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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 September 30, 2008

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 hereby furnishing the information to the Commission pursuant to Rule 12g 3-2(b) under the Securities Exchange Act of 1934.

Yes

 

o

 

No

 

ý



BIOVAIL CORPORATION

FORM 6-K

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2008

        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 September 30, 2008 and December 31, 2007

    1  
   

Consolidated Statements of Income for the three months and nine months ended September 30, 2008 and 2007

    2  
   

Consolidated Statements of Deficit for the three months and nine months ended September 30, 2008 and 2007

    3  
   

Consolidated Statements of Cash Flows for the three months and nine months ended September 30, 2008 and 2007

    4  
   

Condensed Notes to the Consolidated Financial Statements

    5  

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

    31  


Part II — Other Information


 

Legal Proceedings

    62  

Exhibits

    62  

 



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®, BIOVAIL & SWOOSH DESIGN®, BPI®, BVF®, CARDISENSE™, CARDIZEM®, CEFORM®, CRYSTAAL PHARMACEUTICALS™, DITECH™, FLASHDOSE®, GLUMETZA®, INSTATAB™, ISORDIL®, JOVOLA™, JUBLIA™, MIVURA™, ONELZA™, ONEXTEN™, ORAMELT™, PALVATA™, RALIVIA™, SHEARFORM™, SMARTCOAT™, SOLBRI™, TESIVEE™, TIAZAC®, TITRADOSE™, TOVALT™, UPZIMIA™, VASERETIC®, VASOCARD™, VASOTEC®, VEMRETA™, VOLZELO™ and ZILERAN™.

        WELLBUTRIN®, WELLBUTRIN® SR, WELLBUTRIN XL® (a once daily formulation of bupropion developed by Biovail), 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. and is used by us under license. XENAZINE® and NITOMAN® are trademarks of Cambridge Laboratories (Ireland) Ltd. and are used by us under license.

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

i



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, and may be forward-looking information under applicable Canadian provincial 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, the intent and ability to implement and effectively execute plans associated with our New Strategic Focus and the anticipated impact of the New Strategic Focus, our intention to complete acquisitions and to successfully integrate such acquisitions into our business and operations and to achieve the anticipated benefits of such acquisitions, the timing regarding the planned closure of our Puerto Rico and Ireland operations, the associated costs and anticipated impact of such closures and possible impact on our manufacturing processes, our manufacturing ability, the Company's intent and ability and the timing and anticipated impact of the proposed sale of the Company's non-core assets, the availability of benefits under tax treaties, the timing, results and progress of our research and development efforts, the anticipated manufacturing and commercializing of pipeline products that are successfully developed, the intent and ability to make future dividend payments, the intent to continue our share repurchase program and to repurchase our common shares, the intention to make additional filings to permit the Company to repurchase common shares on the Toronto Stock Exchange, the expected impact of the acquisition of Prestwick Pharmaceuticals, Inc. ("Prestwick") on earnings per share and cash flows, the timing of the launch of Xenazine® in the U.S., our intention regarding the development of Prestwick's non-tetrabenazine products, the intent and timing to engage a contract sales organization to promote Zovirax®, the expected impact of the introduction of generic competition to the 150mg Wellbutrin XL® product, the timing of the introduction of generic competition to Ultram® ER, the investment recovery, liquidity, valuation and impairment conclusions associated with our investment in auction rate securities, the timing, costs and expected results of certain litigation and regulatory proceedings and the outcome, amount and timing of the potential settlement of certain of these proceedings, the sufficiency of cash resources (including those available under the accordion feature of our credit facility) to support future spending requirements, expected capital expenditures and business development activities, the ability to manage exposure to foreign currency exchange rate changes, 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" 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-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; and 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 and Canadian Therapeutic Products Directorate 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 satisfaction of applicable laws for dividend payments, the continuation of the recent market turmoil, market liquidity for our common shares, our satisfaction of applicable laws for the acquisition of our common shares, 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 facilities, the successful implementation of our New Strategic Focus, our eligibility for benefits under tax treaties, the availability of raw materials and finished products, the regulatory environment, the unpredictability of protection afforded by our patents, the mix of activities

ii



and income in various jurisdictions in which we operate, successful challenges to our generic products, infringement or alleged infringement of the intellectual property rights of others, unanticipated interruptions in our manufacturing operations or transportation services, the expense, timing and uncertain outcome of legal and regulatory proceedings and settlements thereto, payment by insurers of insurance claims, currency 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 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 (including under the heading "Additional Risk Factors"), and under the heading "Risk Factors" under Item 3, Sub-Part D of our Annual Report on Form 20-F for the fiscal year ended December 31, 2007, filed on March 17, 2008. 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.

iii



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
September 30
2008
  At
December 31
2007
 

ASSETS

             

Current

             

Cash and cash equivalents

  $ 219,005   $ 433,641  

Short-term investment

    7,578      

Marketable securities

        3,895  

Accounts receivable

    99,796     111,114  

Insurance recoveries receivable

    1,860     62,942  

Assets held for sale

    7,003      

Inventories

    70,151     80,745  

Prepaid expenses and other current assets

    10,678     14,680  
           

    416,071     707,017  

Marketable securities

    23,141     24,417  

Long-term investments

    192     24,834  

Property, plant and equipment, net

    167,507     238,457  

Intangible assets, net

    745,822     630,514  

Goodwill

    100,294     100,294  

Deferred tax assets, net of valuation allowance

    18,200     20,700  

Other long-term assets, net

    29,734     35,882  
           

  $ 1,500,961   $ 1,782,115  
           

LIABILITIES

             

Current

             

Accounts payable

  $ 30,976   $ 50,415  

Accrued liabilities

    83,160     74,363  

Accrued legal settlements

    26,648     148,000  

Accrued contract costs

        45,065  

Income taxes payable

    10,924     647  

Deferred revenue

    36,582     49,088  
           

    188,290     367,578  

Deferred revenue

    89,251     55,653  

Income taxes payable

    53,000     54,100  

Other long-term liabilities

    6,534     6,965  
           

    337,075     484,296  
           

SHAREHOLDERS' EQUITY

             

Common shares, no par value, unlimited shares authorized, 158,715,752 and 161,023,729 issued and outstanding at September 30, 2008 and December 31, 2007, respectively

    1,468,485     1,489,807  

Additional paid-in capital

    30,815     23,925  

Deficit

    (381,280 )   (278,495 )

Accumulated other comprehensive income

    45,866     62,582  
           

    1,163,886     1,297,819  
           

  $ 1,500,961   $ 1,782,115  
           

Commitments and contingencies (note 19)

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

1



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF INCOME

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

(Unaudited)

 
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
 
  2008   2007   2008   2007  

REVENUE

                         

Product sales

  $ 170,530   $ 178,321   $ 543,110   $ 607,089  

Research and development

    5,465     6,237     18,522     18,456  

Royalty and other

    5,094     4,332     14,050     13,377  
                   

    181,089     188,890     575,682     638,922  
                   

EXPENSES

                         

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

    47,468     50,458     145,080     161,408  

Research and development

    18,668     30,674     76,759     88,843  

Selling, general and administrative

    44,661     33,660     144,891     129,583  

Amortization of intangible assets

    12,342     11,979     35,727     35,942  

Restructuring costs (recovery)

    7,587     (820 )   59,347     712  

Legal settlements

    2,000     2,062     26,648     2,062  

Contract recoveries

        (123 )       (1,735 )
                   

    132,726     127,890     488,452     416,815  
                   

Operating income

    48,363     61,000     87,230     222,107  

Interest income

    1,783     3,789     8,663     19,620  

Interest expense

    (246 )   (245 )   (724 )   (9,375 )

Foreign exchange gain (loss)

    204     5,255     (1,139 )   5,730  

Equity loss

        (432 )   (1,195 )   (1,325 )

Gain on disposal of investments

    4,156         7,617     15,716  

Loss on impairment of investments

    (1,223 )       (5,328 )    

Loss on early extinguishment of debt

                (12,463 )
                   

Income before provision for income taxes

    53,037     69,367     95,124     240,010  

Provision for income taxes

    4,600     3,500     15,600     12,500  
                   

Net income

  $ 48,437   $ 65,867   $ 79,524   $ 227,510  
                   

Basic and diluted earnings per share

  $ 0.31   $ 0.41   $ 0.50   $ 1.41  
                   

Weighted average number of common shares outstanding (000s)

                         

Basic

    158,715     161,020     160,144     160,777  
                   

Diluted

    158,715     161,020     160,144     160,824  
                   

Cash dividends declared per share

  $ 0.375   $ 0.375   $ 1.125   $ 1.125  
                   

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

2



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
September 30
  Nine Months Ended
September 30
 
 
  2008   2007   2008   2007  

Deficit, beginning of period

  $ (370,288 ) $ (191,623 ) $ (278,495 ) $ (232,733 )

Cumulative effect of adoption of SFAS 159

            2,343      

Net income

    48,437     65,867     79,524     227,510  

Cash dividends declared and dividend equivalents

    (59,429 )   (60,385 )   (180,565 )   (180,918 )

Repurchase of common shares

            (4,087 )    
                   

Deficit, end of period

  $ (381,280 ) $ (186,141 ) $ (381,280 ) $ (186,141 )
                   

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

3



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
September 30
  Nine Months Ended
September 30
 
 
  2008   2007   2008   2007  

CASH FLOWS FROM OPERATING ACTIVITIES

                         

Net income

  $ 48,437   $ 65,867   $ 79,524   $ 227,510  

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

                         

Depreciation and amortization

    24,781     21,220     75,199     67,481  

Amortization and write-down of deferred financing costs

    130     117     390     4,691  

Amortization and write-down of discounts on long-term obligations

                962  

Payment of accrued legal settlements, net of insurance recoveries

    (83,048 )   (14,400 )   (93,048 )   (14,400 )

Additions to accrued legal settlements

    2,000         26,648      

Accrued contract costs

    (45,065 )   (8,000 )   (45,065 )   (8,000 )

Stock-based compensation

    1,567     1,734     6,740     8,771  

Gain on disposal of investment

    (4,156 )       (7,617 )   (15,716 )

Impairment charges

    1,465         57,055      

Equity loss

        432     1,195     1,325  

Premium paid on early extinguishment of debt

                7,854  

Contract recoveries

        (123 )       (1,735 )

Other

    429     1,737     (624 )   2,816  

Changes in operating assets and liabilities:

                         
 

Accounts receivable

    (5,952 )   4,094     12,564     32,904  
 

Insurance recoveries receivable

    44     3,509     6,130     (451 )
 

Inventories

    77     891     9,989     (6,641 )
 

Prepaid expenses and other current assets

    (3,306 )   (4,326 )   4,218     3,314  
 

Accounts payable

    (3,896 )   (11,054 )   (16,459 )   (968 )
 

Accrued liabilities

    3,003     (22,757 )   (397 )   (22,743 )
 

Income taxes payable

    2,384     2,677     9,827     (871 )
 

Deferred revenue

    (1,264 )   1,797     (28,907 )   (24,583 )
                   

Net cash provided by (used in) operating activities

    (62,370 )   43,415     97,362     261,520  
                   

CASH FLOWS FROM INVESTING ACTIVITIES

                         

Acquisition of business, net of cash acquired

    (99,630 )       (99,630 )    

Transfer from restricted cash

    83,048         83,048      

Transfer to restricted cash

            (83,048 )    

Proceeds from the sale of short-term investments

            79,735      

Addition to short-term investments

            (79,725 )    

Additions to property, plant and equipment, net

    (3,931 )   (10,561 )   (21,316 )   (23,640 )

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

    8,712         20,899     37,769  

Additions to restricted assets

    (16 )       (4,931 )    

Additions to marketable securities

    (999 )   (31,938 )   (4,781 )   (32,270 )

Proceeds from sales and maturities of marketable securities

        1,285     4,450     1,599  
                   

Net cash used in investing activities

    (12,816 )   (41,214 )   (105,299 )   (16,542 )
                   

CASH FLOWS FROM FINANCING ACTIVITIES

                         

Cash dividends paid

    (59,518 )   (60,385 )   (180,286 )   (261,140 )

Repurchase of common shares

            (25,538 )    

Repayment of deferred compensation obligation, net

    (31 )   (23 )   (183 )   (283 )

Redemption of Senior Subordinated Notes

                (406,756 )

Repayments of other long-term obligations

                (11,250 )

Issuance of common shares

        527         11,217  
                   

Net cash used in financing activities

    (59,549 )   (59,881 )   (206,007 )   (668,212 )
                   

Effect of exchange rate changes on cash and cash equivalents

    (316 )   128     (692 )   600  
                   

Net decrease in cash and cash equivalents

    (135,051 )   (57,552 )   (214,636 )   (422,634 )

Cash and cash equivalents, beginning of period

    354,056     469,458     433,641     834,540  
                   

Cash and cash equivalents, end of period

  $ 219,005   $ 411,906   $ 219,005   $ 411,906  
                   

NON-CASH INVESTING ACTIVITIES

                         

Accrued but unpaid business acquisition costs

  $ (2,341 ) $   $ (2,341 ) $  

Proceeds receivable from sale of long-term investment

    1,001         1,001    
 

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

4



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

5



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)

6



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)

7



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)

3.     ACQUISITION OF PRESTWICK PHARMACEUTICALS, INC.

8



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.     ACQUISITION OF PRESTWICK PHARMACEUTICALS, INC. (Continued)

 

Current assets (excluding cash acquired)

  $ 2,164  
 

Intangible assets

    157,916  
 

Current liabilities (excluding deferred revenue)

    (8,109 )
 

Deferred revenue:

       
   

Current

    (3,000 )
   

Long-term

    (47,000 )
         
 

Net assets acquired

  $ 101,971  
         

9



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.     ACQUISITION OF PRESTWICK PHARMACEUTICALS, INC. (Continued)

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2008   2007   2008   2007  
 

Revenue

  $ 182,219   $ 190,226   $ 579,638   $ 642,529  
 

Net income

    42,324     56,544     58,606     200,346  
 

Basic and diluted earnings per share

  $ 0.27   $ 0.35   $ 0.37   $ 1.25  
                     

4.     RESTRUCTURING

   
   
   
  Employee
Termination
Benefits
  Operating
Lease
Obligation
   
   
 
   
  Asset Impairments   Contract
Termination
and Other
Costs
   
 
   
  Puerto Rico   Ireland   Puerto Rico   Ireland   Bridgewater   Total  
 

Balance, January 1, 2008

  $   $   $   $   $   $   $  
 

Costs incurred and charged to expense

    42,275     9,000     275             210     51,760  
 

Cash payments

                        (210 )   (210 )
 

Non-cash adjustments

    (42,275 )   (9,000 )                   (51,275 )
                                 
 

Balance, June 30, 2008

            275                 275  
                                 
 

Costs incurred and charged to expense

        242     1,718     2,896     2,533     198     7,587  
 

Cash payments

                        (198 )   (198 )
 

Non-cash adjustments

        (242 )       (65 )   (769 )       (1,076 )
                                 
 

Balance, September 30, 2008

  $   $   $ 1,993   $ 2,831   $ 1,764   $   $ 6,588  
                                 

10



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.     RESTRUCTURING (Continued)

11



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.     RESTRUCTURING (Continued)

5.     FAIR VALUE OF FINANCIAL INSTRUMENTS

   
  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

  $ 128,777   $ 114,928   $ 13,849   $  
 

Available-for-sale equity securities

    7,770     7,770          
 

Auction rate securities

    12,499             12,499  
                     
 

Total financial assets

  $ 149,046   $ 122,698   $ 13,849   $ 12,499  
                     
 

Cash and cash equivalents

  $ 118,135   $ 114,928   $ 3,207   $  
 

Short-term investment

    7,578     7,578          
 

Marketable securities

    23,141         10,642     12,499  
 

Long-term investments

    192     192          
                     
 

Total financial assets

  $ 149,046   $ 122,698   $ 13,849   $ 12,499  
                     

12



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.     FAIR VALUE OF FINANCIAL INSTRUMENTS (Continued)

   
  Three Months
Ended
September 30
2008
  Nine Months
Ended
September 30
2008
 
 

Balance, beginning of period

  $ 13,459   $ 18,000  
 

Total unrealized losses:

             
   

Included in net income(1):

             
     

Arising during period

        (2,920 )
     

Reclassification from other comprehensive income (loss)

    (960 )   (1,230 )
   

Included in other comprehensive income (loss):

             
     

Arising during period

    (960 )   (2,531 )
     

Reclassification to net income

    960     1,230  
 

Settlements

        (50 )
             
 

Balance, end of period

  $ 12,499   $ 12,499  
             
 

Total amount of unrealized losses for the period included in net income relating to securities still held at September 30, 2008

  $ (960 ) $ (4,150 )
             

13



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.     FAIR VALUE OF FINANCIAL INSTRUMENTS (Continued)

6.     SHORT-TERM INVESTMENT

7.     INVENTORIES

   
  At
September 30
2008
  At
December 31
2007
 
 

Raw materials

  $ 20,659   $ 32,577  
 

Work in process

    19,480     14,748  
 

Finished goods

    30,012     33,420  
             
 

  $ 70,151   $ 80,745  
             

14



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)

8.     ASSETS HELD FOR SALE

9.     LONG-TERM INVESTMENTS

10.   INTANGIBLE ASSETS

   
  At September 30, 2008   At December 31, 2007  
   
  Cost   Accumulated
Amortization
  Cost   Accumulated
Amortization
 
 

Trademarks

  $ 573,751   $ 199,010   $ 573,751   $ 177,210  
 

Product rights

    502,845     139,469     344,929     119,402  
 

Technology

    14,800     7,095     14,800     6,354  
                     
 

    1,091,396   $ 345,574     933,480   $ 302,966  
                         
 

Less accumulated amortization

    345,574           302,966        
                         
 

  $ 745,822         $ 630,514        
                         
   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2008   2007   2008   2007  
 

Royalty and other revenue

  $ 268   $ 268   $ 804   $ 804  
 

Cost of goods sold

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

Amortization expense

    12,342     11,979     35,727     35,942  
                     
 

  $ 14,636   $ 14,273   $ 42,608   $ 42,823  
                     

15



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.   RESTRICTED ASSETS

12.   ACCRUED LEGAL SETTLEMENTS

   
  At
September 30
2008
  At
December 31
2007
 
 

U.S. Department of Justice investigation

  $ 24,648   $  
 

U.S. securities class action

        138,000  
 

SEC investigation

        10,000  
 

Other

    2,000      
             
 

  $ 26,648   $ 148,000  
             

13.   ACCRUED CONTRACT COSTS

16



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)

14.   SHARE REPURCHASE PROGRAM

15.   STOCK-BASED COMPENSATION

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2008   2007   2008   2007  
 

Stock options

  $ 1,111   $ 1,734   $ 4,319   $ 8,771  
 

RSUs

    456         2,421      
                     
 

Stock-based compensation expense

  $ 1,567   $ 1,734   $ 6,740   $ 8,771  
                     
 

Cost of goods sold

  $ 194   $ 160   $ 449   $ 714  
 

Research and development expenses

    247     275     684     1,319  
 

Selling, general and administrative expenses

    1,126     1,299     5,607     6,738  
                     
 

Stock-based compensation expense

  $ 1,567   $ 1,734   $ 6,740   $ 8,771  
                     

17



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)

15.   STOCK-BASED COMPENSATION (Continued)

   
  Options
(000s)
  Weighted-Average
Exercise Price
  Weighted-Average
Remaining
Contractual
Term (Years)
  Aggregate
Intrinsic
Value
 
 

Outstanding, January 1, 2008

    5,256   $ 23.02              
 

Granted

    1,059     10.71              
 

Expired or forfeited

    (1,594 )   26.89              
 

Cancelled

    (37 )   10.83              
                           
 

Outstanding, September 30, 2008

    4,684   $ 19.07     2.7   $  
                     
 

Vested and exercisable, September 30, 2008

    3,086   $ 20.44     2.1   $  
                     
   
  RSUs
(000s)
  Weighted-Average
Grant-Date
Fair Value
 
 

Outstanding, January 1, 2008

    125   $ 20.18  
 

Granted

    217     13.26  
 

Reinvested dividend equivalents

    25     11.38  
 

Vested

    (10 )   13.20  
 

Forfeited

    (27 )   13.16  
 

Cancelled

    (89 )   19.75  
               
 

Outstanding, September 30, 2008

    241   $ 14.25  
             

18



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)

15.   STOCK-BASED COMPENSATION (Continued)

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

Outstanding, January 1, 2008                                        

    244   $ 20.49  
 

Granted

    130     9.97  
 

Reinvested dividend equivalents

    14     11.17  
 

Settled for cash

    (162 )   20.46  
               
 

Outstanding, September 30, 2008

    226   $ 13.86  
             

16.   INCOME TAXES

19



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)

17.   EARNINGS PER SHARE

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2008   2007   2008   2007  
 

Net income

  $ 48,437   $ 65,867   $ 79,524   $ 227,510  
                     
 

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

    158,715     161,020     160,144     160,777  
 

Dilutive effect of stock options and RSUs (000s)

                47  
                     
 

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

    158,715     161,020     160,144     160,824  
                     
 

Basic and diluted earnings per share

  $ 0.31   $ 0.41   $ 0.50   $ 1.41  
                     

18.   COMPREHENSIVE INCOME

   
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
   
  2008   2007   2008   2007  
 

Net income

  $ 48,437   $ 65,867   $ 79,524   $ 227,510  
                     
 

Comprehensive income

                         
 

Foreign currency translation adjustment:

                         
   

Arising during period

    (7,941 )   6,874     (12,442 )   20,017  
   

Reclassification to net income(1)

    (868 )       828      
 

Unrealized holding loss on auction rate securities:

                         
   

Arising during period

    (960 )   (2,700 )   (2,531 )   (2,700 )
   

Reclassification to net income

    960         1,230      
 

Net unrealized holding loss on available-for-sale securities

                         
   

Arising during period

    2,886     (10,516 )   2,374     (6,904 )
   

Reclassification to net income

    (3,832 )       (3,832 )    
 

Cumulative effect of adoption of SFAS 159

            (2,343 )    
                     
 

Other comprehensive income (loss)

    (9,755 )   (6,342 )   (16,716 )   10,413  
                     
 

Comprehensive income

  $ 38,682   $ 59,525   $ 62,808   $ 237,923  
                     

20



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)

19.   LEGAL PROCEEDINGS

21



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)

19.   LEGAL PROCEEDINGS (Continued)

22



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)

19.   LEGAL PROCEEDINGS (Continued)

23



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)

19.   LEGAL PROCEEDINGS (Continued)

24



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)

19.   LEGAL PROCEEDINGS (Continued)

25



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)

19.   LEGAL PROCEEDINGS (Continued)

26



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)

19.   LEGAL PROCEEDINGS (Continued)

27



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)

19.   LEGAL PROCEEDINGS (Continued)

28



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)

19.   LEGAL PROCEEDINGS (Continued)

29



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)

19.   LEGAL PROCEEDINGS (Continued)

20.   SEGMENT INFORMATION

30



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 September 30, 2008. 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, 2007, filed on March 17, 2008 with the U.S. Securities and Exchange Commission ("SEC") and the Canadian Securities Administrators ("CSA") (the "2007 Form 20-F").

        Additional information relating to our Company, including the 2007 Form 20-F, is available on SEDAR at www.sedar.com and on the SEC's website at www.sec.gov.

        The discussion and analysis contained in this MD&A are as of November 7, 2008.

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 under applicable Canadian provincial 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:

31



BIOVAIL CORPORATION

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" 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 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 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; and 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") and Canadian Therapeutic Products Directorate 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

32



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


of capital and ability to generate operating cash flows and satisfaction of applicable laws for dividend payments, the continuation of the recent market turmoil, market liquidity for our common shares, our satisfaction of applicable laws for the acquisition of our common shares, 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 facilities, the successful implementation of our New Strategic Focus, our eligibility for benefits under tax treaties, the availability of raw materials and finished products, the regulatory environment, the unpredictability of protection afforded by our patents, 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, unanticipated interruptions in our manufacturing operations or transportation services, the expense, timing and uncertain outcome of legal and regulatory proceedings and settlements thereto, payment by insurers of insurance claims, currency 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 (including below under the heading "Additional Risk Factors"), as well as under the heading "Risk Factors" under Item 3, Sub-Part D of the 2007 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. Our core competency lies in our expertise in the development and large-scale manufacture of pharmaceutical products incorporating oral drug-delivery technologies. We have a portfolio of products that includes the following brand names:

        We market and/or distribute our products in the U.S. principally through supply and distribution agreements with third-party strategic partners. Under those agreements, we manufacture and supply Wellbutrin XL® to GlaxoSmithKline plc ("GSK"); Ultram® ER to Ortho-McNeil, Inc. ("OMI"); Cardizem® LA to Kos Pharmaceuticals, Inc. ("Kos") (a subsidiary of Abbott Laboratories); Tiazac® branded and generic products to Forest Laboratories, Inc. ("Forest"); and bioequivalent (Generic) products to Teva Pharmaceuticals Industries Ltd. ("Teva").

        Our Zovirax® products are distributed in the U.S. by our subsidiary BTA Pharmaceuticals, Inc., and were promoted by Sciele Pharma, Inc. ("Sciele") until October 10, 2008 under an exclusive promotional services agreement. On October 10, 2008, we terminated that agreement with Sciele as a result of Sciele's merger with Shionogi & Co., Ltd. effective October 9, 2008. We intend to engage a contract sales organization to take up the promotion of Zovirax® beginning in early 2009.

        In Canada, we market and/or distribute a number of products, including Tiazac® XC, Wellbutrin® XL, Ralivia™ and Glumetza®, directly through our internal sales organization, Biovail Pharmaceuticals Canada ("BPC").

33



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

NEW STRATEGIC FOCUS

        On May 8, 2008, we announced a new strategic focus (our "New Strategic Focus") on developing products targeted towards specialty central nervous system ("CNS") disorders. We also announced our intention to rationalize our manufacturing operations, pharmaceutical sciences operations, and general and administrative expenses. In addition, we announced our intention to commence a share repurchase program of up to 14,000,000 common shares.

Acquisition of Prestwick

        On September 16, 2008, we acquired 100% of Prestwick for a total net purchase price of approximately $102.0 million (as described in note 3 to the unaudited consolidated financial statements for the interim period ended September 30, 2008). The acquisition of Prestwick was accounted for as a business combination under the purchase method of accounting. Accordingly, the results of Prestwick's operations have been included in our consolidated financial statements since September 16, 2008.

        Prestwick holds the Canadian and U.S. licensing rights to tetrabenazine tablets (known as Xenazine® in the U.S. and Nitoman® in Canada). Prestwick acquired those licensing rights from Cambridge Laboratories (Ireland) Ltd. ("Cambridge"), the worldwide license holder of tetrabenazine. On August 15, 2008, a New Drug Application ("NDA") for Xenazine® received FDA approval for the treatment of chorea associated with Huntington's disease and was granted Orphan Drug designation by the FDA, which provides this product with seven years of market exclusivity in the U.S. Nitoman® has been available in Canada since 1996.

        Xenazine® will be commercialized in the U.S. by Ovation Pharmaceuticals, Inc. ("Ovation") under an exclusive supply and marketing agreement entered into between Prestwick and Ovation prior to our acquisition of Prestwick. Ovation paid Prestwick $50.0 million for the exclusive rights to market and distribute Xenazine® for an initial term of 15 years. We will supply Xenazine® product to Ovation for a variable percentage of Ovation's annual net sales of the product. For annual net sales up to $125 million, our supply price will be 72% of net sales. Beyond $125 million, our supply price will be 65% of net sales. At both tiers, we will acquire Xenazine® product from Cambridge at a supply price of 50% of Ovation's net sales. In addition, Prestwick held options to develop future related products with Ovation for the U.S. market in conjunction with Cambridge.

Restructuring

        The following table summarizes the major components of the restructuring costs recognized in the third quarter and first nine months of 2008:

 
   
   
  Employee Termination
Benefits
  Operating
Lease
Obligation
   
   
 
 
  Asset Impairments   Contract
Termination
and Other
Costs
   
 
($ in 000s)
  Puerto Rico   Ireland   Puerto Rico   Ireland   Bridgewater   Total  

Balance, January 1, 2008

  $   $   $   $   $   $   $  

Costs incurred and charged to expense

    42,275     9,000     275             210     51,760  

Cash payments

                        (210 )   (210 )

Non-cash adjustments

    (42,275 )   (9,000 )                   (51,275 )
                               

Balance, June 30, 2008

            275                 275  
                               

Costs incurred and charged to expense

        242     1,718     2,896     2,533     198     7,587  

Cash payments

                        (198 )   (198 )

Non-cash adjustments

        (242 )       (65 )   (769 )       (1,076 )
                               

Balance, September 30, 2008

  $   $   $ 1,993   $ 2,831   $ 1,764   $   $ 6,588  
                               

34



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Puerto Rico Manufacturing Facilities

        In May 2008, we announced our intention to close our two Puerto Rico manufacturing facilities, and transfer certain manufacturing processes to our Steinbach, Manitoba facility, over a period of 18 to 24 months (the "shutdown period"). We believe the closure of the Puerto Rico facilities will reduce our cost infrastructure and improve the capacity utilization of our manufacturing operations.

        We conducted an impairment review of the property, plant and equipment located in Puerto Rico to determine if the carrying value of those assets was recoverable based on the expected cash flows from their remaining use during the shutdown period and their eventual disposition. That review indicated that the cash flows were not sufficient to recover the carrying value of the property, plant and equipment, and, as a result, an impairment charge of $42.3 million was required in the second quarter of 2008 to write down the carrying value of those assets to their estimated fair value. Fair value was determined based on market values for comparable assets.

        We also expect to incur employee termination costs of approximately $9.6 million for severance and related benefits payable to the approximately 255 employees who will be terminated as a result of the planned closure of the Puerto Rico facilities. Those employees will be required to provide service during the shutdown period in order to be eligible for termination benefits. Accordingly, we will recognize the cost of those employee termination benefits ratably over the required future service period, including $1.7 million and $2.0 million recognized in the third quarter and first nine months of 2008, respectively.

Ireland Research and Development Facility

        As part of our plans to rationalize our pharmaceutical sciences operations, we have decided to close our research and development facility in Dublin, Ireland. As a result, we recorded impairment charges of $242,000 and $9.2 million in the third quarter and first nine months of 2008, respectively, to write down the carrying value of the building and equipment located in Ireland to their estimated fair value. Fair value was determined based on market values for comparable assets. We have initiated a program to locate a buyer for the Ireland facility and expect to complete a sale transaction within the next 12 months subject to market conditions.

        In August 2008, we concluded a 30-day consultation process with an employee representative group to discuss matters associated with the closure of the Ireland facility, including support for the approximately 50 employees who would be affected by this closure. Based on the outcome of that consultation process, we recognized costs related to employee terminations of $2.9 million in the third quarter of 2008. The termination of the affected employees and closure of the Ireland facility is expected to be completed prior to the end of 2008.

Bridgewater Facility

        In connection with the May 2005 restructuring of our U.S. commercial operations, we vacated a portion of our Bridgewater, New Jersey facility. We recognized a restructuring charge at that time for a gross operating lease obligation related to the vacant space offset by estimated sublease rentals that could be reasonably obtained. Our evaluation of general economic and commercial real estate market conditions indicated that an additional charge of $2.5 million was required in the third quarter of 2008 to reflect lower estimated future sublease rentals, based on the expected time required to locate and contract a suitable sublease and the expected market rates for such a sublease.

Sale of Non-Core Assets

        We have identified certain non-core assets for divestiture including our equity investments in Depomed Inc. ("Depomed") and Financière Verdi ("Verdi"). In the third quarter of 2008, we realized a gain of $4.2 million on the sale of 2,326,394 common shares of Depomed for cash proceeds of $9.7 million. In October 2008, we received cash proceeds of $1.2 million on the sale of a further 556,943 common shares of Depomed. Subject to

35



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


market conditions, we intend to dispose of our remaining 1,519,171 common shares of Depomed within the next 12 months. Those remaining shares had an estimated fair value of $3.3 million as of October 31, 2008.

        In the second quarter of 2008, we sold our entire investment in common shares and convertible debt of Verdi for cash proceeds of $12.2 million, resulting in a gain on disposal of $3.5 million.

        In addition, we have received a conditional offer to purchase a vacant parcel of land adjacent to our corporate office with a carrying value of $1.1 million. We expect to complete the sale of this property prior to the end of 2008, subject to satisfaction of the closing conditions.

Share Repurchase Program

        In the second quarter of 2008, we repurchased a total of 2,318,400 common shares under our share repurchase program, at a weighted-average price of $11.01 per share, for total consideration of $25.5 million. The excess of the cost of the common shares repurchased over their assigned value totaled $4.1 million. Since the second quarter of 2008, we have not repurchased any additional common shares; however, we intend to resume purchases in the fourth quarter of 2008. The share repurchase program will terminate on June 1, 2009, or upon such earlier time that we complete our purchases.

        The terms of our credit facility require lenders' consent for share repurchases in excess of $50 million in the aggregate per calendar year. To date, we have not requested or obtained such consent from the lenders.

OUTLOOK

        We are currently reviewing procurement levels and practices and the structure of our support functions to ensure they are appropriately aligned with our Company's size and revenue base. We also remain focused on the resolution of legacy litigation matters, many of which have been resolved in the current year.

        Over the next several quarters, our ongoing and planned efficiency initiatives are expected to result in additional charges to earnings as our Company repositions itself. Cumulatively, these charges, including $56.8 million recorded in the first nine months of 2008, are expected to be in the range of $80 million to $100 million, of which the cash component is expected to be $30 million to $40 million. We anticipate that these efficiency initiatives, including the closures of our Puerto Rico and Ireland facilities, once fully implemented, will result in annual savings of $30 million to $40 million.

        We expect to record period-over-period declines in sales of our existing portfolio of products for the next several quarters, mainly as a result of the introduction of generic competition to the 150mg Wellbutrin XL® product on May 30, 2008. We do not anticipate any meaningful contribution from our product-development pipeline until the 2010-2011 timeframe. We expect the acquisition of Prestwick to be accretive to both earnings per share and cash flows in 2009 based on our expectation that Ovation will launch Xenazine® in the U.S. prior to the end of 2008.

        We continue to target an investment of over $600 million in research and development through 2012, targeting unmet medical needs in specialty CNS markets. In this regard, business development efforts to in-license or acquire products targeting specialty CNS markets are active with a number of U.S. and international companies.

CHANGES IN DIRECTORS AND OFFICERS

        At our reconvened 2008 annual meeting of shareholders held on August 8, 2008, the following new members were elected to our Board of Directors: Serge Gouin, Chairman of Quebecor Media Inc.; David Laidley, retired partner and former Chairman of Deloitte & Touche Canada; Spencer Lanthier, retired partner and former Chairman and Chief Executive of KPMG Canada; Mark Parrish, President of the International Association of Pharmaceutical Wholesalers and Senior Advisor, Frazer Healthcare Ventures; and Robert Power,

36



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


former Executive Vice-President of Global Business Operations of Wyeth. In addition, Dr. Douglas Squires, Laurence Paul, Lloyd Segal, Michael Van Every, and William Wells were re-elected to our Board of Directors at the reconvened meeting of shareholders.

        Following the 2008 annual meeting of shareholders, the independent members of our Board of Directors appointed Mr. Lanthier as Lead Director.

        Effective May 1, 2008, our Board of Directors appointed Dr. Squires as Chairman of the Board of Directors. Dr. Squires was previously our Interim Chairman and CEO. Also effective May 1, 2008, our Board of Directors appointed Mr. Wells as our new CEO. Mr. Wells joined our Board of Directors in 2005, and had been Lead Director since June 30, 2007. As CEO, Mr. Wells remains on our Board of Directors. Consistent with our historical practice and our Company's corporate, operational and tax structure, Mr. Wells, as our key decision maker, will be based in Barbados, where he will also serve as President of Biovail Laboratories International SRL, our Company's principal operating subsidiary.

        Effective September 3, 2008, Margaret Mulligan, FCA was appointed as our new Chief Financial Officer ("CFO"). Mrs. Mulligan succeeds Adrian de Saldanha, who had served as our Interim CFO since March 24, 2008.

        On November 6, 2008, we announced the appointment of Dr. Christian Fibiger to the newly created role of Chief Scientific Officer ("CSO"). As CSO, Dr. Fibiger will be based in Barbados and will oversee the development of our Company's product pipeline.

GOVERNMENTAL AND REGULATORY INQUIRIES

DOJ Agreement

        On May 16, 2008, we announced that a subsidiary of our Company, had reached an agreement with the DOJ in respect of criminal allegations related to activities surrounding the 2003 commercial launch of Cardizem® LA. In particular, the allegations relate to prior management's actions in 2002 and 2003 in respect of the Cardizem® LA clinical experience program, titled P.L.A.C.E. (Proving L.A. Through Clinical Experience). The agreement eliminates any criminal liability for Biovail Corporation and its subsidiaries, other than Biovail Pharmaceuticals LLC arising from this matter.

        Under the terms of the agreement, Biovail Pharmaceuticals, Inc. (now Biovail Pharmaceuticals LLC) would plead guilty to charges relating to making payments to induce purchasing or ordering of Cardizem® LA in 2003 and would pay $24.6 million to fully settle this matter, which we accrued in the second quarter of 2008. As part of the agreement, Biovail Corporation and its subsidiaries, other than Biovail Pharmaceuticals LLC, expect to receive full releases for all matters related to the DOJ's investigation. The agreement is subject to approval at a Court hearing that is expected to take place in December 2008.

SEC Consent Decree

        On March 24, 2008, we announced we had reached a settlement with the SEC in respect of an investigation of our Company and certain former officers. The investigation related to specific accounting and financial disclosure practices, as previously disclosed, that occurred between 2001 and 2003 and resulted in a civil complaint filed by the SEC. We have entered into a Consent Decree with the SEC in which we have not admitted to the civil charges contained in the complaint; we paid $10.0 million on March 24, 2008 to fully settle this matter. As part of the settlement, we also agreed to an examination of our accounting and related functions by an independent Consultant.

        The settlement does not include four former officers who were also named in the complaint: Eugene Melnyk (then Chairman and CEO); Brian Crombie (then CFO); Kenneth Howling (then responsible for Corporate Communications, and later CFO until March 24, 2008); and John Miszuk (Vice-President, Controller

37



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


and Assistant Corporate Secretary until March 24, 2008). To our knowledge, the allegations against these individuals have not been resolved. Effective March 24, 2008, Mr. Howling and Mr. Miszuk were reassigned to different non-officer positions within our Company. Mr. Miszuk left our Company on September 30, 2008.

OSC Notice of Hearing

        On March 24, 2008, the OSC issued a Notice of Hearing against our Company and the four former officers referred to above under "SEC Consent Decree" in respect of substantially the same matters as are described in the SEC complaint. The Notice of Hearing was accompanied by a Statement of Allegations setting out OSC staff's allegations concerning certain accounting and financial disclosure items dating from 2001 to 2003. On April 16, 2008, the hearing was adjourned on consent of all parties until February 2, 2009.

OVERVIEW

 
  Three Months Ended
September 30
  Nine Months Ended
September 30
 
($ in 000s, except per share data)
  2008   2007   2008   2007  

Revenue

  $ 181,089   $ 188,890   $ 575,682   $ 638,922  

Net income

    48,437     65,867     79,524     227,510  

Basic and diluted earnings per share

  $ 0.31   $ 0.41   $ 0.50   $ 1.41  
                   

Cash dividends declared per share

  $ 0.375   $ 0.375   $ 1.125   $ 1.125  
                   

 

 
  At
September 30
2008
  At
December 31
2007
 

Cash and cash equivalents

  $ 219,005   $ 433,641  
           

Revenue

        Total revenue declined $7.8 million, or 4%, to $181.1 million in the third quarter of 2008, compared with $188.9 million in the third quarter of 2007, and declined $63.2 million, or 10%, to $575.7 million in the first nine months of 2008, compared with $638.9 million in the first nine months of 2007. A significant factor in those declines was lower revenue from Wellbutrin XL® as a result of the launch of a generic version of the 150mg product on May 30, 2008. In the third quarter of 2008, that factor was partially offset by higher quarter-over-quarter sales of Ultram® ER reflecting the impact of price increases and a change in product mix in 2008, and lower shipments in third quarter of 2007 due to a backorder situation. Also partially offsetting the decline in Wellbutrin XL® revenue in the third quarter of 2008 was the impact of higher pricing of our Legacy products, which more than offset declining prescription volumes for those products.

        In addition to the factors above, the decline in total revenue year-to-date also reflected a reduction in Cardizem® LA product sales, due to lower prescription volumes in the first nine months of 2008, and higher shipments of 120mg and 180mg strengths in the first quarter of 2007 as a result of addressing a backorder that existed at the end of 2006.

        Changes in foreign currency exchange rates increased total revenue by approximately $136,000 and $5.5 million, or 0.1% and 1.0%, in the third quarter and first nine months of 2008, respectively, compared with the corresponding periods of 2007, due to the strengthening of the Canadian dollar relative to the U.S. dollar.

38



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Results of Operations

        Net income declined $17.4 million, or 26%, to $48.4 million (basic and diluted earnings per share of $0.31) in the third quarter of 2008, compared with $65.9 million (basic and diluted earnings per share of $0.41) in the third quarter of 2007, and net income declined $148.0 million, or 65%, to $79.5 million (basic and diluted earnings per share of $0.50) in the first nine months of 2008, compared with $227.5 million (basic and diluted earnings per share of $1.41) in the first nine months of 2007.

        The following table displays specific items that impacted net income in the third quarters and first nine months of 2008 and 2007, and the impact of those items (individually and in the aggregate) on basic and diluted earnings per share ("EPS"). EPS figures may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
 
  2008   2007   2008   2007  
($ in 000s, except per share data; Income (Expense))
  Amount   EPS Impact   Amount   EPS Impact   Amount   EPS Impact   Amount   EPS Impact  

Restructuring costs

  $ (7,587 ) $ (0.05 ) $ 820   $ 0.01   $ (59,347 ) $ (0.37 ) $ (712 ) $  

Legal settlements

    (2,000 ) $ (0.01 )   (2,062 ) $ (0.01 )   (26,648 ) $ (0.17 )   (2,062 ) $ (0.01 )

Gain on disposal of investments

    4,156   $ 0.03       $     7,617   $ 0.05     15,716   $ 0.10  

Proxy contest costs

    (728 ) $       $     (6,142 ) $ (0.04 )     $  

Management succession costs

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

Loss on impairment of investments

    (1,223 ) $ (0.01 )     $     (5,328 ) $ (0.03 )     $  

Equity loss

      $     (432 ) $     (1,195 ) $ (0.01 )   (1,325 ) $ (0.01 )

Loss on early extinguishment of debt

      $       $       $     (12,463 ) $ (0.08 )

Contract recoveries

      $     123   $       $     1,735   $ 0.01  
                                   

Total

  $ (7,382 ) $ (0.05 ) $ (1,551 ) $ (0.01 ) $ (97,095 ) $ (0.61 ) $ 889   $ 0.01  
                                   

Cash Dividends

        Cash dividends declared per share were $0.375 in each of the first three quarters of 2008 and 2007. In November 2008, our Board of Directors declared a quarterly cash dividend of $0.375 per share, payable on January 5, 2009. Upon payment of this dividend, we will have distributed $4.50 per share to our shareholders since implementing our dividend program in December 2005.

Financial Condition

        At September 30, 2008 and December 31, 2007, we had cash and cash equivalents of $219.0 million and $433.6 million, respectively, and there were no borrowings outstanding under our $250 million credit facility, or other long-term debt. The decline in cash and cash equivalents was primarily related to the following amounts paid during the first nine months of 2008:

39



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

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 third quarters and first nine months of 2008 and 2007; the percentage of each source of revenue compared with total revenue in the respective period; and the dollar and percentage change in the dollar amount of each source of revenue. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
($ in 000s)
  2008   2007   Change   2008   2007   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Product sales

    170,530     94     178,321     94     (7,791 )   (4 )   543,110     94     607,089     95     (63,979 )   (11 )

Research and development

    5,465     3     6,237     3     (772 )   (12 )   18,522     3     18,456     3     66      

Royalty and other

    5,094     3     4,332     2     762     18     14,050     2     13,377     2     673     5  
                                                       

    181,089     100     188,890     100     (7,801 )   (4 )   575,682     100     638,922     100     (63,240 )   (10 )
                                                   

Product Sales

        The following table displays product sales by internal reporting category in the third quarters and first nine months of 2008 and 2007; the percentage of each category compared with total product sales in the respective period; and the dollar and percentage changes in the dollar amount of each category. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
($ in 000s)
  2008   2007   Change   2008   2007   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Wellbutrin XL®

    16,587     10     53,516     30     (36,929 )   (69 )   105,863     19     167,969     28     (62,106 )   (37 )

Ultram® ER

    20,837     12     13,765     8     7,072     51     64,107     12     63,346     10     761     1  

Nitoman®

    466                 466     NM     466                 466     NM  

Zovirax®

    32,767     19     31,017     17     1,750     6     107,422     20     103,517     17     3,905     4  

Biovail Pharmaceuticals Canada

    18,246     11     14,654     8     3,592     25     52,899     10     42,551     7     10,348     24  

Cardizem® LA

    13,191     8     14,429     8     (1,238 )   (9 )   33,883     6     61,064     10     (27,181 )   (45 )

Legacy

    42,139     25     30,606     17     11,533     38     115,477     21     101,163     17     14,314     14  

Generic

    25,669     15     20,334     11     5,335     26     61,836     11     67,479     11     (5,643 )   (8 )

Glumetza® (U.S.)

    628                 628     NM     1,157                 1,157     NM  
                                                       

    170,530     100     178,321     100     (7,791 )   (4 )   543,110     100     607,089     100     (63,979 )   (11 )
                                                   

NM — Not meaningful

Wholesaler Inventory Levels

        Three drug wholesale customers account for the majority of our Zovirax® and off-patent branded pharmaceutical (Legacy) product sales in the U.S. Our distribution agreements with those 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 September 30, 2008, those wholesalers owned overall 1.2 months of supply of our products

40



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


(compared with 1.5 months at December 31, 2007), of which only $197,000 of inventory had less than 12 months remaining shelf life.

 
   
  At September 30, 2008   At December 31, 2007  
($ 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   $ 12,608     1.2   $ 103   $ 15,863     1.5   $ 93  

Cardizem®

    36-48     7,530     1.2     22     8,437     1.6     12  

Ativan®

    24     2,399     1.1     66     2,425     1.0     9  

Vasotec® and Vaseretic®

    24     2,085     1.4     5     1,705     1.2     17  

Isordil®

    36-60     229     1.3     1     376     2.4     4  
                                     

Total

    24-60   $ 24,851     1.2   $ 197   $ 28,806     1.5   $ 135  
                               

Wellbutrin XL®

        Wellbutrin XL® product sales declined $36.9 million, or 69%, to $16.6 million in the third quarter of 2008, compared with $53.5 million in the third quarter of 2007, and declined $62.1 million, or 37%, to $105.9 million in the first nine months of 2008, compared with $168.0 million in the first nine months of 2007. Those declines reflected the adverse impact on volumes resulting from the introduction of generic competition to the 150mg product on May 30, 2008, as well as the continuing generic erosion of the 300mg product. Those factors were partially offset by the positive effect on our supply prices for the 300mg and 150mg products of price increases implemented by GSK over the last 12 months.

        As a result of the introduction of generic competition to the 150mg product, GSK total sales of Wellbutrin XL® are not expected to meet the sales dollar-threshold to increase our supply price above the first tier in 2008, or thereafter.

Ultram® ER

        Ultram® ER product sales increased $7.1 million, or 51%, to $20.8 million in the third quarter of 2008, compared with $13.8 million in the third quarter of 2007, and increased $761,000, or 1%, to $64.1 million in the first nine months of 2008, compared with $63.3 million in the first nine months of 2007. Those increases reflected the positive effect on our supply price of price increases implemented by OMI over the last 12 months and a change in prescription mix from the 100mg product to the higher 200mg and 300mg strengths. In addition, Ultram® ER product sales in the third quarter of 2007 were negatively impacted by the backorder of certain lots. Those factors were partially offset by lower sales of sample supplies to OMI in the third quarter and first nine months of 2008.

        Effective January 1, 2009, our contractual supply price to OMI (which is determined based on a percentage of OMI's net selling price for Ultram® ER) will decline by 2.5 percentage points.

        Par Pharmaceuticals Companies, Inc. ("Par") is seeking FDA approval for 100mg, 200mg and 300mg generic versions of Ultram® ER (as described in note 19 to the unaudited consolidated financial statements for the interim period ended September 30, 2008). Patent infringement trial proceedings are expected to commence in January 2009. In our view, 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 second quarter of 2009, at the earliest, should Par obtain FDA approval of its generic formulation and should it decide to launch at risk pending appeal.

41



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Nitoman®

        In the period following our acquisition of Prestwick on September 16, 2008, we recognized $466,000 of revenue related to Nitoman® product sales in Canada.

Zovirax®

        Zovirax® product sales increased $1.8 million, or 6%, to $32.8 million in the third quarter of 2008, compared with $31.0 million in the third quarter of 2007, and increased $3.9 million, or 4%, to $107.4 million in the first nine months of 2008, compared with $103.5 million in the first nine months of 2007. Those increases reflected price increases implemented for these products over the last 12 months, which more than offset lower prescription volumes.

BPC

        Sales of BPC products increased $3.6 million, or 25%, to $18.2 million in the third quarter of 2008, compared with $14.7 million in the third quarter of 2007, and increased $10.3 million, or 24%, to $52.9 million in the first nine months of 2008, compared with $42.6 million in the first nine months of 2007. Excluding the positive effect on our Canadian dollar-denominated revenue of the strengthening of the Canadian dollar relative to the U.S. dollar, BPC product sales increased 24% and 15% in the third quarter and first nine months of 2008, respectively, compared with corresponding periods of 2007. Those increases reflected that higher sales of our promoted Wellbutrin® XL, Tiazac® XC, Ralivia™ (launched in November 2007) and Glumetza® products more than offset lower sales of our genericized Tiazac® and Wellbutrin® SR products.

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. That amortization amounted to $3.8 million and $11.3 million in each of the third quarters and first nine months of 2008 and 2007, respectively.

        Revenue from sales of Cardizem® LA declined $1.2 million, or 9%, to $13.2 million in the third quarter of 2008, compared with $14.4 million in the third quarter of 2007, and declined $27.2 million, or 45%, to $33.9 million in the first nine months of 2008, compared with $61.1 million in the first nine months of 2007. Those declines reflected lower prescription volumes in the third quarter and first nine months of 2008, and higher shipments of 120mg and 180mg Cardizem® LA products to Kos in the first quarter of 2007 as a result of addressing the backorder for those strengths that existed at the end of 2006. Those factors were partially offset by the positive effect on our supply price of price increases implemented by Kos over the last 12 months.

        Under the terms of a settlement agreement entered into in December 2007, Watson Pharmaceuticals, Inc. may commence the marketing and sales of a generic version of Cardizem® LA no earlier than April 1, 2009, at which time royalty payments to us will begin.

Legacy

        Sales of Legacy products increased $11.5 million, or 38%, to $42.1 million in the third quarter of 2008, compared with $30.6 million in the third quarter of 2007, and increased $14.3 million, or 14%, to $115.5 million in the first nine months of 2008, compared with $101.2 million in the first nine months of 2007. Those increases reflected price increases implemented for these products (other than Tiazac®) over the last 12 months that more than offset declining prescription volumes.

        In June 2008, we received notice that Sun Pharmaceutical Industries, Ltd., India ("Sun India") is seeking FDA approval for generic versions of Cardizem® CD (as described in note 19 to the unaudited consolidated

42



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


financial statements for the interim period ended September 30, 2008), including the 360mg strength which currently is not subject to generic competition. There are currently no unexpired patents listed against our 360mg Cardizem® CD product listed in the FDA's Orange Book database. FDA approval of Sun India's 360mg product could have a material adverse impact on the overall sales of our Cardizem® CD branded product, and on the carrying value of the intangible asset associated with the Cardizem® trademark.

Generic

        Sales of Generic products increased $5.3 million, or 26%, to $25.7 million in the third quarter of 2008, compared with $20.3 million in the third quarter of 2007, due mainly to the recognition of a $4.5 million adjustment made by Teva in the third quarter of 2008 to reduce its chargeback provision related to past sales of our Generic products. Despite the recognition of that amount in the third quarter of 2008, sales of Generic products declined $5.6 million, or 8%, to $61.8 million in the first nine months of 2008, compared with $67.5 million in the first nine months of 2007, primarily due to lower prescription volumes and pricing for these products because of increased competition and changes in Teva's customer base.

Glumetza® (U.S.)

        In the third quarter and first nine months of 2008, we recognized revenue of $628,000 and $1.2 million, respectively, related to our initial supply of 1000mg Glumetza® product and samples to Depomed for the U.S. market.

Research and Development Revenue

        Research and development revenue from clinical research and laboratory testing services provided to external customers by our contract research division declined $772,000, or 12%, to $5.5 million in the third quarter of 2008, compared with $6.2 million in the third quarter of 2007, and increased $2.0 million, or 12%, to $18.5 million in the first nine months of 2008, compared with $16.5 million in the first nine months of 2007. Research and development revenue in the first nine months of 2007 included $1.9 million from Kos related to development activities completed on Vasocard™ prior to the termination of that project.

Royalty and Other Revenue

        Royalties from third parties on sales of products we developed or acquired and other revenue increased $762,000, or 18%, to $5.1 million in the third quarter of 2008, compared with $4.3 million in the third quarter of 2007, and increased $673,000, or 5%, to $14.1 million in the first nine months of 2008, compared with $13.4 million in the first nine months of 2007.

Operating Expenses

        The following table displays the dollar amount of each operating expense category in the third quarters and first nine months of 2008 and 2007; the percentage of each category compared with total revenue in the

43



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


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

 
  Three Months Ended September 30   Nine Months Ended September 30  
($ in 000s)
  2008   2007   Change   2008   2007   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Cost of goods sold

    47,468     26     50,458     27     (2,990 )   (6 )   145,080     25     161,408     25     (16,328 )   (10 )

Research and development

    18,668     10     30,674     16     (12,006 )   (39 )   76,759     13     88,843     14     (12,084 )   (14 )

Selling, general and administrative

    44,661     25     33,660     18     11,001     33     144,891     25     129,583     20     15,308     12  

Amortization of intangible assets

    12,342     7     11,979     6     363     3     35,727     6     35,942     6     (215 )   (1 )

Restructuring costs (recovery)

    7,587     4     (820 )       8,407     NM     59,347     10     712         58,635     NM  

Legal settlements

    2,000     1     2,062     1     (62 )   (3 )   26,648     5     2,062         24,586     NM  

Contract recoveries

            (123 )       123     (100 )           (1,735 )       1,735     (100 )
                                                       

    132,726     73     127,890     68     4,836     4     488,452     85     416,815     65     71,637     17  
                                                   

NM — Not meaningful

Cost of Goods Sold and Gross Margins

        Gross margins based on product sales were 72% in each of the third quarters of 2008 and 2007 and 73% in each of the first nine months of 2008 and 2007. The following factors had an unfavourable impact on gross margins in the third quarter and first nine months of 2008, compared with the corresponding periods of 2007:

        Those factors were offset by:

44



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Research and Development Expenses

        The following table displays the dollar amount of each research and development expense category for the third quarters and first nine months of 2008 and 2007; the percentage of each category compared with total revenue in the respective period; and the percentage changes in the dollar amount of each category. Percentages may not add due to rounding.

 
  Three Months Ended September 30   Nine Months Ended September 30  
($ in 000s)
  2008   2007   Change   2008   2007   Change  
 
  $   %   $   %   $   %   $   %   $   %   $   %  

Internal research and development

    13,141     7     25,773     14     (12,632 )   (49 )   59,359     10     75,857     12     (16,498 )   (22 )

Contract research services provided to external customers

    5,527     3     4,901     3     626     13     17,400     3     12,986     2     4,414     34  
                                                       

Total research and development expenses

    18,668     10     30,674     16     (12,006 )   (39 )   76,759     13     88,843     14     (12,084 )   (14 )
                                                   

        Internal research and development expenses declined $12.6 million, or 49%, to $13.1 million in the third quarter of 2008, compared with $25.8 million in the third quarter of 2007, and declined $16.5 million, or 22%, to $59.4 million in the first nine months of 2008, compared with $75.9 million in the first nine months of 2007. Those declines reflected reduced direct project spending as we are currently in the process of reviewing and optimizing the projects in our development portfolio to reflect our New Strategic Focus on specialty CNS products. Those declines also reflected the cost of clinical trial and scale-up activities conducted in the third quarter and first nine months of 2007 related to Aplenzin™ and the BVF-146 program.

        On April 23, 2008, the FDA approved our NDA for Aplenzin™ (formerly known as BVF-033) for the treatment of depression. Aplenzin™ is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. We are currently reviewing our commercial options for Aplenzin™ including ongoing discussions with potential commercialization partners.

        The BVF-146 program was terminated in March 2008 following a reassessment of the commercial opportunity for a once-daily combination product consisting of tramadol and a non-steroidal anti-inflammatory drug. In the first quarter of 2008, we accrued $7.9 million for the estimated contractual obligations to wind down and close out a long-term safety study that was underway for BVF-146. Those obligations primarily consisted of fees and other costs that we are contractually obligated to pay to the contract research organization and investigators conducting this study. We expect to substantially settle those obligations prior to the end of 2008. The anticipated findings from this study were determined to have no alternative future use in other identifiable projects.

        In the first nine months of 2008, we filed Abbreviated New Drug Applications for BVF-065 (venlafaxine) for the treatment of depression and BVF-203 (fenofibrate) for the treatment of high cholesterol. As previously disclosed, we terminated the BVF-239 program (for the treatment of a cardiovascular disease) as a consequence of our New Strategic Focus.

        Costs associated with providing contract research services to external customers increased $626,000, or 13%, to $5.5 million in the third quarter of 2008, compared with $4.9 million in the third quarter of 2007, and increased $4.4 million, or 34%, to $17.4 million in the first nine months of 2008, compared with $13.0 million in the first nine months of 2007. Those increases reflected a higher volume of clinical research and laboratory testing services provided to external customers by our contract research division, as well as unabsorbed overhead costs at that division due to the decline in activity related to internal product-development programs.

45



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Selling, General and Administrative Expenses

        Selling, general and administrative expenses increased $11.0 million, or 33%, to $44.7 million in the third quarter of 2008, compared with $33.7 million in the third quarter of 2007, and increased $15.3 million, or 12%, to $144.9 million in the first nine months of 2008, compared with $129.6 million in the first nine months of 2007, primarily due to:

        Those factors were partially offset by:

        The aforementioned proxy contest costs were incurred in connection with the contested election of our nominees to the Board of Directors at our 2008 annual meeting of shareholders.

        The aforementioned management succession costs were associated with the contractual obligations related to Dr. Squires ceasing to serve as our CEO and the ensuing appointment of Mr. Wells to that role, as well as previously unrecognized compensation expense in the amount of $2.1 million recognized upon the cancellation in May 2008 of certain stock options and RSUs previously granted to Dr. Squires.

        Legal costs comprised a significant portion of our selling, general and administrative expenses in the periods presented. In the third quarter and first nine months of 2008, those costs amounted to $10.8 million and

46



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


$26.8 million respectively, compared with $8.0 million and $36.8 million, respectively, in the corresponding periods of 2007. Legal costs in the third quarter and first nine months of 2007 were reported net of insurance recoveries of $5.4 million and $12.6 million, respectively. Legal costs included amounts related to matters we do not consider to be in the ordinary course of business, such as the S.A.C. complaint; governmental and regulatory inquiries; securities class actions; and defamation claims (as described in note 19 to the unaudited consolidated financial statements for the interim period ended September 30, 2008). As we have settled the SEC investigation and the U.S. and Canadian securities class action complaints, and have entered into an agreement in principle to settle the DOJ investigation in respect of the Cardizem® LA clinical experience program, we do not expect to incur additional significant legal costs related to those matters. However, we may continue to incur considerable legal costs related to new litigation proceedings and to the remaining unresolved legacy matters (including the cost of legal representation of certain former officers and directors pursuant to indemnification agreements) for an indefinite period, as we cannot predict the outcome or timing of when each of those matters may be resolved. In addition, we have exhausted our Director and Officer liability insurance for claims related to the litigation and regulatory matters in respect of our 2002 to 2004 policy period.

Amortization Expense

        Amortization expense increased $363,000, or 3%, to $12.3 million in the third quarter of 2008, compared with $12.0 million in the third quarter of 2007, and declined $215,000, or 1%, to $35.7 million in the first nine months of 2008, compared with $35.9 million in the first nine months of 2007. In the third quarter and first nine months of 2008, amortization expense reflected the amortization of Prestwick's identifiable intangible assets in the period following our acquisition of Prestwick on September 16, 2008, offset by reduced amortization related to certain intangible assets written-down in December 2007.

Restructuring Costs

        In the third quarter and first nine months of 2008, we incurred restructuring charges of $7.6 million and $59.3 million, respectively, as described above under "New Strategic Focus — Restructuring".

Legal Settlements

        In the third quarter and first nine months of 2008, we recorded charges for potential legal settlements of $2.0 million and $26.6 million, respectively, of which $24.6 million related to the agreement in principle to settle with the DOJ (as described above under "Governmental and Regulatory Inquiries — DOJ Agreement").

Non-Operating Items

Interest Income and Expense

        Interest income declined $2.0 million, or 53%, to $1.8 million in the third quarter of 2008, compared with $3.8 million in the third quarter of 2007, and declined $11.0 million, or 56%, to $8.7 million in the first nine months of 2008, compared with $19.6 million in the first nine months of 2007, reflecting a decline in our cash balances following the redemption of our 77/8% Senior Subordinated Notes ("Notes") effective April 1, 2007 and legal settlement and other payments made in the first nine months of 2008, together with lower prevailing interest rates.

        Interest expense declined $8.7 million, or 92%, to $724,000 in the first nine months of 2008, compared with $9.4 million in the first nine months of 2007. Interest expense in the first nine months of 2007 was mainly comprised of interest on our Notes prior to April 1, 2007.

47



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Foreign Exchange Gain or Loss

        We recognized a foreign exchange gain of $204,000 and a foreign exchange loss of $1.1 million in the third quarter and first nine months of 2008, respectively. In September 2007, the Canadian dollar was trading at a then 30-year high relative to the U.S. dollar, which contributed to foreign exchange gains of $5.3 million and $5.7 million recognized in the third quarter and first nine months of 2007, respectively.

Equity Loss

        We recorded equity losses of $1.2 million in the first nine months of 2008, and $432,000 and $1.3 million in the third quarter and first nine months of 2007, respectively, related to our investment in Western Life Sciences ("WLS"). As of the end of the first quarter of 2008, our cumulative share of the net losses of WLS exceeded our investment; as we are not committed to make further capital contributions to WLS, we did not recognize any additional equity losses related to this investment in the third quarter of 2008.

Gain on Disposal of Investments

        In the third quarter of 2008, we recognized a gain of $4.2 million on the sale of a portion of our investment in common shares of Depomed and, in the second quarter of 2008, we recognized a gain of $3.5 million on the disposal of our investment in common shares and convertible debt of Verdi (as described above under "New Strategic Focus — Sale of Non-Core Assets").

        In the second quarter of 2007, we recorded a gain of $15.7 million (net of costs) on the sale to Verdi of a portion of our investment in common shares of Ethypharm S.A. ("Ethypharm"). We received proceeds on disposal of $39.4 million in cash and $5.6 million in convertible bonds of Verdi. We exchanged the remaining portion of our Ethypharm investment for common shares of Verdi.

Loss on Impairment of Investments

        In the third quarter and first nine months of 2008, we recorded losses of $1.2 million and $5.3 million, respectively, related primarily 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").

Loss on Early Extinguishment of Debt

        In the second quarter of 2007, we recorded a charge of $12.5 million on the early redemption of our Notes, which included a premium paid to Noteholders of $7.9 million.

Provision for Income Taxes

        We recorded provisions for income taxes of $4.6 million and $15.6 million in the third quarter and first nine months of 2008, respectively, compared with $3.5 million and $12.5 million, respectively, in the corresponding periods of 2007. Those provisions reflect the fact that most of our income was derived from a foreign subsidiary with lower statutory tax rates than those that apply in Canada. The increase in the effective tax rates in the third quarter and first nine months of 2008, compared with the corresponding periods of 2007, was primarily due to the charges associated with the agreement in principle to settle the DOJ investigation (as described above under "Governmental and Regulatory Inquiries — DOJ Agreement") and restructuring activities (as described above under "New Strategic Focus — Restructuring") that are not deductible or do not affect the income tax provision because of unrecognized tax losses in the local jurisdictions. In addition, certain components of the provision for income taxes do not vary with pre-tax income, including withholding taxes and provisions for uncertain tax positions.

48



BIOVAIL CORPORATION

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:

 
  2008   2007   2006  
($ in 000s, except per share data)
  Q3   Q2   Q1   Q4   Q3   Q2   Q1   Q4  

Revenue

  $ 181,089   $ 186,095   $ 208,498   $ 203,896   $ 188,890   $ 203,027   $ 247,005   $ 307,648  

Expenses

    132,726     210,368     145,358     237,989     127,890     140,567     148,358     188,045  
                                   

Operating income (loss)

    48,363     (24,273 )   63,140     (34,093 )   61,000     62,460     98,647     119,603  
                                   

Net income (loss)

    48,437     (25,289 )   56,376     (31,971 )   65,867     67,824     93,819     117,976  
                                   

Basic and diluted earnings (loss) per share

  $ 0.31   $ (0.16 ) $ 0.35   $ (0.20 ) $ 0.41   $ 0.42   $ 0.58   $ 0.74  
                                   

Net cash provided by (used in) operating activities

  $ (62,370 ) $ 67,056   $ 92,676   $ 79,333   $ 43,415   $ 98,277   $ 119,828   $ 235,637  
                                   

Third Quarter of 2008 Compared To Second Quarter of 2008

Revenue

        Total revenue declined $5.0 million, or 3%, to $181.1 million in the third quarter of 2008, compared with $186.1 million in the second quarter of 2008, primarily due to the decline in Wellbutrin XL® product sales as a result of the introduction of generic competition to the 150mg product on May 30, 2008.

Results of Operations

        Net income increased $73.7 million to $48.4 million in the third quarter of 2008, compared with a net loss of $25.3 million in the second quarter of 2008, primarily due to:

        Those factors were partially offset by:

Cash Flows

        Net cash provided by operating activities decreased $129.4 million, or 193%, to net cash used of $62.4 million in the third quarter of 2008, compared with net cash provided of $67.1 million in the second quarter of 2008, primarily due to payments made in the third quarter of 2008 of $83.0 million to fund the U.S. securities class action and $45.1 million to GSK to settle the Wellbutrin XL® contract costs.

49



BIOVAIL CORPORATION

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 September 30, 2008 and December 31, 2007:

($ in 000s)
  At
September 30
2008
  At
December 31
2007
 

Working capital(1)

  $ 227,781   $ 339,439  

Long-lived assets(2)

    1,013,623     969,265  

Shareholders' equity

    1,163,886     1,297,819  

(1)
Total current assets less total current liabilities.

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

Working Capital

        Working capital declined $111.7 million, or 33%, to $227.8 million at September 30, 2008, compared with $339.4 million at December 31, 2007, primarily due to:

        Those factors were partially offset by:


Long-Lived Assets

        Long-lived assets increased $44.4 million, or 5%, to $1,013.6 million at September 30, 2008, compared with $969.3 million at December 31, 2007, primarily due to:

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

        Those factors were partially offset by:

Shareholders' Equity

        Shareholders' equity declined $133.9 million, or 10%, to $1,163.9 million at September 30, 2008, compared with $1,297.8 million at December 31, 2007, primarily due to:

        Those factors were partially offset by:

CASH FLOWS

        The following table displays cash flow information for the third quarters and first nine months of 2008 and 2007:

 
  Three Months Ended
September
  Nine Months Ended
September 30
 
($ in 000s)
  2008   2007   2008   2007  

Net cash provided by (used in) operating activities

  $ (62,370 ) $ 43,415   $ 97,362   $ 261,520  

Net cash used in investing activities

    (12,816 )   (41,214 )   (105,299 )   (16,542 )

Net cash used in financing activities

    (59,549 )   (59,881 )   (206,007 )   (668,212 )

Effect of exchange rate changes on cash and cash equivalents

    (316 )   128     (692 )   600  
                   

Net decrease in cash and cash equivalents

    (135,051 )   (57,552 )   (214,636 )   (422,634 )

Cash and cash equivalents, beginning of period

    354,056     469,458     433,641     834,540  
                   

Cash and cash equivalents, end of period

  $ 219,005   $ 411,906   $ 219,005   $ 411,906  
                   

51



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Operating Activities

        Net cash provided by operating activities declined $105.8 million, or 244%, to net cash used of $62.4 million in the third quarter of 2008, compared with net cash provided of $43.4 million in the third quarter of 2007, primarily due to:

        That factor was partially offset by:

        Net cash provided by operating activities declined $164.2 million, or 63%, to $97.4 million in the first nine months of 2008, compared with $261.5 million in the first nine months of 2007, primarily due to:

        Those factors were partially offset by:

Investing Activities

        Net cash used in investing activities declined $28.4 million, or 69%, to $12.8 million in the third quarter of 2008, compared with $41.2 million in the third quarter of 2007, primarily due to:

52



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

        Those factors were partially offset by:

        Net cash used in investing activities increased $88.8 million, or 537%, to $105.3 million in the first nine months of 2008, compared with $16.5 million in the first nine months of 2007, primarily due to:

        Those factors were partially offset by:

Financing Activities

        Net cash used in financing activities declined $332,000, or 1%, to $59.5 million in the third quarter of 2008, compared with $59.9 million in the third quarter of 2007, primarily due to a reduction in cash dividends as a result of the repurchase of a portion of our common shares under our share repurchase program (as described above under "New Strategic Focus — Share Repurchase Program").

        Net cash used in financing activities declined $462.2 million, or 69%, to $206.0 million in the first nine months of 2008, compared with $668.2 million in the first nine months of 2007, primarily due to:

        Those factors were partially offset by:

53



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

LIQUIDITY AND CAPITAL RESOURCES

($ in 000s)
  At
September 30
2008
  At
December 31
2007
 

Financial assets

             

Cash and cash equivalents

  $ 219,005   $ 433,641  

Short-term investment

    7,578      

Marketable securities

    23,141     28,312  
           

Total financial assets

  $ 249,724   $ 461,953  
           

        We had no long-term debt at September 30, 2008 or December 31, 2007.

General

        We believe that our existing cash resources, together with cash expected to be generated by operations and from the potential sale of non-core assets (as described above under "New Strategic Focus — Sale of Non-Core Assets"), as well as funds available under our undrawn $250 million credit facility, will be sufficient to meet our operational and capital expenditure requirements; support our current 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 $25 million in 2008. Major projects in 2008 include the expansion of our corporate office (now complete), the construction of a new facility in Barbados (now occupied), and ongoing upgrades to our manufacturing facilities.

        We cannot, however, predict the amount or timing of our need for additional funds under various circumstances, such as a significant future acquisition; 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 or equity securities. In addition, certain contingent events, such as the resolution of certain legal proceedings (as described in note 19 to the unaudited consolidated financial statements for the interim period ended September 30, 2008), if realized, could have a material adverse impact on our liquidity and capital resources. The credit and capital markets have experienced unprecedented deterioration in 2008, including the failure of a number of significant and established financial institutions in the U.S. and abroad, all of which will have an impact on the availability of credit and capital in the near term. Accordingly, it is recognized that those existing market conditions may limit our access to additional funding at any reasonable rate.

Cash and Cash Equivalents

        Our cash and cash equivalents are held in cash operating accounts, or are invested in securities such as treasury bills, money market funds, term deposits, or commercial paper with a minimum investment-grade credit rating of "A1/P1".

Short-Term Investment

        We have classified our remaining investment in common shares of Depomed as a short-term investment based on our intent to dispose of those shares within the next 12 months (as described above under "New Strategic Focus — Sale of Non-Core Assets").

54



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. These securities have long-term maturities for which the interest rates are reset through a dutch auction typically each month. Those auctions historically have provided a liquid market for these securities. These securities represent interests in collateralized debt obligations supported by pools of residential and commercial mortgages or credit cards, insurance securitizations, and other structured credits, including corporate bonds. Some of the underlying collateral for these securities consists of sub-prime mortgages. With the liquidity issues experienced in global credit and capital markets, these securities have experienced multiple failed auctions as the amount of auction rate securities submitted for sale has exceeded the amount of purchase orders.

        The estimated fair values of the auction rate securities at September 30, 2008 and December 31, 2007 were $12.5 million and $18.0 million, respectively, which reflected write-downs of $14.3 million and $8.8 million, respectively, to the cost bases at those dates. Although these securities continue to pay interest according to their stated terms, we recorded impairment charges of $4.2 million in the first nine months of 2008 and $6.0 million in 2007, reflecting the portion of the auction rate securities that we have concluded has an other-than-temporary decline in estimated fair value due to a shortfall in the underlying collateral value for those securities. Those charges did not have a material impact on our liquidity.

        In addition, we recorded unrealized losses in other comprehensive income of $1.3 million in the first nine months of 2008 and $2.8 million in 2007, 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 this decline in estimated fair to be other-than-temporary based on the adequacy of the underlying collateral value for those securities. In addition, it is our intent to hold those securities until a recovery in market value occurs (or until maturity if necessary), and based on our existing cash resources, together with cash expected to be generated by operations, we do not expect to be required to sell those securities at a loss.

        Due to the lack of observable market quotes for the auction rate securities, we utilized valuation models based on unobservable inputs in order to estimate the fair value of these securities at September 30, 2008 and December 31, 2007, including models that consider the expected cash flow streams, and collateral values as reported in the Trustee Reports for the respective securities, which include adjustments for defaulted securities and further adjustments for purposes of collateralization tests as outlined in Trust Indentures. The key assumptions used in those models relate to the timing of cash flows, discount rates, estimated amount of recovery, and probabilities assigned to various liquidation scenarios. The valuation of the auction rate securities is subject to uncertainties that are difficult to predict. Factors that may impact our valuation include changes to the credit ratings of these securities, the underlying assets supporting these securities, the rates of default of the underlying assets, the underlying collateral value, and overall market liquidity.

        The credit and capital markets may continue to deteriorate in during the last quarter of 2008 and into 2009. If uncertainties in these markets continue, 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, financial condition and cash flows. We have discontinued additional investments in auction rate securities.

Debt Capacity

        We currently do not have any outstanding borrowings under our $250 million committed credit facility. In June 2007, we received lender consent, pursuant to our request under the annual extension option, to extend the maturity date of this facility for an additional year to June 2010. This facility may be used for general corporate purposes, including acquisitions. This facility includes an accordion feature which allows it to be increased up to $400 million; however, in the current global credit environment, it is not expected that this feature would be

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


available at any reasonable terms. At September 30, 2008, we were in compliance with all financial and non-financial covenants associated with this facility.

Credit Ratings

        On September 23, 2008, Standard and Poor's lowered our corporate credit rating from "BB" to "BB-" and our bank loan rating from "BBB-" to "BB+" with stable outlook, citing concerns that our New Strategic Focus and rationalization of our operations will involve a long time frame, significant investments and high execution risk, and that our share repurchase program could weaken our liquidity.

CONTRACTUAL OBLIGATIONS

        As a result of the termination of our exclusive promotional services agreement with Sciele on October 10, 2008 (as described above under "Company Profile"), we are no longer obligated to pay Sciele the annual fee that would have otherwise been due under the terms of that agreement in fiscal years 2009 through 2011. With that exception, there have been no 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 2007 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 2007 Form 20-F.

OUTSTANDING SHARE DATA

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

        At October 31, 2008, we had 158,716,777 issued and outstanding common shares, as well as 4,625,468 stock options and 236,124 RSUs outstanding.

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.

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 or euros. We also face foreign currency exposure on the translation of our operations in Canada and Ireland from their local currencies to the U.S. dollar. Where possible, we manage foreign currency risk by managing same currency assets in relation to same currency liabilities, and same currency revenue in relation to same currency expenses. As a result, both favourable and unfavourable foreign currency impacts to our non-U.S. dollar-denominated operating expenses are mitigated to a certain extent by the natural, opposite impact on our

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


non-U.S. dollar-denominated revenue. At September 30, 2008, the effect of a hypothetical 10% immediate and adverse change in foreign currency exchange rates (relative to the U.S. dollar) on our foreign currency-denominated cash, cash equivalent, accounts receivable, accounts payable, and intercompany balances would not have a material impact on our net income. Currently, we do not utilize forward contracts to hedge against foreign currency risk.

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 reset of the interest rates, 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 do not currently have any long-term debt, nor do we currently utilize interest rate swap contracts to hedge against interest rate risk.

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 September 30, 2008, 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 those 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").

ADDITIONAL RISK FACTORS

        Investment in our common shares involves a degree of risk. The following risk factors and the risk factors set out under the heading "Risk Factors" in the 2007 Form 20-F should be carefully considered before any investment is made. These risk factors are some of the key risk factors generally associated with our business. However, the risk factors outlined below and in the 2007 Form 20-F are not the only ones that we face. Additional risks not currently known to us or that we currently deem immaterial may also impair our business operations.

New Strategic Focus

        Under our New Strategic Focus, we anticipate investing over $600 million in research and development in the 2008-2012 timeframe, which includes in-licensing and milestone payments, but excludes acquisition costs (as in the Prestwick transaction). Such investment is for the exploration of niche in-licensed and new chemical entities ("NCEs"), new indications and in-house reformulation opportunities in the specialty CNS market. Our

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


success in implementing this New Strategic Focus is subject to a number of risks, including: our ability to develop a commercial expertise in specialty neurology; our ability to develop in-house research and development expertise in specialty neurology; our ability to build and develop the necessary expertise to identify, evaluate and acquire high priority compounds; and our ability to successfully commercialize any CNS compounds that we develop or acquire. Over the next few years, if we are unable to commercialize new CNS products successfully, there could be a material adverse effect on our business, financial condition and results of operations and it could cause the market value of our common shares to decline.

        The failure to successfully implement our New Strategic Focus, or parts of it, including our ability to realize the projected benefits of cost-reduction initiatives, may have an adverse impact on our business, financial condition and results of operations and could cause the market value of our common shares to decline.

Closure of our Puerto Rico Facilities

        As part of our New Strategic Focus, we are consolidating our manufacturing resources through the closure of our two Puerto Rico manufacturing facilities and the transfer of certain manufacturing processes to our Steinbach, Manitoba facility. If we experience a delay in transitioning such manufacturing processes to Steinbach, or if we experience other disruptions or issues in transitioning these manufacturing processes to Steinbach, we could fail to deliver our products in a timely manner, which could adversely affect our relationships with our customers and business partners, which, in turn, could adversely affect our business, financial condition and results of operations and could cause the market value of our common shares to decline.

Integration of Acquisitions

        Should we complete an acquisition or license or acquire specialty CNS compounds in clinical development in accordance with our New Strategic Focus, we may be unable to successfully integrate the personnel and operations of a new business or achieve the operational synergies or other benefits that we had anticipated. Moreover, we might fail to discover liabilities of a business or operating or other problems prior to completing a transaction. We could experience adverse accounting and financial consequences, such as the need to make large provisions against the acquired assets or to write down acquired assets. We might also experience a dilutive effect on our earnings. Depending on how any such transaction is structured, there may be an adverse impact on our capital structure and on our ability to pay dividends in accordance with our current dividend policy. Further, an acquisition could disrupt our ongoing business, distract our management and employees or lead to increased expenses.

        On September 16, 2008, we acquired Prestwick, a privately-held, U.S.-based pharmaceutical company that holds the Canadian and U.S. licensing rights to tetrabenazine tablets (known as Xenazine® in the U.S. and Nitoman® in Canada), a drug used in the treatment of chorea associated with Huntington's disease. In addition to the integration risks noted above, there are a number of risks associated with this acquisition, which include, but are not limited to the following:

        If we are unable to successfully integrate the operations and manage these risks, the anticipated benefits of this acquisition may not be realized and we may experience material adverse consequences to our business, financial condition and results of operations.

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Deterioration in the Global Credit and Capital Markets

        The credit and capital markets have experienced unprecedented deterioration in 2008, including the failure of a number of significant and established financial institutions in the U.S and abroad, all of which will have an impact on the availability of credit and capital in the near term. If uncertainties in these markets continue, or these markets deteriorate further, it could have a material adverse impact on our liquidity and capital resources.

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 2007 Form 20-F.

RECENT ACCOUNTING PRONOUNCEMENTS

Adoption of New Accounting Standards

        Effective January 1, 2008, we adopted Financial Accounting Standards Board ("FASB") Statement of Financial Accounting Standards ("SFAS") No. 157, "Fair Value Measurements" ("SFAS 157") for financial assets and financial liabilities. 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. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (i.e., an exit price). In determining fair value, we use various valuation techniques. SFAS 157 establishes a hierarchy for inputs to valuation techniques used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that reflect assumptions market participants would use in pricing the asset or liability developed based on market data obtained from independent sources. Unobservable inputs are inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. To the extent that the valuation technique is based on inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. The adoption of SFAS 157 for financial assets and financial liabilities did not have a material effect on our consolidated financial statements, or result in any significant changes to our valuation techniques or key considerations used in valuations.

        In October 2008, the FASB issued FASB Staff Position ("FSP") No. FAS 157-3, "Determining the Fair Value of a Financial Asset When the Market for That Asset Is Not Active" ("FSP 157-3"), which clarifies the application of SFAS 157 in a market that is not active. FSP 157-3 was effective for us at September 30, 2008. The effect of the adoption of FSP 157-3 on our consolidated financial statements was not material.

        Effective January 1, 2008, we adopted SFAS No. 159, "The Fair Value Option for Financial Assets and Financial Liabilities" ("SFAS 159"). SFAS 159 provides companies with an option to report many financial instruments and certain other items at fair value. We elected the fair value option for available-for-sale securities owned by Western Life Sciences ("WLS"), our equity method investee, in order to conform to the classification of those investments as trading securities by WLS. At January 1, 2008, the cumulative effect of the adoption of SFAS 159 resulted in the reclassification of an unrealized holding gain on those investments of $2.3 million from

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BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


accumulated other comprehensive income to opening deficit. We did not elect the fair value option for any other eligible financial assets and financial liabilities that were not previously recorded at fair value.

        Emerging Issues Task Force ("EITF") Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities" ("EITF 07-3"), became effective for new contracts entered into on or after January 1, 2008. Under EITF 07-3, non-refundable advance payments for goods and services that will be used in future research and development activities should be recognized as an expense as the goods are delivered or the services are performed rather than when the payment is made. The adoption of EITF Issue No. 07-3 did not have any impact on our consolidated financial statements.

Recently Issued Accounting Standards, Not Adopted as of September 30, 2008

        In June 2008, the FASB issued SFAS No. 162, "The Hierarchy of Generally Accepted Accounting Principles" ("SFAS 162"). SFAS 162 indentifies the sources of accounting principles and the framework for selecting the principles used in the preparation of financial statements presented in conformity with U.S. GAAP. This Statement is effective 60 days following the SEC's approval of the Public Company Accounting Oversight Board amendments to AU Section 411, "The Meaning of Present Fairly in Conformity with Generally Accepted Accounting Principles". The adoption of SFAS 162 is not expected to have any impact on our consolidated financial statements.

        In April 2008, the FASB issued FSP No. FAS 142-3, "Determination of the Useful Life of Intangible Assets" ("FSP 142-3"). FSP 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 142-3 is effective for fiscal years beginning after December 15, 2008. Early adoption is prohibited. Accordingly, we are required to apply the guidance of FSP 142-3 for determining useful life to intangible assets acquired on or after January 1, 2009 and the disclosure requirements of FSP 142-3 to intangible assets recognized as of or after January 1, 2009.

        In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133" ("SFAS 161"). SFAS 161 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. SFAS 161 is effective for fiscal years beginning after December 15, 2008, with early adoption permitted. Accordingly, we are required to adopt the disclosure requirements of this standard beginning January 1, 2009.

        In February 2008, the FASB issued FSP No. FAS 157-2, "Effective Date of FASB Statement No. 157", which defers the effective date of SFAS 157 for one year for certain nonfinancial assets and liabilities, except those that are recognized or disclosed at fair value on a recurring basis (at least annually). Accordingly, we are required to adopt SFAS 157 beginning January 1, 2009 for nonfinancial assets and liabilities. We are currently evaluating the effect that the adoption of SFAS 157 for nonfinancial assets and liabilities will have on our consolidated financial statements.

        In December 2007, the EITF issued EITF Issue No. 07-1, "Accounting for Collaborative Arrangements" ("EITF 07-1"). 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 fiscal years beginning after December 15, 2008, and is required to be applied retrospectively to all prior periods

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MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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


where collaborative arrangements existed as of the effective date. Accordingly, we are required to adopt EITF 07-1 beginning January 1, 2009. We are currently evaluating the effect that the adoption of EITF 07-1 will have on our consolidated financial statements.

        In December 2007, the FASB issued SFAS No. 141(R), "Business Combinations" ("SFAS 141R") and SFAS 160, "Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51" ("SFAS 160"). These standards 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 and SFAS 160 are required to be adopted simultaneously, and are effective for fiscal years beginning after December 15, 2008. Early adoption is prohibited. Accordingly, we are required to adopt SFAS 141R for business combinations occurring on or after January 1, 2009. As we currently have no minority interests, the adoption of SFAS 160 beginning January 1, 2009 is not expected to have a material effect on our consolidated financial statements.

UNRESOLVED SEC STAFF COMMENTS

        On May 2, 2008, we were advised by the staff of the SEC that they had completed their review of our 2007 Form 20-F.

OSC CONTINUOUS DISCLOSURE REVIEW

        On July 18, 2008, we were advised that the OSC's Corporate Finance Branch had completed its most recent review of our continuous disclosure record.

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 September 30, 2008 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 SEPTEMBER 30, 2008


PART II — OTHER INFORMATION

1.     LEGAL PROCEEDINGS

2.     EXHIBITS

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BIOVAIL CORPORATION
FORM 6-K
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2008


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: November 7, 2008

 

By:

 

/s/ MARGARET MULLIGAN

Margaret Mulligan
Chief Financial Officer

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QuickLinks

BIOVAIL CORPORATION FORM 6-K FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2008
INDEX
BASIS OF PRESENTATION
FORWARD-LOOKING STATEMENTS
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)
BIOVAIL CORPORATION CONSOLIDATED STATEMENTS OF INCOME 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)
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)
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)
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)
BIOVAIL CORPORATION MANAGEMENT'S DISCUSSION AND ANALYSIS (All dollar amounts are expressed in U.S. dollars)
PART II — OTHER INFORMATION
SIGNATURES