QuickLinks -- Click here to rapidly navigate through this document



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

FORM 6-K/A

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, 2003

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

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

QUARTERLY REPORT

        This Report of Foreign Private Issuer on Form 6-K/A is incorporated by reference into the registration statements on Form S-8 (Registration No. 333-92229) and on Form F-10 (Registration No. 333-14048) of Biovail Corporation.


INDEX

PART I — FINANCIAL INFORMATION

Financial Statements    
 
Consolidated Balance Sheets as at June 30, 2003 and December 31, 2002

 

1
  Consolidated Statements of Income (Loss) for the three months and six months ended June 30, 2003 and 2002   2
  Consolidated Statements of Deficit for the three months and six months ended June 30, 2003 and 2002   3
  Consolidated Statements of Cash Flows for the six months ended June 30, 2003 and 2002   4
  Condensed Notes to the Consolidated Financial Statements   5

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

 

17

Quantitative and Qualitative Disclosure about Market Risk

 

26


PART II — OTHER INFORMATION

Operational Information   28

Legal Proceedings

 

28

Exhibits

 

28

        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 and logos are trademarks of the Company and may be registered in Canada, the United States and certain other jurisdictions: Biovail, Cardizem®, Tiazac®, Teveten®, Vasotec®, Vaseretic®, Ativan®, Isordil®, CEFORM™, Shearform™, FlashDose®, Instatab™, SportSafe™, DrinkUp™ and Cardisense®.

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)

 
  June 30
2003

  December 31
2002

 
 
  (Unaudited)

  (Audited)

 
 
  (Restated —
note 2)

   
 
ASSETS              
Current              
Cash and cash equivalents   $ 102,592   $ 56,080  
Accounts receivable     216,438     190,980  
Inventories     77,436     53,047  
Deposits and prepaid expenses     15,666     21,524  
   
 
 
      412,132     321,631  
Long-term investments     95,754     79,324  
Property, plant and equipment, net     157,409     136,784  
Goodwill, net     102,450     102,212  
Intangible assets, net     1,144,439     1,080,503  
Other assets, net     118,259     113,350  
   
 
 
    $ 2,030,443   $ 1,833,804  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 74,568   $ 71,641  
Accrued liabilities     100,836     106,005  
Income taxes payable     42,096     35,691  
Deferred revenue     11,321     9,231  
Current portion of long-term obligations     101,605     122,590  
   
 
 
      330,426     345,158  
Deferred revenue     16,200     18,200  
Long-term obligations     749,328     624,760  
   
 
 
      1,095,954     988,118  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares, no par value, unlimited shares authorized, 158,678,917 and 158,120,144 issued and outstanding at June 30, 2003 and December 31, 2002, respectively     1,443,956     1,433,624  
Stock options outstanding     4,678     4,856  
Executive Stock Purchase Plan loans     (9,988 )   (9,988 )
Deficit     (527,754 )   (580,413 )
Accumulated other comprehensive income (loss)     23,597     (2,393 )
   
 
 
      934,489     845,686  
   
 
 
    $ 2,030,443   $ 1,833,804  
   
 
 

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

1



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF INCOME (LOSS)
In accordance with U.S. generally accepted accounting principles

(All dollar amounts are expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

 
  Three Months Ended
June 30

  Six Months Ended
June 30

 
 
  2003
  2002
  2003
  2002
 
 
  (Restated —
note 2)

   
  (Restated —
note 2)

   
 
REVENUE                          
Product sales   $ 157,730   $ 157,788   $ 284,644   $ 287,642  
Research and development     3,673     5,802     6,273     11,515  
Co-promotion, royalty and licensing     55,880     21,541     117,756     41,227  
   
 
 
 
 
      217,283     185,131     408,673     340,384  
   
 
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     11,332     41,291     48,744     77,007  
Research and development     21,813     14,453     39,819     24,921  
Selling, general and administrative     55,593     39,512     102,301     78,338  
Amortization     45,886     14,019     86,407     26,528  
Acquired research and development     84,200         84,200      
Settlements     (9,300 )       (34,055 )    
   
 
 
 
 
      209,524     109,275     327,416     206,794  
   
 
 
 
 
Operating income     7,759     75,856     81,257     133,590  
Interest income     1,635     1,047     4,702     2,561  
Interest expense     (9,507 )   (10,104 )   (19,489 )   (11,797 )
Foreign exchange gain (loss)     (5,284 )   531     (10,125 )   20  
Other income (expense)     6,157     (66 )   6,664     (66 )
   
 
 
 
 
Income before provision for income taxes     760     67,264     63,009     124,308  
Provision for income taxes     5,700     4,707     10,350     8,700  
   
 
 
 
 
Net income (loss)   $ (4,940 ) $ 62,557   $ 52,659   $ 115,608  
   
 
 
 
 
Earnings (loss) per share                          
Basic   $ (0.03 ) $ 0.42   $ 0.33   $ 0.76  
   
 
 
 
 
Diluted   $ (0.03 ) $ 0.39   $ 0.33   $ 0.70  
   
 
 
 
 
Weighted average number of common shares outstanding (000s)                          
Basic     158,386     149,948     158,291     152,735  
   
 
 
 
 
Diluted     160,428     161,423     159,960     164,885  
   
 
 
 
 

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

 
 
  2003
  2002
  2003
  2002
 
 
  (Restated —
note 2)

   
  (Restated —
note 2)

   
 
Deficit, beginning of period   $ (522,814 ) $ (436,670 ) $ (580,413 ) $ (280,004 )
Net income (loss)     (4,940 )   62,557     52,659     115,608  
   
 
 
 
 
      (527,754 )   (374,113 )   (527,754 )   (164,396 )
Excess of cost of common shares acquired over the stated capital thereof         (148,815 )       (358,532 )
   
 
 
 
 
Deficit, end of period   $ (527,754 ) $ (522,928 ) $ (527,754 ) $ (522,928 )
   
 
 
 
 

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

 
 
  2003
  2002
 
 
  (Restated —
note 2)

   
 
CASH FLOWS FROM OPERATING ACTIVITIES              
Net income   $ 52,659   $ 115,608  

Add items not involving cash

 

 

 

 

 

 

 
Depreciation and amortization     94,355     32,025  
Amortization of deferred financing costs     1,369     1,160  
Amortization of discounts on long-term obligations     3,978     2,074  
Compensation cost for employee stock options     999     999  
Acquired research and development     84,200      
Other     1,478      
   
 
 
      239,038     151,866  
Net change in non-cash operating items     (64,847 )   (25,388 )
   
 
 
Cash provided by operating activities     174,191     126,478  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Acquisitions of intangible assets     (196,052 )   (383,302 )
Additions to property, plant and equipment     (16,572 )   (20,436 )
Increase in loan receivable     (5,000 )    
Acquisitions of long-term investments     (4,536 )   (70,694 )
Proceeds on disposal of intangible asset     10,000      
   
 
 
Cash used in investing activities     (212,160 )   (474,432 )
   
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 
Issuance of common shares, net of issue costs     10,332     5,232  
Repurchase of common shares         (452,001 )
Proceeds from the exercise of warrants         794  
Advances under revolving term credit facility     144,000     34,954  
Repayments of other long-term obligations     (70,386 )   (24,740 )
Issuance of Senior Subordinated Notes, net of financing costs         384,280  
   
 
 
Cash provided by (used in) financing activities     83,946     (51,481 )
   
 
 
Effect of exchange rate changes on cash and cash equivalents     535     49  
   
 
 
Increase (decrease) in cash and cash equivalents     46,512     (399,386 )
Cash and cash equivalents, beginning of period     56,080     434,891  
   
 
 
Cash and cash equivalents, end of period   $ 102,592   $ 35,505  
   
 
 

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.     RESTATEMENT AND RECLASSIFICATION OF COMPARATIVE FIGURES

 
  Three Months
Ended
June 30
2003

  Six Months
Ended
June 30
2003

 
Net income (loss) as previously reported   $ (1,012 ) $ 61,979  
Foreign exchange adjustments     (3,928 )   (9,320 )
   
 
 
Net income (loss) as restated   $ (4,940 ) $ 52,659  
   
 
 
Basic earnings (loss) per share              
As previously reported   $ (0.01 ) $ 0.39  
As restated   $ (0.03 ) $ 0.33  

Diluted earnings (loss) per share

 

 

 

 

 

 

 
As previously reported   $ (0.01 ) $ 0.39  
As restated   $ (0.03 ) $ 0.33  
   
 
 
 
  June 30 2003
Current portion of long-term obligations as previously reported   $ 92,285
Foreign exchange adjustment     9,320
   
Current portion of long-term obligations as restated   $ 101,605
   

5


3.     SIGNIFICANT ACCOUNTING POLICIES

 
  Three Months
Ended
June 30

  Six Months
Ended
June 30

 
  2003
  2002
  2003
  2002
 
  (Restated —
note 2)

   
  (Restated —
note 2)

   
Net income (loss) as reported   $ (4,940 ) $ 62,557   $ 52,659   $ 115,608
Total stock-based compensation expense determined under fair value-based method     4,201     3,627     9,441     6,636
   
 
 
 
Pro forma net income (loss)     (9,141 )   58,930     43,218     108,972
   
 
 
 
Basic earnings (loss) per share                        
As reported   $ (0.03 ) $ 0.42   $ 0.33   $ 0.76
Pro forma   $ (0.06 ) $ 0.39   $ 0.27   $ 0.71
Diluted earnings (loss) per share                        
As reported   $ (0.03 ) $ 0.39   $ 0.33   $ 0.70
Pro forma   $ (0.06 ) $ 0.37   $ 0.27   $ 0.66
   
 
 
 

6


 
  Three Months
Ended
June 30

  Six Months
Ended
June 30

 
  2003
  2002
  2003
  2002
Expected option life (years)   3.6   3.9   4.0   3.8
Volatility   46.9%   49.8%   52.3%   46.8%
Risk-free interest rate   3.6%   4.6%   4.0%   4.5%

4.     ACQUISITIONS

7


8


5.     ACCOUNTS RECEIVABLE

 
  June 30
2003

  December 31
2002

Trade   $ 123,363   $ 141,308
Royalties     45,764     30,104
Other     47,311     19,568
   
 
    $ 216,438   $ 190,980
   
 

6.     INVENTORIES

 
  June 30
2003

  December 31
2002

Raw materials   $ 34,330   $ 14,949
Work in process     11,942     11,901
Finished goods     31,164     26,197
   
 
    $ 77,436   $ 53,047
   
 

9


7.     INTANGIBLE ASSETS

 
  June 30, 2003
  December 31, 2002
 
  Cost
  Accumulated amortization
  Cost
  Accumulated amortization
Brand names   $ 703,026   $ 63,030   $ 596,223   $ 47,794
Product rights     612,569     125,513     571,105     55,531
Core technology     20,412     3,025     18,885     2,385
   
 
 
 
      1,336,007   $ 191,568     1,186,213   $ 105,710
         
       
less accumulated amortization     191,568           105,710      
   
       
     
    $ 1,144,439         $ 1,080,503      
   
       
     

8.     OTHER ASSETS

10


9.     LONG-TERM OBLIGATIONS

 
  June 30
2003

  December 31
2002

 
 
  (Restated —
note 2)

   
 
Senior Subordinated Notes   $ 400,000   $ 400,000  
Unamortized discount     (2,464 )   (2,646 )
Fair value adjustment     14,585     15,239  
   
 
 
      412,121     412,593  
Revolving term credit facility     254,000     110,000  
Wellbutrin® obligation     63,050     69,961  
Vasotec® obligation     56,819     67,942  
Zovirax obligation     41,419     80,656  
Ativan® obligation     17,497      
Deferred compensation     6,027     6,198  
   
 
 
      850,933     747,350  
Less current portion     101,605     122,590  
   
 
 
    $ 749,328   $ 624,760  
   
 
 

11


10.     COMMON SHARES

11.   SETTLEMENTS

12


12.   EARNINGS (LOSS) PER SHARE

 
  Three Months
Ended
June 30

  Six Months
Ended
June 30

 
  2003
  2002
  2003
  2002
 
  (Restated —
note 2)

   
  (Restated —
note 2)

   
Net income (loss)   $ (4,940 ) $ 62,557   $ 52,659   $ 115,608
   
 
 
 
Basic weighted average number of common shares outstanding (000s)     158,386     149,948     158,291     152,735
Dilutive effect of stock options (000s)     2,042     3,152     1,669     3,522
Dilutive effect of warrants (000s)         8,323         8,628
   
 
 
 
Diluted weighted average number of common shares outstanding (000s)     160,428     161,423     159,960     164,885
   
 
 
 
Basic earnings (loss) per share   $ (0.03 ) $ 0.42   $ 0.33   $ 0.76
Diluted earnings (loss) per share   $ (0.03 ) $ 0.39   $ 0.33   $ 0.70
   
 
 
 

13.   COMPREHENSIVE INCOME

 
  Three Months
Ended
June 30

  Six Months
Ended
June 30

 
 
  2003
  2002
  2003
  2002
 
 
  (Restated —
note 2)

   
  (Restated —
note 2)

   
 
Net income (loss)   $ (4,940 ) $ 62,557   $ 52,659   $ 115,608  
   
 
 
 
 
Other comprehensive income (loss)                          
Foreign currency translation adjustment     8,469     1,680     14,679     1,572  
Unrealized holding gain (loss) on long-term investments     10,590     (571 )   11,311     (571 )
   
 
 
 
 
Other comprehensive income     19,059     1,109     25,990     1,001  
   
 
 
 
 
Comprehensive income   $ 14,119   $ 63,666   $ 78,649   $ 116,609  
   
 
 
 
 

13


14.   CASH FLOW INFORMATION

 
  Six Months
Ended
June 30

 
 
  2003
  2002
 
Accounts receivable   $ (20,171 ) $ (42,443 )
Inventories     (23,833 )   (10,968 )
Deposits and prepaid expenses     4,554     (341 )
Accounts payable and accrued liabilities     (32,038 )   31,568  
Income taxes payable     6,551     7,194  
Deferred revenue     90     (10,398 )
   
 
 
    $ (64,847 ) $ (25,388 )
   
 
 

15.   LEGAL PROCEEDINGS

14


15


16.   SEGMENTED INFORMATION

17.   SUBSEQUENT EVENTS

16



BIOVAIL CORPORATION

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS (RESTATED)

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 Financial Condition and Results of Operations ("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 contained in our Annual Report on Form 20-F for the fiscal year ended December 31, 2002.

RESTATEMENT AND RECLASSIFICATION OF COMPARATIVE FIGURES

        During the course of the preparation of our annual consolidated financial statements, we determined that we had applied an inappropriate exchange rate to a Canadian dollar denominated long-term obligation. In December 2002, we acquired the rights, through a subsidiary whose functional currency is the U.S. dollar, to Wellbutrin® SR and Zyban in Canada from GlaxoSmithKline plc ("GSK") in a transaction denominated in Canadian dollars. At the date of acquisition, we recorded the acquired assets and the related long-term obligation in U.S. dollars at the exchange rate existing at that date. However, in our previously issued interim financial statements for 2003, we did not adjust the Wellbutrin® obligation to reflect changes in the exchange rate except for payments made on that obligation when a foreign exchange loss ($2.7 million in both the second quarter and first half of 2003) was recorded on those transactions. U.S. GAAP requires monetary balances denominated in a currency other than an entity's functional currency be translated to reflect the exchange rates in existence at each balance sheet date. Consequently, the translation of the Wellbutrin® obligation, using the exchange rates existing at March 31, 2003 and June 30, 2003, resulted in an increase in the net loss in the second quarter of 2003 from $1.0 million (basic and diluted loss per share of $0.01) as previously reported to $4.9 million (basic and diluted loss per share of $0.03) as restated, and a decrease in net income in the first half of 2003 from $62.0 million (basic and diluted earnings per share of $0.39) as previously reported to $52.7 million (basic and diluted earnings per share of $0.33) as restated. In addition, the current portion of long-term obligations increased from $92.3 million as previously reported to $101.6 million as restated.

        Prior to the fourth quarter of 2003, we included foreign exchange gains or losses as a component of selling, general and administrative expenses. During the course of the preparation of our annual consolidated financial statements, we decided to present foreign exchange gains or losses as an individual line item below operating income. Comparative figures have been reclassified to conform to this new presentation.

RESULTS OF OPERATIONS

        Total revenue in the second quarter of 2003 was $217.3 million, an increase of $32.2 million or 17% from $185.1 million in the second quarter of 2002. Net loss in the second quarter of 2003 was $4.9 million, or diluted loss per share of $0.03, compared to net income of $62.6 million, or diluted earnings per share of $0.39, in the second quarter of 2002.

        Total revenue in the first half of 2003 was $408.7 million, an increase of $68.3 million or 20% from $340.4 million in the first half of 2002. Net income in the first half of 2003 was $52.7 million, or diluted earnings per share of $0.33, compared to net income of $115.6 million, or diluted earnings per share of $0.70, in the first half of 2002.

REVENUE

        Our revenue is derived from sales of pharmaceutical products, providing research and development services, the co-promotion of pharmaceutical products, and from royalties and license fees. Product sales include sales of products developed and manufactured by us for distribution by our licensees and through direct

17



marketing to physicians in the United States and Canada of proprietary and in-licensed products. Research and development revenue relates to product development activities in collaboration with third parties and pharmaceutical contract research services. Fees for co-promotion services are earned on the sales of co-promoted products developed by other companies. Royalties primarily arise on the sales of products we developed or acquired and from our interests in certain licensed products. License fees are derived from the license of our technologies or product rights.

        The following table displays, for each period indicated, the dollar amount of each source of revenue and the total, and the percentage change in the dollar amount of each source and the total as compared to the corresponding prior year period.

 
  Three Months Ended June 30
  Six Months Ended June 30
 
[In 000s]

  2003
  2002
  Percentage Change
  2003
  2002
  Percentage Change
 
Product sales   $ 157,730   $ 157,788   —%   $ 284,644   $ 287,642   (1% )
Research and development     3,673     5,802   (37% )   6,273     11,515   (46% )
Co-promotion, royalty and licensing     55,880     21,541   159%     117,756     41,227   186%  
   
 
     
 
     
    $ 217,283   $ 185,131   17%   $ 408,673   $ 340,384   20%  
   
 
 
 
 
 
 

Product sales

        Product sales were $157.7 million in the second quarter of 2003 compared to $157.8 million in the second quarter of 2002. Product sales were $284.6 million in the first half of 2003 compared to $287.6 million in the first half of 2002.

        In February 2003, we received U.S. Food and Drug Administration ("FDA") approvals for Teveten® HCT and Cardizem® LA, each indicated for the treatment of hypertension. We began to actively promote Teveten® HCT and Cardizem® LA in March 2003 and April 2003, respectively, in collaboration with our co-promotion partner Reliant Pharmaceuticals, LLC ("Reliant"). In addition to Teveten® HCT and Cardizem® LA, our U.S. sales organization and Reliant are co-promoting our Zovirax and Teveten® products in the United States.

        In May 2003, we acquired the U.S. rights to Ativan® (lorazepam), indicated for the management of anxiety disorders, and Isordil® (isosorbide dinitrate), indicated for the prevention of angina pectoris due to coronary artery disease, from Wyeth Pharmaceuticals Inc. ("Wyeth").

        In June 2003, the FDA issued an approvable letter for Wellbutrin XL (bupropion hydrochloride extended-release tablets) for the treatment of depression. We expected to receive final approval for Wellbutrin XL in the third quarter of 2003 and, accordingly, in the second quarter of 2003 we began to manufacture and supply Wellbutrin XL to our marketing partner, GSK. On August 28, 2003, GSK received FDA approval for Wellbutrin XL.

        The added contribution from the aforementioned products, as well as from Wellbutrin® SR and Zyban® in Canada, was offset by a decline in sales of Cardizem® CD, Tiazac® in the United States, and our bioequivalent products. Sales of Cardizem® CD were impacted by a backlog in the supply of the product from the manufacturer, Aventis Pharmaceuticals, Inc. Sales of Tiazac® in the United States were impacted by the introduction of a bioequivalent version of the product by Andrx Corporation ("Andrx"). We have launched our own bioequivalent version of Tiazac® through our marketing partner, Forest Laboratories Inc., to compete with Andrx's product. In addition, we are entitled to receive a royalty from Andrx based on the net sales of its

18



product. Sales of bioequivalent products were below our expectations and we are working with our marketing partner, Teva Pharmaceuticals USA, Inc. ("Teva"), to address the reasons for the decline. As a result, for the balance of 2003 we anticipate that sales of our bioequivalent products and total product sales will be approximately $20 million to $30 million below our previous expectations.

        In July 2003, we launched Zovirax Cream, indicated for the treatment of cold sores.

Research and development

        Research and development activities generated revenue of $3.7 million in the second quarter of 2003 compared to $5.8 million in the second quarter of 2002, a decrease of $2.1 million or 37%. Research and development activities generated revenue of $6.3 million in the first half of 2003 compared to $11.5 million in the first half of 2002, a decrease of $5.2 million or 46%.

        In the second quarter and first half of 2002, research and development revenue included revenue associated with the development of Wellbutrin XL in collaboration with GSK. During 2002, we completed the development of Wellbutrin XL.

Co-promotion, royalty and licensing

        Co-promotion, royalty and licensing activities generated revenue of $55.9 million in the second quarter of 2003 compared to $21.5 million in the second quarter of 2002, an increase of $34.4 million or 159%. Co-promotion, royalty and licensing activities generated revenue of $117.8 million in the first half of 2003 compared to $41.2 million in the first half of 2002, an increase of $76.6 million or 186%.

        In the first quarter of 2003, we concluded our co-promotion of Wellbutrin SR in the United States and we earned the final quarterly increment of $10 million from GSK. In the second quarter and first half of 2002, we earned $10 million and $20 million, respectively, related to the co-promotion of Wellbutrin SR. Our remaining co-promotion revenue was related to the co-promotion of H. Lundbeck A/S' Celexa in Canada.

        Royalty revenue increased in the second quarter and first half of 2003 compared to the corresponding periods of 2002 due to the added contribution from our participating interest in the gross profit on sales by a third party of a bioequivalent version of Prilosec (omeprazole). In May 2003, we made an additional payment relative to the interest in omeprazole. Third party sales of omeprazole are exceeding our previous expectations. As a result, for the balance of 2003 we anticipate that our co-promotion, royalty and licensing revenue will be approximately $20 million above our previous expectations.

19



OPERATING EXPENSES

        The following table displays, for each period indicated, the dollar amount of each operating expense item and the total, and the percentage change in the dollar amount of each item and the total as compared to the corresponding prior year period.

 
  Three Months Ended June 30
  Six Months Ended June 30
 
[In 000s]

  2003
  2002
  Percentage Change
  2003
  2002
  Percentage Change
 
Cost of goods sold   $ 11,332   $ 41,291   (73% ) $ 48,744   $ 77,007   (37% )
Research and development     21,813     14,453   51%     39,819     24,921   60%  
Selling, general and administrative     55,593     39,512   41%     102,301     78,338   31%  
Amortization     45,886     14,019   227%     86,407     26,528   226%  
Acquired research and development     84,200       —%     84,200       —%  
Settlements     (9,300 )     —%     (34,055 )     —%  
   
 
     
 
     
    $ 209,524   $ 109,275   92%   $ 327,416   $ 206,794   58%  
   
 
 
 
 
 
 

Cost of goods sold and gross margins

        Cost of goods sold was $11.3 million in the second quarter of 2003 compared to $41.3 million in the second quarter of 2002, a decrease of $30.0 million or 73%. Cost of goods sold was $48.7 million in the first half of 2003 compared to $77.0 million in the first half of 2002, a decrease of $28.3 million or 37%. Gross margins based on product sales were 93% and 83% in the second quarter and first half of 2003, respectively, compared to 74% and 73% in the second quarter and first half of 2002, respectively.

        The decreases in cost of goods sold, and the related increases in the gross margins, in the second quarter and first half of 2003 compared to the corresponding periods of 2002 were mainly related to Zovirax. Effective October 1, 2002, we amended several terms of the original Zovirax distribution agreement with GSK, including a reduction in the supply price for the product. We have been paying the reduced supply price since the effective date; however, the reduced supply price is subject to repayment if Wellbutrin XL is not approved by the FDA. Accordingly, we have been deferring the value of the reduced supply price pending the outcome of the product approval. In June 2003, GSK received an approvable letter relating to Wellbutrin XL, which raised only routine matters. As a result, we believe that the likelihood of repaying the reduced supply price is low and, accordingly, we have reversed the liability for the deferred value of the reduced supply price. The reversal of the aggregate deferred value of $25.5 million, as of the date of the approvable letter, was recorded as a reduction to the cost of Zovirax sold in the second quarter of 2003.

Research and development

        Research and development expenses were $21.8 million in the second quarter of 2003 compared to $14.5 million in the second quarter of 2002, an increase of $7.3 million or 51%. As a percentage of total revenue, research and development expenses were 10% in the second quarter of 2003 compared to 8% in the second quarter of 2002. Research and development expenses were $39.8 million in the first half of 2003 compared to $24.9 million in the first half of 2002, an increase of $14.9 million or 60%. As a percentage of total revenue, research and development expenses were 10% in the first half of 2003 compared to 7% in the first half of 2002.

        Research and development expenses reflect direct spending on the development of products utilizing advanced oral drug delivery technologies. In the ordinary course of business, we enter into research and development collaborations with third parties to provide formulation and other services for our products under

20



development. Those third party developers are typically compensated through a combination of fees for service, milestone payments and/or royalty payments from future sales of the products under development.

        The increase in research and development expenses in the second quarter and first half of 2003 compared to the corresponding periods of 2002 reflected an increase in clinical activity to support the June 2003 submission of a supplemental New Drug Application ("NDA") for an angina indication for Cardizem® LA, as well as to support the upcoming NDA submissions for our once-daily formulations of tramadol, for the signs and symptoms of osteoarthritis, and metformin, for the treatment of Type II diabetes. Additional products under development in the second quarter and first half of 2003 compared to the corresponding periods of 2002 include clinically enhanced versions of venlafaxine, fenofibrate, acyclovir, simvastatin, sumatriptan and lorazepam, as well as four cardiovascular products being developed by us in collaboration with Athpharma Limited ("Athpharma"). In addition, research and development expenses in the second quarter of 2003 included the costs associated with a clinical experience program designed to evaluate the use of Cardizem® LA in a clinical practice setting.

Selling, general and administrative

        Selling, general and administrative expenses were $55.6 million in the second quarter of 2003 compared to $39.5 million in the second quarter of 2002, an increase of $16.1 million or 41%. As a percentage of total revenue, selling, general and administrative expenses were 26% in the second quarter of 2003 compared to 21% in the second quarter of 2002. Selling, general and administrative expenses were $102.3 million in the first half of 2003 compared to $78.3 million in the first half of 2002, an increase of $24.0 million or 31%. As a percentage of total revenue, selling, general and administrative expenses were 25% in the first half of 2003 compared to 23% in the first half of 2002.

        The increases in selling, general and administrative expenses in the second quarter and first half of 2003 compared to the corresponding periods of 2002 reflected an increase in costs associated with our expanded U.S. sales organization, as well as increases in advertising and promotion expenses and co-promotion fees payable to Reliant. In the second quarter of 2003, all previously deferred advertising costs related to Cardizem® LA were expensed on the launch of the product. Advertising costs related to Teveten® and Teveten® HCT were recorded net of a $6 million and $8.5 million marketing allowance paid by Solvay Pharmaceuticals Marketing & Licensing AG in the second quarter and first half of 2003, respectively. Effective April 1, 2003, we amended certain terms of our co-promotion agreement with Reliant such that Reliant is responsible for its pro-rata share of the advertising and promotion costs incurred during 2003 related to the co-promoted products. As a result, we are able to increase the level of spending on advertising and promotion related to the co-promoted products during 2003. The terms of the amended co-promotion agreement also increased Reliant's interest in the net sales of the co-promoted products.

Amortization

        Amortization expense was $45.9 million in the second quarter of 2003 compared to $14.0 million in the second quarter of 2002, an increase of $31.9 million or 227%. Amortization expense was $86.4 million in the first half of 2003 compared to $26.5 million in the first half of 2002, an increase of $59.9 million or 226%. As a percentage of total revenue, amortization expense was 21% in both the second quarter and first half of 2003 compared to 8% in both the second quarter and first half of 2002.

        The increases in amortization expense in the second quarter and first half of 2003 compared to the corresponding periods of 2002 primarily reflected the incremental amortization of the interest in omeprazole, as well as the incremental amortization associated with other acquired intangible assets.

21



Acquired research and development

        In April 2003, we entered into an agreement with Athpharma to acquire four cardiovascular products under development for $44.2 million. The four products under development are Bisochron (bisoprolol), a beta-1 selective beta-blocker formulation for the treatment of hypertension, Isochron (isosorbide-5-mononitrate), a long-acting nitrate formulation for the treatment of angina, and Hepacol I (pravastatin) and Hepacol II (simvastatin), two liver- selective statin formulations for the treatment of high cholesterol.

        In May 2003, in connection with our acquisition of Ativan® and Isordil®, we also acquired a license to use certain technologies relating to Wyeth's Canadian sublingual version of Ativan® to develop new Ativan® sublingual products to be sold in the United States. The purchase price for Ativan® and Isordil® included $40 million allocated to the Ativan® sublingual products under development. As of August 29, 2003, the purchase price allocation for Ativan® and Isordil® has not been finalized. We are in the process of obtaining a third party valuation of the acquired assets and expect to receive the final valuation report during the third quarter of 2003. Accordingly, the preceding purchase price allocated to the sublingual products could be subject to adjustment.

        At the dates of acquisition, the acquired products were in various stages of completion, had not reached technological feasibility and had no known alternative future uses. In addition, none of the acquired products had been submitted for approval by the FDA. Consequently, there was considerable uncertainty as to the technological feasibility of the acquired products at the dates of acquisition. The research being undertaken on the acquired products relates specifically to developing novel formulations of the associated molecules. We do not foresee any alternative future benefit from the acquired research and development other than specifically related to the acquired products under development. There is significant technological and regulatory approval risk associated with the acquired products under development. The completion of the acquired products will require significant amounts of future time and effort, as well as additional development costs, which we will incur. We estimate that our share of the aggregate costs to complete the cardiovascular products will be $20 million and that our costs to complete the sublingual products will be $23.5 million. The efforts required to develop the acquired research and development into commercially viable products include the completion of the development stages of the products, clinical-trial testing, regulatory approval and commercialization. The principal risks relating to the acquired products under development are the outcomes of the formulation development, clinical studies and regulatory filings. Since pharmaceutical products cannot be marketed without regulatory approvals, we will not receive any benefits unless regulatory approval is obtained. Accordingly, the consideration for the acquired products was allocated to acquired research and development, which was expensed at the dates of acquisition.

Settlements

        In the second quarter of 2003, we negotiated an overall settlement with Pfizer Inc. ("Pfizer"), Bayer AG, Bayer Corporation, Teva, Mylan Pharmaceuticals Inc. ("Mylan") and Mylan Laboratories Inc. through which all pending actions relating to bioequivalent versions of Procardia XL ("Nifedical XL") and Adalat CC, including actions alleging patent infringement and antitrust breaches, were dismissed. In addition, in the second quarter of 2003, we settled with Elan Corporation, plc ("Elan") with respect to the termination of our rights to Elan's 30 mg and 60 mg bioequivalent versions of Adalat CC. In the first quarter of 2003, we reached settlements with Eli Lilly and Company ("Lilly"), with respect to Lilly's breach of contract due to its inability to supply us with Keftab, and with Mylan, with respect to Mylan's breach of contract relating to its supply to us of its bioequivalent version of Verelan ("Verapamil").

        During the six months ended June 30, 2003, in relation to the matters described above, we recorded settlement payments of $34.1 million, mainly related to our lost profits on sales of Nifedical XL, Keftab and

22



Verapamil and additional payments of $16.2 million, mainly related to a reduction in cost of goods sold, a reimbursement of legal and other expenses, and interest income. We recorded a $3.5 million increase in our provision for income taxes related to those items. In addition, we recorded a $14.6 million reduction in assets related to the recoverable value of the Keftab product right and the long-term receivable from Lilly.

OPERATING INCOME

        Operating income was $7.8 million in the second quarter of 2003 compared to $75.9 million in the second quarter of 2002, a decrease of $68.1 million or 90%. Operating income was $81.3 million in the first half of 2003 compared to $133.6 million in the first half of 2002, a decrease of $52.3 million or 39%.

        The decreases in operating income in the second quarter and first half of 2003 compared to the corresponding periods of 2002 were mainly due to the charge for acquired research and development in the second quarter of 2003, partly offset by the recognition of the aggregate value of the lower Zovirax supply price and our settlements with Pfizer et al, Lilly and Mylan.

NON-OPERATING ITEMS

Interest income and expense

        Interest income was $1.6 million and $4.7 million in the second quarter and first half of 2003, respectively, compared to $1.0 million and $2.6 million in the second quarter and first half of 2002, respectively. Interest income included interest earned on our investment portfolio, which is comprised primarily of high-grade government and corporate securities.

        Interest expense was $9.5 million in the second quarter of 2003 compared to $10.1 million in the second quarter of 2002, a decrease of $0.6 million or 6%. Interest expense was $19.5 million in the first half of 2003 compared to $11.8 million in the first half of 2002, an increase of $7.7 million or 65%. Interest expense mainly comprised interest on our 77/8% Senior Subordinated Notes due April 1, 2010 ("Notes"). In June 2002, we entered into three interest rate swap contracts, of aggregate $200 million notional amount, which involve the receipt of amounts based on a fixed rate of 77/8% in exchange for floating rate interest payments based on six-month London Interbank Offering Rate ("LIBOR") plus a spread. Net receipts or payments relating to the interest rate swaps are recorded as an adjustment to interest expense.

Foreign exchange gain or loss

        We recorded foreign exchange losses of $5.3 million and $10.1 million in the second quarter and first half of 2003, respectively, compared to foreign exchange gains of $0.5 million and $20 thousand in the second quarter and first half of 2002, respectively. The foreign exchange losses in the second quarter and first half of 2003 were primarily related to the translation to U.S. dollars of our Canadian dollar denominated obligation to GSK for the rights to Wellbutrin® SR and Zyban in Canada, and were the result of a strengthening of the Canadian dollar relative to the U.S. dollar during those periods.

Other income and expense

        Prior to April 1, 2003, the interest rate swaps effectively modified our exposure to interest rate fluctuations by converting the interest payable on one-half of our fixed rate Notes to a floating rate. Accordingly, the change in the fair values of the interest rate swaps and the offsetting change in the fair value of the portion of our Notes being hedged were recognized in other income (expense). The net gain or loss recognized prior to April 1, 2003 related to the ineffective portion of the fair value hedge.

23



        On June 30, 2003, we determined that, effective April 1, 2003, the interest rate swaps no longer qualified as a highly effective hedge and, accordingly, we discontinued the application of hedge accounting as of April 1, 2003. As a result, for the period from April 1, 2003 to June 30, 2003, the change in the fair values of the interest rate swaps were recognized in other income; however, the Notes were not adjusted for the change in their fair value during that period. In the second quarter and first half of 2003, we recorded other income of $6.2 million and $6.7 million, respectively, related to the change in the fair values of the interest rate swaps, as well as the change in the fair value of the Notes recognized prior to the termination of hedge accounting.

Provision for income taxes

        Our tax rate was affected by the relative profitability of our operations in various foreign tax jurisdictions. We recorded provisions for income taxes of $5.7 million and $10.4 million in the second quarter and first half of 2003, respectively, compared to $4.7 million and $8.7 million in the second quarter and first half of 2002, respectively. The low 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. In addition, our effective tax rate was affected by the low profitability of our operations in the United States due to the expansion of our sales organization and sales and marketing expenses related to new product launches.

LIQUIDITY AND CAPITAL RESOURCES

        At June 30, 2003, we had cash and cash equivalents of $102.6 million compared to cash and cash equivalents of $56.1 million at December 31, 2002. We also maintain a $600 million revolving term credit facility, which may be used for general corporate purposes, including acquisitions. At June 30, 2003, we were in compliance with all financial and non-financial covenants associated with our credit facility. At June 30, 2003, we had advances of $254 million borrowed under our credit facility and we had a letter of credit with a balance of $77.2 million issued under our credit facility. The letter of credit secures the remaining semi-annual payments we are required to make under the Vasotec® and Vaseretic® agreement.

        In the first half of 2003, cash provided by operating activities was $174.2 million comprising net income, after adjustments for items not involving cash, of $239.0 million and net changes in non-cash operating items that used cash of $64.8 million, mainly due to increases in accounts receivable and inventories, and decreases in accounts payable and accrued liabilities. In the first half of 2002, cash provided by operating activities was $126.5 million comprising net income, after adjustments for items not involving cash, of $151.9 million and net changes in non-cash operating items that used cash of $25.4 million, mainly due to increases in accounts receivable and inventories and a decrease in deferred revenue, offset by increases in accounts payable and accrued liabilities.

        Net cash used in investing activities was $212.2 million in the first half of 2003 compared to $474.4 million in the first half of 2002. In the first half of 2003, we acquired $196.1 million of intangible assets including initial payments of $139.3 million for Ativan® and Isordil®, $33 million relative to the interest in omeprazole and an initial payment of $21.2 million for the Athpharma cardiovascular products. In the first half of 2002, we acquired $383.3 million of intangible assets comprising initial payments of $155.6 million for Vasotec® and Vaseretic®, $133.4 million for Zovirax and $94.3 million for Teveten®. Additions to property, plant and equipment were $16.6 million in the first half of 2003 compared to $20.4 million in the first half of 2002. In the first half of 2003, we advanced an additional $5 million, for a total of $35 million, to Reliant under its secured credit facility with us. In the first half of 2003, we acquired long-term investments of $4.5 million including an additional $3.5 million equity investment in DepoMed, Inc. In the first half of 2002, we acquired long-term investments of $70.7 million comprising equity investments in Ethypharm S.A. and Procyon Biopharma Inc. of $68.2 million

24



and $2.5 million, respectively. In the first half of 2003, we recorded $10 million of the Lilly settlement payment, related to the recoverable value of the Keftab product rights, as proceeds on the disposal of intangible assets.

        Net cash provided by financing activities was $83.9 million in the first half of 2003 compared to net cash used in financing activities of $51.5 million in the first half of 2002. Proceeds from the issuance of common shares on the exercise of stock options and warrants were $10.3 million in the first half of 2003 compared to $6.0 million in the first half of 2002. In the first half of 2002, we repurchased 11.0 million of our common shares on the open market, under our stock repurchase program, at an average purchase price of $41.60 per share for total consideration of $452.0 million. We borrowed $144.0 million under our credit facility in the first half of 2003 compared to $35.0 million in the first half of 2002. In the first half of 2003, we repaid $70.4 million of long-term obligations comprising $40 million of the Zovirax obligation, $17.5 million of the Wellbutrin® obligation and $12.9 million of the Vasotec® obligation. In the first half of 2002, we repaid $24.7 million of long-term obligations comprising $17.2 million of the Vasotec® obligation and $7.5 million of the Adalat obligation. In the first half of 2002, we received net proceeds of $384.3 million on the issue of our Notes.

        Overall, our cash and cash equivalents increased by $46.5 million in the first half of 2003 and decreased by $399.4 million in the first half of 2002.

Obligations and other matters

        At June 30, 2003, we had total long-term obligations of $850.9 million, including the current portion thereof, which included the carrying value of our Notes of $412.1 million, borrowings under our credit facility of $254 million and obligations related to the acquisitions of intangible assets of aggregate $178.8 million.

        On November 5, 2001, we filed a $1.5 billion base shelf prospectus with the Canadian provincial securities commissions covering the potential sale of any combination of common shares, debt securities or warrants. On the same date, we filed a registration statement on Form F-10 covering those securities with the U.S. Securities and Exchange Commission ("SEC") under the multijurisdictional disclosure system. We may offer one or more of these types of securities in one or more offerings during the succeeding 25 months. One or more shareholders may also sell common shares pursuant to the base shelf prospectus. We will not receive any of the proceeds from any sale of common shares by the selling shareholders.

        At June 30, 2003, we had a balance of $424.4 million available under our base shelf prospectus to offer at our discretion. Our base shelf prospectus will expire in December 2003.

        We believe that the cash expected to be generated by our operations during 2003 along with existing capital resources and sources of financing will be sufficient to support our remaining 2003 operational, capital expenditure and interest requirements, as well as to meet our obligations as they become due.

        In June 2003, we agreed to increase our total commitment to the credit facility established in favour of Reliant from $40 million to $70 million. At August 29, 2003, we had advanced a total of $70 million to Reliant under the credit facility.

        In July 2003, we established a limited liability company together with Pharma Pass II, LLC ("PPII") to develop super-bioavailable formulations of Coreg, Flomax and Teveten®. Coreg (carvedilol) is a beta-blocker indicated for the treatment of congestive heart failure and Flomax (tamsulosin) is indicated for the treatment of benign prostatic hyperplasia. PPII contributed all of its intellectual property relating to those products for a 51% interest in the company and we contributed cash in the amount of $30.1 million for a 49% interest in the company.

25



        In August 2003, we entered into a lease for 110,000 square feet of office space in Bridgewater, NJ where we will be establishing our U.S. head office. Certain sales and marketing, and research and development personal will be relocated to the new facility. We expect to complete this transition prior to the end of 2003.

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 currently use derivative financial instruments to manage our exposure to interest rate risk. 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 transacted in U.S. dollars. Our only other significant transactions are in Canadian dollars. A 10% change in foreign currency exchange rates would have a material effect on our consolidated results of operations, financial position or cash flows.

Interest rate risk

        The primary objective of our investment policy is the protection of principal and, accordingly, we invest in high-grade government and corporate securities with varying maturities, but typically less than 90 days. External independent fund administrators manage our investments. As it is our intent and policy to hold these investments until maturity, we do not have a material exposure to interest rate risk.

        We are exposed to interest rate risk on borrowings under our credit facility. Our credit facility bears interest based on LIBOR, 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, therefore, the fair values of those obligations are affected by changes in interest rates.

        The fair value of our fixed rate Notes is affected by changes in interest rates. We manage this exposure to interest rate changes through the use of interest rate swaps, which modify our exposure to interest rate fluctuations by converting one-half of our fixed rate Notes to floating rate.

        Based on our overall interest rate exposure at June 30, 2003, a 10% change in interest rates would not have a material effect on our consolidated results of operations, financial position or cash flows.

Investment risk

        We are exposed to investment risks on our cost method and available-for-sale investments in other companies. The fair values of our investments are subject to significant fluctuations due to stock market volatility and changes in general economic conditions. We regularly review the carrying values of our investments and record losses when events and circumstances indicate that there have been declines in their fair values. A 10% change in the aggregate fair values of our investments would have a material effect on our consolidated results of operations; however, it would not have a material effect on our consolidated financial position or cash flows.

26



RECENT ACCOUNTING PRONOUNCEMENTS

        In November 2002, the Financial Accounting Standards Board ("FASB") issued FASB Interpretation ("FIN") No. 45, "Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others". FIN No. 45 clarifies and expands on existing disclosure requirements for a guarantor regarding its obligations under certain guarantees it has issued. FIN No. 45 also requires that the guarantor must recognize a liability for the fair value of its obligations under certain guarantees. The provisions of FIN No. 45 are effective for guarantees entered into after December 31, 2002. At June 30, 2003, we had no outstanding guarantees.

        In January 2003, the FASB issued FIN No. 46, "Consolidation of Variable Interest Entities". FIN No. 46 requires consolidation of a variable interest entity by the primary beneficiary of the entity's expected results of operations. FIN No. 46 also requires certain disclosures by all holders of a significant variable interest in a variable interest entity that are not the primary beneficiary. FIN No. 46 is effective immediately for variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, FIN No. 46 is effective in the first interim or annual period beginning after June 15, 2003. We are performing a review to determine if we are the primary beneficiary of any variable interest entities. We will complete this review in the third quarter of 2003. Provided that we are not the primary beneficiary, the maximum exposure to losses related to any entity that may be determined to be a variable interest entity is limited to the carrying amount of our investment in the entity.

        In May 2003, the FASB issued Statement of Financial Accounting Standards ("SFAS") No. 149, "Amendment of Statement 133 on Derivative Instruments and Hedging Activities". SFAS No. 149 amends and clarifies the accounting for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities under SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities". SFAS No. 149 is effective for contracts entered into or modified after June 30, 2003 and for hedging relationships designated after June 30, 2003. We do not expect that the initial adoption of SFAS No. 149 will have a material effect on our financial position or results of operations.

        In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity". SFAS No. 150 establishes standards for the measurement and classification of certain financial instruments with characteristics of both liabilities and equity. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003. The initial adoption of SFAS No. 150 had no effect on our financial position or results of operations.

FORWARD-LOOKING STATEMENTS

        To the extent any statements made or incorporated by reference in this MD&A contain information that is not historical, these statements are essentially forward-looking. As such, these statements are subject to risks and uncertainties, including the difficulty of predicting FDA and Canadian Therapeutic 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, availability of raw materials, production interruptions or supply delays at third party suppliers or at our own manufacturing facilities, the outcome of litigation, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in our filings with the SEC, including the risks set forth in Item 3 of our Annual Report on Form 20-F for the fiscal year ended December 31, 2002, and securities commissions or other securities regulatory authorities in Canada.

27



BIOVAIL CORPORATION

PART II — OTHER INFORMATION

1. OPERATIONAL INFORMATION

 

The press releases issued by the Company subsequent to the filing of its Form 6-K on May 30, 2003 were as follows:

 

(a)

June 2, 2003

 

Biovail Acquires Ativan® and Isordil® from Wyeth
  (b) June 2, 2003   Biovail Corporation to Present at UBS Warburg Global Specialty Pharmaceutical Conference
  (c) June 5, 2003   Biovail Appoints Praveen Tyle Group Vice President, Pharmaceutical Sciences and Manufacturing Operations
  (d) June 26, 2003   Biovail Announces Receipt of an Approvable Letter for Wellbutrin XL
  (e) July 2, 2003   Biovail Submits Cardizem® LA NDA for Angina
  (f) July 9, 2003   Biovail Confirms Submission of Response to Wellbutrin XL Approvable Letter
  (g) July 22, 2003   Biovail Announces Second Quarter 2003 Earnings Release Conference Call Details
  (h) July 23, 2003   Biovail Confirms FDA Class I Status for Wellbutrin XL Submission
  (i) July 29, 2003   Biovail Reports Record Second Quarter 2003 Financial Results
  (j) August 22, 2003   Biovail Receives Administrative Inquiry
  (k) August 29, 2003   FDA Approves Wellbutrin XL

2.

LEGAL PROCEEDINGS

 

For detailed information concerning legal proceedings, reference is made to note 15 to the consolidated financial statements included under Part I of this report and to Item 8.A. of the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2002.

3.

EXHIBITS

 

Exhibit 99.1

 

Second Quarter 2003 Interim Report For Canadian Regulatory Purposes (Restated)

 

Exhibit 99.2

 

Certifications of the Chief Executive Officer and Chief Financial Officer


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 14, 2004

 

By:

 

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

28




QuickLinks

BIOVAIL CORPORATION QUARTERLY REPORT
INDEX PART I — FINANCIAL INFORMATION
PART II — OTHER INFORMATION
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF INCOME
CONSOLIDATED STATEMENTS OF DEFICIT
CONSOLIDATED STATEMENTS OF CASH FLOWS
BIOVAIL CORPORATION MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (RESTATED) In accordance with U.S. generally accepted accounting principles (All dollar amounts are expressed in U.S. dollars)
PART II — OTHER INFORMATION
SIGNATURES