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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 September 30, 2005

Commission File Number 001-11145

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

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

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

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

        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 September 30, 2005 and December 31, 2004   1
  Consolidated Statements of Income for the three months and nine months ended September 30, 2005 and 2004   2
  Consolidated Statements of Deficit for the three months and nine months ended September 30, 2005 and 2004   3
  Consolidated Statements of Cash Flows for the nine months ended September 30, 2005 and 2004   4
  Condensed Notes to the Consolidated Financial Statements   5
Management's Discussion and Analysis of Results of Operations and Financial Condition   24

Part II — Other Information

 

 
Legal Proceedings   44
Exhibits   44


BASIS OF PRESENTATION

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

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


FORWARD-LOOKING STATEMENTS

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

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

i


BIOVAIL CORPORATION
CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

 
  At September 30, 2005
  At December 31, 2004
 
ASSETS              

Current

 

 

 

 

 

 

 
Cash and cash equivalents   $ 326,727   $ 34,324  
Marketable securities     931     5,016  
Accounts receivable     125,716     148,762  
Inventories     88,103     110,154  
Assets of discontinued operation held for sale     3,865      
Deposits and prepaid expenses     11,042     16,395  
   
 
 
      556,384     314,651  
Long-term assets of discontinued operation held for sale     375      
Long-term investments     76,014     68,046  
Property, plant and equipment, net     187,678     186,556  
Goodwill     100,294     100,294  
Intangible assets, net     874,670     978,073  
Other assets, net     117,309     63,440  
   
 
 
    $ 1,912,724   $ 1,711,060  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 36,852   $ 41,120  
Accrued liabilities     89,728     82,917  
Liabilities of discontinued operation held for sale     1,240      
Income taxes payable     30,431     24,594  
Deferred revenue     23,367     8,141  
Current portion of long-term obligations     24,691     33,465  
   
 
 
      206,309     190,237  
Deferred revenue     97,581     16,525  
Deferred leasehold inducements     5,171     4,914  
Long-term obligations     422,648     445,471  
   
 
 
      731,709     657,147  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares, no par value, unlimited shares authorized, 159,467,602 and 159,383,402 issued and outstanding at September 30, 2005 and December 31, 2004, respectively     1,458,183     1,457,065  
Stock options outstanding     1,450     1,450  
Deficit     (330,182 )   (446,684 )
Accumulated other comprehensive income     51,564     42,082  
   
 
 
      1,181,015     1,053,913  
   
 
 
    $ 1,912,724   $ 1,711,060  
   
 
 

        Commitments and contingencies (note 13)

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 September 30
  Nine Months Ended September 30
 
 
  2005
  2004
  2005
  2004
 
REVENUE                          
Product sales   $ 244,455   $ 202,243   $ 609,505   $ 572,604  
Research and development     7,647     5,432     21,216     12,162  
Royalty and other     5,956     5,943     17,201     19,040  
   
 
 
 
 
      258,058     213,618     647,922     603,806  
   
 
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     51,991     50,111     152,964     158,076  
Research and development     19,913     16,979     62,135     49,929  
Selling, general and administrative     42,402     68,273     174,263     181,538  
Amortization     15,443     16,262     46,818     48,965  
Restructuring costs     1,118         19,725      
Write-down (gain on disposal) of assets         (1,471 )   26,560     (1,471 )
Acquired research and development                 8,640  
   
 
 
 
 
      130,867     150,154     482,465     445,677  
   
 
 
 
 
Operating income     127,191     63,464     165,457     158,129  
Interest income     2,386     186     3,676     757  
Interest expense     (9,450 )   (10,103 )   (27,921 )   (30,467 )
Foreign exchange loss     (1,462 )   (802 )   (2,153 )   (1,158 )
Other expense     (271 )       (804 )   (2,434 )
   
 
 
 
 
Income from continuing operations before provision for income taxes     118,394     52,745     138,255     124,827  
Provision for income taxes     9,095     2,100     11,975     5,200  
   
 
 
 
 
Income from continuing operations     109,299     50,645     126,280     119,627  
Loss from discontinued operation     (7,636 )   (1,010 )   (9,778 )   (4,678 )
   
 
 
 
 
Net income   $ 101,663   $ 49,635   $ 116,502   $ 114,949  
   
 
 
 
 

Basic and diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 
Income from continuing operations   $ 0.69   $ 0.32   $ 0.79   $ 0.75  
Loss from discontinued operation     (0.05 )   (0.01 )   (0.06 )   (0.03 )
   
 
 
 
 
Net income   $ 0.64   $ 0.31   $ 0.73   $ 0.72  
   
 
 
 
 

Weighted average number of common shares outstanding (000s)

 

 

 

 

 

 

 

 

 

 

 

 

 
Basic     159,421     158,801     159,402     159,060  
   
 
 
 
 
Diluted     159,583     158,904     159,491     159,227  
   
 
 
 
 

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 September 30
  Nine Months Ended September 30
 
 
  2005
  2004
  2005
  2004
 
Deficit, beginning of period   $ (431,845 ) $ (542,364 ) $ (446,684 ) $ (607,678 )
Net income     101,663     49,635     116,502     114,949  
   
 
 
 
 
Deficit, end of period   $ (330,182 ) $ (492,729 ) $ (330,182 ) $ (492,729 )
   
 
 
 
 

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)

 
  Nine Months Ended September 30
 
 
  2005
  2004
 
  CASH FLOWS FROM OPERATING ACTIVITIES              
  Net income   $ 116,502   $ 114,949  
  Adjustments to reconcile net income to cash provided by continuing operating activities              
  Loss from discontinued operation     3,665     4,678  
  Depreciation and amortization     74,984     64,223  
  Amortization and write-down of deferred financing costs     2,671     3,510  
  Amortization of discounts on long-term obligations     1,929     2,438  
  Write-down (gain on disposal) of assets     26,560     (1,471 )
  Write-down of assets of discontinued operation     6,113      
  Acquired research and development         8,640  
  Other     652     (823 )
  Changes in operating assets and liabilities     45,413     (28,731 )
   
 
 
  Net cash provided by continuing operating activities     278,489     167,413  
   
 
 
  CASH FLOWS FROM INVESTING ACTIVITIES              
  Proceeds on disposal of intangible assets, net of withholding tax     98,127     3,000  
  Acquisitions of intangible assets     (26,000 )    
  Additions to property, plant and equipment, net     (24,121 )   (20,178 )
  Purchases of marketable securities     (6,345 )    
  Proceeds from sales and maturities of marketable securities     5,317      
  Acquisition of business, net of cash acquired         (9,319 )
  Acquisitions of long-term investments         (2,877 )
   
 
 
  Net cash provided by (used in) continuing investing activities     46,978     (29,374 )
   
 
 
  CASH FLOWS FROM FINANCING ACTIVITIES              
  Repayments of other long-term obligations     (28,894 )   (52,796 )
  Proceeds (payments) on termination of interest rate swaps     (1,419 )   6,300  
  Repayments under revolving term credit facility, including financing costs     (1,300 )   (182,550 )
  Issuance of common shares, net of issue costs     1,118     3,687  
   
 
 
  Net cash used in continuing financing activities     (30,495 )   (225,359 )
   
 
 
  Net cash used in discontinued operation     (2,775 )   (2,055 )
   
 
 
  Effect of exchange rate changes on cash and cash equivalents     206     157  
   
 
 
  Net increase (decrease) in cash and cash equivalents     292,403     (89,218 )
  Cash and cash equivalents, beginning of period     34,324     133,261  
   
 
 
  Cash and cash equivalents, end of period   $ 326,727   $ 44,043  
   
 
 

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

4



BIOVAIL CORPORATION

CONDENSED NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

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

(Unaudited)

1.     GOVERNING STATUTE AND NATURE OF OPERATIONS

2.     SIGNIFICANT ACCOUNTING POLICIES

5


6


 
  Three Months Ended September 30
  Nine Months Ended September 30
 
 
  2005
  2004
  2005
  2004
 
Net income as reported   $ 101,663   $ 49,635   $ 116,502   $ 114,949  
Pro forma stock-based compensation expense determined under fair value-based method     (1,485 )   (5,020 )   (3,757 )   (16,398 )
   
 
 
 
 
Pro forma net income     100,178     44,615     112,745     98,551  
   
 
 
 
 

Basic and diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 
As reported   $ 0.64   $ 0.31   $ 0.73   $ 0.72  
Pro forma   $ 0.63   $ 0.28   $ 0.71   $ 0.62  
   
 
 
 
 
 
  Three Months Ended September 30
  Nine Months Ended September 30
 
 
  2005
  2004
  2005
  2004
 
Expected option life (years)   4.2   4.0   4.0   3.8  
Volatility   52.0 % 55.7 % 53.3 % 56.0 %
Risk-free interest rate   3.2 % 3.8 % 3.7 % 3.6 %
Dividend yield  

%


%


%


%
   
 
 
 
 

7


3.     DISPOSITION AND RESTRUCTURING

8


9


 
  At June 30 2005
  Adjustments
  Paid or Settled
  At September 30 2005
Employee termination benefits   $ 8,518   $ 523   $ (8,945 ) $ 96
Contract termination costs     4,473     198     (2,528 )   2,143
Professional fees and other         397     (397 )  
   
 
 
 
    $ 12,991   $ 1,118   $ (11,870 ) $ 2,239
   
 
 
 

4.     DISCONTINUED OPERATION

10


 
  At September 30 2005
 
Assets        
Accounts receivable   $ 1,390  
Inventories     2,243  
Deposits and prepaid expenses     232  
   
 
Current assets     3,865  
Machinery and equipment     2,215  
Other equipment and leasehold improvements     1,902  
Technology     2,371  
Less write-down of assets     (6,113 )
   
 
Long-term assets     375  
   
 
Total assets     4,240  
   
 

Liabilities

 

 

 

 
Accounts payable     372  
Accrued liabilities     451  
Deferred revenue     417  
   
 
Current liabilities     1,240  
   
 
Net assets held for sale   $ 3,000  
   
 

11


 
  Three Months Ended
September 30

  Nine Months Ended
September 30

 
 
  2005
  2004
  2005
  2004
 
REVENUE                          
Product sales   $ 701   $ 1,214   $ 1,643   $ 3,163  
Research and development     162     510     824     669  
Royalty and other     419     383     1,602     1,026  
   
 
 
 
 
      1,282     2,107     4,069     4,858  
   
 
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     1,022     1,724     3,003     4,952  
Research and development     495     669     1,512     1,540  
Selling, general and administrative     1,220     656     3,015     2,840  
Amortization     68     68     204     204  
   
 
 
 
 
      2,805     3,117     7,734     9,536  
   
 
 
 
 

Loss from discontinued operation before write-down of assets

 

 

(1,523

)

 

(1,010

)

 

(3,665

)

 

(4,678

)
Write-down of assets     (6,113 )       (6,113 )    
   
 
 
 
 
Loss from discontinued operation   $ (7,636 ) $ (1,010 ) $ (9,778 ) $ (4,678 )
   
 
 
 
 

5.     INVENTORIES

 
  At September 30 2005
  At December 31 2004
Raw materials   $ 45,519   $ 48,801
Work in process     12,705     14,862
Finished goods     29,879     46,491
   
 
    $ 88,103   $ 110,154
   
 

12


6.     INTANGIBLE ASSETS

 
  At September 30, 2005
  At December 31, 2004
 
  Cost
  Accumulated amortization
  Cost
  Accumulated amortization
Trademarks   $ 703,698   $ 142,765   $ 703,698   $ 116,453
Product rights     391,432     90,204     459,773     84,877
Technology     16,956     4,447     21,041     5,109
   
 
 
 
      1,112,086   $ 237,416     1,184,512   $ 206,439
         
       
Less accumulated amortization     237,416           206,439      
   
       
     
    $ 874,670         $ 978,073      
   
       
     

13


7.     LONG-TERM OBLIGATIONS

 
  At September 30 2005
  At December 31 2004
 
77/8% Senior Subordinated Notes due April 1, 2010   $ 400,000   $ 400,000  
Unamortized discount     (1,642 )   (1,916 )
Fair value adjustment     2,208     7,443  
   
 
 
      400,566     405,527  
Zovirax obligation     21,681     32,230  
Vasotec® and Vaseretic® obligation     21,057     27,704  
Ativan® and Isordil® obligation         9,037  
Deferred compensation     4,035     4,438  
   
 
 
      447,339     478,936  
Less current portion     24,691     33,465  
   
 
 
    $ 422,648   $ 445,471  
   
 
 

14


8.     STOCK OPTIONS OUTSTANDING

9.     INCOME TAXES

10.   EARNINGS PER SHARE

 
  Three Months Ended
September 30

  Nine Months Ended
September 30

 
  2005
  2004
  2005
  2004
Net income   $ 101,663   $ 49,635   $ 116,502   $ 114,949
   
 
 
 
Basic weighted average number of common shares outstanding (000s)     159,421     158,801     159,402     159,060
Dilutive effect of stock options (000s)     162     103     89     167
   
 
 
 
Diluted weighted average number of common shares outstanding (000s)     159,583     158,904     159,491     159,227
   
 
 
 
Basic and diluted earnings per share   $ 0.64   $ 0.31   $ 0.73   $ 0.72
   
 
 
 

15


11.   COMPREHENSIVE INCOME

 
  Three Months Ended September 30
  Nine Months Ended September 30
 
 
  2005
  2004
  2005
  2004
 
Net income   $ 101,663   $ 49,635   $ 116,502   $ 114,949  
   
 
 
 
 

Comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 
Foreign currency translation adjustment     8,198     6,790     5,120     3,957  
Unrealized holding gain (loss) on long-term investments     8,585     849     4,362     (7,612 )
   
 
 
 
 
Other comprehensive income (loss)     16,783     7,639     9,482     (3,655 )
   
 
 
 
 
Comprehensive income   $ 118,446   $ 57,274   $ 125,984   $ 111,294  
   
 
 
 
 

12.   CHANGES IN OPERATING ASSETS AND LIABILITIES

 
  Nine Months Ended September 30
 
 
  2005
  2004
 
Accounts receivable   $ 21,321   $ 11,034  
Inventories     18,261     (14,898 )
Deposits and prepaid expenses     4,804     6,132  
Accounts payable     (3,779 )   (21,041 )
Accrued liabilities     5,418     (14,258 )
Income taxes payable     8,333     (724 )
Deferred revenue     (8,945 )   5,024  
   
 
 
    $ 45,413   $ (28,731 )
   
 
 

13.   LEGAL PROCEEDINGS

16


17


18


19


20


21


14.   SEGMENT INFORMATION

22


15.   SUBSEQUENT EVENTS

23


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

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

        The following Management's Discussion and Analysis of Results of Operations and Financial Condition ("MD&A") prepared in accordance with U.S. generally accepted accounting principles ("GAAP") should be read in conjunction with the accompanying unaudited consolidated financial statements and condensed notes thereto. This MD&A should also be read in conjunction with the MD&A and audited consolidated financial statements and notes thereto prepared in accordance with U.S. GAAP that are contained in our Annual Report on Form 20-F for the fiscal year ended December 31, 2004.

        The discussion and analysis contained in this MD&A are as of November 14, 2005.

STRATEGIC UPDATE

Tramadol products

        In November 2005, we entered into a ten-year supply agreement with Ortho-McNeil, Inc. ("Ortho-McNeil"), a Johnson & Johnson company, for the distribution of our recently approved extended-release ("ER") and orally disintegrating tablet ("ODT") formulations of tramadol (see Research and development expenses). We will manufacture and supply these products to Ortho-McNeil for distribution in the United States and Puerto Rico under the trade names (pending approval) Ultram® ER and Ultram® ODT. Our contractually determined supply prices will be based on 27.5% to 37.5% of Ortho-McNeil's net selling price for Ultram® ER, depending on the year of sale, and approximately 30% of Ortho-McNeil's net selling price for Ultram® ODT.

Outlook

        Ortho-McNeil anticipates launching Ultram® ER and Ultram® ODT in early 2006. We believe that a considerable market opportunity may exist for ER and ODT formulations of tramadol in the United States analgesia market and, accordingly, we anticipate that these products will have a material positive impact on our future results of operations, financial position and cash flows.

Legacy products

        Our Board of Directors has reviewed a number of options to increase the value of our legacy products. These products comprise Ativan®, Isordil®, Tiazac®, Vasotec® and Vaseretic® that are sold in the United States and Puerto Rico and Cardizem® CD that is sold in the United States, Canada and Puerto Rico. These products are not considered strategic to our business and are in decline (in terms of prescription volumes) due to generic competition. The primary option currently under consideration is a distribution to our shareholders, which would involve the transfer of the legacy assets to a new entity and the distribution of the shares of that entity to our shareholders either as a dividend in kind or as a return of capital. Our Board is expected to make a decision shortly on whether or not to proceed with this option; however, if approved, the timing for completion of such a distribution cannot be determined at this time as it would be subject to a number of conditions including, but not limited to: the resolution of, or at least greater clarity in respect of, certain regulatory and litigation matters; the preparation and filing of a preliminary prospectus and registration statement; the review and approval of those documents by regulatory authorities prior to being finalized and authorized for use in connection with a distribution; receipt of lender and other third-party consents; and approval by our shareholders, if required. The aggregate carrying value of the intangible assets associated with these legacy products was $630.3 million at September 30, 2005. A potential distribution could result in a write-down of the carrying values of certain of these intangible assets.

24



DISPOSITION AND RESTRUCTURING

Kos

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

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

        The Kos transactions comprise multiple deliverables (sale of product and distribution rights, manufacturing and supply activities, and research and development services). In accordance with our revenue recognition accounting policy, we evaluated whether the deliverables represented separate units of accounting. We determined that we had objective and reliable evidence of the fair value of the delivered item (the Teveten and Teveten HCT product rights); however, we did not have sufficient evidence of the fair values of the undelivered items, and therefore the Kos transactions represented a single unit of accounting. As a result, the up-front cash consideration of $105.5 million was recorded in deferred revenue, and will be recognized in product sales on a straight-line basis over the seven-year Cardizem® LA supply term. Revenue and related costs associated with the sale of Cardizem® LA product to Kos will be recognized in earnings as title to the product transfers to Kos.

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

Restructuring

        Concurrent with the Kos transactions, we restructured our U.S. commercial operations. As a result, we reduced our primary-care and specialty sales forces by 307 positions, and our general and administrative functions by 30 positions. We notified the affected employees on May 2, 2005. In addition, Kos offered employment to 186 of our sales representatives, of which 164 accepted positions with Kos. We retained 85 specialty sales representatives who will focus on the promotion of Zovirax Ointment and Zovirax Cream to dermatologists and obstetricians/gynaecologists, as well as provide co-promotion services for Ultram® ER and Ultram® ODT to women's health-care practitioners. In the third quarter and first nine months of 2005, we incurred restructuring charges of $1.1 million and $19.7 million, respectively, which consisted of employee termination benefits, contract termination costs and professional fees. Employee termination costs include

25



severance and related benefits, as well as outplacement services. We did not pay termination benefits to those employees that were offered employment by Kos. Contract termination costs include facility and vehicle lease payments that we will continue to incur without economic benefit.

Outlook

        The Kos transactions and restructuring activities had a material positive impact on our results of operations, financial position and cash flows in the third quarter of 2005, due to the cost savings associated with the reduction in headcount in our U.S. commercial operations, as well as the discontinuance of spending on sales and marketing activities to support Cardizem® LA, Teveten and Teveten HCT. We anticipate that these cost savings will continue to have a material positive impact on our future results of operations, financial position and cash flows. In addition, the net amortization of the deferred revenue and other assets associated with the Kos transactions will positively impact our earnings by $5.9 million annually over the seven-year Cardizem® LA supply term. All of the above factors are partly offset by lower revenue and gross profit on sales of Cardizem® LA product to Kos and the elimination of Teveten and Teveten HCT product sales.

DISCONTINUED OPERATION

        On September 28, 2005, the Board of Directors committed to a plan to sell our Nutravail division. Nutravail develops and manufactures nutraceutical and food-ingredient products. This business is not considered strategic to our core pharmaceutical operations. We have received an offer of $3.0 million from a third-party acquirer to purchase substantially all of the net assets of Nutravail, including intellectual property. Management believes that a sale transaction may be completed prior to December 31, 2005.

        On the consolidated balance sheet at September 30, 2005, the net assets of Nutravail are reported as held for sale at their estimated fair value of $3.0 million based on the purchase offer received. Consequently, we recorded a $6.1 million write-down of the carrying values of Nutravail's long-lived assets.

        Because of the distinct nature of its business, Nutravail has identifiable operations and cash flows that are clearly distinguishable from the rest of Biovail. Nutravail's operations and cash flows will be eliminated from our ongoing operations as a result of the sale transaction, and we will not have any significant continuing involvement in the operations of Nutravail after it is sold. Accordingly, Nutravail has been reported as a discontinued operation in our results of operations for the current and prior periods.

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        For the third quarters and first nine months of 2005 and 2004, the following revenue and expenses of Nutravail have been reclassified from continuing operations to loss from discontinued operation:

 
  Three Months Ended
September 30

  Nine Months Ended
September 30

 
 
  2005
  2004
  2005
  2004
 
REVENUE                          
Product sales   $ 701   $ 1,214   $ 1,643   $ 3,163  
Research and development     162     510     824     669  
Royalty and other     419     383     1,602     1,026  
   
 
 
 
 
      1,282     2,107     4,069     4,858  
   
 
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     1,022     1,724     3,003     4,952  
Research and development     495     669     1,512     1,540  
Selling, general and administrative     1,220     656     3,015     2,840  
Amortization     68     68     204     204  
   
 
 
 
 
      2,805     3,117     7,734     9,536  
   
 
 
 
 

Loss from discontinued operation before write-down of assets

 

 

(1,523

)

 

(1,010

)

 

(3,665

)

 

(4,678

)
Write-down of assets     (6,113 )       (6,113 )    
   
 
 
 
 
Loss from discontinued operation   $ (7,636 ) $ (1,010 ) $ (9,778 ) $ (4,678 )
   
 
 
 
 

Outlook

        Without significant capital investment, Nutravail was expected to continue to incur losses into the foreseeable future. As a result, we anticipate that the sale of Nutravail will have a material positive impact on our future results of operations 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. The nature of our critical accounting policies or estimates has not changed since December 31, 2004.

RESULTS OF OPERATIONS

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

        Revenue increased 21% from $213.6 million in the third quarter of 2004 to $258.1 million in the third quarter of 2005, and 7% from $603.8 million in the first nine months of 2004 to $647.9 million in the first nine months of 2005, due mainly to higher product sales.

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        Income from continuing operations increased 116% from $50.6 million (basic and diluted earnings per share of $0.32) in the third quarter of 2004 to $109.3 million (basic and diluted earnings per share of $0.69) in the third quarter of 2005. There were no material events impacting our income from continuing operations in the third quarters of 2005 and 2004.

        Net income increased 105% from $49.6 million (basic and diluted earnings per share of $0.31) in the third quarter of 2004 to $101.7 million (basic and diluted earnings per share of $0.64) in the third quarter of 2005.

        Income from continuing operations increased 6% from $119.6 million (basic and diluted earnings per share of $0.75) in the first nine months of 2004 to $126.3 million (basic and diluted earnings per share of $0.79) in the first nine months of 2005. Our income from continuing operations in the first nine months of 2005 was impacted by the following events:

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

        Net income increased 1% from $114.9 million (basic and diluted earnings per share of $0.72) in the first nine months of 2004 to $116.5 million (basic and diluted earnings per share of $0.73) in the first nine months of 2005.

REVENUE

        Our revenue is derived primarily from the following sources:

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

 
  Three Months Ended September 30
   
   
 
($ in 000s)

   
   
 
  2005
  2004
  Change
 
Product sales   $ 244,455   95 % $ 202,243   95 % $ 42,212   21 %
Research and development     7,647   3     5,432   3     2,215   41  
Royalty and other     5,956   2     5,943   3     13    
   
 
 
 
 
     
    $ 258,058   100 % $ 213,618   100 % $ 44,440   21 %
   
 
 
 
 
 
 
 
 
  Nine Months Ended September 30
   
   
 
($ in 000s)
  2005
  2004
  Change
 
Product sales   $ 609,505   94 % $ 572,604   95 % $ 36,901   6 %
Research and development     21,216   3     12,162   2     9,054   74  
Royalty and other     17,201   3     19,040   3     (1,839 ) (10 )
   
 
 
 
 
     
    $ 647,922   100 % $ 603,806   100 % $ 44,116   7 %
   
 
 
 
 
 
 

Product sales

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

 
  Three Months Ended September 30
   
   
 
($ in 000s)
  2005
  2004
  Change
 
Wellbutrin XL   $ 109,261   45 % $ 86,423   43 % $ 22,838   26 %
Zovirax     22,770   9     9,747   5     13,023   134  
Cardizem® LA     17,292   7     5,243   3     12,049   230  
Teveten           5,261   3     (5,261 ) (100 )
Biovail Pharmaceuticals Canada     23,354   10     25,350   13     (1,996 ) (8 )
Legacy     29,517   12     31,856   16     (2,339 ) (7 )
Generic     42,261   17     38,363   19     3,898   10  
   
 
 
 
 
     
    $ 244,455   100 % $ 202,243   100 % $ 42,212   21 %
   
 
 
 
 
 
 

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  Nine Months Ended September 30
   
   
 
($ in 000s)
  2005
  2004
  Change
 
Wellbutrin XL   $ 216,486   36 % $ 207,583   36 % $ 8,903   4 %
Zovirax     68,175   11     44,664   8     23,511   53  
Cardizem® LA     46,271   8     43,301   8     2,970   7  
Teveten     6,534   1     12,377   2     (5,843 ) (47 )
Biovail Pharmaceuticals Canada     72,076   12     72,192   13     (116 )  
Legacy     98,441   16     85,916   15     12,525   15  
Generic     101,522   17     106,571   19     (5,049 ) (5 )
   
 
 
 
 
     
    $ 609,505   100 % $ 572,604   100 % $ 36,901   6 %
   
 
 
 
 
 
 

Wellbutrin XL

        Our bupropion ER tablets ("Wellbutrin XL") are sold by GlaxoSmithKline plc ("GSK") in the United States. Our revenue from sales of Wellbutrin XL increased 26% and 4% in the third quarter and first nine months of 2005, respectively, compared with the corresponding periods of 2004. In the third quarter of 2005, GSK's net sales of Wellbutrin XL exceeded the sales-dollar threshold to increase our supply price to GSK from the second to third and highest tier.

        Wellbutrin XL revenue increased at a higher rate of growth in the third quarter of 2005, relative to the first nine months of 2005, due to a reduction in the level of GSK's safety stock of trade product in the first quarter of 2005. During 2004, GSK had increased its safety stock of trade product in anticipation of our need to shift production in 2005 from Wellbutrin XL to scale-up activities for various products under development, including our Tramadol ER product.

Zovirax products

        Combined sales of Zovirax Ointment and Zovirax Cream increased 134% and 53% in the third quarter and first nine months of 2005, respectively, compared with the corresponding periods of 2004. The increases in Zovirax sales reflected higher prescription volumes in the third quarter and first nine months of 2005, and reductions in inventory levels of Zovirax at the wholesale level in the corresponding periods of 2004. These reductions related to the transition to distribution service agreements with our three major U.S. wholesalers in late 2004 and early 2005. These agreements generally establish limits on inventory levels held by these wholesalers and eliminates investment buying by these wholesalers, which can result in sales fluctuations unrelated to end-customer demand.

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

Cardizem® LA

        After May 2, 2005 (the date of the Kos transactions), we sell Cardizem® LA to Kos at contractual prices that are lower than what we historically charged for this product when selling direct to wholesalers; however, Cardizem® LA sales included $3.8 million and $6.3 million in the third quarter and first nine months of 2005,

30



respectively, related to the amortization of the deferred revenue associated with Kos transactions. Sales of Cardizem® LA increased 230% and 7% in the third quarter and first nine months of 2005, respectively, compared with the corresponding periods of 2004. The increases in Cardizem® LA sales reflected reductions in inventories of this product at the wholesale level during the last three quarters of 2004, which were related to the transition to wholesaler distribution services agreements, and were not related to end-customer demand for this product.

        Cardizem® LA revenue increased at a higher rate of growth in the third quarter of 2005, relative to the first nine months of 2005, due to unanticipated returns of expired product in the first quarter of 2005, primarily related to low end-customer demand for one package size of this product.

Teveten products

        Sales of Teveten and Teveten HCT reflected only those sales made prior to May 2, 2005 (the date of the Kos transactions).

Biovail Pharmaceuticals Canada ("BPC") products

        BPC products are Tiazac® XC, Tiazac®, Wellbutrin® SR, Zyban®, Monocor and Retavase, which are sold in Canada. Sales of BPC products declined 8% in the third quarter of 2005, compared with the third quarter of 2004, and were unchanged in the first nine months of 2005, compared with the first nine months of 2004. BPC product sales reflected a decline in sales of Wellbutrin® SR due to the introduction of generic competition, offset partly by growth in Tiazac® sales and the launch of Tiazac® XC in January 2005.

        In October 2005, the Federal Court of Canada issued a decision finding that RhoxalPharma Inc.'s ("RhoxalPharma") formulation for a generic version of Tiazac® did not infringe on our patents. This decision allowed the Therapeutic Products Directorate ("TPD") in Canada to issue a Notice of Compliance to RhoxalPharma in October 2005. As a result, we expect that RhoxalPharma will introduce its generic version of Tiazac® into the Canadian marketplace in late 2005. We anticipate that this introduction will result in a significant decline in BPC's sales of Tiazac®, which were $13.8 million and $39.8 million in the third quarter and first nine months of 2005, respectively. However, in November 2005, we entered into an agreement with Novopharm Limited ("Novopharm"), a subsidiary of Teva Pharmaceutical Industries Ltd. ("Teva"), for the distribution in Canada of our own generic version of Tiazac® to compete with RhoxalPharma's product. We will manufacture and supply generic Tiazac® to Novopharm for five years at a supply price equal to 37.5% of the listed formulary price. Novopharm intends to immediately launch generic Tiazac® in Canada. The introduction of generic formulations of Tiazac® does not affect our ongoing conversion strategy for Tiazac® XC.

Legacy products

        Our legacy products are Ativan®, Cardizem® CD, Isordil®, Tiazac®, Vasotec® and Vaseretic®, which are sold primarily in the United States. We sell Tiazac® (brand and generic) to Forest Laboratories, Inc. ("Forest") for distribution in the United States. Our other legacy products are primarily sold directly to wholesalers in the United States. Sales of our legacy products declined 7% overall in the third quarter of 2005, compared with the third quarter of 2004, and increased 15% overall in the first nine months of 2005, compared with the first nine months of 2004. The decrease in legacy product sales in the third quarter of 2005 was due to lower sales of both brand and generic Tiazac®, offset partly by higher sales of our other legacy products. The increase in the legacy product sales in the first nine months of 2005 reflected lower sales of brand Tiazac®, which were more than offset by higher sales of our other legacy products.

31



        The increases in overall sales of our other legacy products in the third quarter and first nine months of 2005, reflected reductions in inventories of these products at the wholesale level during the last three quarters of 2004, which were related to the transition to wholesaler distribution service agreements.

Generic products

        Our generic products are bioequivalent versions of Adalat CC, Cardizem® CD, Procardia XL, Trental and Voltaren XR, which we manufacture and sell to a subsidiary of Teva for distribution in the United States. Sales of our generic products increased 10% overall in the third quarter of 2005, compared with the third quarter of 2004, and declined 5% overall in the first nine months of 2005, compared with the first nine months of 2004. The increase in generic product sales in the third quarter of 2005 was mainly due to stronger sales of generic Procardia XL. The decline in generic product sales in the first nine months of 2005 was mainly due to weaker sales of generic Adalat CC.

Research and development revenue

        Research and development revenue increased 41% and 74% in the third quarter and first nine months of 2005, compared with the corresponding periods of 2004. The increases 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 revenue

        Royalty and other revenue were unchanged in the third quarter of 2005, compared with the third quarter of 2004, and declined 10% in the first nine months of 2005, compared with the first nine months of 2004. Royalty and other revenue reflected a decrease in royalty income on Tiazac® brand sales by Forest, due to generic competition that resulted in lower end-customer demand for this product, offset by an increase in royalty income from our interest in Tricor (fenofibrate).

OPERATING EXPENSES

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

 
  Three Months Ended September 30
   
   
 
($ in 000s)
  2005
  2004
  Change
 
Cost of goods sold   $ 51,991   20 % $ 50,111   23 % $ 1,880   4 %
Research and development     19,913   8     16,979   8     2,934   17  
Selling, general and administrative     42,402   16     68,273   32     (25,871 ) (38 )
Amortization     15,443   6     16,262   8     (819 ) (5 )
Restructuring costs     1,118             1,118   N/A  
Gain on disposal of assets           (1,471 ) (1 )   1,471   (100 )
   
 
 
 
 
     
    $ 130,867   51 % $ 150,154   70 % $ (19,287 ) (13 )%
   
 
 
 
 
 
 

32


 
 
  Nine Months Ended September 30
   
   
 
($ in 000s)
  2005
  2004
  Change
 
Cost of goods sold   $ 152,964   24 % $ 158,076   26 % $ (5,112 ) (3 )%
Research and development     62,135   10     49,929   8     12,206   24  
Selling, general and administrative     174,263   27     181,538   30     (7,275 ) (4 )
Amortization     46,818   7     48,965   8     (2,147 ) (4 )
Restructuring costs     19,725   3           19,725   N/A  
Write-down (gain on disposal) of assets     26,560   4     (1,471 )     28,031   N/A  
Acquired research and development           8,640   1     (8,640 ) (100 )
   
 
 
 
 
     
    $ 482,465   74 % $ 445,677   74 % $ 36,788   8 %
   
 
 
 
 
 
 

Cost of goods sold and gross margins

        Cost of goods sold increased 4% in the third quarter of 2005, compared with the third quarter of 2004, and declined 3% in the first nine months of 2005, compared with the first nine months of 2004. Cost of goods sold included $2.0 million and $3.4 million in the third quarter and first nine months of 2005, respectively, related to the amortization of the deferred charge associated with Kos transactions. In addition, cost of goods sold included $1.6 million and $1.8 million in the third quarter and first nine months of 2005, respectively, related to the amortization of the deferred charge related to a reduction in the Zovirax supply price to be paid to GSK.

        Gross margins based on product sales were 79% and 75% in the third quarter and first nine months of 2005, respectively, compared with 75% and 72% in the third quarter and first nine months of 2004, respectively. The increases in gross margins reflected mainly manufacturing efficiencies that we are continuing to achieve in the production of Wellbutrin XL, as well as a decrease in the proportion of lower margin Wellbutrin XL sample supplies versus trade product sales in the third quarter and first nine months of 2005, compared with the corresponding periods of 2004.

        In the second quarter of 2005, following a review of existing market conditions for Cardizem® CD, we recorded a provision of $5.7 million for inventory of this product in excess of expected demand. We anticipate a continuing decline in Cardizem® CD prescriptions due to increasing competition from generics and Cardizem® LA. In addition, we wrote off the $4.9 million of Cardizem® LA, Teveten and Teveten HCT inventories not purchased by Kos. Excluding these inventory charges, our normalized gross margins were 77% in the first nine months of 2005.

Research and development expenses

        Research and development expenses increased 17% and 24% in the third quarter and first nine months of 2005, respectively, compared with the corresponding periods of 2004. We invested 8% and 10% of total revenue in research and development activities in the third quarter and first nine months of 2005, respectively, compared with 8% in both the third quarter and first nine months of 2004. The increases in research and development expenses were primarily due to increased spending on our late-stage product development programs, and costs associated with a higher level of contract research services provided to external customers. Research and development activities in the third quarter and first nine months of 2005 included line extension and enhanced formulation programs for tramadol, bupropion, and the anti-depressant venlafaxine.

33



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

Selling, general and administrative expenses

        Selling, general and administrative expenses declined 38% and 4% in the third quarter and first nine months of 2005, respectively, compared with the corresponding periods of 2004. As a percentage of total revenue, selling, general and administrative expenses were 16% and 27% in the third quarter and first nine months of 2005, respectively, compared with 32% and 30% in the third quarter and first nine months of 2004, respectively. The declines in selling, general and administrative expenses reflected the impact of the Kos transactions and concurrent restructuring of our U.S. commercial operations. These events resulted in immediate cost savings associated with a reduction in headcount in our primary-care and cardiovascular specialty sales forces and the discontinuance of spending on sales and marketing activities to support Cardizem® LA, Teveten and Teveten HCT. These factors were partially offset by higher corporate expenses resulting from our corporate governance and Sarbanes-Oxley compliance initiatives, as well as an expansion of our executive group and compensation expense related to Deferred Share Units granted in the third quarter of 2005.

34



Amortization expense

        Amortization expense declined 5% and 4% in the third quarter and first nine months of 2005, respectively, compared with the corresponding periods of 2004. The declines in amortization expense reflected the final amortization of our interest in generic omeprazole in the first quarter of 2004, and the discontinuance of amortization of the Teveten and Teveten HCT product rights following the Kos transactions. As a result of the disposal of the Teveten and Teveten HCT product rights, amortization expense will be reduced by $1.2 million per quarter or $4.7 million annually.

Restructuring costs

        In the third quarter and first nine months of 2005, we incurred charges of $1.1 million and $19.7 million, respectively, associated with the restructuring of our U.S. commercial operations. At September 30, 2005, there was a remaining liability balance of $2.2 million for restructuring costs, which was mainly related to a facility lease that will be settled over the remaining 10-year term of this lease.

Write-down or gain on sale of assets

        In the second quarter of 2005, the disposal of the Teveten and Teveten HCT product rights to Kos resulted in a $25.8 million write-down (including costs to sell) of the carrying value of these product rights to reflect their fair value of $53.7 million at the date of disposition. In addition, we wrote-off our $0.7 million investment in convertible debentures of Procyon Biopharma Inc. ("Procyon"), as a result of our decision to terminate the Fibrostat licensing agreement with Procyon.

        In the third quarter of 2004, we disposed of the product rights to Cedax for proceeds of $3.0 million, which resulted in a gain on disposal of $1.5 million.

Acquired research and development expense

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

OPERATING INCOME

        We recorded operating income of $127.2 million and $165.5 million in the third quarter and first nine months of 2005, respectively, compared with $63.5 million and $158.1 million in the third quarter and first nine months of 2004, respectively. In the first nine months of 2005, charges related to the cost of inventories not purchased by Kos, the write-down of assets and restructuring activities reduced operating income by a total of $51.1 million. In the first nine months of 2004, the charge to acquired research and development expense reduced operating income by $8.6 million.

        Operating income in the third quarter and first nine months of 2005, compared with the corresponding periods of 2004, reflected higher gross margins on product sales and lower sales force and marketing costs. These factors were partially offset by increased research and development spending and higher corporate expenses.

35



NON-OPERATING ITEMS

Interest expense

        Interest expense was $9.5 million and $27.9 million in the third quarter and first nine months of 2005, respectively, compared with $10.1 million and $30.5 million in the third quarter and first nine months of 2004, respectively. Interest expense mainly comprised interest on our 77/8% Senior Subordinated Notes due April 1, 2010 ("Notes"). In July 2005, we terminated an interest rate swap of $200.0 million notional amount that was designated as hedge of our Notes.

Provision for income taxes

        Our effective tax rate reflected the fact that most of our income was derived from foreign subsidiaries with lower statutory tax rates than those that apply in Canada. We recorded provisions for income taxes of $9.1 million and $12.0 million in the third quarter and first nine months of 2005, respectively, and $2.1 million and $5.2 million in the third quarter and first nine months of 2004, respectively. Our effective tax rate was affected by the availability of unrecognized tax loss carryforwards that can be used to offset taxable income in Canada and the United States, as well as losses that were incurred in the United States prior to the transactions with Kos and restructuring activities.

        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.

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SUMMARY OF QUARTERLY RESULTS

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

 
  2005
  2004
($ in 000s, except per share data)
  Q3
  Q2
  Q1
  Q4
Revenue   $ 258,058   $ 216,178   $ 173,686   $ 275,350
Income from continuing operations     109,299     4,922     12,059     46,582
Net income     101,663     3,707     11,132     46,045

Basic and diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 
Income from continuing operations   $ 0.69   $ 0.03   $ 0.08   $ 0.29
Net income   $ 0.64   $ 0.02   $ 0.07   $ 0.29
   
 
 
 
 
 
  2004
  2003
 
($ in 000s, except per share data)
  Q3
  Q2
  Q1
  Q4
 
Revenue   $ 213,618   $ 204,886   $ 185,302   $ 195,394  
Income (loss) from continuing operations     50,645     45,784     23,198     (96,621 )
Net income (loss)     49,635     44,208     21,106     (96,038 )

Basic and diluted earnings (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 
Income (loss) from continuing operations   $ 0.32   $ 0.29   $ 0.15   $ (0.61 )
Net income (loss)   $ 0.31   $ 0.28   $ 0.13   $ (0.60 )
   
 
 
 
 

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

        The increase in net income in the third quarter of 2005, compared with the second quarter of 2005, reflected the lower sales force and marketing costs following the Kos transactions and restructuring activities in the second quarter. Also contributing to the increase in net income in the third quarter of 2005, compared with the second quarter of 2005, as well as the decline in net income in the second quarter of 2005, compared with the first quarter of 2005, were the charges related to the write-down of assets and restructuring activities recorded in the second quarter.

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FINANCIAL CONDITION

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

($ in 000s)
  At September 30
2005

  At December 31
2004

Working capital   $ 350,075   $ 124,414
Long-lived assets     1,279,951     1,328,363
Long-term obligations     447,339     478,936
Shareholders' equity     1,181,015     1,053,913
   
 

Working capital

        The $225.7 million increase in working capital from December 31, 2004 to September 30, 2005 was primarily due to:

        Partially offset by:

Long-lived assets

        Long-lived assets comprise property, plant and equipment, goodwill, intangible and other assets, net of accumulated depreciation and amortization. The $48.4 million decrease in long-lived assets from December 31, 2004 to September 30, 2005, reflected primarily the depreciation of plant and equipment of $22.5 million and the amortization of intangible and other assets of $53.5 million, as well as the write-downs of the carrying values of the Teveten and Teveten HCT product rights and Nutravail's long-lived assets of $25.5 million and $6.1 million, respectively. These factors were partially offset by the additions of the Glumetza™ and Tramadol ODT product rights of aggregate $26.0 million and net capital expenditures on property, plant and equipment of $24.1 million, which included expenditures related to the ongoing expansion of our Steinbach, Manitoba manufacturing facility.

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Long-term obligations

        The $31.6 million decrease in long-term obligations, including the current portion thereof, from December 31, 2004 to September 30, 2005, reflected primarily the following instalments:

Shareholders' equity

        The $127.1 million increase in shareholders' equity from December 31, 2004 to September 30, 2005, reflected primarily net income of $116.5 million, as well as a $4.4 million unrealized holding gain on our available-for-sale investments, mainly related to our equity investment in Depomed, and a $5.1 million foreign currency translation gain due to a strengthening of the Canadian dollar relative to the U.S. dollar.

CASH FLOWS

        At September 30, 2005, we had cash and cash equivalents of $326.7 million, compared with $34.3 million at December 31, 2004. The following table displays cash flow information for the first nine months of 2005 and 2004:

 
  Nine Months Ended
September 30

 
($ in 000s)
  2005
  2004
 
Net cash provided by continuing operating activities   $ 278,489   $ 167,413  
Net cash provided by (used in) continuing investing activities     46,978     (29,374 )
Net cash used in continuing financing activities     (30,495 )   (225,359 )
Net cash used in discontinued operation     (2,775 )   (2,055 )
Effect of exchange rate changes on cash and cash equivalents     206     157  
   
 
 
Net increase (decrease) in cash and cash equivalents   $ 292,403   $ (89,218 )
   
 
 

Operating activities

        Net cash provided by continuing operating activities increased $111.1 million from the first nine months of 2004 to the first nine months of 2005, primarily due to:

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        In the first nine months of 2005, net cash provided by continuing operating activities was used to make the milestone payments related to Glumetza™ and Tramadol ODT, to fund the expansion of the Steinbach manufacturing facility and other capital expenditures, and to repay long-term obligations. In the first nine months of 2004, net cash provided by continuing operating activities was primarily used to repay our revolving term credit facility and other long-term obligations.

Investing activities

        Net cash provided by continuing investing activities increased $76.4 million from the first nine months of 2004 to the first nine months of 2005, primarily due to:

        Partially offset by:


Financing activities

        Net cash used in continuing financing activities declined $194.9 million from the first nine months of 2004 to the first nine months of 2005, primarily due to:

Outlook

        We anticipate utilizing our existing cash resources and continuing cash flows from operations to support primarily our growth strategy through potential acquisitions of new products, technologies and/or businesses. We are also considering using part of these funds to redeem a portion of our Notes, repurchase a percentage of our common shares and/or pay a dividend to our shareholders.

LIQUIDITY AND CAPITAL RESOURCES

        At September 30, 2005, we had total long-term obligations of $447.3 million, including the current portion thereof, which included the carrying value of our Notes of $400.6 million and obligations related to the acquisitions of intangible assets of $42.7 million. At September 30, 2005, we had no outstanding borrowings under our revolving term credit facility; however, we had a letter of credit of $27.1 million issued under this facility, which secures the remaining semi-annual payments we are required to make to Merck related to our acquisition of Vasotec® and Vaseretic®. In May 2005, we renewed this credit facility for a one-year term at $250.0 million. This facility is renewable for additional one-year revolving terms at the lenders' option, with a one-year term out at our option if the lenders do not renew. This facility may be used for general corporate purposes, including acquisitions. At September 30, 2005, we were in compliance with all financial and non-financial covenants associated with this facility. Our current corporate credit ratings from Standard & Poor's ("S&P") and Moody's Investors Service ("Moody's") are BB+ and Ba3, respectively, the current ratings

40



on our Notes from S&P and Moody's are BB- and B2, respectively, and S&P's current rate on our revolving term credit facility is BBB-.

        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 September 30, 2005:

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

  2008 and
2009

  Thereafter
Long-term obligations   $ 444,139   $ 7,628   $ 36,511   $   $ 400,000
Operating lease obligations     44,325     1,725     12,600     9,900     20,100
Purchase obligations     30,694     14,505     16,189        
   
 
 
 
 
Total contractual obligations   $ 519,158   $ 23,858   $ 65,300   $ 9,900   $ 420,100
   
 
 
 
 

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

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

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

OFF-BALANCE SHEET ARRANGEMENTS

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

41



QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        We are exposed to financial market risks, including changes in foreign currency exchange rates, interest rates on investments and debt obligations, and equity market prices on long-term investments. We use derivative financial instruments from time to time as a risk management tool and not for trading or speculative purposes.

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

Foreign currency risk

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

Interest rate risk

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

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

Investment risk

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

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 supersedes Accounting Principles Board Opinion ("APB")

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

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

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BIOVAIL CORPORATION
PART II — OTHER INFORMATION

1.     LEGAL PROCEEDINGS

        For detailed information concerning legal proceedings, reference is made to note 13 — Legal Proceedings to the consolidated financial statements included under Part I of this Quarterly Report.

2.     EXHIBITS

Exhibit 99.1   Third 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: November 14, 2005

 

 

 

 

 

By:

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

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