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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 March 31, 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 MARCH 31, 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 March 31, 2008 and December 31, 2007   1
  Consolidated Statements of Income for the three months ended March 31, 2008 and 2007   2
  Consolidated Statements of Deficit for the three months ended March 31, 2008 and 2007   3
  Consolidated Statements of Cash Flows for the three months ended March 31, 2008 and 2007   4
  Condensed Notes to the Consolidated Financial Statements   5
Management's Discussion and Analysis of Results of Operations and Financial Condition   24

Part II — Other Information
Legal Proceedings   45
Exhibits   45
 



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™, 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 ("GSK") and are used by us under license. ULTRAM® is a trademark of Ortho-McNeil, Inc. ("OMI") and is 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.

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FORWARD-LOOKING STATEMENTS

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

        To the extent any statements made in this Form 6-K contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information within the meaning defined under applicable Canadian securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, strategies, beliefs, intentions, plans, estimates and outlook, including, without limitation, statements concerning the commercialization strategy in the U.S., the focus on research and development, the intent and ability to make changes to our strategies, intent and ability to implement and effectively execute plans associated with our new strategic focus, the timing of the closure of our Puerto Rico operations, our manufacturing ability, the timing of the launch of a generic version of the 150mg strength of Wellbutrin XL®, the tiered supply price to be received by GSK for Wellbutrin XL®, the supply price to be received by OMI for Ultram® ER, the availability of benefits under tax treaties, the timing, results and progress of our development efforts, the anticipated manufacturing and commercializing of all pipeline products that are successfully developed, including select products in global markets, the intent and ability to make future dividend payments, the intent to commence a normal course issuer bid and to repurchase our common shares, the expected finalization of supply contracts, the intent and timing of the liquidation of our auction rate securities, the expected results of certain litigation and regulatory proceedings and the outcome, amount and timing of the potential settlement of certain of these proceedings, the estimation of the amount of the U.S. securities class action settlement and the amount that our insurance carriers will pay, the availability of Director and Officer liability insurance as a result of the settlement of certain litigation, the anticipated amount of premiums to be paid in respect of Director and Officer liability insurance, the outcome of the U.S. Securities and Exchange Commission ("SEC") staff reviews of our Annual Report on Form 20-F for the fiscal year ended December 31, 2007, filed on March 17, 2008 (the "2007 Form 20-F"), and amended Annual Report on Form 20-F/A for the fiscal year ended December 31, 2006, filed on May 23, 2007, and the outcome of the continuous disclosure review by the Corporate Finance Branch of the Ontario Securities Commission. 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; the resolution of insurance claims relating to certain litigation and regulatory proceedings; 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 satisfaction of applicable laws for dividend payments, market liquidity for our common shares and our satisfaction of applicable laws for the acquisition of our common shares, reliance on key strategic alliances, our eligibility for benefits under tax treaties, the availability of raw materials and finished products, the regulatory environment, the results of the upcoming U.S. presidential election, the unpredictability of protection afforded by our patents, the mix of activities 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 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 our auction rate securities held as

ii



investments, the outcome of the anticipated proxy contest in connection with the election of the Board of Directors at our upcoming shareholders' meeting, and other risks detailed from time to time in our filings with the SEC 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, and 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.

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BIOVAIL CORPORATION

CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

 
  At
March 31 2008

  At
December 31 2007

 
ASSETS              
Current              
Cash and cash equivalents   $ 431,537   $ 433,641  
Short-term investments     79,725      
Marketable securities     1,502     3,895  
Accounts receivable     82,386     111,114  
Insurance recoveries receivable     61,898     62,942  
Inventories     67,427     80,745  
Prepaid expenses and other current assets     10,741     14,680  
   
 
 
      735,216     707,017  
Marketable securities     23,758     24,417  
Long-term investments     23,637     24,834  
Property, plant and equipment, net     233,799     238,457  
Intangible assets, net     616,526     630,514  
Goodwill     100,294     100,294  
Deferred tax assets, net of valuation allowance     18,000     20,700  
Other long-term assets, net     38,506     35,882  
   
 
 
    $ 1,789,736   $ 1,782,115  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 39,332   $ 50,415  
Dividends payable     60,384      
Accrued liabilities     71,695     74,363  
Accrued legal settlements     138,000     148,000  
Accrued contract costs     45,065     45,065  
Income taxes payable     3,766     647  
Deferred revenue     31,983     49,088  
   
 
 
      390,225     367,578  
Deferred revenue     51,185     55,653  
Income taxes payable     50,800     54,100  
Other long-term liabilities     6,902     6,965  
   
 
 
      499,112     484,296  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares, no par value, unlimited shares authorized, 161,023,729 issued and outstanding at March 31, 2008 and December 31, 2007     1,489,807     1,489,807  
Additional paid-in capital     25,482     23,925  
Deficit     (280,288 )   (278,495 )
Accumulated other comprehensive income     55,623     62,582  
   
 
 
      1,290,624     1,297,819  
   
 
 
    $ 1,789,736   $ 1,782,115  
   
 
 

Commitments and contingencies (note 11)

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
March 31

 
 
  2008
  2007
 
REVENUE              
Product sales   $ 196,914   $ 238,002  
Research and development     7,353     4,841  
Royalty and other     4,231     4,162  
   
 
 
      208,498     247,005  
   
 
 

EXPENSES

 

 

 

 

 

 

 
Cost of goods sold (exclusive of amortization shown separately below)     53,735     56,416  
Research and development     36,332     29,722  
Selling, general and administrative     43,597     49,594  
Amortization     11,694     11,981  
Restructuring costs         645  
   
 
 
      145,358     148,358  
   
 
 
Operating income     63,140     98,647  
Interest income     3,468     9,761  
Interest expense     (242 )   (8,677 )
Foreign exchange gain (loss)     221     (288 )
Equity loss     (1,195 )   (424 )
Loss on impairment of investments     (3,616 )    
   
 
 
Income before provision for income taxes     61,776     99,019  
Provision for income taxes     5,400     5,200  
   
 
 
Net income   $ 56,376   $ 93,819  
   
 
 
Basic and diluted earnings per share   $ 0.35   $ 0.58  
   
 
 
Basic and diluted weighted average number of common shares outstanding (000s)     161,024     160,458  
   
 
 
Cash dividends declared per share   $ 0.375   $ 0.375  
   
 
 

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
March 31

 
 
  2008
  2007
 
Deficit, beginning of period   $ (278,495 ) $ (232,733 )
Cumulative effect of adoption of SFAS 159     2,343      
Net income     56,376     93,819  
Cash dividends declared and dividend equivalents     (60,512 )   (60,205 )
   
 
 
Deficit, end of period   $ (280,288 ) $ (199,119 )
   
 
 

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 March 31
 
 
  2008
  2007
 
CASH FLOWS FROM OPERATING ACTIVITIES              
Net income   $ 56,376   $ 93,819  

Adjustments to reconcile net income to net cash provided by operating activities

 

 

 

 

 

 

 
Depreciation and amortization     25,073     21,885  
Amortization of deferred financing costs     130     531  
Amortization of discounts on long-term obligations         201  
Accrued legal settlements     (10,000 )    
Impairment charges     3,616      
Stock-based compensation     1,429     4,226  
Equity loss     1,195     424  
Other     568     696  
Changes in operating assets and liabilities:              
  Accounts receivable     28,520     15,680  
  Insurance recoveries receivable     1,045      
  Inventories     11,764     (1,049 )
  Prepaid expenses and other current assets     3,937     4,178  
  Accounts payable     (9,236 )   (1,724 )
  Accrued liabilities     (2,687 )   (1,554 )
  Income taxes payable     2,518     (3,100 )
  Deferred revenue     (21,572 )   (14,385 )
   
 
 
Net cash provided by operating activities     92,676     119,828  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Addition to short-term investments     (79,725 )    
Additions to property, plant and equipment, net     (9,678 )   (5,712 )
Addition to restricted assets     (4,900 )    
Proceeds from sales and maturities of marketable securities     2,950     314  
Additions to marketable securities     (2,926 )   (332 )
   
 
 
Net cash used in investing activities     (94,279 )   (5,730 )
   
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 
Repayment of deferred compensation obligation, net     (138 )   (246 )
Cash dividends paid         (80,222 )
Issuance of common shares         1,974  
   
 
 
Net cash used in financing activities     (138 )   (78,494 )
   
 
 

Effect of exchange rate changes on cash and cash equivalents

 

 

(363

)

 

31

 
   
 
 
Net increase (decrease) in cash and cash equivalents     (2,104 )   35,635  
Cash and cash equivalents, beginning of period     433,641     834,540  
   
 
 
Cash and cash equivalents, end of period   $ 431,537   $ 870,175  
   
 
 

NON-CASH FINANCING ACTIVITIES

 

 

 

 

 

 

 
Cash dividends declared but unpaid   $ 60,384   $ 60,205  
   
 
 

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


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

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

Level 3 — Unobservable inputs for the asset or liability.

6


3.     FAIR VALUE OF FINANCIAL INSTRUMENTS

7


 
  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   $ 369,022   $ 356,094   $ 12,928   $
Available-for-sale equity securities     15,079     15,079        
Auction rate securities     14,774             14,774
   
 
 
 
Total financial assets   $ 398,875   $ 371,173   $ 12,928   $ 14,774
   
 
 
 
Cash and cash equivalents   $ 278,811   $ 276,369   $ 2,442   $
Short-term investments     79,725     79,725        
Marketable securities     25,260         10,486     14,774
Long-term investments     15,079     15,079        
   
 
 
 
Total financial assets   $ 398,875   $ 371,173   $ 12,928   $ 14,774
   
 
 
 
 
  Auction Rate
Securities

 
Balance at January 1, 2008   $ 18,000  
Total unrealized losses:        
  Included in loss on impairment of investments     (2,920 )
  Included in other comprehensive income     (256 )
Settlements     (50 )
   
 
Balance at March 31, 2008   $ 14,774  
   
 
Total amount of unrealized losses for the period included in net income relating to securities still held at March 31, 2008   $ (2,920 )
   
 

8


9


4.     INVENTORIES

 
  At
March 31
2008

  At
December 31
2007

Raw materials   $ 26,438   $ 32,577
Work in process     14,320     14,748
Finished goods     26,669     33,420
   
 
    $ 67,427   $ 80,745
   
 

5.     INTANGIBLE ASSETS

 
  At March 31, 2008
  At December 31, 2007
 
  Cost
  Accumulated
Amortization

  Cost
  Accumulated
Amortization

Trademarks   $ 573,751   $ 184,479   $ 573,751   $ 177,210
Product rights     344,929     125,875     344,929     119,402
Technology     14,800     6,600     14,800     6,354
   
 
 
 
      933,480   $ 316,954     933,480   $ 302,966
         
       
Less accumulated amortization     316,954           302,966      
   
       
     
    $ 616,526         $ 630,514      
   
       
     

10


 
  Three Months Ended
March 31

 
  2008
  2007
Royalty and other revenue   $ 268   $ 268
Cost of goods sold     2,026     2,026
Amortization expense     11,694     11,981
   
 
    $ 13,988   $ 14,275
   
 

6.     RESTRICTED ASSETS

7.     STOCK-BASED COMPENSATION

 
  Three Months Ended
March 31

 
  2008
  2007
Stock options   $ 1,252   $ 4,226
RSUs     177    
   
 
Stock-based compensation expense   $ 1,429   $ 4,226
   
 
Cost of goods sold   $ 122   $ 325
Research and development expenses     214     672
Selling, general and administrative expenses     1,093     3,229
   
 
Stock-based compensation expense   $ 1,429   $ 4,226
   
 

11


 
  Options
(000s)

  Weighted-Average
Exercise Price

  Weighted-Average
Remaining
Contractual
Term (Years)

  Aggregate
Intrinsic
Value

Outstanding at January 1, 2008   5,256   $ 23.02          
Expired or forfeited   (507 )   28.24          
   
               
Outstanding at March 31, 2008   4,749   $ 22.46   2.6   $
   
 
 
 
Vested and exercisable at March 31, 2008   3,657   $ 22.33   2.3   $
   
 
 
 
 
  RSUs (000s)
  Weighted-Average
Grant-Date
Fair Value

Outstanding at January 1, 2008   125   $ 20.18
Granted   217     13.26
Reinvested dividend equivalents   12     10.92
Forfeited   (5 )   13.26
   
     
Outstanding at March 31, 2008   349   $ 15.66
   
 

8.     INCOME TAXES

12


9.     EARNINGS PER SHARE

 
  Three Months Ended
March 31

 
  2008
  2007
Net income   $ 56,376   $ 93,819
   
 
Basic weighted average number of common shares outstanding (000s)     161,024     160,458
   
 
Dilutive effect of stock options and RSUs (000s)        
   
 
Diluted weighted average number of common shares outstanding (000s)     161,024     160,458
   
 
Basic and diluted earnings per share   $ 0.35   $ 0.58
   
 

10.     COMPREHENSIVE INCOME

 
  Three Months Ended
March 31

 
 
  2008
  2007
 
Net income   $ 56,376   $ 93,819  
   
 
 

Comprehensive income

 

 

 

 

 

 

 
Foreign currency translation adjustment     (5,419 )   1,531  
Net unrealized holding gain (loss) on available-for-sale securities     803     (1,134 )
Cumulative effect of adoption of SFAS 159     (2,343 )    
   
 
 
Other comprehensive income (loss)     (6,959 )   397  
   
 
 
Comprehensive income   $ 49,417   $ 94,216  
   
 
 

11.   LEGAL PROCEEDINGS

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)

11.   LEGAL PROCEEDINGS (Continued)

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15


16


17


18


19


20


21


22


12.   SEGMENT INFORMATION

13.   SUBSEQUENT EVENT

23


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 March 31, 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.

        The discussion and analysis contained in this MD&A are as of May 12, 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 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:

24


        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; the resolution of insurance claims relating to certain litigation and regulatory proceedings; 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 of capital and satisfaction of applicable laws for dividend payments, market liquidity for our common shares and our satisfaction of applicable laws for the acquisition of our common shares, reliance on key strategic alliances, our eligibility for benefits under tax treaties, the availability of raw materials and finished products, the regulatory environment, the results of the upcoming U.S. presidential election, 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 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 our auction rate securities held as investments, the outcome of the anticipated proxy contest in connection with the election of the Board of Directors at our upcoming shareholders' meeting, and other risks detailed from time to time in our filings with the SEC and the CSA, as well as our ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this MD&A, as well as under the heading "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:

25


        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); 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 Biovail Pharmaceuticals, Inc., and promoted by Sciele Pharma, Inc. ("Sciele") under an exclusive promotional services agreement.

        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").

STRATEGY UPDATE

        On May 8, 2008, we announced a new strategic focus on developing products targeted towards specialty central nervous system disorders such as epilepsy and Parkinson's disease. We also announced our intention to close our two Puerto Rico manufacturing facilities, and transfer certain manufacturing processes to our Steinbach, Manitoba facility, over the next 18 to 24 months. In addition, we announced our intention to commence a share repurchase program of up to 14,000,000 common shares by means of a normal course issuer bid.

CHANGES IN BOARD OF DIRECTORS AND CHIEF EXECUTIVE OFFICER

        Effective May 1, 2008, our Board of Directors appointed Dr. Douglas Squires as Chairman of the Board. Dr. Squires was previously our Interim Chairman and Chief Executive Officer ("CEO").

        Also effective May 1, 2008, our Board of Directors appointed William (Bill) 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 will remain 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 April 21, March 28, and February 25, 2008, Wilfred Bristow, Jamie Sokalsky, and Sheldon Plener, respectively, resigned from our Board of Directors. The Compensation, Nominating and Corporate Governance Committee of our Board of Directors has identified five new independent directors who will be nominated for election at our Company's forthcoming shareholders' meeting.

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, but we paid $10 million on March 24, 2008 to fully settle the 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 Chief Financial Officer ("CFO")), Kenneth Howling

26



(then responsible for Corporate Communications, and later CFO until March 24, 2008) and John Miszuk (Vice-President, Controller 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.

        Also effective March 24, 2008, Adrian de Saldanha, our Vice-President, Finance and Treasurer, was appointed Interim CFO. Mr. de Saldanha is a Chartered Accountant who joined our Company in 2001.

OSC NOTICE OF HEARING

        On March 24, 2008, the OSC issued a Notice of Hearing against our Company and the four individuals 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 disclosure items dating from 2001 to 2003. On April 16, 2008, the hearing was adjourned on consent of all parties until February 2, 2009.

OTHER RECENT DEVELOPMENTS

Aplenzin™

        On April 23, 2008, the FDA approved our New Drug Application 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. Prior to approval, Aplenzin™ had been subject to a six-month review by the FDA. That review followed our submission on October 23, 2007 of a Complete Response to address issues raised by the FDA in a Non-Approval Letter for this product dated July 19, 2007.

        We are currently reviewing our commercial options for Aplenzin™ including ongoing discussions with several potential commercialization partners; however, the delay in FDA approval has negatively impacted the commercial opportunity for Aplenzin™. Our strategy was to convert a portion of the once-daily bupropion market to Aplenzin™ before the genericization of 150mg Wellbutrin XL® occurred, which could happen commencing the earlier of May 30, 2008, or upon an adverse decision of our appeal (heard on September 5, 2007) of the non-infringement summary judgment granted to Anchen Pharmaceuticals, Inc. on August 1, 2006.

Settlement of Canadian Securities Class Action

        On April 23, 2008, we announced that our Company and the named individual defendants have entered into an agreement in principle to settle the class-action shareholder litigation in the claim brought by the Canadian Commercial Workers Industry Pension Plan. Under the terms of the settlement agreement in this matter, the parties have agreed that the sole source of compensation for the plaintiffs in the this matter will be the settlement amount of $138 million previously agreed to in the proposed settlement of the parallel U.S. securities class action, as announced by us on December 11, 2007. The settlement agreement in this matter contains no admission of wrongdoing by our Company or any of the named individual defendants, nor is our Company or any of the individual named defendants acknowledging any liability or wrongdoing by entering into this agreement.

27


OVERVIEW

 
  Three Months Ended
March 31

($ in 000s, except per share data)
  2008
  2007
Revenue   $ 208,498   $ 247,005
Net income     56,376     93,819
Basic and diluted earnings per share   $ 0.35   $ 0.58
   
 
Cash dividends declared per share   $ 0.375   $ 0.375
   
 
 
 
  At March 31 2008
  At December 31 2007
Cash, cash equivalents and short-term investments   $ 511,262   $ 433,641
   
 

Revenue

        Total revenue declined $38.5 million, or 16%, to $208.5 million in the first quarter of 2008, compared with $247.0 million in the first quarter of 2007. That decline was due mainly to lower revenue from Generic product sales, as a result of lower prescription volumes and pricing for those products in the first quarter of 2008, and a reduction in Cardizem® LA product sales, reflecting lower prescription volumes in the first quarter 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 $3.4 million, or 2%, due to the strengthening of the Canadian dollar relative to the U.S. dollar in the first quarter of 2008, compared with the first quarter of 2007.

Results of Operations

        Net income declined $37.4 million, or 40%, to $56.4 million (basic and diluted earnings per share of $0.35) in the first quarter of 2008, compared with $93.8 million (basic and diluted earnings per share of $0.58) in the first quarter of 2007, primarily due to:

        Those factors were partially offset by:

        In addition, net income in the first quarter of 2008 was impacted by a loss of $3.6 million on the impairment of investments, related primarily to an other-than-temporary decline in the fair value of a portion of our auction rate securities, and an equity loss of $1.2 million. In the first quarter of 2007, restructuring costs of $645,000 and an equity loss of $424,000 impacted net income.

28


BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Cash Dividends

        Cash dividends declared per share were $0.375 in each of the first quarters of 2008 and 2007. In May 2008, our Board of Directors declared a quarterly cash dividend of $0.375 per share.

Financial Condition

        At March 31, 2008 and December 31, 2007, we had cash, cash equivalent and short-term investments of $511.3 million and $433.6 million, respectively, and we did not have any borrowings outstanding under our $250 million credit facility, or other long-term debt.

        On April 3, 2008, we paid cash dividends of $60.4 million to our shareholders. On May 9, 2008, we paid $83.0 million to fund the settlement of the U.S. securities class action, and our insurance carriers funded the remaining $55.0 million of the settlement amount.

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 first quarters 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 March 31
 
 
  2008
  2007
  Change
 
($ in 000s)
 
  $
  %
  $
  %
  $
  %
 
Product sales   196,914   94   238,002   96   (41,088 ) (17 )
Research and development   7,353   4   4,841   2   2,512   52  
Royalty and other   4,231   2   4,162   2   69   2  
   
 
 
 
 
     
    208,498   100   247,005   100   (38,507 ) (16 )
   
 
 
 
 
 
 

29


Product Sales

        The following table displays product sales by reporting category in the first quarters 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 March 31
 
 
  2008
  2007
  Change
 
($ in 000s)
 
  $
  %
  $
  %
  $
  %
 
Wellbutrin XL®   58,856   30   61,405   26   (2,549 ) (4 )
Ultram® ER   24,104   12   30,019   13   (5,915 ) (20 )
Zovirax®   37,130   19   37,283   16   (153 )  
Biovail Pharmaceuticals Canada   16,240   8   13,826   6   2,414   17  
Cardizem® LA   10,207   5   23,949   10   (13,742 ) (57 )
Legacy   33,147   17   35,640   15   (2,493 ) (7 )
Generic   17,230   9   35,880   15   (18,650 ) (52 )
   
 
 
 
 
     
    196,914   100   238,002   100   (41,088 ) (17 )
   
 
 
 
 
 
 

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 March 31, 2008, those wholesalers owned overall 1.3 months of supply of our products (compared with 1.5 months at December 31, 2007), of which only $154,000 of inventory had less than 12 months remaining shelf life.

 
   
  At March 31, 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   $ 15,378   1.2   $ 86   $ 15,863   1.5   $ 93
Cardizem®   36-48     7,291   1.2     13     8,437   1.6     12
Vasotec® and Vaseretic®   24     2,315   1.5     39     1,705   1.2     17
Ativan®   24     2,129   1.3     11     2,425   1.0     9
Isordil®   36-60     266   1.7     5     376   2.4     4
       
     
 
     
Total   24-60   $ 27,379   1.3   $ 154   $ 28,806   1.5   $ 135
   
 
 
 
 
 
 

Wellbutrin XL®

        Despite the positive effect on our supply price for Wellbutrin XL® of price increases implemented by GSK in the last 12 months, Wellbutrin XL® product sales declined $2.5 million, or 4%, to $58.9 million in the first quarter of 2008, compared with $61.4 million in the first quarter of 2007. That decline reflected lower prescription volumes for 300mg and 150mg products in the first quarter of 2008, as well as the positive effect that a reduction in GSK's 2006 year-end provision for 300mg product returns — due to slower than anticipated generic erosion — had on our supply price in the first quarter of 2007.

30


        As described above under "Aplenzin™", we anticipate a generic version of the 150mg product could be launched commencing May 30, 2008, or potentially sooner, which is expected to have a material adverse effect on sales of that strength. In addition, 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.

Ultram® ER

        Ultram® ER product sales declined $5.9 million, or 20%, to $24.1 million in the first quarter of 2008, compared with $30.0 million the first quarter of 2007, due mainly to a reduction in inventory levels of Ultram® ER owned by OMI, and lower sales of sample supplies to OMI. Those factors were partially offset by higher prescription volumes, and the positive effect on our supply price of a price increase implemented by OMI in the first quarter of 2008.

Zovirax®

        The modest decline in Zovirax® product sales to $37.1 million in the first quarter of 2008, compared with $37.3 million in the first quarter of 2007, reflected the timing of purchases by our wholesale customers, and lower prescription volumes. Those factors were mostly offset by price increases we implemented for these products in the last 12 months.

BPC

        Sales of BPC products increased $2.4 million, or 17%, to $16.2 million in the first quarter of 2008, compared with $13.8 million in the first quarter of 2007. However, excluding the positive effect on Canadian dollar-denominated revenue of the strengthening of the Canadian dollar relative to the U.S. dollar, BPC product sales increased less than 1% in the first quarter of 2008, compared with corresponding period of 2007, reflecting that increases in sales of our promoted Wellbutrin® XL, Tiazac® XC and Ralivia™ (launched in November 2007) products, were mostly offset by declines in sales of our genericized Tiazac® and Wellbutrin® SR products.

Cardizem® LA

        Cardizem® LA product sales included 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 in each of the first quarters of 2008 and 2007.

        Our revenue from sales of Cardizem® LA declined $13.7 million, or 57%, to $10.2 million in the first quarter of 2008, compared with $23.9 million in the first quarter of 2007. That decline reflected lower prescription volumes in the first quarter 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 in the last 12 months.

Legacy

        Sales of Legacy products declined $2.5 million, or 7%, to $33.1 million in the first quarter of 2008, compared with $35.6 million in the first quarter of 2007. That decline was due mainly to lower prescription volumes for Tiazac® branded and generic products. Overall sales of our other Legacy products (excluding Tiazac®) were largely unchanged as lower prescription volumes were compensated by price increases we implemented for those products in the last 12 months.

31


Generic

        Sales of Generic products declined $18.7 million, or 52%, to $17.2 million in the first quarter of 2008, compared with $35.9 million in the first quarter of 2007, primarily due to lower prescription volumes and pricing for these products because of increased competition and changes in Teva's customer base.

Research and Development Revenue

        Research and development revenue increased $2.5 million, or 52%, to $7.4 million in the first quarter of 2008, compared with $4.8 million in the first quarter of 2007, as a result of an increase in the volume of clinical research and laboratory testing services provided to external customers by our contract research division.

Royalty and Other Revenue

        Royalties from third parties on sales of products we developed or acquired and other revenue were $4.2 million in each of the first quarters of 2008 and 2007.

OPERATING EXPENSES

        The following table displays the dollar amount of each operating expense category in the first quarters of 2008 and 2007; the percentage of each category compared with total revenue in the 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 March 31
 
 
  2008
  2007
  Change
 
($ in 000s)
 
  $
  %
  $
  %
  $
  %
 
Cost of goods sold   53,735   26   56,416   23   (2,681 ) (5 )
Research and development   36,332   17   29,722   12   6,610   22  
Selling, general and administrative   43,597   21   49,594   20   (5,997 ) (12 )
Amortization   11,694   6   11,981   5   (287 ) (2 )
Restructuring costs       645     (645 ) (100 )
   
 
 
 
 
     
    145,358   70   148,358   60   (3,000 ) (2 )
   
 
 
 
 
 
 

Cost of Goods Sold and Gross Margins

        Gross margins based on product sales were 73% and 76% in the first quarters of 2008 and 2007, respectively. The gross margin in the first quarter of 2008, compared with the first quarter of 2007, was unfavourably impacted by the following factors:

        Those factors were partially offset by:

32


Research and Development Expenses

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

 
  Three Months Ended March 31
 
  2008
  2007
  Change
($ in 000s)
  $
  %
  $
  %
  $
  %
Internal research and development   30,189   14   25,909   10   4,280   17
Contract research services provided to external customers   6,143   3   3,813   2   2,330   61
   
 
 
 
 
   
Total research and development expenses   36,332   17   29,722   12   6,610   22
   
 
 
 
 
 

        Internal research and development expenses increased $4.3 million, or 17%, to $30.2 million in the first quarter of 2008, compared with $25.9 million in the first quarter of 2007. In the first quarters of 2008 and 2007, those expenses included costs related to the BVF-146 program to develop a once-daily combination product consisting of tramadol and a non-steroidal anti-inflammatory drug. That program was terminated in March 2008 following a reassessment of the commercial opportunity for BVF-146.

        At March 31, 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 consist 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 settle those obligations over the next nine months. The anticipated findings from this study were determined to have no alternative future use in other identifiable projects.

        The $2.3 million, or 61%, increase in costs associated with providing contract research services to external customers in the first quarter of 2008, compared with the first quarter of 2007, reflected the corresponding increase in the volume of clinical research and laboratory testing services provided by our contract research division.

Selling, General and Administrative Expenses

        Selling, general and administrative expenses declined $6.0 million, or 12%, to $43.6 million in the first quarter of 2008, compared with $49.6 million in the first quarter of 2007, primarily due to:

33


        Those factors were partially offset by:

        Legal costs comprised a significant portion of our selling, general and administrative expenses in each of the first quarters of 2008 and 2007. Those 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 (as described in note 11 to the unaudited consolidated financial statements for the interim period ended March 31, 2008); governmental and regulatory inquiries; securities class actions; and defamation claims. As we have settled the SEC investigation and have entered into agreements in principle to settle the U.S. and Canadian securities class action complaints, 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 the remaining unresolved matters for an indefinite period, as we cannot predict the outcome or timing of when each of those matters may be resolved.

Amortization Expense

        Amortization expense declined $287,000, or 2%, to $11.7 million in the first quarter of 2008, compared with $12.0 million in the first quarter of 2007, reflecting the impact of intangible assets written-down in December 2007.

Restructuring Costs

        In the first quarter of 2007, we recorded costs of $645,000 associated with the December 2006 restructuring program. Costs associated with that program were substantially paid or otherwise settled during 2007.

NON-OPERATING ITEMS

Interest Income and Expense

        Interest income declined $6.3 million, or 64%, to $3.5 million in the first quarter of 2008, compared with $9.8 million in the first quarter of 2007, reflecting a decline in our cash balances following the redemption of our Notes effective April 1, 2007 and lower prevailing interest rates.

        Interest expense declined $8.4 million, or 97%, to $242,000 in the first quarter of 2008, compared with $8.7 million in the first quarter of 2007. Interest expense in the first quarter of 2007 mainly comprised interest on our Notes.

Provision for Income Taxes

        We recorded a provision for income taxes of $5.4 million in the first quarter of 2008, compared with $5.2 million in the first quarter of 2007. Our effective tax rates were 8% and 5% in the first quarters of 2008 and 2007, respectively, which reflected 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 rate in the first quarter of 2008, compared with the first quarter of 2007, was primarily due to the effect of certain components of the provision for income taxes that do not vary with pre-tax income.

34


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)
  Q1
  Q4
  Q3
  Q2
  Q1
  Q4
  Q3
  Q2
Revenue   $ 208,498   $ 203,896   $ 188,890   $ 203,027   $ 247,005   $ 307,648   $ 282,302   $ 255,143
Expenses     145,358     237,989     127,890     140,567     148,358     188,045     336,951     162,965
   
 
 
 
 
 
 
 
Operating income (loss)     63,140     (34,093 )   61,000     62,460     98,647     119,603     (54,649 )   92,178
   
 
 
 
 
 
 
 
Income (loss) from continuing operations     56,376     (31,971 )   65,867     67,824     93,819     117,976     (60,063 )   85,005
   
 
 
 
 
 
 
 
Net income (loss)     56,376     (31,971 )   65,867     67,824     93,819     117,976     (60,063 )   85,277
   
 
 
 
 
 
 
 

Basic and diluted earnings (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Income (loss) from continuing operations   $ 0.35   $ (0.20 ) $ 0.41   $ 0.42   $ 0.58   $ 0.74   $ (0.37 ) $ 0.53
Net income (loss)   $ 0.35   $ (0.20 ) $ 0.41   $ 0.42   $ 0.58   $ 0.74   $ (0.37 ) $ 0.53
   
 
 
 
 
 
 
 
Net cash provided by continuing operating activities   $ 92,676   $ 79,333   $ 43,415   $ 98,277   $ 119,828   $ 235,637   $ 81,382   $ 110,806
   
 
 
 
 
 
 
 

First Quarter of 2008 Compared To Fourth Quarter of 2007

Revenue

        Total revenue increased $4.6 million, or 2%, to $208.5 million in the first quarter of 2008, compared with $203.9 million in the fourth quarter of 2007, primarily due to:

        That factor was partially offset by:

Results of Operations

        Net income increased $88.3 million to $56.4 million in the first quarter of 2008, compared with a net loss of $32.0 million in the fourth quarter of 2007, primarily due to:

        Those factors were partially offset by:

35


BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS (Continued)

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

Cash Flows

        Net cash provided by operating activities increased $13.3 million, or 17%, to $92.7 million in the first quarter of 2008, compared with $79.3 million in the fourth quarter of 2007, primarily due to:

        Those factors were partially offset by:

FINANCIAL CONDITION

        The following table displays a summary of our financial condition at March 31, 2008 and December 31, 2007:

($ in 000s)
  At
March 31 2008

  At
December 31 2007

Working capital(1)   $ 344,991   $ 339,439
Long-lived assets(2)     950,619     969,265
Shareholders' equity     1,290,624     1,297,819
   
 

(1)
Total current assets less total current liabilities

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

Working Capital

        Working capital increased $5.6 million, or 2%, to $345.0 million at March 31, 2008, compared with $339.4 million at December 31, 2007, primarily due to:

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        Those factors were partially offset by:


Long-Lived Assets

        Long-lived assets declined $18.6 million, or 2%, to $950.6 million at March 31, 2008, compared with $969.3 million at December 31, 2007, primarily due to:

        Those factors were partially offset by:

Shareholders' Equity

        Shareholders' equity declined $7.2 million, or less than 1%, to $1,290.6 million at March 31, 2008, compared with $1,297.8 million at December 31, 2007, primarily due to:

        Those factors were partially offset by:

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CASH FLOWS

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

 
  Three Months Ended
March 31

 
($ in 000s)
  2008
  2007
 
Net cash provided by operating activities   $ 92,676   $ 119,828  
Net cash used in investing activities     (94,279 )   (5,730 )
Net cash used in financing activities     (138 )   (78,494 )
Effect of exchange rate changes on cash and cash equivalents     (363 )   31  
   
 
 
Net increase (decrease) in cash and cash equivalents     (2,104 )   35,635  
Cash and cash equivalents, beginning of period     433,641     834,540  
   
 
 
Cash and cash equivalents, end of period   $ 431,537   $ 870,175  
   
 
 

Operating Activities

        Net cash provided by continuing operating activities declined $27.2 million, or 23%, to $92.7 million in the first quarter of 2008, compared with $119.8 million in first quarter of 2007, primarily due to:

        Those factors were partially offset by:

Investing Activities

        Net cash used in investing activities increased $88.5 million to $94.3 million in the first quarter of 2008, compared with $5.7 million in the first quarter of 2007, primarily due to:

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Financing Activities

        Net cash used in financing activities declined $78.4 million to $138,000 in the first quarter of 2008, compared with $78.5 million the first quarter of 2007, primarily due to the timing of our dividend payments.

LIQUIDITY AND CAPITAL RESOURCES

($ in 000s)
  At
March 31 2008

  At
December 31 2007

Financial assets            
Cash and cash equivalents   $ 431,537   $ 433,641
Short-term investments     79,725    
Marketable securities     25,260     28,312
   
 
Total financial assets     536,522     461,953
   
 

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

General

        We believe that our existing cash resources, together with cash expected to be generated by operations and funds available under our $250 million credit facility, will be sufficient to cover our operational and capital expenditure requirements; support our current dividend policy and planned share repurchase program; 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 $30 million to $40 million in 2008 however, certain capital programs are currently under review. Major projects include the completion of the expansion of our corporate office, 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 11 to the unaudited consolidated financial statements for the interim period ended March 31, 2008), if realized, could have a material adverse impact on our liquidity and capital resources.

Cash, Cash Equivalents and Short-Term Investments

        Our cash, cash equivalents and short-term investments 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".

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.

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        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. Our auction rate securities all had "Aaa/AAA" credit ratings at the time of purchase. Prior to December 31, 2007, two of these securities with an aggregate principal amount of $6.0 million were downgraded to "A3/AAA", and one other of these securities with a principal amount of $3.0 million was downgraded to "A2/AAA". Between January 1, 2008 and March 17, 2008 (the date of filing of the 2007 Form 20-F), the two "A3/AAA" rated securities and one "A2/AAA" rated security were downgraded again to "A3/CCC" and "A2/CC", respectively. Subsequent to March 17, 2008, the two "A3/CCC" rated securities and one "A2/CC" rated security have been further downgraded to "B3/CCC" and "B2/CC", respectively. Those three securities continue to be on credit watch with negative implications. One other of our auction rate securities with a rating of "Aaa/AAA" and a principal amount of $2.8 million also continues to be on credit watch with negative implications. We have not been advised of any changes to the "Aaa/AAA" credit ratings on our remaining auction rate securities.

        The estimated fair values of our auction rate securities at March 31, 2008 and December 31, 2007 were $14.8 million and $18.0 million, respectively, which reflected write-downs of $12.0 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, based on our analysis of other-than-temporary impairment factors, we recorded impairment charges of $2.9 million in the first quarter of 2008 and $6.0 million in 2007, reflecting the portion of its auction rate securities that we have concluded has an other-than-temporary decline in estimated fair value. Those charges did not have a material impact on our liquidity. In addition, we recorded unrealized losses in other comprehensive income of $256,000 in the first quarter of 2008 and $2.8 million in 2007, reflecting adjustments to our auction rate securities that we have concluded have a temporary decline in estimated fair value.

        Due to the lack of observable market quotes for these securities, we utilized valuation models based on unobservable inputs in order to estimate the fair value of our auction rate securities at March 31, 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 our 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 2008. If uncertainties in these markets continue, or these markets deteriorate further, or we experience any additional ratings downgrades on our auction rate securities, we may incur additional impairments 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 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, and includes an accordion feature, which allows it to be increased up to $400 million. At March 31, 2008, we were in compliance with all financial and non-financial covenants associated with this facility.

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Credit Ratings

        On May 9, 2008, Standard and Poor's placed our "BB" corporate credit and "BBB-" bank loan ratings on credit watch with negative implications, 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

        There have been no material changes 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 May 8, 2008, we had 161,023,729 issued and outstanding common shares, as well as 5,535,452 stock options and 257,964 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 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 non-U.S. dollar-denominated revenue. At March 31, 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.

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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 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 cost-method and 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 March 31, 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 auction rate securities due to the current market liquidity issues (as described above under "Liquidity and Capital Resources — Auction Rate Securities").

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

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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.

        Also 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 accumulated other comprehensive income to opening retained earnings. 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 March 31, 2008

        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 fro 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 FASB Staff Position 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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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 June 18, 2007, the staff of the SEC advised us that they had reviewed the 2006 Form 20-F/A. Based on their review of that document, the staff provided comments regarding certain accounting disclosures and methods. On July 16, 2007, we provided our responses to the staff's comments. On August 15, 2007, we provided further clarification to the staff with respect to additional comments that were raised by the staff based on their review of our July 16, 2007 responses. Since August 15, 2007, we have not had any further communication with the staff in relation to this matter. Based on our responses, we incorporated certain amended disclosures into our 2007 Form 20-F.

        On April 7, 2008, the staff of the SEC advised us that they have reviewed the 2007 Form 20-F. Based on their review of that document, the staff provided comments regarding certain accounting disclosures. On April 16, 2008, we provided our responses to the staff's comments. Based on our responses, we have incorporated certain amended disclosures into the unaudited consolidated financial statements and condensed notes thereto for the interim period ended March 31, 2008, and we intend to incorporate additional disclosure items into future documents filed with the SEC.

OSC CONTINUOUS DISCLOSURE REVIEW

        On February 5, 2008, we were advised that the OSC's Corporate Finance Branch had selected our Company for a full review of its continuous disclosure record. On the basis of this review, the OSC staff raised questions regarding certain accounting disclosures and methods. On April 4, 2008, we provided our responses to the OSC staff's questions. After reviewing our responses, the OSC staff raised additional questions in a letter to us dated May 6, 2008. We are currently in the process of preparing our responses to those additional questions. The eventual outcome of this matter may result in modifications to past filings with the CSA, and/or the incorporation of additional disclosure items into future documents filed with the CSA.

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 March 31, 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 MARCH 31, 2008


PART II — OTHER INFORMATION

1.     LEGAL PROCEEDINGS

2.     EXHIBITS

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BIOVAIL CORPORATION
FORM 6-K
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 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: May 12, 2008

 

By:

/s/  
ADRIAN DE SALDANHA      
      Adrian de Saldanha
Interim Chief Financial Officer

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QuickLinks

BIOVAIL CORPORATION FORM 6-K FOR THE QUARTERLY PERIOD ENDED MARCH 31, 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)
PART II — OTHER INFORMATION
SIGNATURES