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

FORM 6-K

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

For the Quarterly Period Ended March 31, 2005

Commission File Number 001-11145

BIOVAIL CORPORATION
(Translation of Registrant's name into English)

7150 Mississauga Road, Mississauga, Ontario, CANADA, L5N 8M5
(Address of principal executive office and zip code)

Registrant's telephone number, including area code: (905) 286-3000

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 statement on Form S-8 (Registration No. 333-92229) of Biovail Corporation.


INDEX

PART I — FINANCIAL INFORMATION

Financial Statements (unaudited)    
 
Consolidated Balance Sheets as at March 31, 2005 and December 31, 2004

 

1
  Consolidated Statements of Income for the three months ended March 31, 2005 and 2004   2
  Consolidated Statements of Deficit for the three months ended March 31, 2005 and 2004   3
  Consolidated Statements of Cash Flows for the three months ended March 31, 2005 and 2004   4
  Condensed Notes to the Consolidated Financial Statements   5

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

 

14


PART II — OTHER INFORMATION

Legal Proceedings   26

Exhibits

 

26

        All dollar amounts in this report are expressed in U.S. dollars.

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

        The following words are trademarks of the Company and may be registered in Canada, the United States and certain other jurisdictions: Ativan®, Attenade™, Biovail®, Cardizem®, CEFORM™, Fastab™, FlashDose®, Glumetza™, Isordil®, Ralivia™, Shearform™, Smartcoat™, Tiazac®, Vasotec® and Vaseretic®.

        Wellbutrin®, Wellbutrin SR®, Wellbutrin XL®, Zovirax® and Zyban® are trademarks of "The GlaxoSmithKline Group of Companies" and are used by the Company under license.

i



BIOVAIL CORPORATION

CONSOLIDATED BALANCE SHEETS
In accordance with U.S. generally accepted accounting principles

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

 
  March 31
2005

  December 31
2004

 
ASSETS              

Current

 

 

 

 

 

 

 
Cash and cash equivalents   $ 83,922   $ 34,324  
Marketable securities     1,933     5,016  
Accounts receivable     115,383     148,762  
Inventories     118,834     110,154  
Deposits and prepaid expenses     11,679     16,395  
   
 
 
      331,751     314,651  
Long-term investments     65,557     68,046  
Property, plant and equipment, net     184,950     186,556  
Goodwill     100,294     100,294  
Intangible assets, net     961,771     978,073  
Other assets, net     59,324     63,440  
   
 
 
    $ 1,703,647   $ 1,711,060  
   
 
 

LIABILITIES

 

 

 

 

 

 

 

Current

 

 

 

 

 

 

 
Accounts payable   $ 37,792   $ 41,120  
Accrued liabilities     92,733     82,917  
Income taxes payable     22,761     24,594  
Deferred revenue     6,963     8,141  
Current portion of long-term obligations     33,829     33,465  
   
 
 
      194,078     190,237  
Deferred revenue     15,500     16,525  
Deferred leasehold inducements     5,075     4,914  
Long-term obligations     430,722     445,471  
   
 
 
      645,375     657,147  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

Common shares, no par value, unlimited shares authorized, 159,385,908 and 159,383,402 issued and outstanding at March 31, 2005 and December 31, 2004, respectively

 

 

1,457,072

 

 

1,457,065

 
Stock options outstanding     1,450     1,450  
Deficit     (435,552 )   (446,684 )
Accumulated other comprehensive income     35,302     42,082  
   
 
 
      1,058,272     1,053,913  
   
 
 
    $ 1,703,647   $ 1,711,060  
   
 
 

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

1



BIOVAIL CORPORATION

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

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

 
  Three Months Ended March 31
 
 
  2005
  2004
 
REVENUE              
Product sales   $ 161,168   $ 175,097  
Research and development     7,526     4,216  
Royalty and other     6,567     7,313  
   
 
 
      175,261     186,626  
   
 
 

EXPENSES

 

 

 

 

 

 

 
Cost of goods sold     42,091     52,141  
Research and development     20,487     17,991  
Selling, general and administrative     75,605     59,458  
Amortization     16,034     17,105  
Acquired research and development         8,640  
   
 
 
      154,217     155,335  
   
 
 
Operating income     21,044     31,291  
Interest income     378     404  
Interest expense     (8,897 )   (11,394 )
Foreign exchange gain (loss)     (538 )   962  
Other income (expense)     (270 )   1,143  
   
 
 
Income before provision for income taxes     11,717     22,406  
Provision for income taxes     585     1,300  
   
 
 
Net income   $ 11,132   $ 21,106  
   
 
 

Earnings per share

 

 

 

 

 

 

 
Basic   $ 0.07   $ 0.13  
   
 
 
Diluted   $ 0.07   $ 0.13  
   
 
 

Weighted average number of common shares outstanding (000s)

 

 

 

 

 

 

 
Basic     159,385     159,002  
   
 
 
Diluted     159,447     159,281  
   
 
 

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 March 31
 
 
  2005
  2004
 
Deficit, beginning of period   $ (446,684 ) $ (607,678 )
Net income     11,132     21,106  
   
 
 
Deficit, end of period   $ (435,552 ) $ (586,572 )
   
 
 

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)

 
  Three Months Ended March 31
 
 
  2005
  2004
 
CASH FLOWS FROM OPERATING ACTIVITIES              
Net income   $ 11,132   $ 21,106  

Adjustments to reconcile net income to cash provided by operating activities

 

 

 

 

 

 

 
Depreciation and amortization     22,914     22,594  
Amortization and write-down of deferred financing costs     812     1,887  
Amortization of discounts on long-term obligations     784     941  
Acquired research and development         8,640  
Other     49     (2,965 )

Changes in operating assets and liabilities:

 

 

 

 

 

 

 
  Accounts receivable     33,355     26,995  
  Inventories     (8,686 )   (4,952 )
  Deposits and prepaid expenses     4,716     4,367  
  Accounts payable     (3,330 )   (23,601 )
  Accured liabilities     9,678     9,225  
  Income taxes payable     (1,833 )   154  
  Deferred revenue     (2,203 )   (552 )
   
 
 
Net cash provided by operating activities     67,388     63,839  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Additions to property, plant and equipment, net     (5,140 )   (8,053 )
Purchases of marketable securities     (4,144 )    
Proceeds from sales and maturities of marketable securities     3,258      
Acquisition of business, net of cash acquired         (9,319 )
   
 
 
Net cash used in investing activities     (6,026 )   (17,372 )
   
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 
Repayments of other long-term obligations     (11,722 )   (33,095 )
Issuance of common shares, net of issue costs     7     3,612  
Repayments under revolving term credit facility, including financing costs         (82,250 )
   
 
 
Net cash used in financing activities     (11,715 )   (111,733 )
   
 
 
Effect of exchange rate changes on cash and cash equivalents     (49 )   (46 )
   
 
 
Net increase (decrease) in cash and cash equivalents     49,598     (65,312 )
Cash and cash equivalents, beginning of period     34,324     133,261  
   
 
 
Cash and cash equivalents, end of period   $ 83,922   $ 67,949  
   
 
 

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

4


BIOVAIL CORPORATION

CONDENSED NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

In accordance with U.S. generally accepted accounting principles

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

1.     GOVERNING STATUTE AND NATURE OF OPERATIONS

2.     SIGNIFICANT ACCOUNTING POLICIES

5


 
  Three Months Ended March 31
 
 
  2005
  2004
 
Net income as reported   $ 11,132   $ 21,106  
Pro forma stock-based compensation expense determined under fair value-based method     (216 )   (5,489 )
   
 
 
Pro forma net income     10,916     15,617  
   
 
 

Basic earnings per share

 

 

 

 

 

 

 
As reported   $ 0.07   $ 0.13  
Pro forma   $ 0.07   $ 0.10  

Diluted earnings per share

 

 

 

 

 

 

 
As reported   $ 0.07   $ 0.13  
Pro forma   $ 0.07   $ 0.10  
   
 
 
 
  Three Months Ended March 31
 
  2005
  2004
Expected option life (years)   4.0   3.8
Volatility   53.3%   56.5%
Risk-free interest rate   3.7%   3.3%
Dividend yield   0.0%   0.0%
   
 

6


3.     INVENTORIES

 
  March 31
2005

  December 31
2004

Raw materials   $ 51,126   $ 48,801
Work in process     19,309     14,862
Finished goods     48,399     46,491
   
 
    $ 118,834   $ 110,154
   
 

4.     INTANGIBLE ASSETS

 
  March 31, 2005
  December 31, 2004
 
  Cost
  Accumulated amortization
  Cost
  Accumulated amortization
Trademarks   $ 703,698   $ 125,224   $ 703,698   $ 116,453
Product rights     459,773     92,057     459,773     84,877
Core technology     21,041     5,460     21,041     5,109
   
 
 
 
      1,184,512   $ 222,741     1,184,512   $ 206,439
         
       
Less accumulated amortization     222,741           206,439      
   
       
     
    $ 961,771         $ 978,073      
   
       
     

7


5.     LONG-TERM OBLIGATIONS

 
  March 31
2005

  December 31
2004

 
77/8% Senior Subordinated Notes due April 1, 2010   $ 400,000   $ 400,000  
Unamortized discount     (1,825 )   (1,916 )
Fair value adjustment     3,987     7,443  
   
 
 
      402,162     405,527  
Vasotec® and Vaseretic® obligation     28,097     27,704  
Zovirax obligation     21,282     32,230  
Ativan® and Isordil® obligation     9,104     9,037  
Deferred compensation     3,906     4,438  
   
 
 
      464,551     478,936  
Less current portion     33,829     33,465  
   
 
 
    $ 430,722   $ 445,471  
   
 
 

6.     COMMON SHARES

7.     INCOME TAXES

8.     EARNINGS PER SHARE

 
  Three Months Ended March 31
 
  2005
  2004
Net income   $ 11,132   $ 21,106
   
 
Basic weighted average number of common shares outstanding (000s)     159,385     159,002
Dilutive effect of stock options (000s)     62     279
   
 
Diluted weighted average number of common shares outstanding (000s)     159,447     159,281
   
 
Basic earnings per share   $ 0.07   $ 0.13
Diluted earnings per share   $ 0.07   $ 0.13
   
 

8


9.     COMPREHENSIVE INCOME

 
  Three Months
Ended March 31

 
 
  2005
  2004
 
Net income   $ 11,132   $ 21,106  
   
 
 

Comprehensive income

 

 

 

 

 

 

 
Foreign currency translation adjustment     (695 )   (2,267 )
Unrealized holding gain (loss) on long-term              
  investments     (6,085 )   3,385  
   
 
 
Other comprehensive income (loss)     (6,780 )   1,118  
   
 
 
Comprehensive income   $ 4,352   $ 22,224  
   
 
 

10.   LEGAL PROCEEDINGS

9


10


11


11.   SEGMENT INFORMATION

12


12.   SUBSEQUENT EVENTS

13


BIOVAIL CORPORATION

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

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

The following Management's Discussion and Analysis of Results of Operations and Financial Condition ("MD&A") prepared in accordance with U.S. generally accepted accounting principles ("GAAP") should be read in conjunction with the accompanying unaudited consolidated financial statements and condensed notes thereto. This MD&A should also be read in conjunction with the MD&A and audited consolidated financial statements and notes thereto prepared in accordance with U.S. GAAP for the year ended December 31, 2004 (which are contained in our Report of Foreign Private Issuer on Form 6-K that was submitted to the U.S. Securities and Exchange Commission ("SEC") on April 1, 2005).

The discussion and analysis contained in this MD&A are as of May 13, 2005.

FORWARD-LOOKING STATEMENTS

        To the extent any statements made in this MD&A contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties including, but not necessarily limited to, the difficulty of predicting U.S. Food and Drug Administration ("FDA") and Canadian Therapeutic Products Directorate approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax rate assumptions, fluctuations in operating results and other risks detailed from time to time in our filings with the SEC, the Ontario Securities Commission, and other securities regulatory authorities in Canada. We undertake no obligation to update or revise any forward-looking statement.

STRATEGIC PLAN UPDATE

        We are currently in the process of implementing a long-term strategic plan aimed at revitalizing our commercial operations, aligning our development pipeline and increasing shareholder value. Our most critical priority was to enhance the return on investment of our commercial operations in the United States, as we recognized that the extent of our portfolio of promoted products did not support the level of investment in our primary-care sales force. We addressed this issue by entering into a strategic partnership with Kos Pharmaceuticals, Inc. ("Kos") and realigning our U.S. commercial operations. As a result, we will no longer have a direct primary-care or cardiovascular specialty sales presence in the United States. Our approach to commercializing products in the United States will now be based primarily on partnering with companies that have strong primary-care capabilities in our therapeutic areas of focus. In addition, we have maintained a modest sales force that will focus on a number of select specialty markets.

        On May 2, 2005, we sold all of our rights to Teveten and Teveten HCT, and the distribution rights to Cardizem® LA in the United States, to Kos. We will be the exclusive manufacturer and supplier of Cardizem® LA to Kos over an initial seven-year supply term, at contractually determined prices that are in excess of 30% of Kos's net selling prices. Kos will offer employment to approximately 200 of our U.S. commercial employees. We will also collaborate with Kos on the development of up to three products, including a combination product comprised of Cardizem® LA and enalapril (Vasotec®). Subject to FDA approval, we will be the exclusive manufacturer and supplier of the combination product to Kos. In

14



consideration for these transactions, Kos paid us approximately $104.0 million in cash, and Kos will pay us milestones related to the development of the combination product. We are currently finalizing the accounting for these transactions; however, we expect that the revenue and costs associated with these transactions will be recognized in earnings over the term of the Cardizem® LA supply agreement.

        Concurrent with the above transactions, we reduced our remaining U.S. primary-care and specialty sales forces to approximately 85 sales representatives who will initially focus exclusively on the promotion of Zovirax Ointment and Cream to specialist physicians. We expect to incur a related restructuring charge of $20 million to $25 million primarily associated with employee termination benefits and contract termination costs.

        We anticipate that the aforementioned events will have a material positive impact on our future results of operations and cash flows due to the cost savings associated with the reduction in headcount in our U.S. commercial operations, as well as the discontinuance of spending on sales and marketing activities to support Teveten, Teveten HCT and Cardizem® LA. These factors will be partly offset by the lost gross profit on Teveten, Teveten HCT and Cardizem® LA product sales, as well as the charge for employee termination benefits and contract termination costs. In addition, the sale of Teveten and Teveten HCT to Kos will likely result in a write-down of the carrying value of these product rights to reflect their fair value at the date of disposition.

        We are also continuing to evaluate a number of options to increase the value of our portfolio of legacy products, which are in decline due to generic competition and are not strategic to our business. The options we are considering include: a sale of these products to strategic or financial buyers; the transfer of the assets to a new entity and the sale of shares of that entity pursuant to an initial public offering; or a distribution to our shareholders as a return of capital, which would involve the transfer of the assets to a new entity and the distribution of the shares of that entity to our shareholders. At this time, we cannot assess the impact that this transaction may have on our future results of operations, financial position and cash flows.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

        Critical accounting policies and estimates are those policies and estimates that are most important and material to the preparation of our consolidated financial statements, and which require management's most subjective and complex judgment due to the need to select policies from among alternatives available and make estimates about matters that are inherently uncertain. There have been no material changes to our critical accounting policies or estimates since December 31, 2004.

RESULTS OF OPERATIONS

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

        Revenue declined 6% from $186.6 million in the first quarter of 2004 to $175.3 million in the first quarter of 2005 due to lower product sales, partially offset by higher revenue generated from research and development activities.

        Net income declined 47% from $21.1 million (basic and diluted earnings per share of $0.13) in the first quarter of 2004 to $11.1 million (basic and diluted earnings per share of $0.07) in the first quarter of 2005. Our results of operations in the first quarter of 2004 were impacted by a charge of $8.6 million (basic and diluted impact per share of $0.05) to acquired research and development expense. The declines in net income and earnings per share were due mainly to lower product sales revenue and higher sales force costs and increased spending on sales and marketing activities.

15



REVENUE

        Our revenue is derived primarily from the following sources:

        The following table displays the dollar amount of each source of revenue in the first quarters of 2005 and 2004, the percentage of each source of revenue as compared to total revenue in the respective period, and the dollar and percentage change in the dollar amount of each source of revenue. Percentages may not add due to rounding.

 
  Three Months Ended March 31
   
   
 
 
  2005
  2004
  Change
 
[$ in 000s]

 
  $
  %
  $
  %
  $
  %
 
Product sales   161,168   92   175,097   94   (13,929 ) (8 )
Research and development   7,526   4   4,216   2   3,310   79  
Royalty and other   6,567   4   7,313   4   (746 ) (10 )
   
 
 
 
 
     
    175,261   100   186,626   100   (11,365 ) (6 )
   
 
 
 
 
 
 

Product sales

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

 
  Three Months Ended March 31
   
   
 
 
  2005
  2004
  Change
 
[$ in 000s]

 
  $
  %
  $
  %
  $
  %
 
Promoted products   43,981   27   46,956   27   (2,975 ) (6 )
Wellbutrin XL   36,756   23   42,027   24   (5,271 ) (13 )
BPC products   25,039   16   22,935   13   2,104   9  
Legacy products   30,417   19   26,209   15   4,208   16  
Generic products   24,975   15   36,970   21   (11,995 ) (32 )
   
 
 
 
 
     
    161,168   100   175,097   100   (13,929 ) (8 )
   
 
 
 
 
 
 

Promoted products

        In the first quarters of 2005 and 2004, our promoted products were Zovirax Ointment and Cream, Cardizem® LA, and Teveten and Teveten HCT, which were actively marketed and sold in the United States. Sales of promoted products declined 6% overall in the first quarter of 2005, compared with the first quarter of 2004. The decline in promoted product sales was due mainly to unanticipated returns of expired product

16



primarily related to low end-customer demand for one packaging size of Cardizem® LA. In the first quarter of 2005, compared with the first quarter of 2004, sales of promoted product more closely reflected end-customer demand, as our major U.S. wholesalers had substantively reduced their inventories of these products to normal safety-stock levels during the last three quarters of 2004. In late 2004 and early 2005, we entered into distribution service agreements with our three major wholesalers. These agreements generally establish limits on inventory levels held by these wholesalers and are expected to moderate investment buying by these wholesalers, which can result in sales fluctuations unrelated to end-customer demand. As a result, we anticipate a lower level of product returns in the future from these wholesalers due to product expiration and overstocking.

        As a result of the aforementioned transactions with Kos, we will no longer have any continuing interest in Teveten and Teveten HCT; however, we will maintain a significant interest in Cardizem® LA under the terms of our supply agreement with Kos.

Wellbutrin XL

        Our extended-release ("ER") bupropion hydrochloride tablets ("Wellbutrin XL") are sold under license by GlaxoSmithKline plc ("GSK") in the United States. Sales of Wellbutrin XL declined 13% in the first quarter of 2005, compared with the first quarter of 2004. During the fourth quarter and 12 months of 2004, additional quantities of Wellbutrin XL were sold to GSK in anticipation of our need to shift production in the first quarter of 2005 from Wellbutrin XL to scale-up activities for various products under development, including our tramadol ER product. The anticipated launch date for our tramadol ER product may now be delayed until 2006, as the FDA advised us in March 2005 that additional clinical data may be required to support the New Drug Application ("NDA") for this product. This resulted in a decline in Wellbutrin XL sales as GSK reduced the level of its safety-stock of this product during the first quarter of 2005.

Biovail Pharmaceuticals Canada ("BPC") products

        Our BPC products are Tiazac® XC, Tiazac®, Wellbutrin® SR, Zyban®, Monocor and Retavase, which are sold in Canada. Sales of our BPC products increased 9% overall in the first quarter of 2005, compared with the first quarter of 2004. The increase in BPC product sales was due mainly to growth in Tiazac® sales and the launch of Tiazac® XC in January 2005. Tiazac® XC is indicated for the treatment of hypertension.

Legacy products

        Our legacy products are Tiazac® (brand and generic), Cardizem® CD, Vasotec®, Vaseretic®, Ativan® and Isordil®, which are sold primarily in the United States. Sales of our legacy products increased 16% overall in the first quarter of 2005, compared with the first quarter of 2004. The increase in legacy product sales was due mainly to higher sales of generic Tiazac® to Forest Laboratories, Inc. ("Forest"), which more than offset a decline in Tiazac® brand sales to them. As was the case for our promoted products, our major U.S. wholesalers had substantively reduced their inventories of our other legacy products to normal safety-stock levels during the last three quarters of 2004, which resulted in sales of these products that more closely reflected end-customer demand in the first quarter of 2005, compared with the first quarter of 2004.

Generic products

        Our generic products are bioequivalent versions of Adalat CC, Cardizem® CD, Procardia XL, Trental and Voltaren XR, which we manufacture and sell to Teva Pharmaceutical Industries Ltd. ("Teva") for distribution in the United States. Sales of our generic products declined 32% overall in the first quarter of 2005, compared with the first quarter of 2004. The decline in generic product sales reflected a restocking of inventory by Teva to normal levels in the first quarter of 2004 (following a reduction in inventory levels by them during 2003) and

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general decreases in their selling prices to end-customers in the first quarter of 2005, compared with the first quarter of 2004.

        In the latter half of 2005, we expect that cost of goods sold will include amortization of the asset related to a reduction in the Zovirax supply price to be paid to GSK.

Research and development

        Research and development revenue increased 79% in the first quarter of 2005, compared with the first quarter of 2004. The increase in research and development revenue reflected a higher level of clinical research and laboratory testing services provided to external customers by our contract research operation.

Royalty and other

        Royalty and other revenue declined 10% in the first quarter of 2005, compared with the first quarter of 2004. The decline in royalty and other revenue reflected mainly a decrease in royalty income on Tiazac® brand sales by Forest due to generic competition that resulted in lower end-customer demand for this product.

OPERATING EXPENSES

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

 
  Three Months Ended March 31
   
   
 
 
  2005
  2004
  Change
 
[$ in 000s]

 
  $
  %
  $
  %
  $
  %
 
Cost of goods sold   42,091   24   52,141   28   (10,050 ) (19 )
Research and development   20,487   12   17,991   10   2,496   14  
Selling, general and administrative   75,605   43   59,458   32   16,147   27  
Amortization   16,034   9   17,105   9   (1,071 ) (6 )
Acquired research and development       8,640   5   (8,640 ) (100 )
   
 
 
 
 
     
    154,217   88   155,335   83   (1,118 ) (1 )
   
 
 
 
 
 
 

Cost of goods sold and gross margins

        Cost of goods sold declined 19% in the first quarter of 2005, compared with the first quarter of 2004. Gross margins based on product sales were 74% and 70% in the first quarters of 2005 and 2004, respectively. The increase in gross margin reflected mainly manufacturing efficiencies achieved during 2004 in the production of Wellbutrin XL and a decrease in the proportion of lower margin Wellbutrin XL sample product versus trade product sales in the first quarter of 2005, compared with the first quarter of 2004.

Research and development

        Research and development expenses increased 14% in the first quarter of 2005, compared with the first quarter of 2004. We invested 12% of total revenue in research and development activities in the first quarter of 2005, compared with 10% in the first quarter of 2004. The increase in research and development expenses was primarily associated with the higher level of contract research services provided to external customers. Research and development activities in the first quarter of 2005 included the formulation of a 450 mg dosage of

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Wellbutrin XL to complement existing doses of 150 mg and 300 mg, as well as line extension and enhanced formulation programs for tramadol, bupropion, and the anti-depressant venlafaxine. In addition, we are proceeding with a clinical program to provide additional data to support our NDA filing for tramadol ER. In May 2005, we received final FDA approval for our orally disintegrating tablet ("ODT") formulation of tramadol. We are currently in discussions with potential partners to commercialize tramadol ODT, as well as our tramadol ER formulation.

Selling, general and administrative

        Selling, general and administrative expenses increased 27% in the first quarter of 2005, compared with the first quarter of 2004. As a percentage of total revenue, selling, general and administrative expenses were 43% and 32% in the first quarters of 2005 and 2004, respectively. The increase in selling, general and administrative expenses reflected a higher headcount in our primary-care and specialty sales forces, and increased sales and marketing activities to support our promoted products. In the first quarter of 2004, we undertook an expansion and realignment of our primary-care sales force, which resulted in a number of temporary vacancies in field sales-force positions, as well as the postponement of certain sales and marketing activities during that period. The increase in selling, general and administrative expenses also reflected a higher executive headcount including the separation of the offices of the Executive Chairman and Chief Executive Officer.

        As a result of the aforementioned transactions with Kos and realignment of our U.S. commercial operations, we anticipate a significant decline in the future level of selling, general and administrative expenses due to the reduction in headcount in our primary-care and cardiovascular specialty sales forces, as well as the discontinuance of spending on sales and marketing activities to support Teveten, Teveten HCT and Cardizem® LA.

Amortization

        Amortization expense declined 6% in the first quarter of 2005, compared with the first quarter of 2004, and represented 9% of total revenue in both of those quarters. The decline in amortization expense reflected the final amortization of our interest in generic omeprazole in the first quarter of 2004.

        As a result of the disposal of the Teveten and Teveten HCT product rights, amortization expense will be reduced by $1.2 million per quarter or $4.7 million annually.

Acquired research and development

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

OPERATING INCOME

        We recorded operating income of $21.0 million in the first quarter of 2005, compared with $31.3 million in the first quarter of 2004. The charge to acquired research and development expense had the effect of reducing operating income by $8.6 million in the first quarter of 2004. The decline in operating income in the first quarter

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of 2005, compared with the first quarter of 2004, reflected lower product sales revenue, as well as higher sales force costs and increased spending on sales and marketing activities.

NON-OPERATING ITEMS

Interest expense

        Interest expense was $8.9 million in the first quarter of 2005, compared with $11.4 million in the first quarter of 2004. Interest expense mainly comprised interest on our 77/8% Senior Subordinated Notes due April 1, 2010 ("Notes"). The decline in interest expense reflected lower borrowings under our revolving term credit facility during the first quarter of 2005, compared with the first quarter of 2004.

Provision for income taxes

        Our effective tax rate in the first quarters of 2005 and 2004 reflected the fact that most of our income was derived from foreign subsidiaries with lower statutory tax rates than those that apply in Canada. We recorded provisions for income taxes of $0.6 million and $1.3 million in the first quarters of 2005 and 2004, respectively. Our effective tax rate was affected by the availability of unrecognized tax loss carryforwards that can be used to offset taxable income in Canada and the United States, as well as losses that were incurred in the United States due mainly to sales force costs and spending on sales and marketing activities.

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

SUMMARY OF QUARTERLY RESULTS

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

 
  2004
  2005
[$ in 000s, except per share data]

  Q2
  Q3
  Q4
  Q1
Revenue   $ 206,313   $ 215,725   $ 277,879   $ 175,261
Net income     44,208     49,635     46,045     11,132
Basic and diluted earnings per share   $ 0.28   $ 0.31   $ 0.29   $ 0.07
   
 
 
 
 
 
  2003
  2004
[$ in 000s, except per share data]

  Q2
  Q3
  Q4
  Q1
Revenue   $ 217,283   $ 215,314   $ 199,735   $ 186,626
Net income (loss)     (4,940 )   16,114     (96,038 )   21,106
Basic and diluted earnings (loss) per share   $ (0.03 ) $ 0.10   $ (0.60 ) $ 0.13
   
 
 
 

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        The declines in revenue and net income in the first quarter of 2005, compared with each of the last three quarters of 2004, were due partially to the impact of the tiered supply price for Wellbutrin XL. The Wellbutrin XL supply price is reset to the lowest tier at the start of each calendar year. In addition, these declines reflected the reduction by GSK in the level of its safety-stock of Wellbutrin XL in the first quarter of 2005, after ordering additional quantities of this product during the fourth quarter and 12 months of 2004, in anticipation of our need to shift production from Wellbutrin XL to other of our products under development.

FINANCIAL CONDITION

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

[$ in 000s]

  At March 31 2005
  At December 31 2004
Working capital   $ 137,673   $ 124,414
Long-lived assets     1,306,339     1,328,363
Long-term obligations     464,551     478,936
Shareholders' equity     1,058,272     1,053,913
   
 

Working capital

        The $13.3 million increase in working capital from December 31, 2004 to March 31, 2005 was primarily due to:

        Partially offset by:

Long-lived assets

        Long-lived assets comprise property, plant and equipment, goodwill, intangible and other assets, net of accumulated depreciation and amortization. The $22.0 million decrease in long-lived assets from December 31, 2004 to March 31, 2005, reflected primarily the depreciation of plant and equipment of $6.6 million and the amortization of intangible assets of $16.3 million, as well as a $3.3 million decline in the market value of our

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interest rate swaps. These factors were offset partially by net capital expenditures on property, plant and equipment of $5.1 million, which consisted mainly of additions to manufacturing and laboratory equipment.

Long-term obligations

        The $14.4 million decrease in long-term obligations, including the current portion thereof, from December 31, 2004 to March 31, 2005, reflected primarily the payment of $11.3 million to GSK related to the October 2002 amendments to the Zovirax distribution agreement, as well as a $3.3 million reduction in the fair value adjustment to our Notes that offset the decline in the market value of our interest rate swaps.

Shareholders' equity

        The $4.4 million increase in shareholders' equity from December 31, 2004 to March 31, 2005, reflected primarily net income of $11.1 million, offset partially by a $6.1 million unrealized holding loss on our available-for-sale investments, primarily related to our equity investment in Depomed, Inc. ("Depomed").

CASH FLOWS

        At March 31, 2005, we had cash and cash equivalents of $83.9 million, compared with $34.3 million at December 31, 2004. The following table displays cash flow information for the first quarters of 2005 and 2004:

 
  Three Months Ended March 31
 
[$ in 000s]

 
  2005
  2004
 
Net cash provided by operating activities   $ 67,388   $ 63,839  
Net cash used in investing activities     (6,026 )   (17,372 )
Net cash used in financing activities     (11,715 )   (111,733 )
Effect of exchange rate changes on cash and cash equivalents     (49 )   (46 )
   
 
 
Net increase (decrease) in cash and cash equivalents   $ 49,598   $ (65,312 )
   
 
 

Operating activities

        Net cash provided by operating activities increased $3.5 million from the first quarter of 2004 to the first quarter of 2005, primarily due to the amount and timing of payments of accounts payable, partially offset by lower income from operations (net of non-cash items) of $16.5 million due mainly to lower product sales revenue and higher sales force costs and increased spending on sales and marketing activities. Net cash provided by operating activities was primarily used to repay long-term obligations in the first quarters of 2005 and 2004.

Investing activities

        Net cash used in investing activities declined $11.3 million from the first quarter of 2004 to the first quarter of 2005, primarily due to:

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Financing activities

        Net cash used in financing activities declined $100.0 million from the first quarter of 2004 to the first quarter of 2005, primarily due to:

LIQUIDITY AND CAPITAL RESOURCES

        At March 31, 2005, we had total long-term obligations of $464.6 million, including the current portion thereof, which included the carrying value of our Notes of $402.2 million and obligations related to the acquisitions of intangible assets of $58.5 million. At March 31, 2005, we had no outstanding borrowings under our $400.0 million revolving term credit facility; however, we had a letter of credit of $36.7 million issued under this facility, which secures the remaining semi-annual payments we are required to make to Merck & Co., Inc. ("Merck") related to our acquisition of Vasotec® and Vaseretic®. The revolving period of this facility extends to May 25, 2005. This facility is renewable for one-year revolving terms at the lenders' option, with a one-year term out at our option if the lenders do not renew. We are currently in the process of renewing the revolving portion of this facility. This facility may be used for general corporate purposes, including acquisitions. At March 31, 2005, we were in compliance with all financial and non-financial covenants associated with this facility. Our current corporate credit ratings from Standard & Poor's ("S&P") and Moody's Investors Service ("Moody's") are BB+ and B1, respectively, and the current ratings on our Notes from S&P and Moody's are BB- and B2, respectively.

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

CONTRACTUAL OBLIGATIONS

        The following table summarizes our fixed contractual obligations at March 31, 2005:

 
  Payments Due by Period
[$ in 000s]

  Total
  2005
  2006 and 2007
  2008 and 2009
  Thereafter
Long-term obligations   $ 460,917   $ 24,406   $ 36,511   $   $ 400,000
Operating lease obligations     56,100     7,400     17,300     11,300     20,100
Purchase obligation     7,399     3,810     3,589        
   
 
 
 
 
Total contractual obligations   $ 524,416   $ 35,616   $ 57,400   $ 11,300   $ 420,100
   
 
 
 
 

        The above purchase obligation is in connection with the manufacture and supply of Vasotec® and Vaseretic®. We are obligated to make semi-annual payments to Merck for minimum product quantities (regardless of the actual product supplied).

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        The above table does not reflect any milestone payments in connection with research and development collaborations with third parties. These payments are contingent on the achievement of specific developmental, regulatory and/or commercial milestones. In the event that all research and development projects are successful, we would have to make aggregate milestone payments of $133.7 million, which includes $25.0 million payable to Depomed on FDA approval of Glumetza™ (metformin). We anticipate receiving FDA approval for Glumetza™ in the second quarter of 2005. In addition, under certain arrangements, we may have to make royalty payments based on a percentage of future sales of the products in the event regulatory approval for marketing is obtained. From a business perspective, we view these payments favourably as they signify that the products are moving successfully through the development phase toward commercialization.

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

OFF-BALANCE SHEET ARRANGEMENTS

        We did not have any off-balance sheet arrangements at March 31, 2005, other than operating leases and the purchase obligation in connection with the manufacture and supply of Vasotec® and Vaseretic®, which are disclosed above under contractual obligations.

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 denominated in U.S. dollars. Our only other significant transactions are in Canadian dollars, and we do not have any material non-U.S. dollar-denominated obligations. We also face foreign currency exposure on the translation of our operations in Canada and Ireland from their local currencies to the U.S. dollar. Currently, we do not utilize forward contracts to hedge against foreign currency risk; however, a 10% change in foreign currency exchange rates would not have a material impact on our consolidated results of operations, financial position or cash flows.

Interest rate risk

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

        We are exposed to interest rate risk on borrowings under our revolving term credit facility. This credit facility bears interest based on London Interbank Offering Rate, U.S. dollar base rate, Canadian dollar prime rate or Canadian dollar bankers' acceptance. At our option, we may lock in a rate of interest for a period of up to one year. The imputed rates of interest used to discount our long-term obligations related to the acquisitions

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of intangible assets are fixed and, consequently, the fair values of these obligations are affected by changes in interest rates. The fair value of our fixed rate Notes is affected by changes in interest rates. 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, a 10% change in interest rates would not have a material impact on our consolidated results of operations, financial position or cash flows.

Investment risk

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

RECENT ACCOUNTING PRONOUNCEMENTS

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

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

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BIOVAIL CORPORATION

PART II — OTHER INFORMATION

1. LEGAL PROCEEDINGS

 

For detailed information concerning legal proceedings, reference is made to note 10 — Legal Proceedings to the consolidated financial statements included under Part I of this Quarterly Report.

2.

EXHIBITS
  Exhibit 99.1   First Quarter 2005 Interim Report For Canadian Regulatory Purposes
  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 13, 2005

 

By:

 

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

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QuickLinks

BIOVAIL CORPORATION QUARTERLY REPORT
INDEX PART I — FINANCIAL INFORMATION
PART II — OTHER INFORMATION
BIOVAIL CORPORATION CONSOLIDATED BALANCE SHEETS In accordance with U.S. generally accepted accounting principles (All dollar amounts are expressed in thousands of U.S. dollars) (Unaudited)
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)
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)
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)
BIOVAIL CORPORATION PART II — OTHER INFORMATION
SIGNATURES