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

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended June 30, 2009

Commission File Number 001-14956

BIOVAIL CORPORATION
(Translation of Registrant's name into English)

7150 Mississauga Road, Mississauga, Ontario, CANADA, L5N 8M5
(Address of principal executive office and zip code)

Registrant's telephone number, including area code: (905) 286-3000

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F

 

ý

 

Form 40-F

 

o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1).

Yes

 

o

 

No

 

ý

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7).

Yes

 

o

 

No

 

ý

Indicate by check mark whether by furnishing the information contained in this Form the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g 3-2(b) under the Securities Exchange Act of 1934.

Yes

 

o

 

No

 

ý


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BIOVAIL CORPORATION

FORM 6-K

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2009

        This Report of Foreign Private Issuer on Form 6-K ("Form 6-K") is incorporated by reference into the registration statements on Form S-8 (Registration Nos. 333-92229 and 333-138697) of Biovail Corporation.


INDEX

        

Part I — Financial Information

 

Financial Statements (unaudited)

       
   

Consolidated Balance Sheets as at June 30, 2009 and December 31, 2008

    1  
   

Consolidated Statements of Income (Loss) for the three months and six months ended June 30, 2009 and 2008

    2  
   

Consolidated Statements of Deficit for the three months and six months ended June 30, 2009 and 2008

    3  
   

Consolidated Statements of Cash Flows for the three months and six months ended June 30, 2009 and 2008

    4  
   

Condensed Notes to the Consolidated Financial Statements

    5  

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

    37  

Part II — Other Information

 

Legal Proceedings

    71  

Exhibits

    71  

 



BASIS OF PRESENTATION

General

        Except where the context otherwise requires, all references in this Form 6-K to the "Company", "Biovail", "we", "us", "our" or similar words or phrases are to Biovail Corporation and its subsidiaries, taken together.

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

Trademarks

        The following words are trademarks of our Company and are the subject of either registration, or application for registration, in one or more of Canada, the U.S. or certain other jurisdictions: ATTENADE™, A Tablet Design (Apex Down)®, A Tablet Design (Apex Up)®, APLENZIN™, ATIVAN®, ASOLZA™, BIOVAIL®, BIOVAIL CORPORATION INTERNATIONAL®, BIOVAIL & SWOOSH DESIGN®, BPI®, BVF®, CARDISENSE™, CARDIZEM®, CEFORM®, CRYSTAAL CORPORATION & DESIGN®, DITECH™, FLASHDOSE®, GLUMETZA®, INSTATAB™, ISORDIL®, JOVOLA™, JUBLIA™, MIVURA™, NITOMAN®, ONELZA™, ONEXTEN™, ORAMELT™, PALVATA™, RALIVIA®, SHEARFORM™, SMARTCOAT™, SOLBRI™, TESIVEE™, TIAZAC®, TITRADOSE™, TOVALT™, UPZIMIA™, VASERETIC®, VASOCARD™, VASOTEC®, VEMRETA™, VOLZELO™, XENAZINE® and ZILERAN™.

        WELLBUTRIN®, WELLBUTRIN® SR, WELLBUTRIN® XL, WELLBUTRIN® XR, ZOVIRAX® and ZYBAN® are trademarks of The GlaxoSmithKline Group of Companies and are used by us under license. ULTRAM® is a trademark of Ortho-McNeil, Inc. (now known as PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) and is used by us under license.

        In addition, we have filed trademark applications for many of our other trademarks in Barbados, the U.S., Canada, and in other jurisdictions and have implemented, on an ongoing basis, a trademark protection program for new trademarks.

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FORWARD-LOOKING STATEMENTS

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

        To the extent any statements made in this Form 6-K 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 (the "Exchange Act"), 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, our objectives, goals, strategies, beliefs, intentions, plans, estimates and outlook, including, without limitation, our intent and ability to implement and effectively execute plans and initiatives associated with our strategic focus on products targeting specialty central nervous system ("CNS") disorders and the anticipated impact of this strategy, our intent to complete in-license agreements and acquisitions and to successfully integrate such in-license agreements and acquisitions into our business and operations and to achieve the anticipated benefits of such in-license agreements and acquisitions, our ability to successfully integrate the acquisition of the worldwide development and commercialization rights to tetrabenazine into our business operations, and the expected impact of this acquisition on our revenues and cash flows, the expected impact of the acquisition of the full U.S. commercialization rights to Wellbutrin XL® on our revenues and cash flows, our intent and ability to use a net share settlement approach upon conversion of our 5.375% Senior Convertible Notes due 2014, the timing regarding the planned closure of our two Puerto Rico manufacturing facilities and operations, the associated costs and anticipated impact of such closure, our ability to sell or divest these facilities and the possible impact on our manufacturing processes, our beliefs related to the costs and future benefits regarding the closure of our Mississauga, Ontario research and development facility and consolidation of our Chantilly, Virginia research and development operations and the possible impact on our research and development processes, our intent regarding and timing of the planned disposals of non-core assets and the anticipated proceeds of such dispositions, the timing of the planned sale and leaseback of our corporate headquarters and the amount of the expected loss resulting from such sale, additional expected charges and anticipated annual savings related to ongoing or planned efficiency initiatives, our intent and ability to make future dividend payments, our intent and ability to repurchase our common shares under the share repurchase program, the limited number of customers from which a significant portion of our revenue is derived, our views and beliefs related to the outcome of patent infringement trial proceedings regarding the timing of the introduction of generic competition related to Ultram® ER and the 360mg dosage strength of Cardizem® CD, the expected timing of the introduction of a generic version of Cardizem® LA, our intent regarding the defence of our intellectual property against infringement, the timing, results, and progress of our research and development efforts, including efforts related to the development of BVF-018, RUS-350, BVF-036, BVF-040 and BVF-324, the timing regarding the Zovirax® price allowance and the anticipated impact on our future gross margins, the investment recovery, liquidity, valuation and impairment conclusions associated with our investment in auction rate securities, our conclusion that we do not intend to sell the auction rate securities and it is not more likely than not that we will be required to sell these securities before a recovery of their amortized cost bases, our beliefs and positions related to, results of, and costs associated with, certain litigation and regulatory proceedings, including, but not limited to, the outcome of the court hearing to approve an agreement reached between a subsidiary of our Company and the U.S. Attorney's Office for the District of Massachusetts related to activities surrounding the 2003 commercial launch of Cardizem® LA, the timing, costs and expected impact of the resolution of certain legacy litigation and regulatory proceedings, the sufficiency of cash resources (including those available under the accordion feature of our new credit facility) to support future spending requirements, expected potential milestone payments in connection with pimavanserin and other research and development arrangements, expected capital expenditures and business development activities, the impact of market conditions on our ability to access additional funding at reasonable rates, our ability to manage exposure to foreign currency exchange rate changes and interest rates, and the expected impact of the adoption of new accounting standards. Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may", "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. Although we have indicated above certain of these statements set out herein, all of the statements in this Form 6-K 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-

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looking statements including, but not limited to, factors and assumptions regarding prescription trends, pricing and the formulary and/or Medicare/Medicaid positioning for our products; the competitive landscape in the markets in which we compete, including, but not limited to, the availability or introduction of generic formulations of our products; timelines associated with the development of, and receipt of regulatory approval for, our new products; the opportunities present in the market for therapies for specialty CNS disorders; and the resolution of insurance claims relating to certain litigation and regulatory proceedings. 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 difficulty of predicting U.S. Food and Drug Administration, Canadian Therapeutic Products Directorate, and European regulatory approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the results of continuing safety and efficacy studies by industry and government agencies, uncertainties associated with the development, acquisition and launch of new products, contractual disagreements with third parties, the availability of capital and our ability to generate operating cash flows and satisfy applicable laws for dividend payments, the continuation of the recent market turmoil, market liquidity for our common shares, our ability to secure third-party manufacturing arrangements, our satisfaction of applicable laws for the repurchase of our common shares, our ability to retain the limited number of customers from which a significant portion of our revenue is derived, the impact of a decline in our market capitalization on the carrying value of goodwill, reliance on key strategic alliances, our ability to satisfy the financial and non-financial covenants of our new credit facility, delay in or transition issues arising from the closure of our Puerto Rico and Mississauga, Ontario facilities and the consolidation of our Chantilly, Virginia operations, the successful implementation of our specialty CNS strategy, our eligibility for benefits under tax treaties, the continued availability of low effective tax rates for the business profits of our principal operating subsidiary, the availability of raw materials and finished products, the regulatory environment, the unpredictability of protection afforded by our patents and other intellectual and proprietary property, the mix of activities and income in the various jurisdictions in which we operate, successful challenges to our generic products, infringement or alleged infringement of the intellectual property rights of others, the ability to manufacture and commercialize pipeline products, unanticipated interruptions in our manufacturing operations or transportation services, the expense, timing and uncertain outcome of legal and regulatory proceedings and settlements thereof, payment by insurers of insurance claims, currency and interest rate fluctuations, consolidated tax rate assumptions, fluctuations in operating results, the market liquidity and amounts realized for auction rate securities held as investments, and other risks detailed from time to time in our filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, as well as our ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this Form 6-K, and in particular under Item 3.D, "Key Information — Risk Factors", of our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, filed on February 27, 2009. 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.

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BIOVAIL CORPORATION

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
June 30
2009
  At
December 31
2008
 

ASSETS

             

Current

             

Cash and cash equivalents

  $ 52,918   $ 317,547  

Restricted cash

    5,250      

Short-term investment

        278  

Marketable securities

    5,690     719  

Accounts receivable

    97,302     90,051  

Insurance recoveries receivable

    42     812  

Inventories

    70,085     59,561  

Assets held for sale

    6,151     6,814  

Prepaid expenses and other current assets

    8,601     14,582  
           

    246,039     490,364  

Marketable securities

    14,938     21,916  

Long-term investment

    725     102  

Property, plant and equipment, net

    133,411     148,269  

Intangible assets, net

    1,414,853     720,372  

Goodwill

    100,294     100,294  

Deferred tax assets, net of valuation allowance

    108,600     116,800  

Other long-term assets, net

    39,510     25,448  
           

  $ 2,058,370   $ 1,623,565  
           

LIABILITIES

             

Current

             

Accounts payable

  $ 31,105   $ 41,070  

Dividends payable

    14,240     59,331  

Accrued liabilities

    97,084     85,169  

Accrued legal settlements

    26,648     32,565  

Income taxes payable

    9,310     8,596  

Deferred revenue

    26,914     40,435  

Current portion of long-term obligations

    11,708      
           

    217,009     267,166  

Deferred revenue

    78,027     84,953  

Income taxes payable

    63,700     63,700  

Long-term obligations

    438,955      

Other long-term liabilities

    6,547     6,147  
           

    804,238     421,966  
           

SHAREHOLDERS' EQUITY

             

Common shares, no par value, unlimited shares authorized, 158,227,990 and 158,216,132 issued and outstanding at June 30, 2009 and December 31, 2008, respectively

    1,463,930     1,463,873  

Additional paid-in capital

    89,133     31,966  

Deficit

    (330,509 )   (319,909 )

Accumulated other comprehensive income

    31,578     25,669  
           

    1,254,132     1,201,599  
           

  $ 2,058,370   $ 1,623,565  
           

Commitments and contingencies (note 16)

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

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BIOVAIL CORPORATION

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
June 30
  Six Months Ended
June 30
 
 
  2009   2008   2009   2008  

REVENUE

                         

Product sales

  $ 187,716   $ 175,666   $ 353,109   $ 372,580  

Research and development

    3,255     5,704     6,970     13,057  

Royalty and other

    2,564     4,725     6,775     8,956  
                   

    193,535     186,095     366,854     394,593  
                   

EXPENSES

                         

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

    50,057     43,877     94,897     97,612  

Research and development

    44,692     21,759     59,220     58,091  

Selling, general and administrative

    49,498     56,633     92,742     100,230  

Amortization of intangible assets

    21,778     11,691     37,281     23,385  

Restructuring costs

    11,367     51,760     12,715     51,760  

Acquisition-related costs

    5,596         5,596      

Legal settlements

        24,648     241     24,648  
                   

    182,988     210,368     302,692     355,726  
                   

Operating income (loss)

    10,547     (24,273 )   64,162     38,867  

Interest income

    251     3,412     585     6,880  

Interest expense

    (4,049 )   (236 )   (4,389 )   (478 )

Foreign exchange gain (loss)

    314     (1,564 )   721     (1,343 )

Gain on auction rate security settlement

    22,000         22,000      

Gain on disposal of investments

    344     3,461     338     3,461  

Impairment loss on debt securities

    (1,617 )   (270 )   (4,324 )   (3,190 )

Impairment loss on equity securities

        (219 )       (915 )

Equity loss

                (1,195 )
                   

Income (loss) before provision for income taxes

    27,790     (19,689 )   79,093     42,087  

Provision for income taxes

    3,700     5,600     16,000     11,000  
                   

Net income (loss)

  $ 24,090   $ (25,289 ) $ 63,093   $ 31,087  
                   

Basic and diluted earnings (loss) per share

  $ 0.15   $ (0.16 ) $ 0.40   $ 0.19  
                   

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

                         

Basic

    158,224     160,709     158,222     160,866  

Diluted

    158,331     160,709     158,301     160,866  
                   

Cash dividends declared per share

  $ 0.090   $ 0.375   $ 0.465   $ 0.750  
                   

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

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BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF 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
June 30
  Six Months Ended
June 30
 
 
  2009   2008   2009   2008  

Deficit, beginning of period

  $ (340,356 ) $ (280,288 ) $ (319,909 ) $ (278,495 )

Net income (loss)

    24,090     (25,289 )   63,093     31,087  

Cash dividends declared and dividend equivalents

    (14,243 )   (60,624 )   (73,693 )   (121,136 )

Repurchase of common shares

        (4,087 )       (4,087 )

Cumulative effect of adoption of SFAS 159

                2,343  
                   

Deficit, end of period

  $ (330,509 ) $ (370,288 ) $ (330,509 ) $ (370,288 )
                   

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

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BIOVAIL CORPORATION

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
June 30
  Six Months Ended
June 30
 
 
  2009   2008   2009   2008  

CASH FLOWS FROM OPERATING ACTIVITIES

                         

Net income (loss)

  $ 24,090   $ (25,289 ) $ 63,093   $ 31,087  

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

                         

Depreciation and amortization

    32,089     25,345     58,780     50,418  

Amortization of deferred revenue

    (5,301 )   (4,492 )   (10,601 )   (8,984 )

Amortization and write-down of deferred financing costs

    968     130     1,098     260  

Amortization of discounts on long-term obligations

    564         564      

Deferred income taxes

    400         8,200      

Acquired in-process research and development

    30,414         30,414      

Impairment charges

    9,674     51,974     12,381     55,590  

Stock-based compensation

    1,334     3,744     3,091     5,173  

Gain on sale of investments

    (344 )   (3,461 )   (338 )   (3,461 )

Payment of accrued legal settlements

            (5,917 )   (10,000 )

Addition to accrued legal settlements

        24,648         24,648  

Equity loss

                1,195  

Other

    192     (1,621 )   169     (1,053 )

Changes in operating assets and liabilities:

                         
 

Accounts receivable

    (14,204 )   (10,004 )   (7,365 )   18,516  
 

Insurance recoveries receivable

        5,041     770     6,086  
 

Inventories

    (9,960 )   (1,852 )   (8,734 )   9,912  
 

Prepaid expenses and other current assets

    2,770     3,587     5,980     7,524  
 

Accounts payable

    6,223     (3,327 )   (10,111 )   (12,563 )
 

Accrued liabilities

    20,512     (713 )   11,736     (3,400 )
 

Income taxes payable

    (320 )   4,925     690     7,443  
 

Deferred revenue

    (2,020 )   (1,579 )   (9,847 )   (18,659 )
                   

Net cash provided by operating activities

    97,081     67,056     144,053     159,732  
                   

CASH FLOWS FROM INVESTING ACTIVITIES

                         

Acquisition of intangible assets

    (540,889 )       (540,889 )    

Acquisition of business

    (200,000 )       (200,000 )    

Proceeds from sale and leaseback of assets

    5,300         5,300      

Transfer to restricted cash

        (83,048 )   (5,250 )   (83,048 )

Additions to marketable securities

    (1,744 )   (856 )   (2,763 )   (3,782 )

Additions to property, plant and equipment, net

    (842 )   (7,707 )   (1,628 )   (17,385 )

Proceeds from sales and maturities of marketable securities

    1,065     1,500     1,065     4,450  

Proceeds from sale of long-term investments, net of costs

    357     12,187     370     12,187  

Proceeds from sale of short-term investments

        79,735         79,735  

Additions to short-term investments

                (79,725 )

Additions to restricted assets

        (15 )       (4,915 )
                   

Net cash provided by (used in) investing activities

    (736,753 )   1,796     (743,795 )   (92,483 )
                   

CASH FLOWS FROM FINANCING ACTIVITIES

                         

Issuance of senior convertible notes

    350,000         350,000      

Advances under credit facility

    130,000         130,000      

Cash dividends paid

    (59,331 )   (120,768 )   (118,662 )   (120,768 )

Financing costs paid

    (26,274 )       (26,274 )    

Repayment of deferred compensation obligation, net

    (393 )   (14 )   (393 )   (152 )

Issuance of common shares

    18         18      

Repurchase of common shares

        (25,538 )       (25,538 )
                   

Net cash provided by (used in) financing activities

    394,020     (146,320 )   334,689     (146,458 )
                   

Effect of exchange rate changes on cash and cash equivalents

    876     (13 )   424     (376 )
                   

Net decrease in cash and cash equivalents

    (244,776 )   (77,481 )   (264,629 )   (79,585 )

Cash and cash equivalents, beginning of period

    297,694     431,537     317,547     433,641  
                   

Cash and cash equivalents, end of period

  $ 52,918   $ 354,056   $ 52,918   $ 354,056  
                   

NON-CASH FINANCING ACTIVITIES

                         

Cash dividends declared but unpaid

  $ (14,240 ) $   $ (14,240 ) $  

Long-term obligation related to acquisition of business

    (26,768 )       (26,768 )    
                   

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

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BIOVAIL CORPORATION

CONDENSED 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

Financial Accounting Standards Board ("FASB") Statement of Financial Accounting Standards ("SFAS") No. 165, "Subsequent Events" ("SFAS 165"), defines subsequent events as events or transactions that occur after the balance sheet date, but before the financial statements are issued. SFAS 165 identifies the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements and the disclosures that should be

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BIOVAIL CORPORATION

CONDENSED 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)

FASB Staff Position ("FSP") No. FAS 115-2 and FAS 124-2, "Recognition and Presentation of Other-Than-Temporary Impairments" ("FSP FAS 115-2"), requires entities to separate an other-than-temporary impairment of a debt security into (i) the amount representing the decrease in cash flows expected to be collected, or the credit loss portion, which is recognized in earnings, and (ii) the amount related to all other factors, or the non-credit portion, which is recognized in other comprehensive income in circumstances in which management asserts that it does not have the intent to sell the security, and it is more likely than not that it will not be required to sell the security before recovery of its amortized cost basis. Upon the adoption of FSP FAS 115-2, the cumulative effect adjustment to reclassify the non-credit losses previously recognized through earnings from accumulated other comprehensive income to opening deficit was not material to the Company's consolidated financial statements.

FSP No. FAS 157-4, "Determining Fair Value When Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions that are Not Orderly" ("FSP FAS 157-4"), amends SFAS 157 to provide additional guidance on estimating fair value when there has been a significant decrease in the volume and level of activity for the asset or liability in relation to the normal market activity for the asset or liability. In addition, FSP FAS 157-4 provides additional guidance on circumstances that may indicate that a transaction for the asset or liability is not orderly. The adoption of FSP FAS 157-4 did not have a material impact on the Company's consolidated financial statements.

FSP No. FAS 107-1 and APB 28-1, "Interim Disclosures about Fair Value of Financial Instruments" ("FSP FAS 107-1"), amends FASB Statement No. 107, "Disclosures about Fair Value of Financial Instruments" and Accounting Principle Board Opinion No. 28, "Interim Financial Reporting", to require disclosures about fair value of financial instruments in interim financial statements. The Company has adopted the disclosure requirements of FSP FAS 107-1 as required.
FSP No. APB 14-1, "Accounting for Convertible Debt Instruments that May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)" ("FSP APB 14-1"), requires that the liability (debt) and equity (conversion option) components of convertible debt instruments that may be settled in cash upon conversion be separately accounted for in a manner that reflects an issuer's non-convertible debt borrowing rate. This new method of accounting results in recognizing interest expense at rates reflective of what the issuer would have incurred had it issued non-convertible debt with otherwise similar terms. The adoption of FSP APB 14-1 impacted the accounting for the Company's 5.375% Senior Convertible Notes due 2014 ("Notes") issued June 10, 2009 (as described in note 11). FSP APB 14-1 will have a material impact on interest expense recognized during the period that the Notes are outstanding, but will have no impact on the Company's future cash flows.

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BIOVAIL CORPORATION

CONDENSED 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)

SFAS No. 141(R), "Business Combinations" ("SFAS 141R") and SFAS No. 160, "Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51" ("SFAS 160"), significantly change the accounting for, and reporting of, business combination transactions and noncontrolling (minority) interests in consolidated financial statements, including requirements to: recognize noncontrolling interests at fair value; capitalize in-process research and development assets acquired; and expense acquisition-related costs as incurred. SFAS 141R also requires post-acquisition adjustments related to business combination deferred tax asset valuation allowances and liabilities for uncertain tax positions to be recorded in current period income tax expense. SFAS 141R and SFAS 160 are effective for business combinations occurring on or after January 1, 2009. The adoption of SFAS 141R impacted the accounting for the acquisition of the worldwide development and commercialization rights to tetrabenazine (as described in note 3).

SFAS No. 157, "Fair Value Measurements" ("SFAS 157"), establishes a framework for measuring fair value in U.S. GAAP, clarifies the definition of fair value within that framework, and expands disclosures about the use of fair value measurements. SFAS 157 applies to all other accounting pronouncements that require (or permit) fair value measurements, but does not require any new fair value measurements in U.S. GAAP. SFAS 157 was effective January 1, 2009 for non-financial assets and non-financial liabilities not recognized or disclosed at fair value on a recurring basis. The Company previously adopted SFAS 157 for financial assets and financial liabilities effective January 1, 2008. The adoption of SFAS 157 did not have a material impact on the Company's consolidated financial statements.

Emerging Issues Task Force ("EITF") Issue No. 08-7, "Accounting for Defensive Intangible Assets" ("EITF 08-7"), provides guidance for accounting for defensive intangible assets subsequent to their acquisition in accordance with SFAS 141R and SFAS 157, including the estimated useful life that should be assigned to such assets. EITF 08-7 is effective on a prospective basis for intangible assets acquired on or after January 1, 2009. The adoption of EITF 08-7 did not have a material impact on the Company's consolidated financial statements.

FSP No. FAS 142-3, "Determination of the Useful Life of Intangible Assets" ("FSP FAS 142-3"), amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, "Goodwill and Other Intangible Assets", and also requires expanded disclosure related to the determination of intangible asset useful lives. FSP FAS 142-3 is effective for determining useful life for intangible assets acquired on or after January 1, 2009, and the disclosure requirements of FSP FAS 142-3 are effective for intangible assets recognized as of or after January 1, 2009. The adoption of FSP FAS 142-3 did not have a material impact on the Company's consolidated financial statements.

SFAS No. 161, "Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133" ("SFAS 161"), applies to all derivative instruments and related hedged items accounted for under SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS 133"). SFAS 161 requires disclosures about how and why an entity uses derivative instruments; how derivative instruments and related hedged items are accounted for under SFAS 133; and how derivative instruments and related hedged items affect an entity's financial position, results of operations, and cash flows. The disclosure requirements of SFAS 161 are effective

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BIOVAIL CORPORATION

CONDENSED 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)

EITF Issue No. 07-1, "Accounting for Collaborative Arrangements" ("EITF 07-1"), provides guidance for determining if a collaborative arrangement exists and establishes reporting requirements for revenues and costs generated from transactions between parties within a collaborative arrangement, as well as between the parties in a collaborative arrangement and third parties, and provides guidance for financial statement disclosures of collaborative arrangements. EITF 07-1 is effective for collaborative arrangements existing on or after January 1, 2009. The adoption of EITF 07-1 did not have a material impact on the Company's consolidated financial statements.

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BIOVAIL CORPORATION

CONDENSED 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.     BUSINESS COMBINATION

 

Inventory

  $ 1,068  
 

Intangible assets:

       
   

Product rights

    198,000  
   

Acquired in-process research and development

    27,700  
         
 

Assets acquired

  $ 226,768  
         

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BIOVAIL CORPORATION

CONDENSED 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.     BUSINESS COMBINATION (Continued)

   
  Three Months Ended
June 30
  Six Months Ended
June 30
 
   
  2009   2008   2009   2008  
 

Revenue

  $ 196,849   $ 190,793   $ 373,549   $ 403,076  
 

Net income (loss)

    29,913     (28,626 )   67,163     24,389  
 

Basic and diluted earnings (loss) per share

  $ 0.19   $ (0.18 ) $ 0.42   $ 0.15  
                     

4.     ASSET ACQUISITIONS

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BIOVAIL CORPORATION

CONDENSED 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

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BIOVAIL CORPORATION

CONDENSED 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 (Continued)

   
  Asset Impairments   Employee Termination Benefits    
   
 
   
  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

            1,337         11     1,348  
 

Cash payments

                    (118 )   (118 )
                             
 

Balance, March 31, 2009

            4,646         3,239     7,885  
                             
 

Costs incurred and charged to expense

    6,515     1,542     1,281     1,618     411     11,367  
 

Cash payments

            (555 )   (394 )   (369 )   (1,318 )
 

Non-cash adjustments

    (6,515 )   (1,542 )               (8,057 )
                             
 

Balance, June 30, 2009

  $   $   $ 5,372   $ 1,224   $ 3,281   $ 9,877  
                             

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BIOVAIL CORPORATION

CONDENSED 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 (Continued)

6.     FAIR VALUE MEASUREMENTS

Level 1 — Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets and liabilities in markets that are not active.

Level 3 — Unobservable inputs for the asset or liability.
   
  At June 30, 2009  
   
  Carrying
Value
  Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 
 

Available-for-sale debt securities

  $ 53,367   $ 37,743   $ 15,624   $  
 

Available-for-sale equity securities

    725     725          
 

Auction rate securities

    6,604             6,604  
                     
 

Total financial assets

  $ 60,696   $ 38,468   $ 15,624   $ 6,604  
                     
 

Cash and cash equivalents

 
$

39,343
 
$

37,743
 
$

1,600
 

$

 
 

Marketable securities

    20,628         14,024     6,604  
 

Long-term investment

    725     725          
                     
 

Total financial assets

  $ 60,696   $ 38,468   $ 15,624   $ 6,604  
                     

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BIOVAIL CORPORATION

CONDENSED 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)

   
  At December 31, 2008  
   
  Carrying
Value
  Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 
 

Available-for-sale debt securities

  $ 203,688   $ 112,834   $ 90,854   $  
 

Available-for-sale equity securities

    380     380          
 

Auction rate securities

    10,333             10,333  
                     
 

Total financial assets

  $ 214,401   $ 113,214   $ 90,854   $ 10,333  
                     
 

Cash and cash equivalents

 
$

191,386
 
$

112,834
 
$

78,552
 

$

 
 

Short-term investment

    278     278          
 

Marketable securities

    22,635         12,302     10,333  
 

Long-term investment

    102     102          
                     
 

Total financial assets

  $ 214,401   $ 113,214   $ 90,854   $ 10,333  
                     

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BIOVAIL CORPORATION

CONDENSED 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
June 30
  Six Months Ended
June 30
 
   
  2009   2008   2009   2008  
 

Balance, beginning of period

  $ 7,452   $ 14,774   $ 10,333   $ 18,000  
 

Total unrealized losses:

                         
   

Included in net income (loss)(1):

                         
     

Arising during period

    (1,087 )       (3,822 )   (2,920 )
     

Reclassification from other comprehensive income

    (530 )   (270 )   (502 )   (270 )
   

Included in other comprehensive income:

                         
     

Arising during period

    239     (1,315 )   93     (1,571 )
     

Reclassification to net income (loss)

    530     270     502     270  
 

Settlements

                (50 )
                     
 

Balance, end of period

  $ 6,604   $ 13,459   $ 6,604   $ 13,459  
                     
 

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

  $ (1,617 ) $ (270 ) $ (4,324 ) $ (3,190 )
                     

(1)
Included in impairment loss on debt securities in the consolidated statements of income (loss).
   
  Carrying
Value
  Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
  Significant
Unobservable
Inputs
(Level 3)
  Total Loss  
 

Property, plant and equipment

  $ 15,189   $ 5,189   $ 10,000   $ (7,220 )
                     

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BIOVAIL CORPORATION

CONDENSED 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.     MARKETABLE SECURITIES

   
  At June 30, 2009  
   
   
   
  Gross Unrealized  
   
  Cost
Basis
  Fair
Value
 
   
  Gains   Losses  
 

Corporate and government bonds

  $ 9,611   $ 9,769   $ 158   $  
 

Government-sponsored enterprise securities

    4,110     4,255     145      
 

Auction rate securities

    26,775     6,604         (20,171 )
                     
 

  $ 40,496   $ 20,628   $ 303   $ (20,171 )
                     
   
  At December 31, 2008  
   
   
   
  Gross Unrealized  
   
  Cost
Basis
  Fair
Value
 
   
  Gains   Losses  
 

Corporate and government bonds

  $ 6,869   $ 6,926   $ 70   $ (13 )
 

Government-sponsored enterprise securities

    5,159     5,376     217      
 

Auction rate securities

    26,775     10,333         (16,442 )
                     
 

  $ 38,803   $ 22,635   $ 287   $ (16,455 )
                     
   
  Carrying
Value
  Fair
Value
 
 

Within one year

  $ 5,690   $ 5,690  
 

One to three years

    8,334     8,334  
 

After three years

    6,604     6,604  
             
 

  $ 20,628   $ 20,628  
             

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BIOVAIL CORPORATION

CONDENSED 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.     MARKETABLE SECURITIES (Continued)

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BIOVAIL CORPORATION

CONDENSED 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.     MARKETABLE SECURITIES (Continued)

8.     INVENTORIES

   
  At
June 30
2009
  At
December 31
2008
 
 

Raw materials

  $ 12,669   $ 19,042  
 

Work in process

    19,805     13,563  
 

Finished goods

    37,611     26,956  
             
 

  $ 70,085   $ 59,561  
             

9.     INTANGIBLE ASSETS

   
  At June 30, 2009   At December 31, 2008  
   
  Cost   Accumulated
Amortization
  Cost   Accumulated
Amortization
 
 

Trademarks

  $ 1,084,226   $ 227,186   $ 573,751   $ 206,280  
 

Product rights

    700,977     170,864     502,791     149,890  
 

In-process research and development

    27,700              
                     
 

    1,812,903   $ 398,050     1,076,542   $ 356,170  
                         
 

Less accumulated amortization

    398,050           356,170        
                         
 

  $ 1,414,853         $ 720,372        
                         
   
  Trademarks   Product
Rights
  In-process
Research and
Development
  Total  
 

Wellbutrin XL®

  $ 510,475   $   $   $ 510,475  
 

Tetrabenazine

        198,000     27,700     225,700  
                     
 

  $ 510,475   $ 198,000   $ 27,700   $ 736,175  
                     

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BIOVAIL CORPORATION

CONDENSED 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
June 30
  Six Months Ended
June 30
 
   
  2009   2008   2009   2008  
 

Royalty and other revenue

  $ 268   $ 268   $ 536   $ 536  
 

Cost of goods sold

    2,025     2,025     4,051     4,051  
 

Amortization expense

    21,778     11,691     37,281     23,385  
                     
 

  $ 24,071   $ 13,984   $ 41,868   $ 27,972  
                     
   
  2009   2010   2011   2012   2013  
 

Amortization expense

  $ 112,540   $ 141,588   $ 139,838   $ 133,365   $ 130,664  
                         

10.   ACCRUED LEGAL SETTLEMENTS

   
  At
June 30
2009
  At
December 31
2008
 
 

U.S. Attorney's Office (MA) investigation

  $ 24,648   $ 24,648  
 

Ontario Securities Commission investigation

        5,337  
 

Other

    2,000     2,580  
             
 

  $ 26,648   $ 32,565  
             

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BIOVAIL CORPORATION

CONDENSED 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.   ACCRUED LEGAL SETTLEMENTS (Continued)

11.   LONG-TERM OBLIGATIONS

   
  At
June 30
2009
  At
December 31
2008
 
 

5.375% Senior Convertible Notes due 2014

  $ 350,000   $  
 

Unamortized debt discount

    (56,163 )    
             
 

    293,837      
 

Credit facility

    130,000      
 

Cambridge obligation (net of unamortized debt discount of $3,174)

    26,826      
             
 

    450,663      
 

Less current portion

    11,708      
             
 

  $ 438,955   $  
             
during any calendar quarter if the closing price of the Company's common shares exceeds 130% of the conversion price then in effect during a defined period at the end of the previous quarter;

during a defined period if the trading price of the Notes falls below specified thresholds for a defined trading period;

if the Notes have been called for redemption;

upon the occurrence of specified corporate transactions; or

25 trading days prior to the maturity date.

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BIOVAIL CORPORATION

CONDENSED 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.   LONG-TERM OBLIGATIONS (Continued)

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BIOVAIL CORPORATION

CONDENSED 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.   LONG-TERM OBLIGATIONS (Continued)

   
  Notes   Credit
Facility
  Cambridge
Obligation
  Total  
 

2010

  $   $   $ 12,500   $ 12,500  
 

2011

            17,500     17,500  
 

2012

        130,000         130,000  
 

2014

    350,000             350,000  
                     
 

Total gross maturities

    350,000     130,000     30,000     510,000  
 

Unamortized debt discounts

    (56,163 )       (3,174 )   (59,337 )
                     
 

Total long-term obligations

  $ 293,837   $ 130,000   $ 26,826   $ 450,663  
                     

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BIOVAIL CORPORATION

CONDENSED 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.   STOCK-BASED COMPENSATION

   
  Three Months
Ended
June 30
  Six Months
Ended
June 30
 
   
  2009   2008   2009   2008  
 

Stock options

  $ 592   $ 1,956   $ 1,620   $ 3,208  
 

RSUs

    742     1,788     1,471     1,965  
                     
 

Stock-based compensation expense

  $ 1,334   $ 3,744   $ 3,091   $ 5,173  
                     
 

Cost of goods sold

  $ 135   $ 133   $ 288   $ 255  
 

Research and development expenses

    196     223     440     437  
 

Selling, general and administrative expenses

    1,003     3,388     2,363     4,481  
                     
 

Stock-based compensation expense

  $ 1,334   $ 3,744   $ 3,091   $ 5,173  
                     
   
  Options
(000s)
  Weighted-
Average
Exercise
Price
  Weighted-
Average
Remaining
Contractual
Term
(Years)
  Aggregate
Intrinsic
Value
 
 

Outstanding, January 1, 2009

    4,201   $ 19.06              
 

Granted

    1,087     10.86              
 

Exercised

    (2 )   10.83              
 

Expired or forfeited

    (710 )   18.73              
                           
 

Outstanding, June 30, 2009

    4,576   $ 17.17     3.0   $ 5,147  
                     
 

Vested and exercisable, June 30, 2009

    2,728   $ 20.45     2.0   $ 852  
                     

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BIOVAIL CORPORATION

CONDENSED 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.   STOCK-BASED COMPENSATION (Continued)

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

Outstanding, January 1, 2009

    356   $ 15.29  
 

Granted

    227     10.77  
 

Reinvested dividend equivalents

    31     10.47  
 

Vested

    (6 )   12.84  
 

Forfeited

    (21 )   12.10  
               
 

Outstanding, June 30, 2009

    587   $ 13.43  
             
   
  DSUs
(000s)
  Weighted-
Average
Grant-Date
Fair Value
 
 

Outstanding, January 1, 2009

    226   $ 13.86  
 

Granted

    124     12.68  
 

Reinvested dividend equivalents

    16     10.46  
               
 

Outstanding, June 30, 2009

    366   $ 13.31  
             

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CONDENSED 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.   INCOME TAXES

14.   EARNINGS OR LOSS PER SHARE

   
  Three Months Ended
June 30
  Six Months Ended
June 30
 
   
  2009   2008   2009   2008  
 

Net income (loss)

  $ 24,090   $ (25,289 ) $ 63,093   $ 31,087  
                     
 

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

    158,224     160,709     158,222     160,866  
 

Dilutive effect of stock options and RSUs

    107         79      
                     
 

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

    158,331     160,709     158,301     160,866  
                     
 

Basic and diluted earnings (loss) per share

  $ 0.15   $ (0.16 ) $ 0.40   $ 0.19  
                     

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CONDENSED 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)

15.   COMPREHENSIVE INCOME OR LOSS

   
  Three Months Ended
June 30
  Six Months Ended
June 30
 
   
  2009   2008   2009   2008  
 

Net income (loss)

  $ 24,090   $ (25,289 ) $ 63,093   $ 31,087  
                     
 

Comprehensive income (loss)

                         
 

Foreign currency translation adjustment

                         
   

Arising in period

    11,121     918     4,935     (4,501 )
   

Reclassification to net income (loss)(1)

        1,696         1,696  
 

Unrealized holding gain (loss) on auction rate securities:

                         
   

Arising in period

    239     (1,315 )   93     (1,571 )
   

Reclassification to net income (loss)(2)

    530     270     502     270  
 

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

                         
   

securities

                         
   

Arising in period

    642     (1,571 )   760     (512 )
   

Reclassification to net income (loss)(3)

    (383 )       (381 )    
 

Cumulative effect of adoption of SFAS 159

                (2,343 )
                     
 

Other comprehensive income (loss)

    12,149     (2 )   5,909     (6,961 )
                     
 

Comprehensive income (loss)

  $ 36,239   $ (25,291 ) $ 69,002   $ 24,126  
                     

(1)
Included in foreign exchange gain (loss) in the consolidated statements of income (loss).

(2)
Included in impairment loss on debt securities in the consolidated statements of income (loss).

(3)
Included in gain on disposal of investments in the consolidated statements of income (loss).
   
  Foreign
Currency
Translation
Adjustment
  Net Unrealized
Holding Gain
on Available-
For-Sale
Securities
  Unrealized
Holding Loss
on Auction
Rate
Securities
  Total  
 

Balance, January 1, 2009

  $ 27,066   $ 432   $ (1,829 ) $ 25,669  
 

Foreign currency translation adjustment

    4,935             4,935  
 

Net unrealized holding gain on available-for-sale securities

        760         760  
 

Unrealized holding gain on auction rate securities

            93     93  
 

Reclassification adjustments to net income (loss)

        (381 )   502     121  
                     
 

Balance, June 30, 2009

  $ 32,001   $ 811   $ (1,234 ) $ 31,578  
                     

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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BIOVAIL CORPORATION

CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

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CONDENSED 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)

16.   LEGAL PROCEEDINGS (Continued)

17.   SEGMENT INFORMATION

18.   SUBSEQUENT EVENTS

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CONDENSED 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)

18.   SUBSEQUENT EVENTS (Continued)

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS

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

        The following Management's Discussion and Analysis of Results of Operations and Financial Condition ("MD&A") should be read in conjunction with the unaudited consolidated financial statements, and condensed notes thereto, prepared in accordance with United States ("U.S.") generally accepted accounting principles ("GAAP") for the interim period ended June 30, 2009 (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 our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, filed on February 27, 2009 with the U.S. Securities and Exchange Commission ("SEC") and the Canadian Securities Administrators ("CSA") (the "2008 Form 20-F").

        Additional information relating to our Company, including the 2008 Form 20-F, is available on SEDAR at www.sedar.com and on the SEC's website at www.sec.gov.

        Unless otherwise indicted herein, the discussion and analysis contained in this MD&A are as of August 7, 2009.

FORWARD-LOOKING STATEMENTS

        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, our objectives, goals, strategies, beliefs, intentions, plans, estimates, and outlook, including, without limitation, statements concerning the following:

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

        These forward-looking statements may not be appropriate for other purposes.

        Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may", "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. Although we have indicated certain of these statements set out herein, all of the statements in this MD&A 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 prescription trends, pricing and the formulary and/or Medicare/Medicaid

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


positioning for our products; the competitive landscape in the markets in which we compete, including, but not limited to, the availability or introduction of generic formulations of our products; timelines associated with the development of, and receipt of regulatory approval for, our new products; the opportunities present in the market for therapies for specialty CNS disorders; and the resolution of insurance claims relating to certain litigation and regulatory proceedings. 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 difficulty of predicting U.S. Food and Drug Administration ("FDA"), Canadian Therapeutic Products Directorate and European regulatory approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the results of continuing safety and efficacy studies by industry and government agencies, uncertainties associated with the development, acquisition and launch of new products, contractual disagreements with third parties, availability of capital and ability to generate operating cash flows and satisfy applicable laws for dividend payments, the continuation of the recent market turmoil, market liquidity for our common shares, our ability to secure third-party manufacturing arrangements, our satisfaction of applicable laws for the repurchase of our common shares, our ability to retain the limited number of customers from which a significant portion of our revenue is derived, the impact of a decline in our market capitalization on the carrying value of goodwill, reliance on key strategic alliances, delay in or transition issues arising from the closure of our Puerto Rico and Mississauga facilities and the consolidation of our Chantilly operations, the successful implementation of our specialty CNS strategy, our eligibility for benefits under tax treaties, the continued availability of low effective tax rates for the business profits of our principal operating subsidiary, the availability of raw materials and finished products, the regulatory environment, the unpredictability of protection afforded by our patents and other intellectual proprietary property, the mix of activities and income in the various jurisdictions in which we operate, successful challenges to our generic products, infringement or alleged infringement of the intellectual property rights of others, the ability to manufacture and commercialize pipeline products, unanticipated interruptions in our manufacturing operations or transportation services, the expense, timing and uncertain outcome of legal and regulatory proceedings and settlements thereof, payment by insurers of insurance claims, currency and interest rate fluctuations, consolidated tax rate assumptions, fluctuations in operating results, the market liquidity and amounts realized for auction rate securities held as investments, and other risks detailed from time to time in our filings with the SEC and the CSA, as well as our ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this MD&A, as well as under the heading "Key Information — Risk Factors" under Item 3.D of our 2008 Form 20-F. 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.

COMPANY PROFILE

        We are a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products. We have various research and development, clinical research, manufacturing and commercial operations located in Barbados, Canada, the U.S., and Puerto Rico.

        Prior to May 2008, we focused our growth on the development and large-sale manufacture of pharmaceutical products incorporating oral drug-delivery technologies. Our main therapeutic areas of focus were non-specialty CNS disorders, pain management and cardiovascular disease. In May 2008, as a result of significant changes in the environment for oral controlled-release products over the previous several years, we developed a new business model focused on the development and commercialization of medicines that address unmet medical needs in niche specialty CNS markets.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

RECENT DEVELOPMENTS

Business Development

Tetrabenazine

        On June 19, 2009, we acquired the worldwide development and commercialization rights to the entire portfolio of tetrabenazine products, including Xenazine® and Nitoman®, held by Cambridge Laboratories (Ireland) Limited and its affiliates ("Cambridge"). We had previously obtained certain licensing rights to tetrabenazine in the U.S. and Canada through the acquisition of Prestwick Pharmaceuticals, Inc. ("Prestwick") in September 2008. By means of this acquisition, we have obtained Cambridge's economic interest in the supply of tetrabenazine for the U.S. and Canadian markets, as well as for a number of other countries in Europe and around the world through existing distribution agreements. We assumed Cambridge's royalty obligation to a third party on the worldwide sales of tetrabenazine.

        This acquisition was accounted for as a business combination under the acquisition method of accounting. The total purchase price comprised cash consideration of $200.0 million paid on closing, and additional payments of $12.5 million and $17.5 million due to Cambridge on the first and second anniversaries of the closing date, respectively. These additional payments were fair valued at $26.8 million, using an imputed interest rate comparable to our available borrowing rate at the date of acquisition.

        The total purchase price of $226.8 million was primarily allocated to the identifiable product rights intangible asset ($198.0 million) and the acquired in-process research and development intangible asset ($27.7 million). The fair values of these intangible assets are provisional pending finalization of the valuation for these assets. The product rights intangible asset represents the value of the currently marketed immediate-release tetrabenazine products, with an estimated useful life of approximately 10 years. The acquired in-process research and development intangible asset relates to a new formulation of tetrabenazine under development initially for the treatment of Tourette Syndrome (BVF-018) and the development of an isomer of tetrabenazine (RUS-350). BVF-018 has been granted Orphan Drug status by the FDA, which provides the product with seven years of market exclusivity in the U.S. if successfully developed. We had a pre-Investigational New Drug application meeting with the FDA for this program in early July 2009, and contingent on successful safety assessments, our current plans are to initiate a Phase 2 clinical study in the third quarter of 2010. In respect of RUS-350, we plan to move this program into a Phase 2 clinical study in the first half of 2010, contingent on FDA concurrence and the outcome of preclinical assessments.

        We incurred $5.6 million of costs related to this acquisition, which were expensed in the second quarter of 2009.

        The amount of revenue and earnings recognized from the worldwide sales of tetrabenazine, excluding the U.S. and Canada, from the acquisition date to June 30, 2009, was not material to our consolidated statement of income. However, this transaction is expected to be accretive to revenue and is expected to provide minimal operating cash flows in 2009 and operating cash flows in the range of $23 million to $26 million in 2010.

Wellbutrin XL®

        On May 14, 2009, we acquired the full U.S. commercialization rights to Wellbutrin XL® from GlaxoSmithKline plc ("GSK"). We had supplied Wellbutrin XL® to GSK for marketing and/or distribution in the U.S. since September 2003. The Wellbutrin XL® product formulation was developed and is manufactured by us under our own patents and proprietary technology.

        This acquisition does not materially impact our existing agreement with GSK as it relates to countries outside the U.S. We will continue to manufacture and supply Wellbutrin XL® to GSK for distribution in these countries. In Canada, Wellbutrin® XL will continue to be marketed by our internal sales organization, Biovail Pharmaceuticals Canada ("BPC"). This acquisition is expected to be accretive to revenue by $90 million to

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


$100 million in 2009, and to generate significant cash flows that can be used to further expand our pipeline of specialty CNS products.

        Pursuant to the terms of the asset purchase agreement, we paid $510.0 million to GSK to acquire the U.S. New Drug Application for Wellbutrin XL®. We also obtained an exclusive, royalty-free license to the Wellbutrin XL® trademark for use in the U.S. This acquisition was accounted for as a purchase of identifiable intangible assets. Accordingly, the total purchase price (including costs of acquisition of $0.5 million) was allocated to the trademark intangible asset, with an estimated useful life of 10 years. In addition, we acquired the Wellbutrin XL® finished goods inventory owned by GSK valued at $10.5 million.

Pimavanserin

        On May 1, 2009, we entered into a collaboration and license agreement with ACADIA Pharmaceuticals Inc. ("ACADIA") to acquire the U.S. and Canadian rights to develop, manufacture and commercialize pimavanserin tartrate (a selective 5-HT2A inverse agonist) in a number of neurological and psychiatric conditions, including Parkinson's disease psychosis ("PDP") (BVF-036) and Alzheimer's disease psychosis ("ADP") (BVF-040). Pimavanserin is a new chemical entity currently in Phase 3 clinical development for the treatment of PDP, and data from this study is anticipated in the third quarter of 2009. Pimavanserin is directly aligned with our specialty CNS strategy.

        Pursuant to the terms of the collaboration and license agreement, we paid an upfront fee of $30.0 million to ACADIA, and could pay up to $160 million in potential developmental milestones associated with the successful completion of clinical trials, regulatory submissions, and approvals for pimavanserin in the PDP and ADP indications. Should we pursue a third indication, we could pay up to $45 million in additional success milestones. We will also make tiered royalty payments of 15% to 20% on net sales of products containing pimavanserin, as well as additional milestone payments of up to $160 million as certain net sales thresholds are met.

        This acquisition was accounted for as a purchase of intangible research and development assets with no alternative future use. Accordingly, the $30.0 million upfront payment, together with acquisition costs of $0.4 million, was charged to research and development expense at the acquisition date.

Financing Arrangements

5.375% Senior Convertible Notes due 2014

        On June 10, 2009, we issued $350 million principal amount of Notes in a private placement. The Notes were issued at par and interest is payable semi-annually on February 1 and August 1 of each year, beginning February 1, 2010. The Notes will mature on August 1, 2014. Noteholders may convert their Notes based on a conversion rate of 67.0880 common shares per $1,000 principal amount of Notes, equivalent to a conversion price of approximately $14.91 per share, subject to adjustment, at their option at any time prior to the maturity date under the following circumstances: (i) if the closing price of our common shares reaches, or the trading price of the Notes falls below, specified thresholds; (ii) if the Notes have been called for redemption; (iii) upon the occurrence of specified corporate transactions; and (iv) during the 25 trading days prior to the maturity date. Upon conversion, we will have the option to deliver cash, common shares or a combination of cash and common shares. In addition, following certain corporate transactions, we will in certain circumstances increase the conversion rate for Noteholders who elect to convert their Notes in connection with such corporate transactions. Our current intent and policy is to settle the Notes using a net share settlement approach, such that the principal amount of any Notes tendered for conversion would be settled in cash, and any excess conversion value settled in common shares.

        We may redeem for cash all or a portion of the Notes at any time on or after August 2, 2012, at a purchase price equal to 100% of the principal amount being redeemed, plus any accrued and unpaid interest if the closing price of our common shares reaches a specified threshold. We may not otherwise redeem any of the Notes at our

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


option prior to maturity, except upon the occurrence of certain changes to the laws governing Canadian withholding taxes.

        If we experience specified types of fundamental changes, Noteholders may require us to repurchase for cash all or a portion of their Notes at a price equal to 100% of the principal amount of the Notes to be purchased plus any accrued and unpaid interest to, but excluding, the date of repurchase.

        The liability (debt) and equity (conversion option) components of the Notes were separately accounted for in a manner that reflects our borrowing rate for non-convertible debt with otherwise similar terms. The liability component was fair valued at $293.3 million and the equity component was valued on a residual basis at $56.7 million. The value assigned to the liability component was estimated based on a 9.5% market rate of interest for similar debt with no conversion rights. The value allocated to the liability component will be accreted to the face value of the Notes over the five-year period prior to maturity, using the effective interest method. The accretion of the liability component will be recognized as additional non-cash interest expense. The value assigned to the equity component was recorded in additional paid-in capital in shareholders' equity.

        We recognized a deferred tax liability of $16.0 million for the original basis difference between the principal amount of the Notes and the value allocated to the liability component, which resulted in a corresponding reduction to the valuation allowance recorded against our deferred tax assets. The recognition of the deferred tax liability and the corresponding reduction in the valuation allowance were recorded as offsetting adjustments to additional paid-in capital. In subsequent periods, the deferred tax benefit resulting from the reversal of the deferred tax liability, will be offset by the deferred tax expense related to the corresponding realization of the deferred tax assets.

Credit Facility

        On June 9, 2009, we established a $410 million senior secured revolving credit facility with a syndicate of banks. This facility matures on June 9, 2012 and replaces our former $250 million credit facility. The new facility contains an accordion feature that, subject to certain conditions, allows it to be increased to up to $550 million. This facility is guaranteed by our material subsidiaries and is secured by charges over substantially all of our Company's assets and the assets of our material subsidiaries, and is subject to certain financial and non-financial covenants. At June 30, 2009, we had outstanding borrowings of $130.0 million under this facility.

Auction Rate Security Settlement Agreement

        In May 2008, we commenced an arbitration against the investment bank that invested our assets in auction rate securities. In May 2009, we resolved this matter with the investment bank for a payment in the amount of $22.0 million, which represented a recovery of 82% of the original $26.8 million principal invested in these securities. We retained ownership of these securities under the terms of this settlement. This settlement does not change our conclusion that we do not intend to sell these securities and it is not more likely than not that we will be required to sell these securities before a recovery of their amortized cost bases.

Restructuring

        In support of our specialty CNS strategy, we initiated restructuring measures in May 2008 that were intended to rationalize our manufacturing operations, pharmaceutical sciences operations, and general and administrative expenses. These measures included the closure of our research and development facility in Dublin, Ireland in August 2008, and the planned closure of our two manufacturing facilities in Puerto Rico in 2010. In addition, in May 2009, we announced our intention to close our research and development facility in Mississauga, Ontario, and to consolidate our research and development operations in Chantilly, Virginia.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

        The following table summarizes the major components of the restructuring costs recognized through June 30, 2009:

 
  Asset Impairments   Employee Termination Benefits    
   
 
 
  Contract
Termination
and Other
Costs
   
 
($ in 000s)
  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

            1,337         11     1,348  

Cash payments

                    (118 )   (118 )
                           

Balance, March 31, 2009

            4,646         3,239     7,885  
                           

Costs incurred and charged to expense

    6,515     1,542     1,281     1,618     411     11,367  

Cash payments

            (555 )   (394 )   (369 )   (1,318 )

Non-cash adjustments

    (6,515 )   (1,542 )               (8,057 )
                           

Balance, June 30, 2009

  $   $   $ 5,372   $ 1,224   $ 3,281   $ 9,877  
                           

Manufacturing Operations

        We expect to incur employee termination costs of approximately $8.7 million in total for severance and related benefits payable to the approximately 240 employees who will be terminated as a result of the planned closure of our Puerto Rico manufacturing facilities. As these employees are required to provide service during the shutdown period in order to be eligible for termination benefits, we are recognizing the cost of those termination benefits ratably over the required future service period, including $1.3 million and $2.6 million recognized in the second quarter and first half of 2009, respectively, and $3.3 million recognized in 2008.

        In the second quarter of 2009, we recorded an additional impairment charge of $6.5 million to write-down the carrying value of the property, plant and equipment located in Puerto Rico, based on an assessment of the local real estate market conditions for pharmaceutical facilities. We are continuing to actively market these facilities.

Pharmaceutical Sciences Operations

        In the second quarter of 2009, we incurred employee termination costs of $1.6 million for severance and related benefits payable to the approximately 50 employees who will be terminated as a result of the closure of our Mississauga, Ontario research and development facility, and the consolidation of our Chantilly, Virginia research and development operations. In addition, we recorded an impairment charge of $0.5 million related to the write-down of the carrying value of the equipment and leasehold improvements located at the Mississauga facility to their estimated fair value, and $0.4 million of accelerated depreciation arising from a reduced useful life for the leasehold improvements located at the Chantilly facility. We also expect to incur lease termination costs of approximately $1.4 million related to vacating one of our premises in Chantilly prior to the end of 2009.

        In July 2009, we completed the sale of our Dublin, Ireland research and development facility for net cash proceeds of $5.2 million, which resulted in an additional write-down of $0.7 million to the carrying value of this facility in the second quarter of 2009.

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Research and Development

        In addition to the programs described above under Business Development, other projects in our development pipeline include:

        As a result of the planned initiation of the clinical program for BVF-324, and incremental costs associated with the development of pimavanserin and tetrabenazine, we expect that costs associated with internal research and development programs will increase in the second half of 2009, relative to the level seen in the first half of 2009.

        In March 2009, we announced the formation of an External Advisory Board — comprised of Franklin Berger, Dr. Mark Cochran, Dr. Kathleen Clarence-Smith, Dr. Robert Lenox, Dr. Karoly Nikolich and Dr. Ian Ragan — to oversee and provide medical, scientific, and commercial input into our development-pipeline efforts in specialty CNS disorders.

Sale of Non-Core Assets

        In April 2009, we entered into a sale and leaseback agreement for our corporate headquarters in Mississauga; however, this transaction was terminated in June 2009. We continue to actively seek potential buyers and to complete a transaction for the sale and leaseback of this facility. We estimate that we may recognize a loss on the disposal of this facility of approximately $8 million.

        In April 2009, we completed the sale of our corporate aircraft for proceeds of $5.3 million and entered into a four-year operating lease for this aircraft. This transaction resulted in a gain on disposal of approximately $0.9 million, which was deferred and will reduce future lease rental expense over the lease term.

Share Repurchase Program

        On August 5, 2009, our Board of Directors approved the purchase of up to 15.8 million of our Company's common shares on the open market under a share repurchase program or normal course issuer bid, subject to a maximum of $75 million of common shares being repurchased during any fiscal year (unless such condition is waived or varied by our lenders).

Resolution of Legacy Litigation and Regulatory Matters

Ontario Securities Commission Settlement

        On January 9, 2009, we announced that the Ontario Securities Commission ("OSC") approved a settlement agreement in respect of its investigation of our Company, related to specific accounting and financial disclosure practices from 2001 to March 2004. Pursuant to the terms of this agreement, we paid $5.3 million, including costs, to fully settle this matter.

USAO Agreement

        On May 16, 2008, we announced that a subsidiary of our Company had reached an agreement with the USAO in respect of criminal allegations related to activities surrounding the 2003 commercial launch of Cardizem® LA. This agreement is subject to approval at a Court hearing that is expected to take place on

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


September 14, 2009. Upon receipt of final Court approval, we expect to pay an amount of $24.6 million to fully settle this matter, which we recognized in the second quarter of 2008.

Efficiency Initiatives

        Our restructuring and expense reduction opportunities have proven to be greater than originally expected. As noted in our first quarter 2009 results, we anticipate that these efficiency initiatives, including the rationalization of our manufacturing and pharmaceutical sciences operations, once fully implemented, may now result in annual savings of $40 million to $60 million (previously $30 million to $40 million). Our ongoing and planned efficiency initiatives have resulted in cumulative charges to earnings of $88.9 million recorded through June 30, 2009. These charges are expected to be in the range of $100 million to $120 million (previously $80 million to $100 million), of which the cash component is expected to be $20 million to $40 million, including $15.0 million incurred through June 30, 2009.

        As a result of the real estate market conditions for pharmaceutical facilities in Puerto Rico and other market conditions, we now expect to realize approximately $80 to $90 million in proceeds from the sale of non-core assets, down from our previous estimate of approximately $100 million.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

MAJOR PRODUCTS

        The following table displays selected information regarding our major brand name products by therapeutic area:

 
BRAND NAME
  INDICATION(S)
  MARKET
  COMMERCIALIZATION
 
Specialty CNS
 
Xenazine®   Huntington's chorea     U.S.   Supply and distribution agreement with Ovation Pharmaceuticals, Inc., now known as Lundbeck Inc. ("Lundbeck") (a subsidiary of H. Lundbeck A/S).
 
Nitoman®   Hyperkinetic movement disorders, including Huntington's chorea     Canada   Marketed and distributed by BPC.
 
Xenazine®, Xenazina®   Hyperkinetic movement disorders     Territories
other
than the
U.S. and
Canada
  Supply and distribution agreements with various third-party distributors.
 
Non-Specialty CNS
 
Wellbutrin XL®   Depression     U.S.   Distributed by our subsidiary BTA Pharmaceuticals, Inc. ("BTA")(1).
 
Wellbutrin XL®   Depression     Territories
other
than the
U.S. and
Canada
  Supply and distribution agreement with affiliates of GSK.
 
Ativan®   Anxiety     U.S.   Distributed by BTA.
 
Aplenzin™   Depression     U.S.   Supply and distribution agreement with sanofi-aventis U.S. LLC ("sanofi-aventis").
 
Wellbutrin® XL, SR   Depression     Canada   Marketed and/or distributed by BPC.
 
Zyban®   Smoking cessation     Canada   Distributed by BPC.
 

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

 
BRAND NAME
  INDICATION(S)
  MARKET
  COMMERCIALIZATION
 
Pain Management
 
Ultram® ER   Moderate to moderately severe chronic pain     U.S.   Supply and distribution agreement with Ortho-McNeil, Inc., now known as PriCara (a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.).
 
Ralivia®   Moderate to moderately severe chronic pain     Canada   Marketed and distributed by BPC.
 
Antiviral
 
Zovirax®   Herpes     U.S.   Distributed by BTA and promoted by Sciele Pharma, Inc. ("Sciele") from December 2006 until October 2008. In January 2009, Publicis Selling Solutions, Inc. ("PSS"), a contract sales organization, assumed promotional responsibility.
 
Cardiovascular
 
Cardizem® LA   Hypertension and angina     U.S.   Supply and distribution agreement with Kos Pharmaceuticals, Inc. ("Kos") (a subsidiary of Abbott Laboratories).
 
Cardizem® CD   Hypertension and angina     U.S.   Distributed by BTA.
 
Vasotec®, Vaseretic®   Hypertension and congestive heart failure     U.S.   Distributed by BTA.
 
Tiazac®, Generic Tiazac®   Hypertension and angina     U.S.   Supply and distribution agreement with Forest Laboratories, Inc. ("Forest") and its affiliates.
 
Isordil®   Angina     U.S.   Distributed by BTA.
 
Glumetza®   Type 2 diabetes     U.S.   Supply agreement with Depomed, Inc.
 
Tiazac® XC, Tiazac®   Hypertension and angina     Canada   Marketed and/or distributed by BPC.
 
Glumetza®   Type 2 diabetes     Canada   Marketed and distributed by BPC.
 
Cardizem® CD   Hypertension and angina     Canada   Distributed by BPC.
 
(1)
Prior to May 14, 2009, Wellbutrin XL® was manufactured and supplied to affiliates of GSK for distribution in the U.S. (as described above under "Recent Developments — Business Development — Wellbutrin XL®").

        In addition to the major brand name products noted above, our product portfolio includes bioequivalent ("Generic") versions of Adalat CC, Cardizem® CD, Procardia XL and Voltaren XR products, which we supply to an affiliate of Teva Pharmaceuticals Industries Ltd. ("Teva") for distribution in the U.S.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

OVERVIEW

 
  Three Months Ended June 30   Six Months Ended June 30  
 
  2009   2008   Change   2009   2008   Change  
($ in 000s, except per share data)
  $   $   $   %   $   $   $   %  

Revenue

    193,535     186,095     7,440     4     366,854     394,593     (27,739 )   (7 )

Net income (loss)

    24,090     (25,289 )   49,379     NM     63,093     31,087     32,006     103  

Basic and diluted (loss) earnings per share

    0.15     (0.16 )   0.31     NM     0.40     0.19     0.21     111  
                                   

Cash dividends declared per share

    0.090     0.375     (0.285 )   (76 )   0.465     0.750     (0.285 )   (38 )
                                   

 

 
  At
June 30
2009
  At
December 31
2008
  Change    
   
   
   
 
 
  $   $   $   %    
   
   
   
 

Cash and cash equivalents

    52,918     317,547     (264,629 )   (83 )                        

Long-term obligations, including current portion

    450,663         450,663     NM                          
                                           

NM — Not meaningful

Results of Operations

        Total revenue increased $7.4 million, or 4%, to $193.5 million in the second quarter of 2009, compared with $186.1 million in the second quarter of 2008, and declined $27.7 million, or 7%, to $366.9 million in the first half of 2009, compared with $394.6 million in the first half of 2008. A significant factor in the increase in the second quarter of 2009 was the incremental revenue from Wellbutrin XL®, following the acquisition of the full U.S. commercialization rights in May 2009, which was more than offset in the first half of 2009 by lower overall revenue from Wellbutrin XL®, as a result of the launch of a generic version of the 150mg product on May 30, 2008. We also recorded declines in Ultram® ER, Zovirax® and Cardizem® LA product sales in the second quarter and first half of 2009, due mainly to lower prescription demand. However, these declines were more than offset by the inclusion of sales of Xenazine® and Aplenzin™ products, which were added to our product portfolio since the second quarter of 2008, and the impact of higher pricing of our off-patent branded pharmaceutical ("Legacy") products, which more than offset declining prescription volumes for these products.

        Total operating expenses declined $27.4 million, or 13%, to $183.0 million in the second quarter of 2009, compared with $210.4 million in the second quarter of 2008, and declined $53.0 million, or 15%, to $302.7 million in the first half of 2009, compared with $355.7 million in the first half of 2008. These declines reflected primarily lower restructuring costs and legal settlements, partially offset by higher research and development expenses, due to the acquisition of in-process research and development related to pimavanserin in May 2009, and increased amortization of intangible assets associated with the acquisition of the full U.S. commercialization rights to Wellbutrin XL® in May 2009, and the acquisition of Prestwick in September 2008.

        In the second quarter of 2009, we recognized a gain of $22.0 million in connection with the auction rate security settlement.

        Our effective tax rate, as adjusted for certain items that are not deductible or do not effect the income tax provision because of unrecognized tax losses in the local jurisdictions, increased to approximately 15% in the first half of 2009, compared with approximately 7% in the corresponding period of 2008, as a result of the recording of deferred income tax provisions of $0.4 million and $8.2 million in the second quarter and first half

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


of 2009, respectively, related to the utilization of recognized operating loss carryforwards to reduce taxable income in the U.S.

        Changes in foreign currency exchange rates decreased total revenue by approximately $3.4 million, or 1.8%, and $7.9 million, or 2.2%, in the second quarter and first half of 2009, respectively, compared with the corresponding periods of 2008, due to a weakening of the Canadian dollar relative to the U.S. dollar. A weaker Canadian dollar, while unfavourable on revenue, has a positive impact on our operating expenses. As our Canadian dollar-denominated expenses moderately exceeded our Canadian dollar-denominated revenue base, the depreciation of the Canadian dollar in the second quarter and first half of 2009, compared with the corresponding periods of 2008, had the overall effect of slightly increasing our net income as reported in U.S. dollars.

        Net income increased $49.4 million to $24.1 million (basic and diluted earnings per share ("EPS") of $0.15) in the second quarter of 2009, compared with a net loss of $25.3 million (basic and diluted loss per share of $0.16) in the second quarter of 2008, and increased $32.0 million, or 103%, to $63.1 million (basic and diluted EPS of $0.40) in the first half of 2009, compared with $31.1 million (basic and diluted EPS of $0.19) in the first half of 2008. The following table displays specific items that impacted net income in the second quarters and first halves of 2009 and 2008, and the impact of these items (individually and in the aggregate) on basic and diluted EPS. EPS figures may not add due to rounding.

 
  Three Months Ended June 30   Six Months Ended June 30  
 
  2009   2008   2009   2008  
($ in 000s, except per share data; Income (Expense))
 
  Amount   EPS Impact   Amount   EPS Impact   Amount   EPS Impact   Amount   EPS Impact  

Acquired in-process research and development(1)

  $ (30,414 ) $ (0.19 ) $   $   $ (30,414 ) $ (0.19 ) $   $  

Gain on auction rate security settlement

    22,000   $ 0.14       $     22,000   $ 0.14       $  

Restructuring costs

    (11,367 ) $ (0.07 )   (51,760 ) $ (0.32 )   (12,715 ) $ (0.08 )   (51,760 ) $ (0.32 )

Acquisition-related costs

    (5,596 ) $ (0.04 )     $     (5,596 ) $ (0.04 )     $  

Impairment loss on debt and equity securities

    (1,617 ) $ (0.01 )   (489 ) $     (4,324 ) $ (0.03 )   (4,105 ) $ (0.03 )

SEC Consent Decree — independent consultant costs(2)

    (1,546 ) $ (0.01 )     $     (2,973 ) $ (0.02 )     $  

Proxy contest costs(2)

    (629 ) $     (5,414 ) $ (0.03 )   (629 ) $     (5,414 ) $ (0.03 )

Write-down of deferred financing costs(3)

    (537 ) $       $     (537 ) $       $  

Gain on disposal of investments

    344   $     3,461   $ 0.02     338   $     3,461   $ 0.02  

Legal settlements

      $     (24,648 ) $ (0.15 )   (241 ) $     (24,648 ) $ (0.15 )

Management succession costs(2)

      $     (6,052 ) $ (0.04 )     $     (6,052 ) $ (0.04 )

Equity loss

      $       $       $     (1,195 ) $ (0.01 )
                                   

Total

  $ (29,362 ) $ (0.19 ) $ (84,902 ) $ (0.53 ) $ (35,091 ) $ (0.22 ) $ (89,713 ) $ (0.56 )
                                   

(1)
Included in research and development expenses.

(2)
Included in selling, general and administrative expenses.

(3)
Included in interest expense.

        The net impact of the preceding specific items on our provision for income taxes in each of the periods presented was not material.

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Cash Dividends

        Cash dividends declared per share were $0.09 and $0.465 in the second quarter and first half of 2009, respectively, compared with $0.375 and $0.75 in the corresponding periods of 2008. In May 2009, our Board of Directors approved a modification of our dividend policy, which now contemplates the payment of a quarterly dividend of $0.09, compared with $0.375 per share under the former policy. The declaration of future dividends pursuant to this new policy remains subject to the discretion of the Board of Directors, and our Company's business, results of operations, cash flows, and financial condition. On August 5, 2009, our Board of Directors declared a quarterly cash dividend of $0.09 per share, payable on October 5, 2009.

Financial Condition

        At June 30, 2009 and December 31, 2008, we had cash and cash equivalents of $52.9 million and $317.5 million, respectively. In the second quarter of 2009, we obtained financing of $350 million from the issuance of the Notes, and $410 million under our new credit facility, of which we had drawn $130.0 million at June 30, 2009. We used these proceeds (net of financing costs incurred), together with a substantial portion of our existing cash resources, to fund the following acquisition activities:

        At June 30, 2009, we had a long-term obligation to Cambridge of $26.8 million in connection with the tetrabenazine acquisition. In addition, we had dividends payable of $14.2 million in respect of our first quarter 2009 results, which were paid on July 6, 2009, and we continue to maintain an accrual of $24.6 million in respect of the agreement in principle to settle the USAO investigation, which has not been paid pending final Court approval of the settlement agreement. In the first quarter of 2009, we deposited $5.2 million into escrow (which is recorded as restricted cash on the consolidated balance sheet at June 30, 2009) pursuant to the terms of a potential undisclosed business transaction.

RESULTS OF OPERATIONS

        We operate our business on the basis of a single reportable segment — pharmaceutical products. This basis reflects how management reviews the business, makes investing and resource allocation decisions, and assesses operating performance.

Revenue

        The following table displays the dollar amount of each source of revenue in the second quarters and first halves of 2009 and 2008; 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 June 30   Six Months Ended June 30  
($ in 000s)
  2009   2008   Change   2009   2008   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Product sales

    187,716     97     175,666     94     12,050     7     353,109     96     372,580     94     (19,471 )   (5 )

Research and development

    3,255     2     5,704     3     (2,449 )   (43 )   6,970     2     13,057     3     (6,087 )   (47 )

Royalty and other

    2,564     1     4,725     3     (2,161 )   (46 )   6,775     2     8,956     2     (2,181 )   (24 )
                                                       

Total revenue

    193,535     100     186,095     100     7,440     4     366,854     100     394,593     100     (27,739 )   (7 )
                                                   

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Product Sales

        The following table displays product sales by internal reporting category in the second quarters and first halves of 2009 and 2008; 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 June 30   Six Months Ended June 30  
($ in 000s)
  2009   2008   Change   2009   2008   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Wellbutrin XL®

    37,135     20     30,420     17     6,715     22     57,255     16     89,276     24     (32,021 )   (36 )

Aplenzin™

    1,670     1             1,670     NM     5,491     2             5,491     NM  

Ultram® ER

    16,584     9     19,166     11     (2,582 )   (13 )   37,180     11     43,270     12     (6,090 )   (14 )

Xenazine®

    11,048     6             11,048     NM     17,731     5             17,731     NM  

Zovirax®

    36,278     19     37,525     21     (1,247 )   (3 )   69,189     20     74,655     20     (5,466 )   (7 )

Biovail Pharmaceuticals Canada

    18,219     10     18,413     10     (194 )   (1 )   33,527     9     34,653     9     (1,126 )   (3 )

Cardizem® LA

    8,875     5     10,485     6     (1,610 )   (15 )   17,062     5     20,692     6     (3,630 )   (18 )

Legacy

    40,567     22     40,191     23     376     1     81,146     23     73,338     20     7,808     11  

Generic

    17,154     9     18,937     11     (1,783 )   (9 )   34,025     10     36,167     10     (2,142 )   (6 )

Glumetza® (U.S.)

    186         529         (343 )   (65 )   503         529         (26 )   (5 )
                                                       

Total product sales

    187,716     100     175,666     100     12,050     7     353,109     100     372,580     100     (19,471 )   (5 )
                                                   


NM — Not meaningful

Wholesaler Inventory Levels

        Three drug wholesale customers account for the majority of our Zovirax®, Legacy, and, since May 14, 2009, Wellbutrin XL® product sales in the U.S. Our distribution agreements with these wholesalers limit 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 June 30, 2009, these wholesalers owned overall 1.2 months of supply of our products (compared with 1.1 months at December 31, 2008), of which only $0.2 million of inventory had less than 12 months remaining shelf life.

 
   
  At June 30, 2009   At December 31, 2008  
($ in 000s)
  Original
Shelf Life
(In Months)
  Total
Inventory
  Months
On Hand
(In Months)
  Inventory With
Less Than
12 Months
Remaining
Shelf Life
  Total
Inventory
  Months
On Hand
(In Months)
  Inventory With
Less Than
12 Months
Remaining
Shelf Life
 

Zovirax®

    36-48   $ 13,318     1.3   $ 84   $ 17,769     1.3   $ 91  

Wellbutrin XL®

    18     12,311     0.7     31     NA     NA     NA  

Cardizem®

    36-48     6,807     1.0     11     7,146     0.8     15  

Ativan®

    24     2,287     0.9     85     2,523     1.0     80  

Vasotec® and Vaseretic®

    24     1,409     1.0     2     2,034     1.1     10  

Isordil®

    36-60     278     1.0         273     1.1     1  
                                     

Total

    24-60   $ 36,410     1.2   $ 213   $ 29,745     1.1   $ 197  
                               


NA — Not applicable

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

Wellbutrin XL®

        Wellbutrin XL® product sales increased $6.7 million, or 22%, to $37.1 million in the second quarter of 2009, compared with $30.4 million in the second quarter of 2008, and decreased $32.0 million, or 36%, to $57.3 million in the first half of 2009, compared with $89.3 million the first half of 2008. Wellbutrin XL® product sales in the second quarter and first half of 2009 reflected incremental revenue of approximately $23.0 million earned following the acquisition of the full U.S. commercialization rights in May 2009, and the positive effect on our supply prices of price increases implemented over the last 12 months. Those factors were partially offset in the second quarter of 2009, and more than offset in the first half of 2009, by declines in volumes resulting from the introduction of generic competition to the 150mg dosage strength product in May 2008, as well as the continuing sales erosion of the 300mg dosage strength product following its genericization in December 2006.

Aplenzin™

        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. We supplied sanofi-aventis with $1.7 million and $5.5 million of Aplenzin™, including sample supplies, in the second quarter and first half of 2009, respectively.

Ultram® ER

        Ultram® ER product sales declined $2.6 million, or 13%, to $16.6 million in the second quarter of 2009, compared with $19.2 million in the second quarter of 2008, and declined $6.1 million, or 14%, to $37.2 million in the first half of 2009, compared with $43.3 million in the first half of 2008. The decline in Ultram® ER product sales was due to lower prescription volumes and a reduction in our contractual supply price to PriCara (which is determined based on a percentage of PriCara's net selling price for Ultram® ER) of 2.5 percentage points effective January 1, 2009, which more than offset the positive effect on our supply price of price increases implemented by PriCara over the last 12 months. The decline in product sales in the first half of 2009, was partially offset by higher shipments of 100mg tablets in the first quarter of 2009 to replace certain lots recalled in the fourth quarter of 2008, and a $1.1 million reduction to the related recall provision in the first quarter of 2009, as a result of lower than expected returns from wholesalers and pharmacies in connection with the recall.

        In early May 2009, a competing once-daily formulation of tramadol in 100mg, 200mg and 300mg dosage strengths was launched in the U.S. While the launch of this product did not have a significant impact on Ultram® ER product sales in the second quarter of 2009, we are continuing to monitor the effect this launch may have on prescription volumes for Ultram® ER in future periods. In addition, Par Pharmaceuticals Companies, Inc. ("Par") is seeking FDA approval for 100mg, 200mg and 300mg generic versions of Ultram® ER. We understand that Par has received tentative approval from the FDA for its 100mg and 200mg products. A Court ruling on Hatch-Waxman Act patent infringement proceedings against Purdue Pharma L.P., the patent owner, related to this product is currently pending. We believe a Court ruling of non-infringement in favour of Par could result in the introduction of generic competition to Ultram® ER in the third quarter of 2009, at the earliest, should Par decide to launch at risk pending a possible appeal.

Xenazine®

        Xenazine® was launched in the U.S. by Lundbeck in November 2008. Our revenue from sales of this product to Lundbeck amounted to $11.0 million and $17.7 million in the second quarter and first half of 2009, respectively.

Zovirax®

        Zovirax® product sales declined $1.2 million, or 3%, to $36.3 million in the second quarter of 2009, compared with $37.5 million in the second quarter of 2008, and declined $5.5 million, or 7%, to $69.2 million in

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


the first half of 2009, compared with $74.7 million in the first half of 2008, due to lower prescription volumes, and a reduction in inventory levels by our major wholesale customers in order to remain within the limits prescribed by the distribution agreements. Those factors were partially offset by price increases implemented for these products over the last 12 months. The decline in prescription volumes is partially due to increasing competition from available oral therapies. In addition, PSS did not commence its promotion of Zovirax® until February 2009, and is limiting its detailing efforts to certain specialist physicians.

BPC

        Sales of BPC products declined $0.2 million, or 1%, to $18.2 million in the second quarter of 2009, compared with $18.4 million in the second quarter of 2008, and declined $1.1 million, or 3%, to $33.5 million in the first half of 2009, compared with $34.7 million in the first half of 2008, primarily due to foreign currency exchange rate fluctuations. Excluding the negative effect on our Canadian dollar-denominated revenue of the weakening of the Canadian dollar relative to the U.S. dollar, BPC product sales increased approximately 15% and 16% in the second quarter and first half of 2009, respectively, compared with the corresponding periods of 2008. These increases reflected higher sales of our promoted Wellbutrin® XL, Tiazac® XC, Ralivia® and Glumetza® products, which more than offset lower sales of our genericized Tiazac® and Wellbutrin® SR products. Also contributing to the increase was the inclusion of $1.1 million and $2.1 million of Nitoman® product sales in the second quarter and first half of 2009, respectively.

Cardizem® LA

        Revenue from sales of Cardizem® LA declined $1.6 million, or 15%, to $8.9 million in the second quarter of 2009, compared with $10.5 million in the second quarter of 2008, and declined $3.6 million, or 18%, to $17.1 million in the first half of 2009, compared with $20.7 million in the first half of 2008, due to lower prescription volumes, partially offset by the positive effect on our supply price of price increases implemented by Kos over the last 12 months. In addition, inventory levels in the distribution channels have been reduced in the second quarter and first half of 2009, in anticipation of a potential introduction of a generic version of Cardizem® LA by Watson Pharmaceuticals, Inc. ("Watson") upon its receipt of FDA approval. Under the terms of the settlement agreement we reached with Watson in December 2007, we will receive a royalty based on sales of Watson'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 of the distribution rights to Cardizem® LA in May 2005. This amortization amounted to $3.8 million and $7.5 million in each of the second quarters and first halves, respectively, of 2009 and 2008.

Legacy

        Sales of Legacy products increased $0.4 million, or 1%, to $40.6 million in the second quarter of 2009, compared with $40.2 million in the second quarter of 2008, and increased $7.8 million, or 11%, to $81.1 million in the first half of 2009, compared with $73.3 million in the first half of 2008, reflecting price increases implemented for these products (excluding Tiazac®) over the last 12 months that more than offset declining prescription volumes. In addition, sales of generic Tiazac® by Forest were favourably impacted in the second quarter and first half of 2009, due to a recall involving a competitor's product.

Generic

        Sales of Generic products declined $1.8 million, or 9%, to $17.2 million in the second quarter of 2009, compared with $18.9 million in the second quarter of 2008, and declined $2.1 million, or 6%, to $34.0 million in the first half of 2009, compared with $36.2 million in the first half of 2008, reflecting the effects of lower overall prescription volumes and pricing.

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Research and Development Revenue

        Research and development revenue declined $2.4 million, or 43%, to $3.3 million in the second quarter of 2009, compared with $5.7 million in the second quarter of 2008, and declined $6.1 million, or 47%, to $7.0 million in the first half of 2009, compared with $13.1 million in the first half of 2008, primarily as a result of a lower level of clinical research and laboratory testing services provided to external customers by our contract research division, together with the negative impact of the weakening of the Canadian dollar relative to the U.S. dollar.

Royalty and Other Revenue

        Royalties from third parties on sales of products we developed or acquired and other revenue declined $2.2 million, or 46%, to $2.6 million in the second quarter of 2009, compared with $4.7 million in the second quarter of 2008, and declined $2.2 million, or 24%, to $6.8 million in the first half of 2009, compared with $9.0 million in the first half of 2008, due mainly to lower revenue based on sales of fenofibrate in the U.S.

Operating Expenses

        The following table displays the dollar amount of each operating expense category in the second quarters and first halves of 2009 and 2008; 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 June 30   Six Months Ended June 30  
($ in 000s)
  2009   2008   Change   2009   2008   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Cost of goods sold

    50,057     26     43,877     24     6,180     14     94,897     26     97,612     25     (2,715 )   (3 )

Gross margin

    73%           75%                       73%           74%                    

Research and development

    44,692     23     21,759     12     22,933     105     59,220     16     58,091     15     1,129     2  

Selling, general and administrative

    49,498     26     56,633     30     (7,135 )   (13 )   92,742     25     100,230     25     (7,488 )   (7 )

Amortization of intangible assets

    21,778     11     11,691     6     10,087     86     37,281     10     23,385     6     13,896     59  

Restructuring costs

    11,367     6     51,760     28     (40,393 )   (78 )   12,715     3     51,760     13     (39,045 )   (75 )

Acquisition-related costs

    5,596     3             5,596     NM     5,596     2             5,596     NM  

Legal settlements

            24,648     13     (24,648 )   100     241         24,648     6     (24,407 )   99  
                                                       

Total operating expenses

    182,988     95     210,368     113     (27,380 )   (13 )   302,692     83     355,726     90     (53,034 )   (15 )
                                                   


NM — Not meaningful

Cost of Goods Sold and Gross Margins

        Gross margins based on product sales were 73% in each of the second quarter and first half of 2009, compared with 75% and 74% in the corresponding periods of 2008. The following factors had an unfavourable impact on gross margins in the second quarter and first half of 2009:

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

        Those factors were partially offset by:

        Since October 1, 2002, we have been entitled to purchase a pre-determined quantity of Zovirax® inventory from GSK at reduced prices under a price allowance. We expect that the remaining price allowance will be used up in the fourth quarter of 2009, at which time we will lose the benefit of the reduced supply prices, which will have a material impact on our gross margins on future sales of Zovirax®.

Research and Development Expenses

        The following table displays the dollar amount of research and development expenses by internal reporting category for the second quarters and first halves of 2009 and 2008; 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 June 30   Six Months Ended June 30  
($ in 000s)
  2009   2008   Change   2009   2008   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Internal research and development programs

    10,714     6     16,029     9     (5,315 )   (33 )   21,822     6     46,218     12     (24,396 )   (53 )

Acquired in-process research and development

    30,414     16             30,414     NM     30,414     8             30,414     NM  

Contract research services provided to external customers

    3,564     2     5,730     3     (2,166 )   (38 )   6,984     2     11,873     3     (4,889 )   (41 )
                                                       

Total research and development expenses

    44,692     23     21,759     12     22,933     105     59,220     16     58,091     15     1,129     2  
                                                   


NM — Not meaningful

        Internal research and development expenses declined $5.3 million, or 33%, to $10.7 million in the second quarter of 2009, compared with $16.0 million in the second quarter of 2008, and declined $24.4 million, or 53%, to $21.8 million in the first half of 2009, compared with $46.2 million in the first half of 2008, reflecting reduced direct project spending as we transition from reformulation opportunities to the in-licensing and development of specialty CNS products, and cost savings as a result of the closures of our Dublin, Ireland and Mississauga, Ontario research and development facilities. In addition, in the first quarter of 2008, we had accrued $7.9 million in connection with the termination of the BVF-146 program (combination of tramadol and a non-steroidal anti-inflammatory drug).

        As described above under "Recent Transactions — Business Development — Pimavanserin", we recorded a $30.4 million charge for acquired in-process research and development in the second quarter of 2009.

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

        Costs associated with providing contract research services to external customers declined $2.2 million, or 38%, to $3.6 million in the second quarter of 2009, compared with $5.7 million in the second quarter of 2008, and declined $4.9 million, or 41%, to $7.0 million in the first half of 2009, compared with $11.9 million in the first half of 2008, reflecting the decline in activity levels at our contract research division, and lower labour costs as a result of headcount reductions in the second quarter of 2009 and the fourth quarter of 2008, as well as a positive impact on labour and overhead costs as a result of the weakening of the Canadian dollar relative to the U.S. dollar.

Selling, General and Administrative Expenses

        Selling, general and administrative expenses declined $7.1 million, or 13%, to $49.5 million in the second quarter of 2009, compared with $56.6 million in the second quarter of 2008, and declined $7.5 million, or 7%, to $92.7 million in the first half of 2009, compared with $100.2 million in the first half of 2008, primarily due to:

        Those factors were partially offset by:

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Amortization of Intangible Assets

        Amortization expense increased $10.1 million, or 86%, to $21.8 million in the second quarter of 2009, compared with $11.7 million in the second quarter of 2008, and increased $13.9 million, or 59%, to $37.3 million in the first half of 2009, compared with $23.4 million in the first half of 2008, due to the inclusion of amortization of the Wellbutrin® XL trademark intangible asset acquired in May 2009, and the Xenazine® and Nitoman® product right intangible assets acquired in September 2008 in connection with the Prestwick acquisition.

Restructuring Costs

        In the second quarter and first half of 2009, we recorded restructuring charges of $11.4 million and $12.7 million, respectively, as described above under "Recent Developments — Restructuring". In the second quarter of 2008, we incurred a restructuring charge of $51.8 million, related primarily to the write-down of our various facilities located in Puerto Rico and Ireland.

Acquisition-Related Costs

        In the second quarter of 2009, we incurred direct costs of $5.6 million in connection with the acquisition of the worldwide development and commercialization rights to tetrabenazine.

Legal Settlements

        In the second quarter of 2008, we recorded a charge of $24.6 million related to the agreement in principle to settle with the USAO in respect of the Cardizem® LA matter.

Non-Operating Items

        The following table displays the dollar amount of each non-operating income or expense category for the second quarters and first halves of 2009 and 2008; and the dollar and percentage changes in the dollar amount of each category.

 
  Three Months Ended June 30   Six Months Ended June 30  
($ in 000s; Income (Expense))
  2009   2008   Change   2009   2008   Change  
 
  $   $   $   %   $   $   $   %  

Interest income

    251     3,412     (3,161 )   (93 )   585     6,880     (6,295 )   (91 )

Interest expense

    (4,049 )   (236 )   (3,813 )   NM     (4,389 )   (478 )   (3,911 )   818  

Foreign exchange gain (loss)

    314     (1,564 )   1,878     (120 )   721     (1,343 )   2,064     (154 )

Gain on auction rate security settlement

    22,000         22,000     NM     22,000         22,000     NM  

Gain on disposal of investments

    344     3,461     (3,117 )   (90 )   338     3,461     (3,123 )   (90 )

Impairment loss on debt securities

    (1,617 )   (270 )   (1,347 )   499     (4,324 )   (3,190 )   (1,134 )   36  

Impairment loss on equity securities

        (219 )   219     (100 )       (915 )   915     (100 )

Equity loss

                        (1,195 )   1,195     (100 )
                                       

Total non-operating expense

    17,243     4,584     12,659     276     14,931     3,220     11,711     364  
                                   


NM — Not meaningful

Interest Income

        Interest income declined $3.2 million, or 93%, to $0.3 million in the second quarter of 2009, compared with $3.4 million in the second quarter of 2008, and declined $6.3 million, or 91%, to $0.6 million in the first half of 2009, compared with $6.9 million in the first half of 2008, reflecting lower cash resources as a result of business development activities over the past 12 months.

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Interest Expense

        In the second quarter and first half of 2009, we incurred interest expense of $4.0 million and $4.4 million, respectively, which included non-cash amortization of debt discounts on the Notes and the Cambridge obligation of $0.6 million in the second quarter of 2009, and the non-cash amortization of deferred financing costs associated with the Notes and our new and former credit facilities of $0.4 million and $0.6 million in the second quarter and first half of 2009, respectively. In addition, in the second quarter of 2009, we wrote-off the remaining unamortized deferred financing costs of $0.5 million related to our former credit facility.

Gain on Auction Rate Security Settlement

        As described above under "Recent Developments — Auction Rate Security Settlement Agreement", we settled an arbitration with an investment bank in respect of our investment in auction rate securities, which resulted in a gain of $22.0 million on settlement.

Gain on Disposal of Investments

        In the second quarter of 2009, we sold our remaining equity interest in Depomed, Inc. and recognized a gain of $0.3 million. In the second quarter of 2008, we recorded a gain of $3.5 million on the disposal of our investment in Financière Verdi.

Impairment Loss on Debt Securities

        We recorded losses related to other-than-temporary declines in the estimated fair value of a portion of our investment in auction rate securities (as described below under "Liquidity and Capital Resources — Auction Rate Securities") of $1.6 million and $4.3 million in the second quarter and first half of 2009, respectively, compared with $0.3 million and $3.2 million in the corresponding periods of 2008.

Provision for Income Taxes

        The following table displays the dollar amount of the current and deferred provisions for income taxes for the second quarters and first halves of 2009 and 2008; and the dollar and percentage changes in the dollar amount of each provision. Percentages may not add due to rounding.

 
  Three Months Ended June 30   Six Months Ended June 30  
($ in 000s)
  2009   2008   Change   2009   2008   Change  
 
  $   $   $   %   $   $   $   %  

Current income tax expense

    3,300     5,600     (2,300 )   (41 )   7,800     11,000     (3,200 )   (29 )

Deferred income tax expense

    400         400     NM     8,200         8,200     NM  
                                       

Total provision for income taxes

    3,700     5,600     (1,900 )   (34 )   16,000     11,000     5,000     45  
                                   


NM — Not meaningful

        In the fourth quarter of 2008, we recognized a deferred income tax benefit of $90.0 million related to a change in our assessment of the realizability of deferred tax assets related to approximately $230 million of operating loss carryforwards in the U.S. In the second quarter and first half of 2009, we recorded provisions for deferred income taxes of $0.4 million and $8.2 million, respectively, related to the utilization of a portion of these loss carryforwards to reduce taxable income in the U.S., which resulted in an increase in the overall effective tax rate (as adjusted for certain items that are not deductible or do not effect the income tax provision because of unrecognized tax losses in the local jurisdictions) to approximately 15% in the first half of 2009, compared with approximately 7% in the corresponding period of 2008.

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

SUMMARY OF QUARTERLY RESULTS

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

 
  2009   2008   2007  
($ in 000s, except per share data)
  Q2   Q1   Q4   Q3   Q2   Q1   Q4   Q3  

Revenue

  $ 193,535   $ 173,319   $ 181,496   $ 181,089   $ 186,095   $ 208,498   $ 203,896   $ 188,890  

Expenses

    182,988     119,704     144,617     132,726     210,368     145,358     237,989     127,890  
                                   

Operating income (loss)

    10,547     53,615     36,879     48,363     (24,273 )   63,140     (34,093 )   61,000  
                                   

Net income (loss)

  $ 24,090   $ 39,003   $ 120,380   $ 48,437   $ (25,289 ) $ 56,376   $ (31,971 ) $ 65,867  
                                   

Basic and diluted earnings (loss) per share

  $ 0.15   $ 0.25   $ 0.76   $ 0.31   $ (0.16 ) $ 0.35   $ (0.20 ) $ 0.41  
                                   

Net cash provided by (used in) operating activities

  $ 97,081   $ 46,972   $ 106,963   $ (62,370 ) $ 67,056   $ 92,676   $ 79,333   $ 43,415  
                                   

Second Quarter of 2009 Compared To First Quarter of 2009

Results of Operations

        Total revenue increased $20.2 million, or 12%, to $193.5 million in the second quarter of 2009, compared with $173.3 million in the first quarter of 2009, mainly due to the incremental revenue earned on Wellbutrin XL® product sales following the acquisition of the full U.S. commercialization rights in May 2009.

        Net income declined $14.9 million, or 38%, to $24.1 million in the second quarter of 2009, compared with $39.0 million in the first quarter of 2009, primarily due to the following factors impacting the second quarter of 2009:

        Those factors were partially offset by:

Cash Flows

        Net cash provided by operating activities increased $50.1 million, or 107%, to $97.1 million in the second quarter of 2009, compared with $47.0 million in the first quarter of 2009, primarily due to the receipt of $22.0 million on the auction rate security settlement in the second quarter of 2009, and an increase of $22.9 million related to the change in operating assets and liabilities reflecting the timing of receipts and payments in the normal course of business.

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

FINANCIAL CONDITION

        The following table displays a summary of our financial condition at June 30, 2009 and December 31, 2008:

($ in 000s; Asset (Liability))
  At
June 30
2009
  At
December 31
2008
  Change  
 
  $   $   $   %  

Working capital(1)

    29,030     223,198     (194,168 )   (87 )

Long-lived assets(2)

    1,648,558     968,935     679,623     70  

Long-term obligations, including current portion

    (450,663 )       (450,663 )   NM  

Shareholders' equity

    (1,254,132 )   (1,201,599 )   (52,533 )   4  
                   


NM — Not meaningful

(1)
Total current assets less total current liabilities.

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

Working Capital

        Working capital declined $194.2 million, or 87%, to $29.0 million at June 30, 2009, compared with $223.2 million at December 31, 2008, primarily due to:

        Those factors were partially offset by:

Long-Lived Assets

        Long-lived assets increased $679.6 million, or 70%, to $1,648.6 million at June 30, 2009, compared with $968.9 million at December 31, 2008, primarily due to:

        Those factors were partially offset by:

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Long-term Obligations

        Long-term obligations of $450.7 million at June 30, 2009, comprised the following:

Shareholders' Equity

        Shareholders' equity increased $52.5 million, or 4%, to $1,254.1 million at June 30, 2009, compared with $1,201.6 million at December 31, 2008, primarily due to:

        Those factors were partially offset by:

CASH FLOWS

        The following table displays cash flow information for the second quarters and first halves of 2009 and 2008:

 
  Three Months Ended June 30   Six Months Ended June 30  
($ in 000s)
  2009   2008   Change   2009   2008   Change  
 
  $   $   $   %   $   $   $   %  

Net cash provided by operating activities

    97,081     67,056     30,025     45     144,053     159,732     (15,679 )   (10 )

Net cash provided by (used in) investing activities

    (736,753 )   1,796     (738,549 )   NM     (743,795 )   (92,483 )   (651,312 )   704  

Net cash provided by (used in) financing activities

    394,020     (146,320 )   540,340     (369 )   334,689     (146,458 )   481,147     (329 )

Effect of exchange rate changes on cash and cash equivalents

    876     (13 )   889     NM     424     (376 )   800     (213 )
                                       

Net decrease in cash and cash equivalents

    (244,776 )   (77,481 )   (167,295 )   216     (264,629 )   (79,585 )   (185,044 )   233  

Cash and cash equivalents, beginning of period

    297,694     431,537     (133,843 )   (31 )   317,547     433,641     (116,094 )   (27 )
                                       

Cash and cash equivalents, end of period

    52,918     354,056     (301,138 )   (85 )   52,918     354,056     (301,138 )   (85 )
                                   


NM — Not meaningful

Operating Activities

        Net cash provided by operating activities increased $30.0 million, or 45%, to $97.1 million in the second quarter of 2009, compared with $67.1 million in the second quarter of 2008, primarily due to:

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

        Net cash provided by operating activities declined $15.7 million, or 10%, to $144.1 million in the first half of 2009, compared with $159.7 million in the first half of 2008, primarily due to:

        Those factors were partially offset by:

Investing Activities

        Net cash used in investing activities increased $738.5 million to $736.8 million in the second quarter of 2009, compared with cash provided of $1.8 million in the second quarter of 2008, primarily due to:

        Those factors were partially offset by:

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

        Net cash used in investing activities increased $651.3 million to $743.8 million in the first half of 2009, compared with $92.5 million in the first half of 2008, primarily due to:

        That factor was partially offset by:

Financing Activities

        Net cash provided by financing activities increased $540.3 million to $394.0 million in the second quarter of 2009, compared with cash used of $146.3 million in the second quarter of 2008, primarily due to:

        Those factors were partially offset by:

        Net cash provided by financing activities increased $481.1 million to $334.7 million in the first half of 2009, compared with cash used of $146.5 million in the first half of 2008, primarily due to:

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

LIQUIDITY AND CAPITAL RESOURCES

($ in 000s; Asset (Liability))
  At
June 30
2009
  At
December 31
2008
  Change  
 
  $   $   $   %  

Financial assets

                         

Cash and cash equivalents

    52,918     317,547     (264,629 )   (83 )

Short-term investment

        278     (278 )   (100 )

Marketable securities

    20,628     22,635     (2,007 )   (9 )
                     

Total financial assets

    73,546     340,460     (266,914 )   (78 )
                   

Financial liabilities

                         

5.375% Senior Convertible Notes due 2014

    (293,837 )       (293,837 )   NM  

Credit facility

    (130,000 )       (130,000 )   NM  

Cambridge obligation

    (26,826 )       (26,826 )   NM  
                     

Total financial liabilities

    (450,663 )       (450,663 )   NM  
                     

Net financial assets (liabilities)

    (377,117 )   340,460     (717,577 )   (211 )
                   


NM — Not meaningful

General

        We believe that cash expected to be generated by operations and from the potential sale of non-core assets, as well as funds available under our $410 million credit facility, and its $140 million accordion feature, will be sufficient to: meet our operational and capital expenditure requirements; support our dividend policy and share repurchase program; cover the costs associated with our operating efficiency initiatives; and meet our working capital needs, for at least the next 12 months, based on our current expectations. We anticipate total capital expenditures of approximately $5 million to $10 million in 2009. No major capital expenditure projects are planned for 2009.

        We cannot, however, predict the amount or timing of our need for additional funds under various circumstances, such as: significant business development transactions; new product development projects; changes to our capital structure; or other factors that may require us to raise additional funds through borrowings, or the issuance of debt, equity or equity-linked securities. In addition, certain contingent events, such as the resolution of certain legal proceedings (as described in note 16 to our Consolidated Financial Statements), if realized, could have a material adverse impact on our liquidity and capital resources.

        The credit and capital markets experienced unprecedented deterioration in 2008 and the first half of 2009, including the failure of a number of significant and established financial institutions in the U.S. and abroad, and may continue to deteriorate through the remainder of 2009 and beyond. This environment has impacted the availability of credit and capital at least in the near term, which may limit our access to additional funding.

Cash and Cash Equivalents

        Our cash and cash equivalents are held in cash operating accounts, or are invested in securities such as treasury bills, certain money market funds, term deposits, or commercial paper with the highest investment-grade credit rating obtainable.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Auction Rate Securities

        Our marketable securities portfolio currently includes $26.8 million of principal invested in nine individual auction rate securities. As described above under "Recent Developments — Auction Rate Security Settlement Agreement", we entered into a settlement with an investment bank in respect of our investment in these securities. Under the terms of this settlement, we retained ownership of the securities. The estimated fair values of these securities at June 30, 2009 and December 31, 2008 were $6.6 million and $10.3 million, respectively, which reflected write-downs of $20.2 million and $16.4 million, respectively, to the cost bases at those dates. We recorded impairment charges of $1.6 million and $4.3 million in the second quarter and first half of 2009, respectively, compared with $0.3 million and $3.2 million in the corresponding periods of 2008, reflecting the portion of the auction rate securities that we concluded has an other-than-temporary decline in estimated fair value due to a shortfall in the underlying collateral value for these securities. These charges did not have a material impact on our liquidity.

        Effective April 1, 2009, we adopted Financial Accounting Standards Board ("FASB") Staff Position ("FSP") No. FAS 115-2 and FAS 124-2, "Recognition and Presentation of Other-Than-Temporary Impairments" ("FSP FAS 115-2"). FSP FAS 115-2 requires an other-than-temporary impairment of a debt security to be separated into (i) the amount representing the decrease in cash flows expected to be collected, or the credit loss portion, which is recognized in earnings, and (ii) the amount related to all other factors, or the non-credit portion, which is recognized in other comprehensive income in circumstances in which management asserts that it does not have the intent to sell the security, and it is more likely than not that it will not be required to sell the security before recovery of its amortized cost basis. Prior to the adoption of FSP FAS 115-2, the entire other-than-temporary impairment loss was recognized in earnings. Upon the adoption of FSP FAS 115-2, the cumulative effect adjustment to reclassify the non-credit losses previously recognized through earnings from accumulated other comprehensive income to opening deficit was not material to our consolidated financial statements. In addition, the non-credit portion of the $1.6 million other-than-temporary impairment charge recognized in the second quarter of 2009 was not material to our consolidated financial statements.

        We recorded unrealized gains in other comprehensive income (loss) of $0.2 million and $0.1 million in the second quarter and first half of 2009, respectively, compared with unrealized losses of $1.3 million and $1.6 million in the corresponding periods of 2008, reflecting adjustments to the portion of the auction rate securities that we have concluded have a temporary decline in estimated fair value. We do not consider the overall decline in the estimated fair value of these securities to be other-than-temporary based on the adequacy of the underlying collateral value for the securities. In addition, we concluded that we do not intend to sell these securities and it is not more likely than not that we will be required to sell these securities before a recovery of their amortized cost bases.

        If uncertainties in the credit and capital markets continue through the remainder of 2009, or these markets deteriorate further, or we experience any additional declines in underlying collateral values on the auction rate securities, we may incur additional write-downs to these securities, which could have a material impact on our results of operations and cash flows.

Debt Capacity

        We currently have $350 million principal amount of Notes issued and outstanding, and borrowings of $130.0 million under our $410 million credit facility. This facility, including its $140 million accordion feature, may be used for general corporate purposes, including acquisitions and capital expenditures. At June 30, 2009, we were in compliance with all covenants associated with this facility.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

CONTRACTUAL OBLIGATIONS

        The following table summarizes expected principal and interest payments on long-term obligations as of June 30, 2009:

 
  Payments Due by Period  
($ in 000s)
  Total   2009   2010
and 2011
  2012
and 2013
  Thereafter  

Long-term obligations(1)

  $ 633,052   $ 4,387   $ 89,408   $ 172,012   $ 367,245  
                       

(1)
Expected interest payments assume repayment of the principal amount of the debt obligations at maturity. Interest on our new credit facility is calculated using the effective interest rate on the facility at June 30, 2009.

        As described above under "Recent Developments — Business Development — Pimavanserin", we may be required to make milestone payments to ACADIA of up to $365 million in the aggregate pursuant to the terms of the collaboration and license agreement for pimavanserin. These payments are contingent on the achievement of specific developmental, regulatory and commercial milestones. In addition, we may have to make royalty payments based on a percentage of future net sales of the products containing pimavanserin in the event regulatory approval is obtained.

        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 "Contractual Obligations" in the annual MD&A contained in the 2008 Form 20-F.

OFF-BALANCE SHEET ARRANGEMENTS

        In the normal course of business, we enter into agreements that include indemnification provisions for product liability and other matters. There have been no material changes to the indemnification provisions specified under the heading "Off-Balance Sheet Arrangements" in the annual MD&A contained in the 2008 Form 20-F.

OUTSTANDING SHARE DATA

        Our common shares are listed on the Toronto Stock Exchange and New York Stock Exchange.

        At August 6, 2009, we had 158,229,275 issued and outstanding common shares, as well as 4,545,575 stock options and 588,072 RSUs outstanding. Assuming full share settlement, 23,480,800 common shares are issuable upon the conversion of the Notes (based on a conversion rate of 67.0880 common shares per $1,000 principal amount of Notes, subject to adjustment); however, our intent and policy is to settle the Notes using a net share settlement approach.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        We are exposed to financial market risks, including changes in foreign currency exchange rates, interest rates on investments and debt obligations, and equity market prices on short-term and long-term investments. We have used derivative financial instruments from time to time as a risk management tool and not for trading or speculative purposes.

Inflation; Seasonality

        Our results of operations have not been materially impacted by inflation or seasonality.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Foreign Currency Risk

        We operate internationally, but a majority of our revenue and expense activities and capital expenditures are denominated in U.S. dollars. Our only other significant transactions are denominated in Canadian dollars. 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. At June 30, 2009, the effect of a hypothetical 10% immediate and adverse change in the Canadian dollar exchange rate (relative to the U.S. dollar) on our Canadian dollar-denominated cash, cash equivalent, accounts receivable, accounts payable, and intercompany balances would not have a material impact on our net income. In the first quarter of 2009, we entered into limited short-dated forward contracts to seek to mitigate foreign exchange risk. These contracts were settled prior to March 31, 2009, and did not have a material effect on our consolidated results of operations or cash flows.

Interest Rate Risk

        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 three months. As it is our intent and policy to hold these investments until maturity, we do not have a material exposure to interest rate risk, and, as a result, a hypothetical 10% immediate and adverse change in interest rates would not have a material impact on the realized value of these investments.

        We are also exposed to interest rate risk on our investment in auction rate securities. Interest rates on these securities are typically reset every month; however, following the failure to complete successful auctions and the reset of interest rates due to market liquidity issues, interest on these securities is being calculated and paid based on prescribed spreads to LIBOR. As we are guaranteed a fixed spread to market interest rates, our interest rate risk exposure is minimal, and, as a result, a hypothetical 10% immediate and adverse change in interest rates would not have a material impact on the fair value of these securities.

        We are exposed to interest rate risk on borrowings under our new credit facility. This facility bears interest based on U.S. dollar LIBOR, U.S. dollar base rate, Canadian dollar prime rate, and/or Canadian dollar bankers' acceptance. The fair value of our fixed-rate Notes is affected by changes in interest rates. In addition, the imputed rate of interest used to discount the Cambridge obligation is fixed and, consequently, the fair value of this obligation is also affected by changes in interest rates. Currently, we do not utilize interest rate swap contracts to hedge against interest rate risk; however, based on our overall interest rate exposure, a 10% change in interest rates would not have a material impact on our results of operations, financial position or cash flows.

Investment Risk

        We are exposed to investment risks primarily on our available-for-sale equity investments. The fair values of these investments are subject to significant fluctuations due to: stock market volatility; changes in general economic conditions; and/or changes in the financial condition of each investee. We regularly review the carrying values of our investments and record losses whenever events and circumstances indicate that there have been other-than-temporary declines in their fair values. At June 30, 2009, a hypothetical 10% immediate and adverse change in the quoted market prices of our available-for-sale equity investments would not have a material impact on the fair value of these investments.

        We are also exposed to investment risks on our investment in auction rate securities due to the current market liquidity issues, as described above under "Liquidity and Capital Resources — Auction Rate Securities".

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

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 specified under the heading "Critical Accounting Policies and Estimates" in the annual MD&A contained in the 2008 Form 20-F.

RECENT ACCOUNTING PRONOUNCEMENTS

Adoption of New Accounting Standards

        In addition to the adoption of FSP FAS 115-2 (as described above under "Liquidity and Capital Resources — Auction Rate Securities"), we adopted the following accounting standards effective April 1, 2009:

        Effective January 1, 2009, we adopted the following accounting standards:

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Recently Issued Accounting Standards, Not Adopted as of June 30, 2009

        In June 2009, the FASB issued SFAS No. 168, "The FASB Accounting Standards Codification™ and the Hierarchy of Generally Accepted Accounting Principles, a replacement of FASB Statement No. 162" ("SFAS 168"), which establishes the FASB Accounting Standards Codification (the "Codification") as the source of authoritative accounting principles recognized by the FASB to be applied in the preparation of financial statements in conformity with U.S. GAAP. SFAS 168 explicitly recognizes rules and interpretive releases of the SEC under federal securities laws as authoritative U.S. GAAP for SEC registrants. SFAS 168 is effective for interim and annual periods ending after September 15, 2009. According, we are required to adopt SFAS 168 on October 1, 2009. As the issuance of SFAS 168 and the Codification does not change U.S. GAAP, the adoption of this standard is not expected to have any impact on our consolidated financial statements.

        In June 2009, the FASB issued SFAS No. 167, "Amendments to FASB Interpretation No. 46(R)" ("SFAS 167"), which amends FASB Interpretation No. 46(R), "Variable Interest Entities", for determining whether an entity is a variable interest entity ("VIE") and requires an enterprise to perform an analysis to determine whether the enterprise's variable interest or interests give it a controlling financial interest in a VIE. Under SFAS 167, an enterprise has a controlling financial interest when it has (i) the power to direct the activities of a VIE that most significantly impact the entity's economic performance, and (ii) the obligation to absorb losses of the entity or the right to receive benefits from the entity that could potentially be significant to the VIE. In addition, SFAS 167 requires an enterprise to assess whether it has an implicit financial responsibility to ensure that a VIE operates as designed when determining whether it has power to direct the activities of the VIE that most significantly impact the entity's economic performance. SFAS 167 also requires ongoing assessments of whether an enterprise is the primary beneficiary of a VIE, requires enhanced disclosures and eliminates the scope exclusion for qualifying special-purpose entities. SFAS 167 is effective for interim and annual periods beginning after November 15, 2009. Accordingly, we are required to adopt SFAS 167 beginning January 1, 2009. We are currently evaluating the effect that the adoption of SFAS 167 will have on our consolidated financial statements.

CHANGES IN INTERNAL CONTROLS OVER FINANCIAL REPORTING

        There were no changes in our internal controls over financial reporting that occurred during the three-month period ended June 30, 2009 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

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BIOVAIL CORPORATION
FORM 6-K
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2009


PART II — OTHER INFORMATION

1.     LEGAL PROCEEDINGS

2.     EXHIBITS

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BIOVAIL CORPORATION
FORM 6-K
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2009


SIGNATURES

        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.


 

 

BIOVAIL CORPORATION
         

Date: August 7, 2009

 

By:

 

/s/ MARGARET MULLIGAN

Margaret Mulligan
Senior Vice-President and
Chief Financial Officer

72