QuickLinks -- Click here to rapidly navigate through this document

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549



FORM 6-K

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

For the Quarterly Period Ended March 31, 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 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 March 31, 2003 and December 31, 2002

 

2
  Consolidated Statements of Income for the three months ended March 31, 2003 and 2002   3
  Consolidated Statements of Deficit for the three months ended March 31, 2003 and 2002   4
  Consolidated Statements of Cash Flows for the three months ended March 31, 2003 and 2002   5
  Condensed Notes to the Consolidated Financial Statements   6

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

 

11

Quantitative and Qualitative Disclosure about Market Risk

 

17


PART II — OTHER INFORMATION

Operational Information   20

Legal Proceedings

 

21

Material Issued to Shareholders

 

21

Certifications

 

21

         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®, CEFORM™, Shearform™, FlashDose®, Instatab™, SportSafe™, DrinkUp™ and Cardisense®.

1




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)

 
  March 31
2003

  December 31
2002

 
 
  (Unaudited)

  (Audited)

 
ASSETS              
Current              
Cash and cash equivalents   $ 13,225   $ 56,080  
Accounts receivable     198,923     190,980  
Inventories     65,475     53,047  
Deposits and prepaid expenses     25,433     21,524  
   
 
 
      303,056     321,631  
Long-term investments     80,330     79,324  
Property, plant and equipment, net     146,094     136,784  
Goodwill, net     102,316     102,212  
Intangible assets, net     1,032,995     1,080,503  
Other assets, net     108,575     113,350  
   
 
 
    $ 1,773,366   $ 1,833,804  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 59,173   $ 71,641  
Accrued liabilities     99,709     95,289  
Income taxes payable     38,470     35,691  
Deferred revenue     32,850     19,947  
Current portion of long-term obligations     113,196     122,590  
   
 
 
      343,398     345,158  
Deferred revenue     17,050     18,200  
Long-term obligations     496,299     624,760  
   
 
 
      856,747     988,118  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares, no par value, unlimited shares authorized, 158,251,371 and 158,120,144 issued and outstanding at March 31, 2003 and December 31, 2002, respectively     1,435,313     1,433,624  
Stock options outstanding     4,178     4,856  
Executive Stock Purchase Plan loans     (9,988 )   (9,988 )
Deficit     (517,422 )   (580,413 )
Accumulated other comprehensive income (loss)     4,538     (2,393 )
   
 
 
      916,619     845,686  
   
 
 
    $ 1,773,366   $ 1,833,804  
   
 
 

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

2



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, except per share data)
(Unaudited)

 
  Three Months Ended
March 31

 
 
  2003
  2002
 
REVENUE              
Product sales   $ 126,914   $ 129,854  
Research and development     2,600     5,713  
Co-promotion, royalty and licensing     61,876     19,686  
   
 
 
      191,390     155,253  
   
 
 

EXPENSES

 

 

 

 

 

 

 
Cost of goods sold     37,412     35,716  
Research and development     18,006     10,468  
Selling, general and administrative     46,157     39,337  
Amortization     40,521     12,509  
Recovery from product supply agreements     (24,755 )    
   
 
 
      117,341     98,030  
   
 
 
Operating income     74,049     57,223  
Interest income     3,067     1,514  
Interest expense     (9,982 )   (1,693 )
Other income     507      
   
 
 
Income before provision for income taxes     67,641     57,044  
Provision for income taxes     4,650     3,993  
   
 
 
Net income   $ 62,991   $ 53,051  
   
 
 
Earnings per share              
Basic   $ 0.40   $ 0.35  
   
 
 
Diluted   $ 0.39   $ 0.32  
   
 
 
Weighted average number of common shares outstanding (000s)              
Basic     158,197     153,668  
   
 
 
Diluted     159,493     166,493  
   
 
 

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

3



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
March 31

 
 
  2003
  2002
 
Deficit, beginning of period   $ (580,413 ) $ (280,004 )
Net income     62,991     53,051  
   
 
 
      (517,422 )   (226,953 )
Excess of cost of common shares acquired over the stated capital thereof         (209,717 )
   
 
 
Deficit, end of period   $ (517,422 ) $ (436,670 )
   
 
 

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

4



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)

 
  Three Months Ended
March 31

 
 
  2003
  2002
 
CASH FLOWS FROM OPERATING ACTIVITIES              
Net income   $ 62,991   $ 53,051  

Add (deduct) items not involving cash

 

 

 

 

 

 

 
Depreciation and amortization     44,174     15,104  
Amortization of deferred financing costs     684     380  
Amortization of discounts on long-term obligations     2,090     693  
Compensation cost for employee stock options     500     500  
Other     (1,685 )    
   
 
 
      108,754     69,728  
Net change in non-cash operating items     (4,952 )   41,689  
   
 
 
Cash provided by operating activities     103,802     111,417  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Additions to property, plant and equipment     (8,368 )   (8,149 )
Acquisition of intangible assets         (227,000 )
Acquisition of long-term investment         (2,509 )
   
 
 
Cash used in investing activities     (8,368 )   (237,658 )
   
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 
Issuance of common shares, net of issue costs     1,689     3,326  
Repurchase of common shares         (260,291 )
Proceeds from the exercise of warrants         306  
Repayments under revolving term credit facility     (100,000 )    
Repayments of other long-term obligations     (40,000 )   (4,000 )
Issuance of Senior Subordinated Notes, net of financing costs         384,280  
   
 
 
Cash provided by (used in) financing activities     (138,311 )   123,621  
   
 
 
Effect of exchange rate changes on cash and cash equivalents     22     1  
   
 
 
Decrease in cash and cash equivalents     (42,855 )   (2,619 )
Cash and cash equivalents, beginning of period     56,080     434,891  
   
 
 
Cash and cash equivalents, end of period   $ 13,225   $ 432,272  
   
 
 

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

5


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

 
  Three Months Ended
March 31

 
  2003
  2002
Net income as reported   $ 62,991   $ 53,051
Total stock-based compensation expense determined under fair value-based method     5,240     3,009
   
 
Pro forma net income     57,751     50,042
   
 
Basic earnings per share            
As reported   $ 0.40   $ 0.35
Pro forma   $ 0.37   $ 0.33
Diluted earnings per share            
As reported   $ 0.39   $ 0.32
Pro forma   $ 0.36   $ 0.30

6


 
  Three Months Ended March 31
 
  2003
  2002
Expected option life (years)   4.0   3.7
Volatility   53.6%   44.2%
Risk-free interest rate   4.1%   4.5%

3.     INVENTORIES

 
  March 31 2003
  December 31 2002
Raw materials   $ 23,304   $ 14,949
Work in process     13,376     11,901
Finished goods     28,795     26,197
   
 
    $ 65,475   $ 53,047
   
 

7


4.     INTANGIBLE ASSETS

 
  March 31, 2003
  December 31, 2002
 
  Cost
  Accumulated amortization
  Cost
  Accumulated amortization
Brand names   $ 596,223   $ 55,428   $ 596,223   $ 47,794
Product rights     563,812     87,797     571,105     55,531
Core technology     18,885     2,700     18,885     2,385
   
 
 
 
      1,178,920   $ 145,925     1,186,213   $ 105,710
         
       
Less accumulated amortization     145,925           105,710      
   
       
     
    $ 1,032,995         $ 1,080,503      
   
       
     

5.     LONG-TERM OBLIGATIONS

 
  March 31 2003
  December 31 2002
 
Senior Subordinated Notes   $ 400,000   $ 400,000  
Unamortized discount     (2,555 )   (2,646 )
Fair value adjustment     15,129     15,239  
   
 
 
      412,574     412,593  
Wellbutrin® obligation     70,617     69,961  
Vasotec® obligation     68,904     67,942  
Zovirax obligation     41,037     80,656  
Revolving term credit facility     10,000     110,000  
Deferred compensation     6,363     6,198  
   
 
 
      609,495     747,350  
Less current portion     113,196     122,590  
   
 
 
    $ 496,299   $ 624,760  
   
 
 

8


6.     COMMON SHARES

7.     RECOVERY FROM PRODUCT SUPPLY AGREEMENTS

8.     EARNINGS PER SHARE

 
  Three Months Ended
March 31

 
  2003
  2002
Net income   $ 62,991   $ 53,051
   
 
Basic weighted average number of common shares outstanding (000s)     158,197     153,668
Dilutive effect of stock options (000s)     1,296     3,892
Dilutive effect of warrants (000s)    
    8,933
   
 
Diluted weighted average number of common shares outstanding (000s)     159,493     166,493
   
 
Basic earnings per share   $ 0.40   $ 0.35
Diluted earnings per share   $ 0.39   $ 0.32
   
 

9


9.     COMPREHENSIVE INCOME

 
  Three Months Ended
March 31

 
 
  2003
  2002
 
Net income   $ 62,991   $ 53,051  
   
 
 
Other comprehensive income (loss)              
Foreign currency translation adjustment     6,210     (108 )
Unrealized holding gain on long-term investments     721      
   
 
 
Other comprehensive income (loss)     6,931     (108 )
   
 
 
Comprehensive income   $ 69,922   $ 52,943  
   
 
 

10.   CASH FLOW INFORMATION

 
  Three Months Ended
March 31

 
 
  2003
  2002
 
Accounts receivable   $ 7,074   $ 28,186  
Inventories     (12,293 )   (4,277 )
Deposits and prepaid expenses     (3,909 )   459  
Accounts payable and accrued liabilities     (10,362 )   17,693  
Income taxes payable     2,784     4,453  
Deferred revenue     11,754     (4,825 )
   
 
 
    $ (4,952 ) $ 41,689  
   
 
 

11.   SEGMENTED INFORMATION

12.   SUBSEQUENT EVENT

10



BIOVAIL CORPORATION

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

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.

ACQUISITION

        In April 2003, we entered into an agreement with Athpharma Limited ("Athpharma") to acquire four cardiovascular products under development for $44 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. Athpharma will complete the development of the products and we will pay approximately $20 million of the development costs. We will also make aggregate payments of approximately $24 million to Athpharma subject to the attainment of certain milestones and pay Athpharma royalties on the approval and commercialization of each product.

        We are in the process of determining the allocation of the purchase price; however, we anticipate that a substantial portion of the purchase price will be allocated to acquired research and development, which will be expensed in the second quarter of 2003.

RESULTS OF OPERATIONS

        Total revenue in the first quarter of 2003 was $191.4 million, an increase of $36.1 million or 23% from $155.3 million in the first quarter of 2002. Net income in the first quarter of 2003 was $63.0 million, or diluted earnings per share of $0.39, compared to net income of $53.1 million, or diluted earnings per share of $0.32, in the first quarter of 2002. Net income and diluted earnings per share increased by 19% and 22%, respectively, in the first quarter of 2003 compared to the first quarter of 2002.

REVENUE

        Our revenue is derived from sales of pharmaceutical products, providing research and development services, and the co-promotion of pharmaceutical products, as well as from royalties and license fees. Product sales include sales of products developed and manufactured by us for distribution by our licensees and direct marketing to physicians in the United States and Canada of proprietary and in-licensed products. Research and development revenue relates to product development activity in collaboration with third parties and pharmaceutical contract research services. Fees for co-promotion services are earned on sales of co-promoted products developed by other companies. Royalties primarily arise on sales of the products we developed or acquired and from our interests in certain licensed products obtained through our acquisitions of Pharma Pass LLC and Pharma Pass S.A. (collectively, "Pharma Pass"). License fees are derived from the license of our technologies or product rights.

11



        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 March 31
 
[In 000s]

  2003
  2002
  Percentage
Change

 
Product sales   $ 126,914   $ 129,854   (2% )
Research and development     2,600     5,713   (54% )
Co-promotion, royalty and licensing     61,876     19,686   214%  
   
 
     
    $ 191,390   $ 155,253   23%  
   
 
 
 

Product sales

        Product sales were $126.9 million in the first quarter of 2003 compared to $129.9 million in the first quarter of 2002, a decrease of $3.0 million or 2%.

        In January 2003, we received U.S. Food and Drug Administration ("FDA") approval for Zovirax Cream, indicated for the treatment of cold sores, and we intend to launch this product in mid-2003.

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

        The added contribution from Teveten® HCT, as well as from Vasotec® and Vaseretic® in the United States and Wellbutrin® SR and Zyban® in Canada, was more than offset by a decline in Cardizem® CD sales that occurred in anticipation of our launch of Cardizem® LA in April 2003, resulting in an overall decline in product sales in the first quarter of 2003 compared to the first quarter of 2002.

        In April 2003, Andrx Corporation ("Andrx") received FDA approval to market its bioequivalent version of Tiazac® in the United States. Consequently, we expect a decline in our sales of Tiazac® following the entry of Andrx' product in the U.S. market. Tiazac® sales in the United States have historically represented a significant portion of our total product sales, accounting for approximately 10% of total product sales in the first quarter of 2003. We have launched our own bioequivalent version of Tiazac®, through our marketing partner — Forest Laboratories Inc. ("Forest"), to compete with Andrx' product. In addition, we are entitled to receive a royalty from Andrx based on the net sales of its product.

Research and development

        Research and development activities generated revenue of $2.6 million in the first quarter of 2003 compared to $5.7 million in the first quarter of 2002, a decrease of $3.1 million or 54%.

        In the first quarter of 2002, research and development revenue included revenue associated with the development of our once-daily formulation of bupropion hydrochloride ("Wellbutrin XL") in collaboration with GlaxoSmithKline plc ("GSK"). During 2002, we completed the development of Wellbutrin XL and GSK filed a New Drug Application ("NDA") for the product in August 2002. In the first quarters of 2003 and 2002, our

12



remaining research and development revenue was primarily generated from clinical research and laboratory testing services provided to external customers by our contract research operation.

Co-promotion, royalty and licensing

        Co-promotion, royalty and licensing activities generated revenue of $61.9 million in the first quarter of 2003 compared to $19.7 million in the first quarter of 2002, an increase of $42.2 million or 214%.

        In the first quarters of 2003 and 2002, co-promotion revenue was related to the co-promotion of GSK's Wellbutrin SR in the United States and the co-promotion of H. Lundbeck A/S' Celexa in Canada. 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 from GSK of $10 million.

        Royalty revenue increased in the first quarter of 2003 compared to the first quarter of 2002 due to the contribution from our interest in the gross profit on sales by a third party of a bioequivalent version of Prilosec. in the first quarters of 2003 and 2002, most of our remaining royalty revenue was derived from royalties on sales of Tiazac® by Forest and from royalties associated with sales of bioequivalent versions of Cardizem® by third parties.

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 March 31
[In 000s]

  2003
  2002
  Percentage
Change

Cost of goods sold   $ 37,412   $ 35,716   5%
Research and development     18,006     10,468   72%
Selling, general and administrative     46,157     39,337   17%
Amortization     40,521     12,509   224%
   
 
   
    $ 142,096   $ 98,030   45%
   
 
 

Cost of goods sold and gross margins

        Cost of goods sold was $37.4 million in the first quarter of 2003 compared to $35.7 million in the first quarter of 2002, an increase of $1.7 million or 5%.

        Gross margins based on product sales were 71% and 72% for the first quarters of 2003 and 2002, respectively. Gross margins are impacted period to period by sales volumes, pricing, product mix and manufacturing volumes. The gross margin in the first quarter of 2003 was affected by a lower proportion of higher margin Cardizem® CD sales in the overall product mix and the additions of Zovirax Ointment, Teveten® and Teveten® HCT sales, which had lower margins relative to other of our products, offset by the inclusion of Vasotec® and Vaseretic® sales, which generated higher margins relative to other of our products.

13



Research and development

        Research and development expenses were $18.0 million in the first quarter of 2003 compared to $10.4 million in the first quarter of 2002, an increase of $7.6 million or 72%. As a percentage of total revenue, research and development expenses were 9% in the first quarter of 2003 compared to 7% in the first quarter of 2002.

        Research and development expenses reflect direct spending on the development of branded and bioequivalent 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 development. These 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 first quarter of 2003 compared to the first quarter of 2002 reflected an increase in clinical activity to support the upcoming submission of a supplemental 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.

Selling, general and administrative

        Selling, general and administrative expenses were $46.2 million in the first quarter of 2003 compared to $39.3 million in the first quarter of 2002, an increase of $6.9 million or 17%. As a percentage of total revenue, selling, general and administrative expenses were 24% in the first quarter of 2003 compared to 25% in the first quarter of 2002.

        The increase in selling, general and administrative expenses in the first quarter of 2003 compared to the first quarter of 2002 reflected an increase in costs associated with our expanded U.S. sales organization, as well as co-promotion fees payable to Reliant and sales and marketing costs associated with the launch of Teveten® HCT.

Amortization

        Amortization expense was $40.5 million in the first quarter of 2003 compared to $12.5 million in the first quarter of 2002, an increase of $28.0 million or 224%. As a percentage of total revenue, amortization expense was 21% in the first quarter of 2003 compared to 8% in the first quarter of 2002.

        The increase in amortization expense in the first quarter of 2003 compared to the first quarter of 2002 reflected the incremental amortization associated with the acquisitions of Vasotec® and Vaseretic® in the United States and Wellbutrin® and Zyban® in Canada, as well as the amortization of our interest in the gross profit on sales of a bioequivalent version of Prilosec.

Recovery from product supply agreements

        The $24.8 million reduction in operating expenses attributable to recovery from product supply agreements related to our 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 Pharmaceuticals, Inc. ("Mylan"), with respect to Mylan's breach of contract relating to its supply to us of its bioequivalent version of Verelan.

14



OPERATING INCOME

        Operating income was $74.0 million in the first quarter of 2003 compared to $57.2 million in the first quarter of 2002, an increase of $16.8 million or 29%. As a percentage of total revenue, operating income was 39% in the first quarter of 2003 compared to 37% in the first quarter of 2002.

        The increase in operating income in the first quarter of 2003 compared to the first quarter of 2002 was mainly due to the contribution from our interest in the gross profit on sales of a bioequivalent version of Prilosec, net of the related amortization expense, and the recovery from product supply agreements.

NON-OPERATING ITEMS

Interest income and expense

        Interest income was $3.1 million in the first quarter of 2003 compared to $1.5 million in the first quarter of 2002. Interest income in the first quarter of 2003 included interest on our settlements with Lilly and Mylan. In the first quarters of 2003 and 2002, our remaining interest income was earned on our investment portfolio, which is comprised primarily of high-grade government and corporate securities.

        Interest expense was $10.0 million in the first quarter of 2003 compared to $1.7 million in the first quarter of 2002, an increase of $8.3 million or 490%. The increase in interest expense in the first quarter of 2003 compared to the first quarter of 2002 was primarily related to 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 are designated as a fair value hedge of one-half of our Notes. The contracts 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.

Other income

        The change in the fair values of the interest rate swap contracts and the offsetting change in the fair value of the portion of our Notes being hedged are recognized in other income. The net gain recognized in the first quarter of 2003 related to the ineffective portion of the fair value hedge.

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 $4.7 million and $4.0 million in the first quarters of 2003 and 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.

EBITDA

        EBITDA, defined as earnings before interest, taxes, depreciation and amortization, is a non-GAAP measure that does not have a standardized meaning and, as such, may not be comparable to similarly titled measures presented by other companies. We disclose EBITDA because we understand that certain investors use it as an indicator of a company's ability to meet debt service and capital expenditure requirements. This measure should not be considered in isolation or as a substitute for operating income, or as an indicator of our operating

15



performance, or compared to cash flows from operating activities as a measure of liquidity. The following table displays the calculation of EBITDA.

 
  Three Months Ended
March 31

[In 000s]

  2003
  2002
Net income   $ 62,991   $ 53,051
Net interest expense     6,915     179
Provision for income taxes     4,650     3,993
Depreciation and amortization     44,174     15,104
   
 
EBITDA     118,730     72,327
   
 

        EBITDA was $118.7 million in the first quarter of 2003 compared to $72.3 million in the first quarter of 2002, an increase of $46.4 million or 64%. As a percentage of total revenue, EBITDA was 62% in the first quarter of 2003 compared to 47% in the first quarter of 2002.

        We disclose the ratio of EBITDA compared to interest expense because we understand that certain investors use it as an indicator of a company's ability to meet debt service requirements. This ratio is not necessarily comparable to similarly titled measures presented by other companies. The ratio of EBITDA to interest expense was 11.9 times and 42.7 times for the first quarters of 2003 and 2002, respectively.

LIQUIDITY AND CAPITAL RESOURCES

        At March 31, 2003, we had cash and cash equivalents of $13.2 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 March 31, 2003, we were in compliance with all financial and non-financial covenants associated with our credit facility. At March 31, 2003, we had advances of $10 million borrowed under our credit facility and we had a letter of credit with a balance of $93.2 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. At March 31, 2003, we had a remaining balance of $496.8 million available to borrow under our credit facility.

        Cash provided by operating activities was $103.8 million in the first quarter of 2003 compared to $111.4 million in the first quarter of 2002. Cash provided by operating activities reflected net income, after adjustments for items not involving cash, of $108.8 million in the first quarter of 2003 compared to $69.7 million in the first quarter of 2002. Net changes in non-cash operating items used cash of $5.0 million in the first quarter of 2003, mainly due to an increase in inventories and decreases in accounts payable and accrued liabilities, offset by an increase in deferred revenue. Net changes in non-cash operating items provided cash of $41.7 million in the first quarter of 2002, mainly due to a decrease in accounts receivable and increases in accounts payable and accrued liabilities.

        Net cash used in investing activities was $8.4 million in the first quarter of 2003 compared to $237.7 million in the first quarter of 2002. In the first quarter of 2003, investing activities comprised additions to property, plant and equipment. In the first quarter of 2002, investing activities comprised additions to property, plant and equipment of $8.1 million, the acquisitions of the rights to Zovirax and Teveten® for $133 million and $94 million, respectively, and an equity investment in Procyon Biopharma Inc. of $2.5 million.

16



        Net cash used in financing activities was $138.3 million in the first quarter of 2003 compared to net cash provided by financing activities of $123.6 million in the first quarter of 2002. In the first quarter of 2003, financing activities comprised proceeds of $1.7 million from the issuance of common shares on the exercise of stock options, the repayment of $100 million under our credit facility and the repayment of $40 million of the Zovirax obligation. In the first quarter of 2002, financing activities comprised proceeds of $3.3 million from the issuance of common shares on the exercise of stock options and warrants, as well as through our Employee Stock Purchase Plan, the repurchase of our common shares on the open market, under our stock repurchase program, for $260.3 million, the repayment of $4 million of the Adalat obligation and net proceeds of $384.3 million from the issuance of our Notes.

        Overall, our cash and cash equivalents decreased by $42.9 million and $2.6 million in the first quarters of 2003 and 2002, respectively.

Obligations and other matters

        At March 31, 2003, we had total long-term obligations of $609.5 million, including the current portion thereof, comprising the carrying value of our Notes of $412.6 million, obligations related to the acquisitions of intangible assets of aggregate $180.6 million, borrowings under our credit facility of $10 million and other of $6.4 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 March 31, 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 most of our remaining 2003 operational, capital expenditure and interest requirements and our investment objectives, as well as to meet our obligations as they become due. We may issue additional debt in the remainder of 2003 to fund any remaining cash requirements. There can be no assurance that, if required, we would be able to issue such debt on favourable terms.

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

17



foreign currency exchange rates would not 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 swap contracts, which effectively modify our exposure to interest rate fluctuations by converting one-half of our fixed rate Notes to floating rate. At March 31, 2003, the fair value of the contracts was $19.0 million in our favour, which has been recorded in other assets, and the respective offsetting fair value adjustment to the carrying value of our Notes was $15.1 million, which has been recorded in long-term obligations.

        Based on our overall interest rate exposure at March 31, 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. At March 31, 2003, we had cost method investments of $72.7 million and available-for-sale investments at fair value of $7.6 million. Based on the carrying values of our available-for-sale investments at March 31, 2003, adverse changes of 25% and 50% in equity market prices would result in a corresponding decline in the total fair value of those investments of approximately $2 million and $4 million, respectively.

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 March 31, 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

18



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. The adoption of FIN No. 46 is not expected to have a material effect on our financial position or results of operations.

        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 have not determined what effect, if any, the adoption of SFAS No. 149 will have 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. Effective June 1, 2003, we will account for financial instruments in accordance with SFAS No. 150.

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 Products Programme 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.

19




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 November 25, 2002 were as follows:


a)

 

December 11, 2002

 

Biovail Acquires Pharma PASS Companies for $190 Million

b)

 

December 27, 2002

 

Biovail Acquires Canadian Rights to Wellbutrin® SR and Zyban® From GSK

c)

 

December 27, 2002

 

Biovail Announces Extended Marketing Agreement for Zovirax Ointment and Zovirax Cream; Biovail Extends Promotion Agreement for Zovirax products by Ten Years

d)

 

January 3, 2003

 

Biovail Announces FDA Approval for Zovirax Cream

e)

 

February 3, 2003

 

Biovail and DepoMed Report Positive Phase III Clinical Results for Metformin GR Extended Release Formulation

f)

 

February 7, 2003

 

FDA Approves Biovail's Cardizem® LA for Hypertension

g)

 

February 7, 2003

 

Biovail Provides 2003 Guidance

h)

 

February 20, 2003

 

Biovail Announces FDA Approval of Teveten® HCT for Hypertension — Promotional Activities for This Combination ARB/Diuretic Product Will Begin March 10, 2003

i)

 

February 27, 2003

 

Biovail Expands Co-Promotion Arrangement With Reliant Pharmaceuticals for Cardizem® XL

j)

 

February 27, 2003

 

Biovail Announces Fourth Quarter and Year End 2002 Earnings Release Conference Call Details

k)

 

March 4, 2003

 

Biovail Reports Record Fourth Quarter and Full Year 2002 Financial Results

l)

 

March 5, 2003

 

Biovail Reports Clinical Trial Results

m)

 

March 28, 2003

 

Biovail to Present at American College of Cardiology in Chicago on March 29 & 30, 2003

n)

 

March 30, 2003

 

Biovail: Study Suggests Bedtime Dose of Cardizem® LA Protects Angina Patients from Morning Risks

o)

 

April 2, 2003

 

Biovail Launches Cardizem® LA to Physicians; Schedules Q1 Earnings Release for April 29, 2003

p)

 

April 9, 2003

 

Biovail Acquires Rights to Controlled Release Acyclovir -Genvir — from Flamel Technologies

q)

 

April 25, 2003

 

Biovail Appoints Gregory Szpunar Senior Vice President, Research & Development and Chief Scientific Officer

r)

 

April 28, 2003

 

Biovail Acquires Four Cardiovascular Pipeline Products from Athpharma Limited

s)

 

April 29, 2003

 

Biovail Reports Positive Cardizem® LA Launch Results

t)

 

April 29, 2003

 

Biovail Reports Record First Quarter 2003 Financial Results

u)

 

May 6, 2003

 

Biovail Appoints Kristine Peterson Senior Vice President, Commercial Operations

v)

 

May 7, 2003

 

Biovail's Cardizem® LA Obtains Favorable Formulary Coverage; Access to over 74 Million Managed Care Lives
         

20



w)

 

May 14, 2003

 

Biovail Presents Three Poster Presentations at the American Society of Hypertension

x)

 

May 16, 2003

 

Study Shows Nighttime Dosing of Biovail's Cardizem® LA Lowers Blood Pressure and Other Risks More Than Nighttime Dosing of Altace

y)

 

May 16, 2003

 

Study Shows Nighttime Dosing of Biovail's Cardizem® LA May Be More Effective Than Norvasc in Controlling Morning Blood Pressure and Other Risks in Hypertensive African-Americans

2.     LEGAL PROCEEDINGS

3.     MATERIAL ISSUED TO SHAREHOLDERS

Exhibit 99.1   First Quarter 2003 Interim Report For Canadian Regulatory Purposes
Exhibit 99.2   First Quarter Report 2003

4.     CERTIFICATIONS

Exhibit 99.3   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 30, 2003

 

By:

 

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

21




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 PART II — OTHER INFORMATION
SIGNATURES