumstances, legal and contractual restrictions may limit our ability to obtain cash from our subsidiaries. Certain non-guarantor subsidiaries include non-U.S. subsidiaries that may be prohibited by law or other regulations from distributing funds to us. In addition, we may be subject to payment of repatriation taxes and withholdings. In the event that we do not receive distributions from our subsidiaries or receive cash via cash repatriation strategies for services rendered

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and intellectual property, we may be unable to make required principal and interest payments on our indebtedness.

We may be unable to identify, acquire and integrate acquisition targets successfully.

        Part of our business strategy includes acquiring and integrating complementary businesses, products, technologies or other assets, and forming strategic alliances, joint ventures and other business combinations, to help drive future growth. Acquisitions or similar arrangements may be complex, time consuming and expensive. They may fail to further our business strategy as anticipated, expose us to increased competition or challenges with respect to our products or geographic markets, and expose our to additional liabilities associated with acquired business, product, technology or other asset or arrangement. Any one of these challenges or risks could impair our ability to realize any benefit from our acquisition or arrangement after we have expended resources on them.

        In addition, our acquisitions strategy may require us to use a significant portion of our available cash, obtain additional debt or contingent liabilities that may increase leverage, or issue additional equity that may dilute ownership of our shareholders. We may not be able to finance acquisitions on terms satisfactory to us.

        Finally, we may not consummate some negotiations for acquisitions or arrangements. Negotiations for acquisitions or arrangements that are not ultimately consummated could result in significant diversion of management time, as well as substantial out-of-pocket costs. Our competitors may have greater resources than us and therefore be better able to complete acquisitions or may cause the ultimate price we pay for acquisitions to increase.

        We cannot forecast the number, timing or size of future acquisitions or arrangements, or the effect that any such transactions might have on our operating or financial results. Any such acquisition or arrangement could disrupt our business and negatively impact our operating results and financial condition. Our failure to implement successfully our acquisition strategy would limit our potential growth and could have a material adverse effect on our business.

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 U.S. 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.

Legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably.

        In the U.S. 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. On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act ("PPACA"), which includes a number of health care reform provisions and requires most U.S. citizens to have health insurance. Effective January 1, 2010, the new law increases the minimum Medicaid drug rebates for pharmaceutical companies, expands the 340B drug discount program, and makes changes to affect the Medicare Part D coverage gap, or "donut hole." The law also revises the definition of "average manufacturer price" for reporting purposes, effective October 1, 2010, which could increase the amount of our Medicaid drug rebates to states, once the provision is effective. Beginning in 2011, the new law also imposes a significant annual fee on companies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance also have been added, which may require us to modify our business practices with health care practitioners.

        The reforms imposed by the new law will significantly impact the pharmaceutical industry; however, the full effects of PPACA cannot be known until these provisions are implemented and the Centers for Medicare & Medicaid Services and other federal and state agencies issue applicable regulations or guidance. Moreover, in

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the coming years, additional changes could be made to governmental healthcare programs that could significantly impact the success of our products.

        The high cost of pharmaceuticals continues to generate substantial governmental interest. 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 managed care organizations and additional legislative proposals. Our results of operations could be adversely affected by current and future health care reform.

Our future revenue growth and profitability are dependent upon our ability to in-license or otherwise acquire new compounds or other commercially viable products and to further develop or enhance such products. Our failure to do so successfully could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        Our future revenue growth and profitability are dependent upon our ability to in-license or otherwise acquire new compounds or other commercially viable products and to further develop or enhance such products. We are engaged in programs involving compounds which we may develop and/or commercialize ourselves, or with a partner or by a licensee. We may also participate in the development and/or commercialization of our partners' product candidates.

        Commercializing products is time consuming, expensive and unpredictable. There can be no assurance that we will be able to, either by ourselves or in collaboration with our partners or through our licensees, successfully develop or commercialize new products, complete clinical trials, obtain regulatory approvals, or gain market acceptance for such products. Collaborating with partners and licensees requires the commitment of substantial effort and expense in seeking out, evaluating and negotiating collaboration or acquisition agreements, which expense we may incur without achieving our desired results and which effort involves inherent risks, including uncertainties due to matters that may affect the successful development or commercialization of in-licensed products, as well as the possibility of contractual disagreements with regard to terms such as patent rights, license scope or termination rights. Our existing arrangements with our partners and licensees contain, and future arrangements are likely to contain, various provisions, such as repayment upon termination rights, that, if exercised, could have a negative impact on efforts to commercialize the applicable products, or on our company in general. It may be necessary for us to enter into other 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 arrangements on terms favorable to us or at all.

If ezogabine/retigabine and other product candidates in development do not become approved and commercially successful products, our ability to generate future growth in revenue and earnings will be adversely affected.

        We focus our development activities on areas in which we have particular strengths. The outcome of any development program is highly uncertain. Products in clinical trials may fail to yield a commercial product, or a product may be approved by the FDA yet not be a commercial success. Success in preclinical and early stage clinical trials may not necessarily translate into success in large-scale clinical trials.

        In addition, we or a partner will need to obtain and maintain regulatory approval in order to market retigabine and other product candidates. Even if such products appear promising in large-scale Phase III clinical trials, regulatory approval may not be achieved. The results of clinical trials are susceptible to varying interpretations that may delay, limit or prevent approval or result in the need for post-marketing studies. In addition, changes in regulatory policy for product approval during the period of product development and FDA review of a new application may cause delays or rejection. Even if we receive regulatory approval, this approval may include limitations on the indications for which we can market a product or onerous risk management programs, thereby reducing the size of the market that we would be able to address or our product may not be chosen by physicians for use by their patients. There is no guarantee that we will be able to satisfy the needed regulatory requirements, and we may not be able to generate significant revenue, if any, from retigabine and other product candidates.

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Obtaining necessary government approvals is time consuming and not assured.

        FDA and the Canadian Therapeutic Products Directorate ("TPDA") approval must be obtained in the U.S. and Canada, respectively, and approval must be obtained from comparable agencies in other countries prior to marketing or manufacturing new pharmaceutical products for use by humans. Obtaining FDA, TPD and other regulatory approval for new products and manufacturing processes can take a number of years and involves the expenditure of substantial resources. Numerous requirements must be satisfied, including preliminary testing programs on animals and subsequent clinical testing programs on humans, to establish product safety and efficacy. No assurance can be given that we will obtain approval in the U.S., Canada or any other country, of any application we may submit for the commercial sale of a new or existing drug or compound. Nor can any assurance be given that if such approval is secured, the approved labeling will not have significant labeling limitations, or that those drugs or compounds will be commercially successful.

        Furthermore, changes in existing regulations or adoption of new regulations could prevent or delay us from obtaining future regulatory approvals or jeopardize existing approvals, which could significantly increase our costs associated with obtaining approvals and negatively impact our market position.

        If we do not receive regulatory approval to sell our pipeline products, we will not be able to generate revenues in future periods for such products, which could have a material adverse effect on our business and results of operations and could cause the market value of our shares to decline.

We will not be able to commercialize our pipeline products if preclinical studies do not produce successful results or if clinical trials do not demonstrate safety and efficacy in humans.

        The Company and its development partners, as applicable, conduct extensive preclinical studies and clinical trials to demonstrate the safety and efficacy in humans of our pipeline products in order to obtain regulatory approval for the sale of our pipeline products. Preclinical studies and clinical trials are expensive, can take many years and have uncertain outcomes.

        Our success will depend on the success of the preclinical and clinical trials conducted by us and our development partners. It can take several years to complete the preclinical and clinical trials of a product, and a failure of one or more of these preclinical or clinical trials can occur at any stage of testing. We believe that the development of each of our pipeline products involves significant risks at each stage of testing. If preclinical or clinical trial difficulties and failures arise, our pipeline products may never be approved for sale or become commercially viable.

        In addition, the possibility exists that:

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Our approved products may not achieve or maintain expected levels of market acceptance, which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        Even if we are able to obtain regulatory approvals for our new pharmaceutical products, generic or branded, the success of those products is dependent upon achieving and maintaining market acceptance. New product candidates that appear promising in development may fail to reach the market or may have only limited or no commercial success. Levels of market acceptance for our new products could be impacted by several factors, many of which are not within our control, including but not limited to the:

        Further, the discovery of significant problems with a product similar to one of our products that implicate (or are perceived to implicate) an entire class of products could have an adverse effect on sales of the affected products. Accordingly, new data about our products, or products similar to our products, could negatively impact demand for our products due to real or perceived side effects or uncertainty regarding efficacy and, in some cases, could result in product withdrawal.

        These situations, should they occur, could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

Our marketed drugs will be subject to ongoing regulatory review. If we fail to comply with U.S. and Canadian regulatory requirements and those in other territories where our products are sold, we could lose our marketing approvals or be subject to fines or other sanctions.

        Following initial regulatory approval of any drugs we or our partners may develop, we will be subject to continuing regulatory review by the FDA, the TPD and other regulatory authorities in territories where our products are marketed or intended to be marketed, including the review of adverse drug events and clinical results that are reported after product candidates become commercially available. This may include results from any post-marketing follow-up studies or other reporting required as a condition to approval. The manufacturing, labeling, packaging, storage, distribution, advertising, promotion, reporting and recordkeeping related to the product will also be subject to extensive ongoing regulatory requirements. In addition, incidents of adverse drug reactions ("ADRs"), unintended side effects or misuse relating to our products could result in additional regulatory controls or restrictions, or even lead to withdrawal of a product from the market.

Our approved products may be subject to additional clinical trials which could result in the loss of marketing approval, changes in product labeling or new or increased concerns about side effects or efficacy.

        As a condition to granting marketing approval of a product, the FDA and TPD may require a company to conduct additional clinical trials. The results generated in these trials could result in the subsequent loss of marketing approval, changes in product labeling or new or increased concerns about side effects or efficacy of a product. On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 ("FDAA") was enacted, giving the FDA enhanced post-market authority, including the explicit authority to require post-market studies and clinical trials, labeling changes based on new safety information and compliance with FDA-approved risk evaluation and mitigation strategies. The FDA's exercise of this authority could result in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with post-approval regulatory requirements and potential restrictions on sales of approved products. Post-marketing studies, whether conducted by us or by others and whether mandated by regulatory agencies or undertaken

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voluntarily, and other emerging data about marketed products, such as adverse event reports, may also adversely affect sales of our products. Such studies, which increasingly employ sophisticated methods and techniques, may call into question the utilization, safety and efficacy of previously marketed products. In some cases, studies may result in the discontinuance of product marketing or the need for risk management programs. In addition, government agencies may determine that a product should be scheduled as a controlled substance under the Controlled Drugs and Substances Act (the "CDSA"), as has been proposed by Health Canada for our tramadol products. If one of our products is scheduled under the CDSA or a similar regulation, such regulation would reduce practitioner prescriptions for such product, which may lead to a reduction in revenues from such product. Such regulation may also increase the costs of manufacturing and distributing such product in order to meet the regulatory requirements applicable to controlled substances, such as process upgrades and renovations required at our facilities and changes to our manufacturing, storage and transportation practices.

If we or our third-party manufacturers are unable to manufacture our products or the manufacturing process is interrupted due to failure to comply with regulations or for other reasons, the manufacture of our products could be interrupted.

        We manufacture and have contracted with third parties to manufacture some of our drug products, including products under the rights acquired from other pharmaceutical companies. Manufacturers are required to adhere to current good manufacturing ("cGMP") regulations enforced by the FDA, the TPD or the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use or similar regulations required by regulatory agencies in other countries. Compliance with cGMP requirements applies to both drug products seeking regulatory approval and to approved drug products. Our manufacturing facilities and those of our contract manufacturers must be inspected and found to be in full compliance with cGMP or similar standards before approval for marketing.

        Our dependence upon others to manufacture our products may adversely affect our profit margins and our ability to develop and obtain approval for our products on a timely and competitive basis, if at all. Our failure or that of our contract manufacturers to comply with cGMP regulations or similar regulations outside of the U.S. can result in enforcement action by the FDA or its foreign counterparts, including, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, suspension or withdrawal of regulatory approval for approved or in-market products, refusal of the government to renew marketing applications or approve pending applications or supplements, suspension of ongoing clinical trials, imposition of new manufacturing requirements, closure of facilities and criminal prosecution. In addition, delays or difficulties by us or with our contract manufacturers in producing, packaging, or distributing our products could adversely affect the sales of our current products or introduction of other products.

        In addition to regulatory compliance risks, our contract manufacturers in the U.S. and in other countries are subject to a wide range of business risks, such as seizure of assets by governmental authorities, natural disasters, and domestic and international economic conditions. Were we or any of our contract manufacturers not able to manufacture our products because of regulatory, business or any other reasons, the manufacture of our products would be interrupted. This could have a negative impact on our sales, financial condition and competitive position.

        Under certain circumstances, regulatory agencies also have the authority to revoke previously granted drug approvals. These policies may change and additional U.S. or Canadian federal, provincial, state or local governmental regulations or foreign governmental regulations may be enacted that could affect our ability to maintain compliance. We cannot predict the likelihood, nature or extent of adverse governmental regulation that may arise from future legislation or administrative action.

        If we or our third-party manufacturers were deemed to be deficient regarding regulatory compliance in any significant way, it could have a material adverse effect on our business, financial condition and results of operations and it could cause the market value of our common shares to decline.

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Manufacturing difficulties or delays may adversely affect our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        Our manufacturing and other processes use complicated and sophisticated equipment, which sometimes requires a significant amount of time to obtain and install. Manufacturing complexity, testing requirements and safety and security processes combine to increase the overall difficulty of manufacturing these products and resolving manufacturing problems that we may encounter. Although we endeavour to properly maintain our equipment, including through on-site quality control and experienced manufacturing supervision, and have key spare parts on hand, our business could suffer if certain manufacturing or other equipment, or all or a portion of our remaining facility, were to become inoperable for a period of time. This could occur for various reasons, including catastrophic events, such as hurricanes, earthquakes or other natural disasters, explosions, environmental accidents, pandemics, quarantine, equipment failures or delays in obtaining components or replacements, construction delays or defects and other events, both within and outside of our control. We could experience substantial production delays in the event of any such occurrence until we build or locate replacement equipment or a replacement facility, as applicable, and seek to obtain necessary regulatory approvals for such replacement. Any interruption in our manufacture of products could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

We have entered into distribution agreements with other companies to distribute certain of our generic products at supply prices based on net sales. Declines in the pricing and/or volume, over which we have no control, of such generic products, and therefore the amounts paid to us, may have a material adverse effect on our business and results of operations and could cause the market value of our common shares to decline.

        Our portfolio of generic products is the subject of various agreements, pursuant to which we manufacture and sell generic products to other companies, which distribute such products in the U.S. and Canada at a supply price typically based on net sales. These companies make all distribution and pricing decisions independently of us. If the pricing or volume of such generic products declines, our revenues could be adversely impacted which could have a material adverse effect on our business and results of operations and could cause the market value of our common shares to decline.

Disruptions of delivery of our products and the routine flow of manufactured goods across the U.S. border could adversely impact our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        The supply of our products to our customers is subject to and dependent upon the use of transportation services. Disruption of transportation services could adversely impact our financial results. In addition, several of our manufacturing facilities are located outside the continental U.S. while most of our sales take place within the U.S. A significant portion of our revenue is derived from products that are imported into the U.S. in finished dosage form from Canada or other countries and must undergo review by the Department of Homeland Security — U.S. Customs and Border Protection ("DHS-CBP"). We also purchase products from third parties outside the U.S. Disruption to the routine flow of manufactured goods across the border could have a significant impact on when revenues are recognized and the willingness of customers to continue to purchase products that we import from outside of the U.S. As such, any change in policy or policy implementation relating to U.S. border controls may have an adverse impact on our access to the U.S. marketplace that, in turn, could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        Over the past few years, pharmaceutical products manufactured outside of the U.S. have been associated with significant adverse health effects and/or as posing elevated risks even in the absence of adverse effects. As a result, there is increased interest in disclosure with regard to foreign sourcing of ingredients. Current practice within the pharmaceutical industry with respect to country of origin marking ("COOM") is in a period of transition toward more disclosure. Compliance determinations at U.S. border stations are complicated by the fact that the country of origin for tariff purposes may not be the same as for COOM purposes and may be different still from the FDA "manufactured by" statement. The result can be that DHS-CBP may issue a Notice to Mark and/or Notice to Redeliver — incurring relabeling costs and delay — that may or may not be well

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founded and/or penalties and fines for products deemed to be improperly presented for importation. Not all of our customers have adopted the same approach to COOM and instructions from border officials can vary. In addition, repeated presentation of goods with similar compliance deficiencies can result in fines. We may be exposed to such costs and disruption until we can establish and confirm agreement with our customers to accept a consistent set of labeling rules that are also acceptable to DHS-CBP.

If we are unable to obtain components or raw materials, or products supplied by third parties, our ability to manufacture and deliver our products to the market may be impeded, which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        Some components and raw materials used in our manufactured products, and some products sold by us, are currently available only from one or a limited number of domestic or foreign suppliers. Such suppliers must be qualified in accordance with applicable regulatory requirements and the process of qualifying a supplier can be costly and time consuming. In the event an existing supplier becomes unavailable through business interruption or financial insolvency or loses its regulatory status as an approved source and we do not have a second supplier, we will attempt to locate a qualified alternative; however, we may be unable to obtain the required components, raw materials or products on a timely basis or at commercially reasonable prices. We are also vulnerable to supply interruptions should we be unable to renew or replace, or successfully transfer, current supply agreements when such agreements expire. A prolonged interruption in the supply of a single-sourced raw material, including the API, or finished product or the occurrence of quality deficiencies in the products which our suppliers provide, could have a material adverse effect on our business, financial condition and results of operations, and the market value of our common shares could decline.

        Our arrangements with foreign suppliers are subject to certain additional risks, including the availability of government clearances, export duties, transport issues, political instability, currency fluctuations and restrictions on the transfer of funds. Arrangements with international raw material suppliers are subject to, among other things, FDA and TPD regulation, various import duties and required government clearances. Acts of governments outside the U.S. and Canada may affect the price or availability of raw materials needed for the development or manufacture of our products. The degree of impact such a situation could have would, in part, depend on the product affected.

Our marketing, promotional and pricing practices, as well as the manner in which sales forces interact with purchasers, prescribers and patients, are subject to extensive regulation and any material failure to comply could result in significant sanctions against the Company.

        The marketing, promotional, and pricing practices of pharmaceutical companies, as well as the manner in which companies, in-house or third-party sales forces interact with purchasers, prescribers, and patients, are subject to extensive regulation. Regulatory enforcement by the applicable agency may result in the imposition of civil and/or criminal penalties, injunctions, and/or limitations on marketing practice for our products. Many companies, including the Company, have been the subject of claims related to these practices asserted by federal authorities. These claims have resulted in fines and other consequences to the Company. We are now operating under a CIA that requires us to maintain a comprehensive compliance program governing our sales, marketing and government pricing and contracting functions. Material failures to comply with the CIA could result in significant sanctions to the Company. For example, enforcement actions could result in expansion of the existing restrictions on our sales and marketing activities under the CIA. See note 14 to the condensed consolidated financial statements included under Part I, Item 1, of this Form 10-Q. Even in jurisdictions like Canada where certain types of marketing practices are regulated more through guidelines and codes of conduct than legislation, engaging in certain types of marketing practices can result in significant scrutiny, negative publicity and harm to business relationships even if the company is not breaching any legislation.

We are involved in various legal proceedings that could adversely affect us.

        We are involved in several legal proceedings, including those described in Note 14 to the condensed consolidated financial statements included under Part I, Item 1, of this Form 10-Q. Defending against claims and any unfavorable legal decisions, settlements or orders could have a material adverse effect on us.

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We may incur significant liability if it is determined that we are promoting the "off-label" use of drugs.

        Companies may not promote drugs for "off-label" uses — that is, uses that are not described in the product's labeling and that differ from those approved by the FDA, TPD or other applicable regulatory agencies. Physicians may prescribe drug products for off-label uses, and such off-label uses are common across medical specialties. Although the FDA, TPD and other regulatory agencies do not regulate a physician's choice of treatments, the FDA, TPD and other regulatory agencies do restrict communications by pharmaceutical companies or their sales representatives on the subject of off-label use. The FDA, TPD and other regulatory agencies actively enforce regulations prohibiting promotion of off-label uses and the promotion of products for which marketing clearance has not been obtained. A company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions. Notwithstanding the regulatory restrictions on off-label promotion, the FDA, TPD and other regulatory authorities allow companies to engage in truthful, non-misleading, and non-promotional speech concerning their products. Although we believe that all of our communications regarding all of our products are in compliance with the relevant regulatory requirements, the FDA, TPD or another regulatory authority may disagree, and we may be subject to significant liability, including civil and administrative remedies, as well as criminal sanctions. In addition, management's attention could be diverted from our business operations and our reputation could be damaged. Our distribution partners may also be the subject of regulatory investigations involving, or remedies or sanctions for, off-label uses of products we have licensed to them, which may have an adverse impact on sales of such licensed products, which may, in turn, have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

If our products cause, or are alleged to cause, serious or widespread personal injury, we may have to withdraw those products from the market and/or incur significant costs, including payment of substantial sums in damages, and we may be subject to exposure relating to product liability claims.

        Even in well designed clinical trials, the potential of a drug to cause serious or widespread personal injury may not be apparent. In addition, the existence of a correlation between use of a drug and serious or widespread personal injury may not be apparent until it has been in widespread use for some period of time. Particularly when a drug is used to treat a disease or condition which is complex and the patients are taking multiple medications, such correlations may indicate, but do not necessarily indicate, that the drug has caused the injury; nevertheless, we may decide to, or regulatory authorities may require that we, withdraw the drug from the market and/or we may incur significant costs, including the potential of paying substantial damages.

        Moreover, we face an inherent business risk of exposure to significant product liability and other claims in the event that the use of our products caused, or is alleged to have caused, adverse effects. Furthermore, our products may cause, or may appear to have caused, adverse side effects (including death) or potentially dangerous drug interactions that we may not learn about or understand fully until the drug has been administered to patients for some time.

        Our product liability insurance coverage may not be sufficient to cover our claims and we may not be able to obtain sufficient coverage at a reasonable cost in the future. An inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the growth of our business or the number of products we can successfully market.

        The withdrawal of a product following complaints and/or incurring significant costs, including the requirement to pay substantial damages in personal injury cases or product liability cases, could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

Products representing a significant amount of our revenue are not protected by patent or data exclusivity rights.

        A majority of the products we sell have no meaningful exclusivity protection via patent or data exclusivity rights. These products represent a significant amount of our revenues. Without exclusivity protection, competitors face fewer barriers in introducing competing products. The introduction of competing products could adversely affect our results of operations and financial condition.

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We may be involved in infringement actions which are uncertain, costly and time-consuming and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

        In order to protect or enforce patent rights, we may initiate litigation against third parties, and we may also become subject to infringement claims by third parties. The outcomes of infringement action are uncertain and infringement actions are costly and divert technical and management personnel from their normal responsibilities.

        The existence of a patent will not necessarily protect us from competition. The pharmaceutical industry historically has generated substantial litigation concerning the manufacture, use and sale of products and we expect this litigation activity to continue. Generic drug manufacturers seek to sell and, in a number of cases have sold generic versions of many of our most important products prior to the expiration of our patents, and have exhibited a readiness to do so for other products in the future. As a result, we expect that patents related to our products will be routinely challenged, and our patents may not be upheld. Additionally, competitors may produce similar drugs that do not infringe our patents or produce drugs in countries that do not respect our patents. If we are not successful in defending an attack on our patents and maintaining exclusive rights to market one or more of our major products still under patent protection, we could lose a significant portion of sales in a very short period.

        Moreover, the patents of our competitors may impair our ability to do business in a particular area. In the event we discover that we may be infringing third-party patents or other intellectual property rights, we may not be able to obtain licenses from those third parties on commercially attractive terms or at all. We may have to defend against charges that we violated patents or the proprietary rights of third parties. If we infringe the intellectual property rights of others, we could lose our right to develop, manufacture or sell products, including our generic products, or could be required to pay monetary damages or royalties to license proprietary rights from third parties. An adverse determination in a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent us from manufacturing or selling our products.

We are subject to "fraud and abuse" and similar laws and regulations, and a failure to comply with such regulations or prevail in any litigation related to noncompliance could harm our business.

        Pharmaceutical and biotechnology companies have faced lawsuits and investigations pertaining to violations of health care "fraud and abuse" laws, such as the federal False Claims Act, the federal Anti-kickback Statute, the U.S. Foreign Corrupt Practices Act ("FCPA") and other state and federal laws and regulations. Increasingly, states require pharmaceutical companies to have comprehensive compliance programs and to disclose certain payments made to healthcare providers or funds spent on marketing and promotion of drug products. If we are in violation of any of these requirements or any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.

        The 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 U.S. and Canada. 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.

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Due to the large portion of our business conducted outside the United States, we have significant foreign currency risk.

        We sell products in many countries that are susceptible to significant foreign currency risk. In some of these markets we sell products for U.S. dollars. While this eliminates our direct currency risk in such markets, it increases our risk that we could lose market share to competitors because if a local currency is devalued significantly, it becomes more expensive for customers in that market to purchase our products in U.S. dollars. The international scope of our operations may also lead to volatile financial results and difficulties in managing our operations.

        We also face foreign currency exposure on the translation of our operations in Canada from Canadian dollars to U.S. dollars. Where possible, we manage foreign currency risk by managing same currency assets in relation to same currency liabilities, and same currency revenue in relation to same currency expenses. As a result, both favourable and unfavourable foreign currency impacts to our Canadian dollar-denominated operating expenses are mitigated to a certain extent by the natural, opposite impact on our Canadian dollar-denominated revenue. Effective with the Merger, we have additional foreign currency exposure related to the Polish zloty (and other Eastern European currencies), the Mexican peso, the Brazilian real and the Australian dollar.

The general business and economic conditions in Canada, the U.S. and other countries in which we conduct business could have a material adverse impact on our liquidity and capital resources, revenues and operating results.

        The market environment, the lack of liquidity in certain markets, the level of activity and volatility in capital markets and the stability of various financial markets may continue to have an impact on the availability of credit and capital in the near term. If uncertainties in these markets continue, or these markets deteriorate, it could have a material adverse impact on our liquidity, our ability to raise capital and interest costs.

        Adverse economic conditions impacting our customers, including among others, increased taxation, higher unemployment, lower customer confidence in the economy, higher customer debt levels, lower availability of customer credit, higher interest rates and hardships relating to declines in the stock markets, could cause purchases of our products to decline, which could adversely affect our revenues and operating results.

        Moreover, our projected revenues and operating results are based on assumptions concerning certain levels of customer spending. Any failure to attain our projected revenues and operating results as a result of adverse economic or market conditions estimated by us, our investors or the securities analysts that follow our common stock, could have a material adverse effect on our business and result in a decline in the price of our common stock.

The current business and economic conditions, coupled with the current regulatory environment, could have a negative impact on the pharmaceutical industry, which in turn could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        The current business and economic conditions in the national and global markets may negatively affect our operations in the future. Our revenues are contingent upon our ability to develop, license or otherwise acquire new commercially viable products and obtain associated regulatory approvals in multiple jurisdictions. Recently, companies globally have experienced volatility in the ability and cost to raise capital in the equity and debt markets or through traditional credit markets to fund business activities. In addition, the increased regulatory environment from the FDA has increased the costs of research and development ("R&D") for pharmaceutical companies. Accordingly, faced with the uncertainty of the availability and cost of raising capital and the potential for increased costs due to regulatory changes, many pharmaceutical companies have recently cut costs, including canceling current clinical trials and not pursuing additional clinical trials. These changes in both the economic and regulatory environments directly affect our business, and, in the event we are unable to conduct necessary R&D activities, our ability to generate revenues could be hindered, which could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

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We are exposed to risks related to interest rates.

        The primary objective of our policy for the investment of temporary cash surpluses is the protection of principal and, accordingly, we invest in investment grade securities with varying maturities, but typically less than one year. Our credit facility bears interest based on U.S. dollar London Interbank Offering Rates or U.S. dollar base rate. Thus, a change in interest rates could have a material adverse effect on our results of operations, financial condition or cash flows. As of September 30, 2010, we do not have any outstanding interest rate swap contracts.

Our failure to comply with applicable environmental laws and regulations worldwide could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        We are subject to laws and regulations concerning the environment, safety matters, regulation of chemicals and product safety in the countries where we manufacture and sell our products or otherwise operate our business. These requirements include regulation of the handling, manufacture, transportation, use and disposal of materials, including the discharge of pollutants into the environment. In the normal course of our business, hazardous substances may be released into the environment, which could cause environmental or property damage or personal injuries, and which could subject us to remediation obligations regarding contaminated soil and groundwater or potential liability for damage claims. Under certain laws, we may be required to remediate contamination at certain of our properties regardless of whether the contamination was caused by us or by previous occupants of the property or by others.

        In recent years, the operations of all companies have become subject to increasingly stringent legislation and regulation related to occupational safety and health, product registration and environmental protection. Such legislation and regulations are complex and constantly changing, and future changes in laws or regulations may require us to install additional controls for certain of our emission sources, to undertake changes in our manufacturing processes or to remediate soil or groundwater contamination at facilities where such cleanup is not currently required.

Rising insurance costs or our inability to obtain insurance could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

        The cost of insurance, including insurance for directors and officers, workers' compensation, property, product liability and general liability insurance, may increase in future years. Such insurance may also become unavailable to us. For example, as a result of the recent settlements in a number of our legacy legal and regulatory proceedings, we will have exhausted our coverage under our director and officer liability insurance for claims reported in respect of our 2002-2004 policy period. Rising insurance costs or the inability to obtain insurance could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our common shares to decline. In response to increased costs, we may increase deductibles or decrease certain coverages to mitigate cost increases. These increases, and our increased risk due to increased deductibles and reduced coverages, could have a material adverse effect on our business, financial condition and results of operations.

We are exposed to risks if we are unable to comply with laws and future changes to laws affecting public companies, including the Sarbanes-Oxley Act of 2002 ("SOX"), and also to increased costs associated with complying with such laws.

        Any future changes to the laws and regulations affecting public companies, as well as compliance with existing provisions of SOX in the U.S. and Part XXIII.1 of the Securities Act (Ontario), R.S.O. 1990, c. S.5 (the"Ontario Securities Act") and related rules and applicable stock exchange rules and regulations, may cause us to incur increased costs as we evaluate the implications of new rules and respond to new requirements. As we are no longer exempt from certain requirements under the U.S. securities laws and applicable U.S. stock exchange rules and regulations due to the cessation of our status as a foreign private issuer effective January 1, 2010, we are now subject to additional U.S. filing, disclosure and compliance requirements, which may also cause us to incur an increase in costs. Delays, or a failure to comply with any new laws, rules and regulations that apply

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to us, could result in enforcement actions, the assessment of other penalties and civil suits. New laws and regulations could make it more expensive for us under indemnities we provide to our officers and directors and could make it more difficult for us to obtain certain types of insurance, including liability insurance for directors and officers; as such, we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on the board of directors or as officers. We may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services — all of which could cause our general and administrative costs to increase beyond what we currently have planned. We are continuing to evaluate and monitor developments with respect to these laws, rules and regulations, and we cannot predict or estimate the amount of the additional costs we may incur or the timing of such costs.

        We are required annually to review and report on the effectiveness of our internal control over financial reporting in accordance with applicable securities laws. Our registered public accounting firm is also required to report on the effectiveness of our internal control over financial reporting.

        If we fail to maintain effective internal controls over our financial reporting, there is the possibility of errors or omissions occurring or misrepresentations in our disclosures which could have a material adverse effect on our business and financial condition and the value of our common shares.

The implementation of U.S. healthcare reform legislation could adversely affect our business.

        In March 2010, healthcare reform legislation was enacted in the U.S. This new legislation imposes cost containment measures that adversely affect the amount of reimbursement for our products. These measures include increasing the minimum rebates for our drugs covered by Medicaid programs and extending such rebates to drugs dispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations, as well as expansion of the 340(B) Public Health Services drug pricing program. This legislation also requires that drug manufacturers provide a specified discount to Medicare Part D beneficiaries, and imposes a new fee on drug manufacturers and importers that sell branded prescription drugs to specified U.S. government programs. A number of the provisions of the legislation require new and revised regulations and guidance by governmental agencies to implement, which has not yet occurred. Moreover, additional reforms to healthcare programs may be introduced in the coming years. Accordingly, while it is too early to predict the ultimate impact of this new legislation on our business, the legislation could have a material adverse effect on our business, cash flows, financial condition and results of operations.

Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds

        None.

Item 3.    Defaults Upon Senior Securities

        None.

Item 4.    (Removed and Reserved)

Item 5.    Other Information

        None.

Item 6.    Exhibits

3.1   Articles of Amendment to the Articles of Continuance of Valeant Pharmaceuticals International, Inc., dated September 28, 2010 (incorporated by reference herein to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

4.1

 

Indenture, dated as of September 28, 2010, by and among Valeant Pharmaceuticals International, Valeant Pharmaceuticals International, Inc., The Bank of New York Mellon Trust Company, N.A., as trustee, and the guarantors listed therein ((incorporated by reference herein to Exhibit 4.1 to the Registrant's Current Report on Form 8-K filed October 1, 2010)

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4.2   First Supplemental Indenture, dated as of September 27, 2010, and effective as of September 28, 2010, to the Indenture dated as of November 19, 2003, among Valeant Pharmaceuticals International, Ribopharm Inc. and The Bank of New York Mellon Trust Company, N.A., as successor to The Bank of New York Mellon (formerly The Bank of New York) (the "Convertible Notes Trustee"), among Valeant Pharmaceuticals International, Valeant Pharmaceuticals International, Inc., and the Convertible Notes Trustee (incorporated by reference herein to Exhibit 4.2 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

4.3

 

Indenture, dated as of November 19, 2003, among Valeant Pharmaceuticals International, Ribopharm Inc. and The Bank of New York Mellon Trust Company, N.A., as successor to The Bank of New York Mellon (formerly The Bank of New York) (incorporated by reference herein to Exhibit 4.3 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

10.1

 

Credit and Guaranty Agreement, dated as of September 27, 2010, among Valeant Pharmaceuticals International and, upon consummation of the Merger and delivery of the Counterpart Agreement pursuant to Section 5.16 thereto, Valeant Pharmaceuticals International, Inc., certain subsidiaries of Valeant Pharmaceuticals International, as guarantors, and, upon consummation of the Merger and delivery of the Counterpart Agreement pursuant to Section 5.16 thereto, certain subsidiaries of Valeant Pharmaceuticals International, Inc., as guarantors, each of the lenders named therein, Goldman Sachs Lending Partners LLC ("GSLP"), Morgan Stanley Senior Funding, Inc. and Jefferies Finance LLC, as Joint Lead Arrangers, Joint Bookrunners and Syndication Agents, GSLP, as Administrative Agent and Collateral Agent, and each of Bank of America, N.A., DnB NOR Bank ASA, SunTrust Bank and The Bank of Nova Scotia, as Documentation Agent (incorporated by reference herein to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

10.2

 

Counterpart Agreement, dated as of September 28, 2010, between Valeant Pharmaceuticals International, Inc., and Goldman Sachs Lending Partners LLC, as Administrative Agent and Collateral Agent (incorporated by reference herein to Exhibit 10.2 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

10.3

 

Valeant Pharmaceuticals International 2003 Equity Incentive Plan (incorporated by reference herein to Annex B to Valeant Pharmaceuticals International's Proxy Statement on Schedule 14A filed April 25, 2003).

10.4

 

Valeant Pharmaceuticals International 2006 Equity Incentive Plan, as amended (incorporated by reference herein to Annex E to the Valeant Pharmaceuticals International's Proxy Statement on Schedule 14A filed April 4, 2008).

10.5

 

Asset Purchase Agreement, dated as of January 22, 2004, by and between Xcel Pharmaceuticals, Inc. and VIATRIS GmbH and Co. KG. (incorporated by reference herein to Exhibit 10.7 to Valeant Pharmaceuticals International's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005).

10.6

 

Form of Restricted Stock Unit Award Agreement under the Valeant Pharmaceuticals International 2003 Equity Incentive Plan (incorporated by reference herein to Exhibit 99.1 to Valeant Pharmaceuticals International's Current Report on Form 8-K filed June 27, 2006).

10.7

 

Form of Restricted Stock Unit Award Grant Notice for Directors under the Valeant Pharmaceutical International 2006 Equity Incentive Plan (incorporated by reference herein to Exhibit 10.1 to Valeant Pharmaceuticals International's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007).

105


10.8   Form of Restricted Stock Unit Award Agreement for Directors under the Valeant Pharmaceuticals International 2006 Equity Incentive Plan (incorporated by reference herein to Exhibit 10.2 to Valeant Pharmaceuticals International's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007).

10.9

 

License and Collaboration Agreement, dated as of August 27, 2008, between Valeant Pharmaceuticals North America and Glaxo Group Limited (incorporated by reference herein to Exhibit 10.1 to Valeant Pharmaceuticals International's Current Report on Form 8-K/A filed August 29, 2008).

10.10

 

First Amendment to the GSK Retigabine Agreement, dated as of February 10, 2009, between Valeant Pharmaceuticals North America and Glaxo Group Limited (incorporated by reference herein to Exhibit 10.35 to Valeant Pharmaceuticals International's Annual Report on Form 10-K for the year ended December 31, 2008).

31.1

 

Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2

 

Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1

 

Certification of the Chief Executive Officer pursuant to 18 U.S.C. § 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2

 

Certification of the Chief Financial Officer pursuant to 18 U.S.C. § 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS

 

XBRL Instance Document*

101.SCH

 

XBRL Taxonomy Extension Schema*

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase*

101.LAB

 

XBRL Taxonomy Extension Label Linkbase*

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase*

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase*

*
Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability.

106



SIGNATURE

        Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


 

 

Valeant Pharmaceuticals International, Inc.

(Registrant)
     

Date: November 5, 2010

 

/s/ MARGARET MULLIGAN

Margaret Mulligan
Executive Vice President, Chief Financial Officer
(Principal Financial Officer, Principal Accounting Officer and Duly Authorized Officer)

107



INDEX TO EXHIBITS

Exhibit No.
  Exhibit Description
  3.1   Articles of Amendment to the Articles of Continuance of Valeant Pharmaceuticals International, Inc., dated September 28, 2010 (incorporated by reference herein to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

 

4.1

 

Indenture, dated as of September 28, 2010, by and among Valeant Pharmaceuticals International, Valeant Pharmaceuticals International, Inc., The Bank of New York Mellon Trust Company, N.A., as trustee, and the guarantors listed therein ((incorporated by reference herein to Exhibit 4.1 to the Registrant's Current Report on Form 8-K filed October 1, 2010)

 

4.2

 

First Supplemental Indenture, dated as of September 27, 2010, and effective as of September 28, 2010, to the Indenture dated as of November 19, 2003, among Valeant Pharmaceuticals International, Ribopharm Inc. and The Bank of New York Mellon Trust Company, N.A., as successor to The Bank of New York Mellon (formerly The Bank of New York) (the "Convertible Notes Trustee"), among Valeant Pharmaceuticals International, Valeant Pharmaceuticals International, Inc., and the Convertible Notes Trustee (incorporated by reference herein to Exhibit 4.2 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

 

4.3

 

Indenture, dated as of November 19, 2003, among Valeant Pharmaceuticals International, Ribopharm Inc. and The Bank of New York Mellon Trust Company, N.A., as successor to The Bank of New York Mellon (formerly The Bank of New York) (incorporated by reference herein to Exhibit 4.3 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

 

10.1

 

Credit and Guaranty Agreement, dated as of September 27, 2010, among Valeant Pharmaceuticals International and, upon consummation of the Merger and delivery of the Counterpart Agreement pursuant to Section 5.16 thereto, Valeant Pharmaceuticals International, Inc., certain subsidiaries of Valeant Pharmaceuticals International, as guarantors, and, upon consummation of the Merger and delivery of the Counterpart Agreement pursuant to Section 5.16 thereto, certain subsidiaries of Valeant Pharmaceuticals International, Inc., as guarantors, each of the lenders named therein, Goldman Sachs Lending Partners LLC ("GSLP"), Morgan Stanley Senior Funding, Inc. and Jefferies Finance LLC, as Joint Lead Arrangers, Joint Bookrunners and Syndication Agents, GSLP, as Administrative Agent and Collateral Agent, and each of Bank of America, N.A., DnB NOR Bank ASA, SunTrust Bank and The Bank of Nova Scotia, as Documentation Agent (incorporated by reference herein to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

 

10.2

 

Counterpart Agreement, dated as of September 28, 2010, between Valeant Pharmaceuticals International, Inc., and Goldman Sachs Lending Partners LLC, as Administrative Agent and Collateral Agent (incorporated by reference herein to Exhibit 10.2 to the Registrant's Current Report on Form 8-K filed October 1, 2010).

 

10.3

 

Valeant Pharmaceuticals International 2003 Equity Incentive Plan (incorporated by reference herein to Annex B to Valeant Pharmaceuticals International's Proxy Statement on Schedule 14A filed April 25, 2003).

 

10.4

 

Valeant Pharmaceuticals International 2006 Equity Incentive Plan, as amended (incorporated by reference herein to Annex E to the Valeant Pharmaceuticals International's Proxy Statement on Schedule 14A filed April 4, 2008).

 

10.5

 

Asset Purchase Agreement, dated as of January 22, 2004, by and between Xcel Pharmaceuticals, Inc. and VIATRIS GmbH and Co. KG. (incorporated by reference herein to Exhibit 10.7 to Valeant Pharmaceuticals International's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005).

108


Exhibit No.
  Exhibit Description
  10.6   Form of Restricted Stock Unit Award Agreement under the Valeant Pharmaceuticals International 2003 Equity Incentive Plan (incorporated by reference herein to Exhibit 99.1 to Valeant Pharmaceuticals International's Current Report on Form 8-K filed June 27, 2006).

 

10.7

 

Form of Restricted Stock Unit Award Grant Notice for Directors under the Valeant Pharmaceutical International 2006 Equity Incentive Plan (incorporated by reference herein to Exhibit 10.1 to Valeant Pharmaceuticals International's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007).

 

10.8

 

Form of Restricted Stock Unit Award Agreement for Directors under the Valeant Pharmaceuticals International 2006 Equity Incentive Plan (incorporated by reference herein to Exhibit 10.2 to Valeant Pharmaceuticals International's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007).

 

10.9

 

License and Collaboration Agreement, dated as of August 27, 2008, between Valeant Pharmaceuticals North America and Glaxo Group Limited (incorporated by reference herein to Exhibit 10.1 to Valeant Pharmaceuticals International's Current Report on Form 8-K/A filed August 29, 2008).

 

10.10

 

First Amendment to the GSK Retigabine Agreement, dated as of February 10, 2009, between Valeant Pharmaceuticals North America and Glaxo Group Limited (incorporated by reference herein to Exhibit 10.35 to Valeant Pharmaceuticals International's Annual Report on Form 10-K for the year ended December 31, 2008).

 

31.1

 

Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

31.2

 

Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

32.1

 

Certification of the Chief Executive Officer pursuant to 18 U.S.C. § 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

32.2

 

Certification of the Chief Financial Officer pursuant to 18 U.S.C. § 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

101.INS

 

XBRL Instance Document*

 

101.SCH

 

XBRL Taxonomy Extension Schema*

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase*

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase*

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase*

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase*

*
Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability.

109




QuickLinks

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Item 1A. Risk Factors
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. (Removed and Reserved)
Item 5. Other Information
Item 6. Exhibits
SIGNATURE
INDEX TO EXHIBITS