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

FORM 6-K

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

For the Quarterly Period Ended June 30, 2005

Commission File Number 001-11145

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

IIndicate 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

        This Report of Foreign Private Issuer on Form 6-K is incorporated by reference into the registration statement on Form S-8 (Registration No. 333-92229) of Biovail Corporation.


INDEX

Part I — Financial Information

 
   
Financial Statements (unaudited)    
  Consolidated Balance Sheets as at June 30, 2005 and December 31, 2004   1
  Consolidated Statements of Income for the three months and six months ended June 30, 2005 and 2004   2
  Consolidated Statements of Deficit for the three months and six months ended June 30, 2005 and 2004   3
  Consolidated Statements of Cash Flows for the six months ended June 30, 2005 and 2004   4
  Condensed Notes to the Consolidated Financial Statements   5
Management's Discussion and Analysis of Results of Operations and Financial Condition   21

Part II — Other Information
Legal Proceedings   38
Exhibits   38


BASIS OF PRESENTATION

        All dollar amounts in this report are expressed in U.S. dollars. As used in this report, unless the context otherwise indicates, the terms "we", "us", "our" and similar terms, as well as references to "Biovail" or the "Company", mean Biovail Corporation together with its subsidiaries.

        The following words are trademarks of the Company and may be registered in Canada, the United States and certain other jurisdictions: Ativan®, Biovail®, Cardisense®, Cardizem®, Cardizem® LA, CEFORM™, DrinkUp™, FlashDose®, Glumetza™, Instatab™, Isordil®, Ralivia™, Shearform™, Smartcoat™, Tiazac®, Tiazac® XC, Vasotec® and Vaseretic®. Wellbutrin®, Wellbutrin SR®, Wellbutrin XL®, Zovirax® and Zyban® are trademarks of "The GlaxoSmithKline Group of Companies" and are used by the Company under license.


FORWARD-LOOKING STATEMENTS

        "Safe Harbor" statement under the United States Private Securities Litigation Reform Act of 1995:

        To the extent any statements made in this report 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. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by 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. These forward-looking statements are subject to various risks and uncertainties including, but not necessarily limited to, 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, new product development and launch, reliance on key strategic alliances, reliance on third parties to distribute, promote and price certain of our key products, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax rate assumptions, fluctuations in operating results and other risks detailed from time to time in our filings with the U.S. Securities and Exchange Commission, the Ontario Securities Commission, and other securities regulatory authorities in Canada. We undertake no obligation to update or revise any forward-looking statement.

i


BIOVAIL CORPORATION
CONSOLIDATED BALANCE SHEETS

In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)

(Unaudited)

 
  At June 30,
2005

  At December 31,
2004

 
ASSETS              
Current              
Cash and cash equivalents   $ 245,443   $ 34,324  
Marketable securities     1,257     5,016  
Accounts receivable     99,017     148,762  
Inventories     101,195     110,154  
Deposits and prepaid expenses     7,995     16,395  
   
 
 
      454,907     314,651  
Long-term investments     67,043     68,046  
Property, plant and equipment, net     179,625     186,556  
Goodwill     100,294     100,294  
Intangible assets, net     892,819     978,073  
Other assets, net     121,755     63,440  
   
 
 
    $ 1,816,443   $ 1,711,060  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 33,885   $ 41,120  
Accrued liabilities     120,417     82,917  
Income taxes payable     22,732     24,594  
Deferred revenue     20,530     8,141  
Current portion of long-term obligations     24,396     33,465  
   
 
 
      221,960     190,237  
Deferred revenue     103,881     16,525  
Deferred leasehold inducements     4,955     4,914  
Long-term obligations     423,997     445,471  
   
 
 
      754,793     657,147  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares, no par value, unlimited shares authorized, 159,405,116 and 159,383,402 issued and outstanding at June 30, 2005 and December 31, 2004, respectively     1,457,264     1,457,065  
Stock options outstanding     1,450     1,450  
Deficit     (431,845 )   (446,684 )
Accumulated other comprehensive income     34,781     42,082  
   
 
 
      1,061,650     1,053,913  
   
 
 
    $ 1,816,443   $ 1,711,060  
   
 
 

Commitments and contingencies (notes 11 and 12)

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

1



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF INCOME

In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)

(Unaudited)

 
  Three Months Ended June 30
  Six Months Ended June 30
 
 
  2005
  2004
  2005
  2004
 
REVENUE                          
Product sales   $ 204,824   $ 197,213   $ 365,992   $ 372,310  
Research and development     6,705     2,673     14,231     6,889  
Royalty and other     5,861     6,427     12,428     13,740  
   
 
 
 
 
      217,390     206,313     392,651     392,939  
   
 
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     60,863     59,052     102,954     111,193  
Research and development     22,752     15,830     43,239     33,821  
Selling, general and administrative     58,051     55,991     133,656     115,449  
Amortization     15,477     15,734     31,511     32,839  
Write-down of assets     26,560         26,560      
Restructuring costs     18,607         18,607      
Acquired research and development                 8,640  
   
 
 
 
 
      202,310     146,607     356,527     301,942  
   
 
 
 
 
Operating income     15,080     59,706     36,124     90,997  
Interest income     912     167     1,290     571  
Interest expense     (9,574 )   (8,970 )   (18,471 )   (20,364 )
Foreign exchange loss     (153 )   (1,318 )   (691 )   (356 )
Other expense     (263 )   (3,577 )   (533 )   (2,434 )
   
 
 
 
 
Income before provision for income taxes     6,002     46,008     17,719     68,414  
Provision for income taxes     2,295     1,800     2,880     3,100  
   
 
 
 
 
Net income   $ 3,707   $ 44,208   $ 14,839   $ 65,314  
   
 
 
 
 

Earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 
Basic   $ 0.02   $ 0.28   $ 0.09   $ 0.41  
   
 
 
 
 
Diluted   $ 0.02   $ 0.28   $ 0.09   $ 0.41  
   
 
 
 
 

Weighted average number of common shares outstanding (000s)

 

 

 

 

 

 

 

 

 

 

 

 

 
Basic     159,398     159,084     159,391     159,043  
   
 
 
 
 
Diluted     159,441     159,201     159,444     159,241  
   
 
 
 
 

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

2



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF DEFICIT

In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)

(Unaudited)

 
  Three Months Ended June 30
  Six Months Ended June 30
 
 
  2005
  2004
  2005
  2004
 
Deficit, beginning of period   $ (435,552 ) $ (586,572 ) $ (446,684 ) $ (607,678 )
Net income     3,707     44,208     14,839     65,314  
   
 
 
 
 
Deficit, end of period   $ (431,845 ) $ (542,364 ) $ (431,845 ) $ (542,364 )
   
 
 
 
 

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

3



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)

(Unaudited)

 
  Six Months Ended June 30
 
 
  2005
  2004
 
  CASH FLOWS FROM OPERATING ACTIVITIES              
  Net income   $ 14,839   $ 65,314  
  Adjustments to reconcile net income to cash provided by operating activities              
  Depreciation and amortization     50,579     44,009  
  Amortization and write-down of deferred financing costs     2,074     2,699  
  Amortization of discounts on long-term obligations     1,344     1,526  
  Write-down of assets     26,560      
  Acquired research and development         8,640  
  Other     176     (401 )
  Changes in operating assets and liabilities:              
    Accounts receivable     49,238     23,900  
    Inventories     5,849     (10,805 )
    Deposits and prepaid expenses     8,190     4,268  
    Accounts payable     (7,309 )   (16,269 )
    Accrued liabilities     11,004     (10,945 )
    Income taxes payable     (1,881 )   (2,044 )
    Deferred revenue     (5,733 )   (2,232 )
   
 
 
  Net cash provided by operating activities     154,930     107,660  
   
 
 
  CASH FLOWS FROM INVESTING ACTIVITIES              
  Proceeds on disposal of intangible assets, net of withholding tax     98,127      
  Additions to property, plant and equipment, net     (11,314 )   (14,155 )
  Purchases of marketable securities     (5,470 )    
  Proceeds from sales and maturities of marketable securities     4,618      
  Acquisition of business, net of cash acquired         (9,319 )
  Acquisitions of long-term investments         (245 )
   
 
 
  Net cash provided by (used in) investing activities     85,961     (23,719 )
   
 
 
  CASH FLOWS FROM FINANCING ACTIVITIES              
  Repayments of other long-term obligations     (28,500 )   (52,796 )
  Repayments under revolving term credit facility, including financing costs     (1,300 )   (122,550 )
  Issuance of common shares, net of issue costs     199     3,678  
  Proceeds on termination of interest rate swaps         6,300  
   
 
 
  Net cash used in financing activities     (29,601 )   (165,368 )
   
 
 
  Effect of exchange rate changes on cash and cash equivalents     (171 )   (175 )
   
 
 
  Net increase (decrease) in cash and cash equivalents     211,119     (81,602 )
  Cash and cash equivalents, beginning of period     34,324     133,261  
   
 
 
  Cash and cash equivalents, end of period   $ 245,443   $ 51,659  
   
 
 

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 U.S. generally accepted accounting principles
(Tabular amounts are expressed in thousands of U.S. dollars,
except number of shares and per share data)

(Unaudited)

1.     GOVERNING STATUTE AND NATURE OF OPERATIONS

2.     SIGNIFICANT ACCOUNTING POLICIES

5


6


 
  Three Months Ended June 30
  Six Months Ended June 30
 
 
  2005
  2004
  2005
  2004
 
Net income as reported   $ 3,707   $ 44,208   $ 14,839   $ 65,314  
  Pro forma stock-based compensation expense determined under fair value-based method     (2,056 )   (5,889 )   (2,272 )   (11,378 )
   
 
 
 
 
Pro forma net income     1,651     38,319     12,567     53,936  
   
 
 
 
 

Basic earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 
As reported   $ 0.02   $ 0.28   $ 0.09   $ 0.41  
Pro forma   $ 0.01   $ 0.24   $ 0.08   $ 0.34  

Diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 
As reported   $ 0.02   $ 0.28   $ 0.09   $ 0.41  
Pro forma   $ 0.01   $ 0.24   $ 0.08   $ 0.34  
   
 
 
 
 
 
  Three Months Ended June 30
  Six Months Ended June 30
 
 
  2005
  2004
  2005
  2004
 
Expected option life (years)   4.0   3.7   4.0   3.8  
Volatility   52.2 % 55.5 % 53.3 % 56.0 %
Risk-free interest rate   3.4 % 4.0 % 3.7 % 3.6 %
Dividend yield   0.0 % 0.0 % 0.0 % 0.0 %

7


3.     DISPOSITION AND RESTRUCTURING

8


 
  At May 2, 2005
  Paid or Settled
  At June 30, 2005
Employee termination benefits   $ 12,505   $ (3,987 ) $ 8,518
Contract termination costs     5,241     (768 )   4,473
Professional fees and other     861     (861 )  
   
 
 
    $ 18,607   $ (5,616 ) $ 12,991
   
 
 

9


4.     INVENTORIES

 
  June 30, 2005
  December 31, 2004
Raw materials   $ 48,164   $ 48,801
Work in process     20,910     14,862
Finished goods     32,121     46,491
   
 
    $ 101,195   $ 110,154
   
 

5.     INTANGIBLE ASSETS

 
  June 30, 2005
  December 31, 2004
 
  Cost
  Accumulated amortization
  Cost
  Accumulated amortization
Trademarks   $ 703,698   $ 133,995   $ 703,698   $ 116,453
Product rights     391,432     83,547     459,773     84,877
Core technology     21,041     5,810     21,041     5,109
   
 
 
 
      1,116,171   $ 223,352     1,184,512   $ 206,439
         
       
Less accumulated amortization     223,352           206,439      
   
       
     
    $ 892,819         $ 978,073      
   
       
     

10


11


6.     LONG-TERM OBLIGATIONS

 
  June 30, 2005
  December 31, 2004
 
7/8% Senior Subordinated Notes due April 1, 2010   $ 400,000   $ 400,000  
Unamortized discount     (1,734 )   (1,916 )
Fair value adjustment     3,621     7,443  
   
 
 
      401,887     405,527  
Vasotec® and Vaseretic® obligation     20,762     27,704  
Zovirax obligation     21,481     32,230  
Ativan® and Isordil® obligation         9,037  
Deferred compensation     4,263     4,438  
   
 
 
      448,393     478,936  
Less current portion     24,396     33,465  
   
 
 
    $ 423,997   $ 445,471  
   
 
 

7.     STOCK OPTIONS OUTSTANDING

8.     INCOME TAXES

12


9.     EARNINGS PER SHARE

 
  Three Months Ended
June 30

  Six Months Ended
June 30

 
  2005
  2004
  2005
  2004
Net income   $ 3,707   $ 44,208   $ 14,839   $ 65,314
   
 
 
 
Basic weighted average number of common shares outstanding (000s)     159,398     159,084     159,391     159,043
Dilutive effect of stock options (000s)     43     117     53     198
   
 
 
 
Diluted weighted average number of common shares outstanding (000s)     159,441     159,201     159,444     159,241
   
 
 
 
Basic earnings per share   $ 0.02   $ 0.28   $ 0.09   $ 0.41
Diluted earnings per share   $ 0.02   $ 0.28   $ 0.09   $ 0.41
   
 
 
 

10.   COMPREHENSIVE INCOME

 
  Three Months Ended June 30
  Six Months Ended June 30
 
 
  2005
  2004
  2005
  2004
 
Net income   $ 3,707   $ 44,208   $ 14,839   $ 65,314  
   
 
 
 
 

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 
Foreign currency translation adjustment     (2,383 )   (566 )   (3,078 )   (2,833 )
Unrealized holding gain (loss) on long-term investments     1,862     (11,846 )   (4,223 )   (8,461 )
   
 
 
 
 
Other comprehensive loss     (521 )   (12,412 )   (7,301 )   (11,294 )
   
 
 
 
 
Comprehensive income   $ 3,186   $ 31,796   $ 7,538   $ 54,020  
   
 
 
 
 

13


11.   LEGAL PROCEEDINGS

14


15


16


17


18


19


12.   CONTRACTUAL OBLIGATION

13.   SEGMENT INFORMATION

20


BIOVAIL CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION

In accordance with U.S. generally accepted accounting principles
(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") prepared in accordance with U.S. generally accepted accounting principles ("GAAP") should be read in conjunction with the accompanying unaudited consolidated financial statements and condensed notes thereto. This MD&A should also be read in conjunction with the 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, 2004.

        The discussion and analysis contained in this MD&A are as of August 11, 2005.

STRATEGIC UPDATE

        In May 2005, we entered into a strategic partnership with Kos Pharmaceuticals, Inc. ("Kos") and restructured our U.S. commercial operations. As a result, we no longer have a direct primary-care or cardiovascular specialty sales presence in the United States. Our approach to commercializing products in the United States will involve partnering with companies that have strong primary-care capabilities in our therapeutic areas of focus. In addition, we have maintained a specialty sales force that will focus on a number of select markets.

        We are also continuing to evaluate a number of options to increase the value of our legacy products (Ativan®, Isordil®, Tiazac®, Vasotec® and Vaseretic® that are sold in the United States and Cardizem® CD that is sold in the United States and Canada). These products are in decline (in terms of prescription volumes) due to generic competition and are not strategic to our business. The options we are considering include: a sale of these products to strategic or financial buyers; the transfer of the assets to a new entity and the sale of shares of that entity pursuant to an initial public offering; or a distribution to our shareholders, which would involve the transfer of the assets to a new entity and the distribution of the shares of that entity to our shareholders. At this time, we cannot assess the impact that this transaction may have on our future results of operations, financial position and cash flows.

DISPOSITION AND RESTRUCTURING

Kos

        On May 2, 2005, we sold all of our rights to Teveten and Teveten HCT, and the distribution rights to Cardizem® LA in the United States and Puerto Rico, to Kos. We will be the exclusive manufacturer and supplier of Cardizem® LA to Kos at contractually determined prices over an initial seven-year supply term. We will also collaborate with Kos on the development of up to three products, including a combination product comprising Cardizem® LA and Vasotec®. Subject to U.S. Food and Drug Administration ("FDA") approval, we will be the exclusive manufacturer and supplier of the combination product to Kos.

        In consideration for these transactions, Kos paid us $105.5 million in cash, less withholding tax of $7.4 million. Kos may make additional payments to us related to the development of the combination product; however, we will only recognize these payments if the development milestones are achieved. Under the terms of the Cardizem® LA distribution agreement, we agreed to indemnify Kos (subject to certain conditions and limits) for lost profits in the event of generic competition to Cardizem® LA prior to December 31, 2008.

        The Kos transactions comprise multiple deliverables (sale of product and distribution rights, manufacturing and supply activities, and research and development services). In accordance with our revenue recognition accounting policy, we evaluated whether the deliverables represented separate units of accounting. We determined that we had objective and reliable evidence of the fair value of the delivered

21



item (the Teveten and Teveten HCT product rights); however, we did not have sufficient evidence of the fair values of the undelivered items, and therefore the Kos transactions represented a single unit of accounting. As a result, the up-front cash consideration of $105.5 million was recorded in deferred revenue, and will be recognized in product sales on a straight-line basis over the seven-year Cardizem® LA supply term. Revenue and related costs associated with the sale of Cardizem® LA product to Kos will be recognized in earnings as title to the product transfers to Kos.

        The disposal of Teveten and Teveten HCT to Kos resulted in a $25.5 million write-down of the carrying value of these product rights to reflect their fair value of $53.7 million (determined based on an independent valuation) at the date of disposition. The fair value of the Teveten and Teveten HCT product rights, as well as the cost of Teveten and Teveten HCT inventories of $3.0 million that were sold to Kos, were re-characterized as a deferred charge associated with the Cardizem® LA manufacturing and supply arrangement. The total deferred charge of $56.7 million and the withholding tax of $7.4 million were recorded in other assets, and will be amortized to cost of goods sold and income tax expense, respectively, on the same seven-year, straight-line basis as the deferred revenue described above. Inventories of Cardizem® LA, Teveten and Teveten HCT totaling $4.9 million that were not purchased by Kos were written off to cost of goods sold in the second quarter of 2005.

Restructuring

        Concurrent with the Kos transactions, we restructured our U.S. commercial operations. As a result, we reduced our primary-care and specialty sales forces by 307 positions, and our general and administrative functions by 30 positions. We notified the affected employees on May 2, 2005. In addition, Kos offered employment to 186 of our sales representatives, of which 164 accepted positions with Kos. We retained 85 specialty sales representatives who will initially focus exclusively on the promotion of Zovirax Ointment and Zovirax Cream to dermatologists and obstetricians/gynaecologists. We incurred a restructuring charge of $18.6 million primarily related to employee termination benefits, contract termination costs and professional fees. Employee termination costs include severance and related benefits, as well as outplacement services. We did not pay termination benefits to those employees that were offered employment by Kos. Contract termination costs include facility and vehicle lease payments that we will continue to incur without economic benefit. At June 30, 2005, we had a remaining liability balance related to the restructuring of $13.0 million, of which $8.5 million related to employee termination benefits that we expect will be substantially paid during the third quarter of 2005.

Outlook

        We anticipate that the aforementioned events will have a material positive impact on our future results of operations and cash flows due to the cost savings associated with the reduction in headcount in our U.S. commercial operations, as well as the discontinuance of spending on sales and marketing activities to support Cardizem® LA, Teveten and Teveten HCT. In addition, the net amortization of the deferred revenue and other assets associated with the Kos transactions will positively impact our earnings by $5.9 million annually over the seven-year Cardizem® LA supply term. These factors will be partly offset by lower revenue and gross profit on sales of Cardizem® LA product to Kos and the elimination of Teveten and Teveten HCT product sales.

22



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 or estimates since December 31, 2004.

RESULTS OF OPERATIONS

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

        Revenue increased 5% from $206.3 million in the second quarter of 2004 to $217.4 million in the second quarter of 2005 due to higher product sales and revenue generated from research and development activities. Revenue declined less than 1% from $392.9 million in the first half of 2004 to $392.7 million in the first half of 2005 due to lower product sales, offset by higher revenue generated from research and development activities.

        Net income decreased 92% from $44.2 million (basic and diluted earnings per share of $0.28) in the second quarter of 2004 to $3.7 million (basic and diluted earnings per share of $0.02) in the second quarter of 2005. Net income decreased 77% from $65.3 million (basic and diluted earnings per share of $0.41) in the first half of 2004 to $14.8 million (basic and diluted earnings per share of $0.09) in the first half of 2005.

        Our results of operations in the second quarter and first half of 2005 were impacted by the following events:

        Our results of operations in the first half of 2004 were impacted by a charge of $8.6 million (basic and diluted impact per share of $0.05) to acquired research and development expense, associated with our acquisition of Pharma Pass II's ("PPII") remaining interest in BNC-PHARMAPASS, LLC ("BNC-PHARMAPASS").

REVENUE

        Our revenue is derived primarily from the following sources:

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        The following tables display the dollar amount of each source of revenue in the second quarters and first halves of 2005 and 2004, the percentage of each source of revenue compared with total revenue in the respective period, and the dollar and percentage change in the dollar amount of each source of revenue. Percentages may not add due to rounding.

 
  Three Months Ended June 30
 
($ in 000s)

 
  2005
  2004
  Change
 
Product sales   $ 204,824   94 % $ 197,213   96 % $ 7,611   4 %
Research and development     6,705   3     2,673   1     4,032   151  
Royalty and other     5,861   3     6,427   3     (566 ) (9 )
   
 
 
 
 
     
    $ 217,390   100 % $ 206,313   100 % $ 11,077   5 %
   
 
 
 
 
 
 
 
 
  Six Months Ended June 30
 
($ in 000s)

 
  2005
  2004
  Change
 
Product sales   $ 365,992   93 % $ 372,310   95 % $ (6,318 ) (2 )%
Research and development     14,231   4     6,889   2     7,342   107  
Royalty and other     12,428   3     13,740   3     (1,312 ) (10 )
   
 
 
 
 
     
    $ 392,651   100 % $ 392,939   100 % $ (288 ) (— )%
   
 
 
 
 
 
 

Product sales

        The following tables display product sales by reporting category in the second quarters and first halves of 2005 and 2004, the percentage of each category compared with total product sales in the respective period, and the dollar and percentage changes in the dollar amount of each category. Percentages may not add due to rounding.

 
  Three Months Ended June 30
 
($ in 000s)

 
  2005
  2004
  Change
 
Wellbutrin XL   $ 70,469   34 % $ 79,133   40 % $ (8,664 ) (11 )%
Zovirax     18,285   9     7,064   4     11,221   159  
Cardizem® LA     17,599   9     23,634   12     (6,035 ) (26 )
Teveten     1,053   1     2,437   1     (1,384 ) (57 )
Biovail Pharmaceuticals Canada     23,683   12     23,907   12     (224 ) (1 )
Legacy     39,449   19     29,800   15     9,649   32  
Generic     34,286   17     31,238   16     3,048   10  
   
 
 
 
 
     
    $ 204,824   100 % $ 197,213   100 % $ 7,611   4 %
   
 
 
 
 
 
 

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  Six Months Ended June 30
 
($ in 000s)

 
  2005
  2004
  Change
 
Wellbutrin XL   $ 107,225   29 % $ 121,160   33 % $ (13,935 ) (12 )%
Zovirax     45,405   12     34,917   9     10,488   30  
Cardizem® LA     28,979   8     38,058   10     (9,079 ) (24 )
Teveten     6,534   2     7,116   2     (582 ) (8 )
Biovail Pharmaceuticals Canada     48,722   13     46,843   13     1,879   4  
Legacy     69,866   19     56,008   15     13,858   25  
Generic     59,261   16     68,208   18     (8,947 ) (13 )
   
 
 
 
 
     
    $ 365,992   100 % $ 372,310   100 % $ (6,318 ) (2 )%
   
 
 
 
 
 
 

Wellbutrin XL

        Our extended-release ("ER") bupropion hydrochloride tablets ("Wellbutrin XL") are sold by GlaxoSmithKline plc ("GSK") in the United States. Our revenue from sales of Wellbutrin XL declined 11% and 12% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. In the second quarter of 2005, GSK's net sales of Wellbutrin XL exceeded the sales-dollar threshold to increase the supply price from the first to second tier.

        The declines in Wellbutrin XL revenue resulted from a reduction in the level of GSK's safety stock of trade product and lower shipments of sample supplies. During 2004, GSK had increased its safety stock of trade product in anticipation of our need to shift production in 2005 from Wellbutrin XL to scale-up activities for various products under development, including our Tramadol ER product.

Zovirax products

        Combined sales of Zovirax Ointment and Zovirax Cream increased 159% and 30% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. The increases in Zovirax sales reflected higher prescription volumes in the second quarter and first half of 2005, and a reduction in inventory levels of Zovirax at the wholesale level in the corresponding periods of 2004. In late 2004 and early 2005, we entered into distribution service agreements with our three major wholesalers. These agreements generally establish limits on inventory levels held by these wholesalers and are expected to moderate investment buying by these wholesalers, which can result in sales fluctuations unrelated to end-customer demand.

        In the first quarters of 2005 and 2004, we effected price increases for Zovirax. In the first quarter of 2004, this event had a significant effect on our Zovirax sales levels, as wholesalers purchased additional quantities of Zovirax in anticipation of the price increase. This resulted in significantly lower sales of Zovirax in the second quarter of 2004, compared with the first quarter of 2004. In the first quarter of 2005, the distribution service agreements reduced investment buying by our three major wholesalers and, as a result, the fluctuations in the sales levels of Zovirax between the first and second quarters of 2005 were not nearly as significant as those in the corresponding periods of 2004.

Cardizem® LA

        Sales of Cardizem® LA declined 26% and 24% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. The decline in Cardizem® LA sales in the second quarter of 2005 reflected that our contractual prices for Cardizem® LA sold to Kos are lower than

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what we historically charged for this product when selling direct to wholesalers. The decline in Cardizem® LA sales in the first half of 2005 was also due to unanticipated returns of expired product in the first quarter of 2005, primarily related to low end-customer demand for one package size of this product.

Teveten products

        Combined sales of Teveten and Teveten HCT declined 57% and 8% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. Sales of Teveten and Teveten HCT in the second quarter and first half of 2005 reflected only those sales made prior to May 2, 2005 (the date of the Kos transactions).

Biovail Pharmaceuticals Canada ("BPC") products

        BPC products are Tiazac® XC, Tiazac®, Wellbutrin® SR, Zyban®, Monocor and Retavase, which are sold in Canada. Sales of BPC products declined 1% overall in the second quarter of 2005, compared with the second quarter of 2004, and increased 4% overall in the first half of 2005, compared with the first half of 2004. The decline in BPC product sales in the second quarter of 2005 was due mainly to the introduction of generic competition for Wellbutrin® SR. The increase in BPC product sales in the first half of 2005 reflected growth in Tiazac® sales and the launch of Tiazac® XC in January 2005. Tiazac® XC is indicated for the treatment of hypertension.

Legacy products

        Our legacy products are Tiazac® (brand and generic), Cardizem® CD, Vasotec®, Vaseretic®, Ativan® and Isordil®, which are sold primarily in the United States. Sales of our legacy products increased 32% and 25% overall in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. The increases in legacy product sales reflected higher sales of generic Tiazac® to Forest Laboratories, Inc. (which more than offset a decline in Tiazac® brand sales) and higher sales to wholesalers of our other legacy products (despite declines in prescription volumes for these products due to generic competition). During the last three quarters of 2004, our three major wholesalers reduced their inventories of our other legacy products in anticipation of the transition to distribution service agreements. As a result, sales of these products more closely reflected end-customer demand in the second quarter and first half of 2005, compared with the corresponding periods of 2004.

Generic products

        Our generic products are bioequivalent versions of Adalat CC, Cardizem® CD, Procardia XL, Trental and Voltaren XR, which we manufacture and sell to a subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva") for distribution in the United States. Sales of our generic products increased 10% overall in the second quarter of 2005, compared with the second quarter of 2004, and declined 13% overall in the first half of 2005, compared with the first half of 2004. The increase in generic product sales in the second quarter of 2005 was mainly due to stronger sales of generic Cardizem® CD and generic Procardia XL. The decline in generic product sales in the first half of 2005 was mainly due to weaker sales of generic Adalat CC.

Research and development revenue

        Research and development revenue increased 151% and 107% in the second quarter and first half of 2005, compared with the corresponding periods of 2004. The increases in research and development

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revenue reflected a higher level of clinical research and laboratory testing services provided to external customers by our contract research operation.

Royalty and other revenue

        Royalty and other revenue declined 9% and 10% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. The declines in royalty and other income reflected a decrease in royalty income on Tiazac® brand sales by Forest due to generic competition that resulted in lower end-customer demand for this product. This factor was partially offset by an increase in royalty income from our interest in Tricor (fenofibrate).

OPERATING EXPENSES

        The following tables display the dollar amount of each operating expense item in the second quarters and first halves of 2005 and 2004, the percentage of each item compared with total revenue in the respective period, and the dollar and percentage change in the dollar amount of each item. Percentages may not add due to rounding.

 
  Three Months Ended June 30
 
($ in 000s)

 
  2005
  2004
  Change
 
Cost of goods sold   $ 60,863   28 % $ 59,052   29 % $ 1,811   3 %
Research and development     22,752   10     15,830   8     6,922   44  
Selling, general and administrative     58,051   27     55,991   27     2,060   4  
Amortization     15,477   7     15,734   8     (257 ) (2 )
Write-down of assets     26,560   12           26,560   N/A  
Restructuring costs     18,607   9           18,607   N/A  
   
 
 
 
 
     
    $ 202,310   93 % $ 146,607   71 % $ 55,703   38 %
   
 
 
 
 
 
 
 
 
  Six Months Ended June 30
 
($ in 000s)

 
  2005
  2004
  Change
 
Cost of goods sold   $ 102,954   26 % $ 111,193   28 % $ (8,239 ) (7 )%
Research and development     43,239   11     33,821   9     9,418   28  
Selling, general and administrative     133,656   34     115,449   29     18,207   16  
Amortization     31,511   8     32,839   8     (1,328 ) (4 )
Write-down of assets     26,560   7           26,560   N/A  
Restructuring costs     18,607   5           18,607   N/A  
Acquired research and development           8,640   2     (8,640 ) (100 )
   
 
 
 
 
     
    $ 356,527   91 % $ 301,942   77 % $ 54,585   18 %
   
 
 
 
 
 
 

Cost of goods sold and gross margins

        Cost of goods sold increased 3% in the second quarter of 2005, compared with the second quarter of 2004, and declined 7% in the first half of 2005, compared with the first half of 2004. Gross margins based on product sales were 70% and 72% in the second quarter and first half of 2005, respectively, compared with 70% in both the second quarter and first half of 2004. In the second quarter of 2005, following a

27



review of existing market conditions for Cardizem® CD, we recorded a provision of $5.7 million for inventory of this product in excess of expected demand. We anticipate a continuing decline in Cardizem® CD prescriptions due to increasing competition from generics and Cardizem® LA. In addition, we wrote off the $4.9 million of Cardizem® LA, Teveten and Teveten HCT inventories not purchased by Kos. Excluding these inventory charges, our normalized gross margins were 75% in both the second quarter and first half of 2005.

        The increases in normalized gross margins reflected mainly manufacturing efficiencies that are continuing to be achieved in the production of Wellbutrin XL, as well as a decrease in the proportion of lower margin Wellbutrin XL sample supplies versus trade product sales in the second quarter and first half of 2005, compared with the corresponding periods of 2004. In the second quarter of 2005, we initiated the amortization of the deferred charge related to a reduction in the Zovirax supply price to be paid to GSK. Although this amortization had an insignificant impact on the Zovirax gross margin in this quarter, we estimate that the amortization of this deferred charge will amount to approximately $7.0 million in the second half of 2005.

Research and development expenses

        Research and development expenses increased 44% and 28% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. We invested 10% and 11% of total revenue in research and development activities in the second quarter and first half of 2005, respectively, compared with 8% and 9% in the second quarter and first half of 2004, respectively. The increases in research and development expenses were primarily due to increased spending on our late-stage product development programs, and costs associated with a higher level of contract research services provided to external customers. Research and development activities in the second quarter and first half of 2005 included line extension and enhanced formulation programs for tramadol, bupropion, and the anti-depressant venlafaxine. In addition, we are proceeding with a clinical program to provide additional data to the FDA to support our New Drug Application ("NDA") filing for Tramadol ER.

        We achieved a number of recent successes from our late-stage product-development pipeline, including the following milestones:

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Selling, general and administrative expenses

        Selling, general and administrative expenses increased 4% and 16% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. As a percentage of total revenue, selling, general and administrative expenses were 27% and 34% in the second quarter and first half of 2005, respectively, compared with 27% and 29% in the second quarter and first half of 2004, respectively. The increase in selling, general and administrative expenses in the second quarter of 2005 reflected higher corporate expenses resulting from our corporate governance and Sarbanes-Oxley compliance initiatives, as well as an expansion of our executive group. These expenses were partially offset by lower compensation costs following the reduction in headcount in our primary-care and specialty sales forces. The increase in selling, general and administrative expenses in the first half of 2005 reflected the higher corporate expenses and a higher average headcount in our primary-care and specialty sales forces, as well as an increase in sales and marketing activities to support our Zovirax products, and the Cardizem® LA and Teveten products prior to the transactions with Kos. In the first half of 2004, we were in the process of expanding and realigning of our primary-care sales force, which resulted in a number of temporary vacancies in field sales-force positions, as well as the postponement of certain sales and marketing activities, during that period.

        The decline in selling, general and administrative expenses as a percentage of total revenue in the second quarter of 2005, compared with the first half of 2005, reflected the impact of the Kos transactions and concurrent restructuring of our U.S. commercial operations. These events resulted in immediate cost savings associated with a reduction in headcount in our primary-care and cardiovascular specialty sales forces and the discontinuance of spending on sales and marketing activities to support the Cardizem® LA and Teveten products.

Amortization expense

        Amortization expense declined 2% and 4% in the second quarter and first half of 2005, respectively, compared with the corresponding periods of 2004. The declines in amortization expense reflected the final amortization of our interest in generic omeprazole in the first quarter of 2004, and the discontinuance of amortization of the Teveten and Teveten HCT product rights following the Kos transactions. As a result of the disposal of the Teveten and Teveten HCT product rights, amortization expense will be reduced by $1.2 million per quarter or $4.7 million annually.

Write-down of assets

        In the second quarter of 2005, the disposal of the Teveten and Teveten HCT product rights to Kos resulted in a $25.5 million write-down of the carrying value of these product rights to reflect their fair value of $53.7 million at the date of disposition. In addition, we wrote-off our $0.7 million investment in convertible debentures of Procyon Biopharma Inc. ("Procyon"), as a result of our decision to terminate the Fibrostat licensing agreement with Procyon.

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Restructuring costs

        In the second quarter of 2005, we incurred a charge of $18.6 million associated with the restructuring of our U.S. commercial operations. At June 30, 2005, the liability balance for restructuring costs incurred, but not paid or settled, was $13.0 million.

Acquired research and development expense

        In the first quarter of 2004, we acquired PPII's remaining interest in BNC-PHARMAPASS, a company that we formed in 2003 with PPII to advance the development of three products (carvedilol, eprosartan and tamsulosin). We subsequently agreed with PPII to terminate the development of tamsulosin, and the intellectual property related to this product was returned to PPII. We recorded a charge of $8.6 million to acquired research and development expense related to the increase in our share of the fair values of the two remaining products (carvedilol and eprosartan). Both of these products are in early clinical phases of development.

OPERATING INCOME

        We recorded operating income of $15.1 million and $36.1 million in the second quarter and first half of 2005, respectively, compared with $59.7 million and $91.0 million in the second quarter and first half of 2004, respectively. In the second quarter and first half of 2005, charges related to the cost of inventories not purchased by Kos, the write-down of assets and restructuring activities reduced operating income by a total of $50.0 million. In the first half of 2004, the charge to acquired research and development expense reduced operating income by $8.6 million.

        Operating income in the second quarter of 2005, compared with the second quarter of 2004, reflected a higher normalized gross margin on product sales and lower sales force costs. These factors were offset by increased research and development spending and higher corporate expenses. Operating income in the first half of 2005, compared with the first half of 2004, reflected increased spending on research and development and sales and marketing activities, as well as higher sales force costs and corporate expenses. These factors were offset by a higher normalized gross margin on product sales.

NON-OPERATING ITEMS

Interest expense

        Interest expense was $9.6 million and $18.5 million in the second quarter and first half of 2005, respectively, compared with $9.0 million and $20.4 million in the second quarter and first half of 2004, respectively. Interest expense mainly comprised interest on our 77/8% Senior Subordinated Notes due April 1, 2010 ("Notes").

Provision for income taxes

        Our effective tax rate reflected the fact that most of our income was derived from foreign subsidiaries with lower statutory tax rates than those that apply in Canada. We recorded provisions for income taxes of $2.3 million and $2.9 million in the second quarter and first half of 2005, respectively, and $1.8 million and $3.1 million in the second quarter and first half of 2004, respectively. Our effective tax rate was affected by the availability of unrecognized tax loss carryforwards that can be used to offset taxable income in Canada and the United States, as well as losses that were incurred in the United States prior to the transactions with Kos and restructuring activities.

30


        Our provision for income taxes is based on a number of estimates and assumptions made by management. Our consolidated income tax rate is affected by the amount of net income earned in our various operating jurisdictions and the rate of taxes payable in respect of that income. We enter into many transactions and arrangements in the ordinary course of business in which the tax treatment is not entirely certain. In particular, certain countries in which we operate could seek to tax a greater share of income than has been provided for by us. The final outcome of any audits by taxation authorities may differ from the estimates and assumptions we have used in determining our consolidated tax provisions and accruals. This could result in a material effect on our consolidated income tax provision and the net income for the period in which such determinations are made.

SUMMARY OF QUARTERLY RESULTS

        The following tables present a summary of our quarterly results for each of the eight most recently completed quarters:

 
  2005
  2004
(In 000s, except per share data)

  Q2
  Q1
  Q4
  Q3
Revenue   $ 217,390   $ 175,261   $ 277,879   $ 215,725
Net income     3,707     11,132     46,045     49,635
Basic and diluted earnings per share   $ 0.02   $ 0.07   $ 0.29   $ 0.31
   
 
 
 
 
 
  2004
  2003
(In 000s, except per share data)

  Q2
  Q1
  Q4
  Q3
Revenue   $ 206,313   $ 186,626   $ 199,735   $ 215,314
Net income (loss)     44,208     21,106     (96,038 )   16,114
Basic and diluted earnings (loss) per share   $ 0.28   $ 0.13   $ 0.60   $ 0.10
   
 
 
 

        The increase in revenue in the second quarter of 2005, compared with the first quarter of 2005, was due mainly to an increase in sales of Wellbutrin XL to GSK. In the first quarter of 2005, GSK reduced the level of its safety stock of Wellbutrin XL, after ordering additional quantities of this product during 2004, in anticipation of our need to shift production from Wellbutrin XL to other of our products under development. In addition, the increase in revenue reflected the impact of the tiered supply price for Wellbutrin XL, which is reset to the lowest tier at the start of each calendar year. In the second quarter, GSK's net sales of Wellbutrin XL exceeded the sales-dollar threshold to increase the supply price from the first to second tier.

        The decline in net income in the second quarter of 2005, compared with the first quarter of 2005, was primarily due to the charges related to the write-down of assets and restructuring activities, as well as the lower gross profit on Cardizem® LA product sales, and the elimination of Teveten and Teveten HCT product sales, following the transactions with Kos. These factors were partially offset by the cost savings associated with the reduction in headcount in our U.S. commercial operations, as well as the discontinuance of spending on sales and marketing activities to support Cardizem® LA, Teveten and Teveten HCT.

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FINANCIAL CONDITION

        The following table presents a summary of our financial condition at June 30, 2005 and December 31, 2004:

($ in 000s)
  At June 30,
2005

  At December 31,
2004

Working capital   $ 232,947   $ 124,414
Long-lived assets     1,294,493     1,328,363
Long-term obligations     448,393     478,936
Shareholders' equity     1,061,650     1,053,913
   
 

Working capital

        The $108.5 million increase in working capital from December 31, 2004 to June 30, 2005 was primarily due to:

        Partially offset by:

Long-lived assets

        Long-lived assets comprise property, plant and equipment, goodwill, intangible and other assets, net of accumulated depreciation and amortization. The $33.9 million decrease in long-lived assets from December 31, 2004 to June 30, 2005, reflected primarily the depreciation of plant and equipment of $16.9 million and the amortization of intangible and other assets of $33.7 million, as well as the

32



$25.5 million write-down of the carrying value of the Teveten and Teveten HCT product rights. These factors were partially offset by the additions of the Glumetza™ and Tramadol ODT product rights of aggregate $26.0 million and net capital expenditures on property, plant and equipment of $11.3 million, which consisted mainly of additions to manufacturing and laboratory equipment, as well as expenditures related to the ongoing expansion of our Steinbach, Manitoba manufacturing facility.

Long-term obligations

        The $30.5 million decrease in long-term obligations, including the current portion thereof, from December 31, 2004 to June 30, 2005, reflected primarily the following instalments:

Shareholders' equity

        The $7.7 million increase in shareholders' equity from December 31, 2004 to June 30, 2005, reflected primarily net income of $14.8 million, offset partially by a $4.2 million unrealized holding loss on our available-for-sale investments, primarily related to our equity investment in Depomed, and a $3.1 million foreign currency translation loss due to a weakening of the Canadian dollar and euro relative to the U.S. dollar.

CASH FLOWS

        At June 30, 2005, we had cash and cash equivalents of $245.4 million, compared with $34.3 million at December 31, 2004. The following table displays cash flow information for the first halves of 2005 and 2004:

 
  Six Months Ended June 30
 
($ in 000s)
  2005
  2004
 
Net cash provided by operating activities   $ 154,930   $ 107,660  
Net cash provided by (used in) investing activities     85,961     (23,719 )
Net cash used in financing activities     (29,601 )   (165,368 )
Effect of exchange rate changes on cash and cash equivalents     (171 )   (175 )
   
 
 
Net increase (decrease) in cash and cash equivalents   $ 211,119   $ (81,602 )
   
 
 

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Operating activities

        Net cash provided by operating activities increased $47.3 million from the first half of 2004 to the first half of 2005, primarily due to the amount and timing of collections of accounts receivable and payments of accounts payable and accrued liabilities. These factors were partially offset by lower income from operations excluding non-cash items of $26.2 million, which included restructuring costs of $18.6 million and inventory charges of $10.6 million. Net cash provided by operating activities was primarily used to repay long-term obligations in the first halves of 2005 and 2004.

Investing activities

        Net cash provided by investing activities increased $109.7 million from the first half of 2004 to the first half of 2005, primarily due to:

Financing activities

        Net cash used in financing activities declined $135.8 million from the first half of 2004 to the first half of 2005, primarily due to:


LIQUIDITY AND CAPITAL RESOURCES

        At June 30, 2005, we had total long-term obligations of $448.4 million, including the current portion thereof, which included the carrying value of our Notes of $401.9 million and obligations related to the acquisitions of intangible assets of $42.2 million. At June 30, 2005, we had no outstanding borrowings under our revolving term credit facility; however, we had a letter of credit of $27.1 million issued under this facility, which secures the remaining semi-annual payments we are required to make to Merck related to our acquisition of Vasotec® and Vaseretic®. In May 2005, we renewed this credit facility for a one-year term at $250.0 million. This facility is renewable for additional one-year revolving terms at the lenders' option, with a one-year term out at our option if the lenders do not renew. This facility may be used for general corporate purposes, including acquisitions. At June 30, 2005, we were in compliance with all financial and non-financial covenants associated with this facility. Our current corporate credit ratings from Standard & Poor's ("S&P") and Moody's Investors Service ("Moody's") are BB+ and B1, respectively, and the current ratings on our Notes from S&P and Moody's are BB- and B2, respectively.

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        We believe that our existing balance of cash and cash equivalents, together with cash expected to be generated by operations and existing funds available under our revolving term credit facility, will be sufficient to support our operational, capital expenditure and interest requirements, as well as to meet our obligations as they become due. However, in the event that we make significant future acquisitions or change our capital structure, we may be required to raise additional funds through additional borrowings or the issuance of additional debt or equity securities.

CONTRACTUAL OBLIGATIONS

        The following table summarizes our fixed contractual obligations at June 30, 2005:

 
  Payments Due by Period
($ in 000s)
  Total
  2005
  2006 and
2007

  2008 and
2009

  Thereafter
Long-term obligations   $ 444,139   $ 7,628   $ 36,511   $   $ 400,000
Operating lease obligations     46,050     3,450     12,600     9,900     20,100
Purchase obligations     30,694     14,505     16,189        
   
 
 
 
 
Total contractual obligations   $ 520,883   $ 25,583   $ 65,300   $ 9,900   $ 420,100
   
 
 
 
 

        The above purchase obligations are in connection with the manufacture and supply of Cardizem® products by Aventis Pharmaceuticals Inc. ("Aventis") and Vasotec® and Vaseretic® by Merck. We are obligated to purchase approximately $12.6 million worth of Cardizem® products from Aventis in both 2005 and 2006. We are obligated to make semi-annual payments to Merck for minimum quantities of Vasotec® and Vaseretic® (regardless of the actual product supplied). The remaining payments to Merck are $1.9 million in 2005 and $3.6 million in 2006.

        The above table does not reflect any milestone payments in connection with research and development collaborations with third parties, as these payments are contingent on the achievement of specific developmental, regulatory and/or commercial milestones. In addition, under certain arrangements, we may have to make royalty payments based on a percentage of future sales of the products in the event regulatory approval for marketing is obtained. From a business perspective, we view these payments favourably as they signify that the products are moving successfully through the development phase toward commercialization.

        The above table also does not reflect a contingent purchase obligation in connection with the acquisition of Ativan® and Isordil®. On the approval by the FDA of the first Ativan® line extension product that may be developed by us, we will be obligated to pay Wyeth a $20.0 million additional rights payment, increasing at 10% per annum from May 2003.

OFF-BALANCE SHEET ARRANGEMENTS

        We did not have any off-balance sheet arrangements at June 30, 2005, other than operating leases and purchase obligations in connection with the manufacture and supply of Cardizem® products, Vasotec® and Vaseretic®, which are disclosed above under contractual obligations.

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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 use derivative financial instruments as a risk management tool and not for trading or speculative purposes.

        Inflation has not had a significant impact on our results of operations.

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 in Canadian dollars, and we do not have any material non-U.S. dollar-denominated obligations. 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. Currently, we do not utilize forward contracts to hedge against foreign currency risk; however, a 10% change in foreign currency exchange rates would not have a material impact on our consolidated results of operations, financial position or cash flows.

Interest rate risk

        The primary objective of our policy for the investment of temporary cash surpluses is the protection of principal and, accordingly, we invest in investment-grade securities with varying maturities. External independent fund administrators manage our investments. As it is our general intent and policy to hold these investments until maturity, we do not have a material exposure to interest rate risk.

        We are exposed to interest rate risk on borrowings under our revolving term credit facility. This credit facility bears interest based on London Interbank Offering Rate, U.S. dollar base rate, Canadian dollar prime rate or Canadian dollar bankers' acceptance. At our option, we may lock in a rate of interest for a period of up to one year. The imputed rates of interest used to discount our long-term obligations related to the acquisitions of intangible assets are fixed and, consequently, the fair values of these obligations are affected by changes in interest rates. The fair value of our fixed rate Notes is affected by changes in interest rates. Prior to July 5, 2005, we managed this exposure to interest rate changes through the use of interest rate swaps, which modified our exposure to interest rate fluctuations by converting one-half of our fixed rate Notes to floating rate; however, effective July 5, 2005, we terminated the interest rate swap. Based on our overall interest rate exposure, a 10% change in interest rates would not have a material impact on our consolidated results of operations, financial position or cash flows.

Investment risk

        We are exposed to investment risks on our investments in other companies. The fair values of our investments are subject to significant fluctuations due to stock market volatility and changes in general market conditions. 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. A 10% change in the aggregate fair values of our investments would have a material impact on our consolidated results of operations; however, it would not have a material impact on our consolidated financial position or cash flows.

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RECENT ACCOUNTING PRONOUNCEMENTS

        In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123 (revised 2004), "Share-Based Payment" ("SFAS No. 123R"), which revises SFAS No. 123, "Accounting for Stock-Based Compensation", and supercedes Accounting Principles Board Opinion ("APB") No. 25, "Accounting for Stock Issued to Employees". SFAS No. 123R requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values. The pro forma disclosures previously permitted under SFAS No. 123 will no longer be an alternative to financial statement recognition. In April 2005, the SEC delayed the effective date of SFAS No. 123R. Under the SEC's rule, SFAS No. 123R is effective at the beginning of the first annual period commencing after June 15, 2005. Accordingly, we are now required to adopt SFAS No. 123R beginning January 1, 2006. We are currently evaluating the requirements of SFAS No. 123R and expect that the adoption of this standard will have a material negative impact on our consolidated results of operations. We have not yet determined the method of adoption or other effects of adopting SFAS No. 123R, and we have not determined whether the adoption will result in amounts that are similar to our current pro forma disclosures under SFAS No. 123.

        In November 2004, the FASB issued SFAS No. 151, "Inventory Costs — An Amendment of ARB No. 43, Chapter 4" ("SFAS No. 151"). SFAS No. 151 requires that items such as idle facility expense, excessive spoilage, double freight, and rehandling costs be excluded from the cost of inventory and expensed as incurred. Additionally, SFAS No. 151 requires that the allocation of fixed overheads be based on the normal capacity of the production facilities. SFAS No. 151 is effective for fiscal years commencing after June 15, 2005. Accordingly, we are required to adopt SFAS No. 151 beginning January 1, 2006. We are currently evaluating the effect that the adoption of SFAS No. 151 will have on our consolidated results of operations and financial position.

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BIOVAIL CORPORATION
PART II — OTHER INFORMATION

1.     LEGAL PROCEEDINGS

        For detailed information concerning legal proceedings, reference is made to note 11 — Legal Proceedings to the consolidated financial statements included under Part I of this Quarterly Report.

2.     EXHIBITS

Exhibit 99.1   Certifications of the Chief Executive Officer and Chief Financial Officer
Exhibit 99.2   Second Quarter 2005 Interim Report For Canadian Regulatory Purposes
Exhibit 99.3   Second Quarter Report 2005
Exhibit 99.4   Press Release — Biovail Reports Second-Quarter 2005 Financial Results


SIGNATURES

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

    BIOVAIL CORPORATION

Date: August 12, 2005

 

 

 

 

 

By:

/s/  
JOHN R. MISZUK      
John R. Miszuk
Vice President, Controller and
Assistant Secretary

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QuickLinks

BIOVAIL CORPORATION
INDEX Part I — Financial Information
BASIS OF PRESENTATION
FORWARD-LOOKING STATEMENTS
CONSOLIDATED BALANCE SHEETS
In accordance with U.S. 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 U.S. generally accepted accounting principles (All dollar amounts are expressed in thousands of U.S. dollars) (Unaudited)
BIOVAIL CORPORATION CONSOLIDATED STATEMENTS OF DEFICIT
In accordance with U.S. generally accepted accounting principles (All dollar amounts are expressed in thousands of U.S. dollars) (Unaudited)
Consolidated Statements of Cash Flows
BIOVAIL CORPORATION PART II — OTHER INFORMATION
SIGNATURES