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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, 2006

Commission File Number 001-14956

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

FORM 6-K

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006

        This Report of Foreign Private Issuer on Form 6-K ("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, 2006 and December 31, 2005   1
  Consolidated Statements of Income for the three months ended March 31, 2006 and 2005   2
  Consolidated Statements of Deficit for the three months ended March 31, 2006 and 2005   3
  Consolidated Statements of Cash Flows for the three months ended March 31, 2006 and 2005   4
  Condensed Notes to the Consolidated Financial Statements   5
Management's Discussion and Analysis of Results of Operations and Financial Condition   29

Part II — Other Information
Legal Proceedings   48
Exhibits   48
 



BASIS OF PRESENTATION

General

        All dollar amounts in this report are expressed in United States ("U.S.") dollars. Except where the context otherwise requires, all references in this Form 6-K to the "Company", "Biovail", "we", "us", "our" or similar words or phrases are to Biovail Corporation and its subsidiaries, taken together.

Trademarks

        The following words are trademarks of the Company and are the subject of either registration, or application for registration, in one or more of Canada, the U.S. or certain other jurisdictions: Ativan®, Biovail®, BPI®, BVF®, Cardisense™, Cardizem®, Cardizem® LA, CEFORM™, DiTech™, DrinkUp®, FlashDose®, Glumetza™, Healthburst™, Instatab™, Isordil®, Nutravail®, Oramelt™, Shearform™, Smartcoat™, SportSafe®, Tiazac® XC, Tiazac®, Vasocard™, Vasotec®, Vaseretic® and Z-Flakes®.

        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®, Ultram® ER, and Ultram® ODT are trademarks of Ortho-McNeil, Inc. and are used by the Company under license.

        Zoladex® is a trademark of AstraZeneca Pharmaceuticals LP and is used by the Company under license.

        In addition, the Company has filed trademark applications for many of its other trademarks in the U.S. and Canada and has implemented on an ongoing basis a trademark protection program for new trademarks.

i




FORWARD-LOOKING STATEMENTS

        Caution regarding forward-looking information and statements and "Safe Harbor" statement under the U.S. Private Securities Litigation Reform Act of 1995:

        To the extent any statements made in this Form 6-K 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, and may be forward-looking information within the meaning of the "safe harbour" provisions of applicable Canadian securities legislation (collectively "forward — looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, strategies, beliefs, intentions, plans, estimates and outlook, and can generally be identified by the use of 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. Although we believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: 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, 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, as well as our ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this document, as well as in our Annual Report on Form 20-F for the fiscal year ended December 31, 2005 under the heading "Risk Factors" under Item 3, Sub-Part D. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement.

ii



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
March 31
2006

  At
December 31
2005

 
ASSETS              
Current              
Cash and cash equivalents   $ 512,819   $ 445,289  
Marketable securities         505  
Accounts receivable     105,523     132,699  
Assets of discontinued operation held for sale         1,893  
Inventories     91,654     89,473  
Deposits and prepaid expenses     11,815     14,923  
   
 
 
      721,811     684,782  
Long-term assets of discontinued operation held for sale         1,107  
Marketable securities     7,620     6,859  
Long-term investments     68,983     66,421  
Property, plant and equipment, net     210,066     199,567  
Intangible assets, net     893,158     910,276  
Goodwill     100,294     100,294  
Other assets, net     56,694     59,506  
   
 
 
    $ 2,058,626   $ 2,028,812  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 37,199   $ 61,453  
Accrued liabilities     110,328     88,870  
Income taxes payable     38,609     37,713  
Deferred revenue     52,627     61,160  
Current portion of long-term obligations     24,654     24,360  
   
 
 
      263,417     273,556  
Deferred revenue     112,327     117,119  
Deferred leasehold inducements     5,366     5,273  
Long-term obligations     401,464     412,508  
   
 
 
      782,574     808,456  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
  Common shares, no par value, unlimited shares authorized, 159,748,839 and 159,587,838 issued and outstanding at March 31, 2006 and December 31, 2005, respectively     1,464,072     1,461,077  
Additional paid-in capital     7,250     377  
Deficit     (245,733 )   (290,242 )
Accumulated other comprehensive income     50,463     49,144  
   
 
 
      1,276,052     1,220,356  
   
 
 
    $ 2,058,626   $ 2,028,812  
   
 
 

Commitments and contingencies (notes 10 and 11)

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

 
 
  2006
  2005
 
REVENUE              
Product sales   $ 209,705   $ 160,531  
Research and development     4,909     7,200  
Royalty and other     5,909     5,955  
   
 
 
      220,523     173,686  
   
 
 

EXPENSES

 

 

 

 

 

 

 
Cost of goods sold     49,329     41,101  
Research and development     22,328     19,954  
Selling, general and administrative     56,550     74,694  
Amortization     14,824     15,966  
   
 
 
      143,031     151,715  
   
 
 
Operating income     77,492     21,971  
Interest income     5,196     378  
Interest expense     (9,024 )   (8,897 )
Foreign exchange loss     (590 )   (538 )
Other expense     (318 )   (270 )
   
 
 
Income from continuing operations before provision for income taxes     72,756     12,644  
Provision for income taxes     4,150     585  
   
 
 
Income from continuing operations     68,606     12,059  
Loss from discontinued operation     (4,120 )   (927 )
   
 
 
Net income   $ 64,486   $ 11,132  
   
 
 

Basic and diluted earnings (loss) per share

 

 

 

 

 

 

 
Income from continuing operations   $ 0.43   $ 0.08  
Loss from discontinued operation     (0.03 )   (0.01 )
   
 
 
Net income   $ 0.40   $ 0.07  
   
 
 
Weighted average number of common shares outstanding (000s)              
Basic     159,663     159,385  
   
 
 
Diluted     159,737     159,447  
   
 
 

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

 
 
  2006
  2005
 
Deficit, beginning of period   $ (290,242 ) $ (446,684 )
Net income     64,486     11,132  
Dividends declared     (19,977 )    
   
 
 
Deficit, end of period   $ (245,733 ) $ (435,552 )
   
 
 

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

 
 
  2006
  2005
 
CASH FLOWS FROM OPERATING ACTIVITIES              
Income from continuing operations   $ 68,606   $ 12,059  
Adjustments to reconcile income from continuing operations to net cash provided by continuing operating activities              
Depreciation and amortization     25,115     22,564  
Amortization of deferred financing costs     622     812  
Amortization of discounts on long-term obligations     491     784  
Stock-based compensation     6,873      
Equity loss     318     270  
Receipt of leasehold inducements     211      
Other     (196 )   (221 )
Changes in operating assets and liabilities:              
  Accounts receivable     25,991     32,332  
  Inventories     (2,201 )   (8,286 )
  Deposits and prepaid expenses     3,087     4,691  
  Accounts payable     (22,918 )   (2,970 )
  Accrued liabilities     966     9,937  
  Income taxes payable     886     (1,833 )
  Deferred revenue     (13,159 )   (2,343 )
   
 
 
Net cash provided by continuing operating activities     94,692     67,796  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Additions to property, plant and equipment, net     (17,913 )   (5,095 )
Purchases of marketable securities     (1,152 )   (4,144 )
Proceeds from sales and maturities of marketable securities     853     3,258  
   
 
 
Net cash used in continuing investing activities     (18,212 )   (5,981 )
   
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 
Repayments of other long-term obligations     (11,352 )   (11,722 )
Issuance of common shares     2,995     7  
   
 
 
Net cash used in continuing financing activities     (8,357 )   (11,715 )
   
 
 

CASH FLOWS FROM DISCONTINUED OPERATION

 

 

 

 

 

 

 
Net cash used in operating activities     (580 )   (408 )
Net cash used in investing activities         (45 )
   
 
 
Net cash used in discontinued operation     (580 )   (453 )
   
 
 
Effect of exchange rate changes on cash and cash equivalents     (13 )   (49 )
   
 
 
Net increase in cash and cash equivalents     67,530     49,598  
Cash and cash equivalents, beginning of period     445,289     34,324  
   
 
 
Cash and cash equivalents, end of period   $ 512,819   $ 83,922  
   
 
 

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 United States 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


3.     DISCONTINUED OPERATION

6


 
  Three Months Ended March 31
 
 
  2006
  2005
 
REVENUE              
Product sales   $ 519   $ 637  
Research and development     59     326  
Royalty and other     162     612  
   
 
 
      740     1,575  
   
 
 
EXPENSES              
Cost of goods sold (including write-down of inventory of $1,711)     2,207     990  
Research and development     861     533  
Selling, general and administrative     708     911  
Amortization         68  
   
 
 
      3,776     2,502  
   
 
 
Loss from discontinued operation before write-down of assets     (3,036 )   (927 )
Write-down of assets     (1,084 )    
   
 
 
Loss from discontinued operation   $ (4,120 ) $ (927 )
   
 
 

4.     INVENTORIES

 
  At
March 31
2006

  At
December 31
2005

Raw materials   $ 52,710   $ 54,525
Work in process     18,694     11,416
Finished goods     20,250     23,532
   
 
    $ 91,654   $ 89,473
   
 

7


5.     INTANGIBLE ASSETS

 
  At March 31, 2006
  At December 31, 2005
 
  Cost
  Accumulated amortization
  Cost
  Accumulated amortization
Trademarks   $ 703,698   $ 160,306   $ 703,698   $ 151,535
Product rights     439,151     101,329     443,151     97,265
Technology     16,956     5,012     16,956     4,729
   
 
 
 
      1,159,805   $ 266,647     1,163,805   $ 253,529
         
       
Less accumulated amortization     266,647           253,529      
   
       
     
    $ 893,158         $ 910,276      
   
       
     
 
  Three Months Ended
March 31

 
  2006
  2005
Royalty and other revenue   $ 268   $ 268
Cost of goods sold     2,026    
Amortization expense     14,824     15,966
Loss from discontinued operation         68
   
 
    $ 17,118   $ 16,302
   
 

6.     LONG-TERM OBLIGATIONS

 
  At
March 31
2006

  At
December 31
2005

 
77/8% Senior Subordinated Notes due April 1, 2010   $ 400,000   $ 400,000  
Unamortized discount     (1,460 )   (1,551 )
Fair value adjustment     1,997     2,103  
   
 
 
      400,537     400,552  
Vasotec® and Vaseretic® obligation     13,815     13,622  
Zovirax® obligation     10,839     21,884  
Deferred compensation     927     810  
   
 
 
      426,118     436,868  
Less current portion     24,654     24,360  
   
 
 
    $ 401,464   $ 412,508  
   
 
 

8


7.     STOCK-BASED COMPENSATION

 
  Three Months Ended
March 31, 2006

Cost of goods sold   $ 460
Research and development expenses     872
Selling, general and administrative expenses     5,541
   
    $ 6,873
   

9


 
  Three Months Ended
March 31, 2005

 
Net income as reported   $ 11,132  
Pro forma stock-based compensation expense determined under fair value-based method     (216 )
   
 
Pro forma net income     10,916  
   
 
Basic and diluted earnings per share        
As reported   $ 0.07  
Pro forma   $ 0.07  
   
 
 
  Three Months Ended
March 31

 
 
  2006
  2005
 
Expected option life (years)   4.0   4.0  
Volatility   53.1 % 53.3 %
Risk-free interest rate   4.1 % 3.7 %
Dividend yield   2.0 % %

10


 
  Options (000s)
  Weighted Average Exercise Price
Outstanding balance, January 1, 2006   7,932   $ 25.94
Granted   1,686     24.50
Exercised   (157 )   18.51
Forfeited      
   
 
Outstanding balance, March 31, 2006   9,461   $ 25.82
   
 
Range of Exercise Prices
  Outstanding
(000s)

  Weighted Average Remaining Contractual Life
(Years)

  Weighted Average Exercise Price
  Exercisable
(000s)

  Weighted Average Exercise Price
$3.52 - $10.00   41   0.4   $ 10.30   41   $ 10.30
$17.50 - $25.00   6,137   3.3     20.77   3,529     20.53
$27.72 - $41.00   2,339   1.6     32.62   2,270     32.52
$42.00 - $48.07   944   1.0     42.41   936     42.36
   
           
     
    9,461   2.7   $ 25.82   6,776   $ 27.50
   
 
 
 
 

11


8.     DIVIDENDS AND EARNINGS PER SHARE

 
  Three Months Ended
March 31

 
  2006
  2005
Net income   $ 64,486   $ 11,132
   
 
Basic weighted average number of common shares outstanding (000s)     159,663     159,385
Dilutive effect of stock options (000s)     74     62
   
 
Diluted weighted average number of common shares outstanding (000s)     159,737     159,447
   
 
Basic and diluted earnings per share   $ 0.40   $ 0.07
   
 

9.     COMPREHENSIVE INCOME

 
  Three Months Ended
March 31

 
 
  2006
  2005
 
Net income   $ 64,486   $ 11,132  
   
 
 

Comprehensive income

 

 

 

 

 

 

 
Foreign currency translation adjustment     (1,259 )   (695 )
Unrealized holding gain (loss) on long-term investments     2,578     (6,085 )
   
 
 
Other comprehensive income (loss)     1,319     (6,780 )
   
 
 
Comprehensive income   $ 65,805   $ 4,352  
   
 
 

10.   LEGAL PROCEEDINGS

12


13


14


15


16


17


18


19


11.   CONTINGENCY

20


12.   SEGMENT INFORMATION

13.   SUBSEQUENT EVENTS

14.   CANADIAN GAAP SUPPLEMENTAL INFORMATION

21


 
  Three Months Ended March 31
 
 
  2006
  2005
 
Net income under U.S. GAAP   $ 64,486   $ 11,132  
   
 
 

Canadian GAAP adjustments

 

 

 

 

 

 

 
Acquired research and development amortization expense (a)     (12,329 )   (24,528 )
Stock-based compensation expense (b)     (190 )   (216 )
Other     111     93  
   
 
 
Net income (loss) under Canadian GAAP   $ 52,078   $ (13,519 )
   
 
 

Basic and diluted earnings (loss) per share under Canadian GAAP

 

 

 

 

 

 

 
Income (loss) from continuing operations   $ 0.35   $ (0.08 )
Net income (loss)   $ 0.33   $ (0.08 )
   
 
 

22


 
  At
March 31
2006

  At
December 31
2005

 
Total assets under U.S. GAAP   $ 2,058,626   $ 2,028,812  
   
 
 

Canadian GAAP adjustments

 

 

 

 

 

 

 
Marketable securities/Long-term investments              
  Unrealized holding gain on available-for-sale investments (c)     (18,815 )   (16,237 )
Intangible assets, net              
  Acquired research and development (a)     162,790     175,121  
Goodwill              
  Value of consideration on acquisition of Fuisz Technologies Ltd. ("Fuisz") (d)     (7,763 )   (7,763 )
  Settlement of Fuisz pre-acquisition contract (e)     7,460     7,460  
  Other     2,918     2,918  
Other assets, net     (2,109 )   (2,218 )
   
 
 
Total assets under Canadian GAAP   $ 2,203,107   $ 2,188,093  
   
 
 

Total liabilities under U.S. GAAP

 

$

782,574

 

$

808,456

 
   
 
 
Canadian GAAP adjustments              
Long-term obligations     86     88  
   
 
 
Total liabilities under Canadian GAAP   $ 782,660   $ 808,544  
   
 
 

23


 
 
  At
March 31
2006

  At
December 31
2005

 
Total shareholders' equity under U.S. GAAP   $ 1,276,052   $ 1,220,356  
   
 
 
Canadian GAAP adjustments              
Common shares              
  Stock-based compensation (b)     36,779     36,779  
  Accretion of convertible debt (f)     26,116     26,116  
  Value of consideration on acquisition of Fuisz (d)     7,763     7,763  
  Other     (1,700 )   (1,700 )
Additional paid-in capital              
  Stock-based compensation (b)     65,690     65,500  
Deficit              
  Acquired research and development (a)     162,790     175,121  
  Stock-based compensation (b)     (102,469 )   (102,279 )
  Accretion of convertible debt (f)     (26,116 )   (26,116 )
  Settlement of Fuisz pre-acquisition contract (e)     (7,460 )   (7,460 )
  Other     1,817     1,706  
Cumulative translation adjustment              
  Unrealized holding gain on available-for-sale investments (c)     (18,815 )   (16,237 )
   
 
 
Total shareholders' equity under Canadian GAAP   $ 1,420,447   $ 1,379,549  
   
 
 

        Under Canadian GAAP, effective January 1, 2004, the Company adopted the fair-value based method for recognizing stock-based compensation cost on a retroactive basis to January 1, 1996, without restatement of prior periods. At January 1, 2004, the cumulative effect of the change in accounting policy on prior periods resulted in a charge to deficit of $88,334,000 relating to the fair value of stock options vested since January 1, 1996, an increase to common shares of $40,945,000 related to the fair value of stock options exercised since January 1, 1996, and an increase of $47,389,000 to additional paid-in capital related to the fair value of options vested but unexercised since January 1, 1996. Stock option forfeitures are recognized as they occur.

        Under Canadian GAAP, long-term investments are accounted for using the cost method. Declines in the fair value of these investments below their cost basis that are considered to be other-than-temporary are recognized in net income or loss.

24



        Under Canadian GAAP, a portion of the proceeds from the issuance of the Debentures was attributed to the holder conversion option. The portion of the debt conversion premium recorded on the redemption of the Debentures in 2001 that was related to the holder conversion option was charged to retained earnings.

25


 
  At
March 31
2006

  At
December 31
2005

  At
December 31
2005

 
 
  (U.S. GAAP)
  (U.S. GAAP)
  (CDN GAAP)
 
ASSETS                    
Current                    
Cash and cash equivalents   $ 512,819   $ 445,289   $ 445,289  
Marketable securities         505     511  
Accounts receivable     105,523     132,699     132,699  
Assets of discontinued operation held for sale         1,893     1,893  
Inventories     91,654     89,473     89,473  
Deposits and prepaid expenses     11,815     14,923     14,923  
   
 
 
 
      721,811     684,782     684,788  
Long-term assets of discontinued operation held for sale         1,107     1,107  
Marketable securities     7,620     6,859     6,920  
Long-term investments     68,983     66,421     50,117  
Property, plant and equipment, net     210,066     199,567     199,567  
Intangible assets, net     893,158     910,276     1,085,397  
Goodwill     100,294     100,294     102,909  
Other assets, net     56,694     59,506     57,288  
   
 
 
 
    $ 2,058,626   $ 2,028,812   $ 2,188,093  
   
 
 
 
LIABILITIES                    
Current                    
Accounts payable   $ 37,199   $ 61,453   $ 61,453  
Accrued liabilities     110,328     88,870     88,870  
Income taxes payable     38,609     37,713     37,713  
Deferred revenue     52,627     61,160     61,160  
Current portion of long-term obligations     24,654     24,360     24,360  
   
 
 
 
      263,417     273,556     273,556  
Deferred revenue     112,327     117,119     117,119  
Deferred leasehold inducements     5,366     5,273     5,273  
Long-term obligations     401,464     412,508     412,596  
   
 
 
 
      782,574     808,456     808,544  
   
 
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 
Common shares     1,464,072     1,461,077     1,530,035  
Additional paid-in capital     7,250     377     65,877  
Deficit     (245,733 )   (290,242 )   (249,270 )
Accumulated other comprehensive income/Cumulative translation adjustment     50,463     49,144     32,907  
   
 
 
 
      1,276,052     1,220,356     1,379,549  
   
 
 
 
    $ 2,058,626   $ 2,028,812   $ 2,188,093  
   
 
 
 

26


CONSOLIDATED STATEMENTS OF INCOME (LOSS)

 
  Three Months Ended March 31
 
 
  2006
  2005
  2005
 
 
  (U.S. GAAP)
  (U.S. GAAP)
  (CDN GAAP)
 
REVENUE                    
Product sales   $ 209,705   $ 160,531   $ 160,531  
Research and development     4,909     7,200     7,200  
Royalty and other     5,909     5,955     5,955  
   
 
 
 
      220,523     173,686     173,686  
   
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     49,329     41,101     41,114  
Research and development     22,328     19,954     19,975  
Selling, general and administrative     56,550     74,694     74,876  
Amortization     14,824     15,966     40,494  
   
 
 
 
      143,031     151,715     176,459  
   
 
 
 
Operating income (loss)     77,492     21,971     (2,773 )
Interest income     5,196     378     378  
Interest expense     (9,024 )   (8,897 )   (8,804 )
Foreign exchange loss     (590 )   (538 )   (538 )
Other expense     (318 )   (270 )   (270 )
   
 
 
 

Income (loss) from continuing operations before provision for income taxes

 

 

72,756

 

 

12,644

 

 

(12,007

)
Provision for income taxes     4,150     585     585  
   
 
 
 
Income (loss) from continuing operations     68,606     12,059     (12,592 )
Loss from discontinued operation     (4,120 )   (927 )   (927 )
   
 
 
 
Net income (loss)   $ 64,486   $ 11,132   $ (13,519 )
   
 
 
 

Basic and diluted earnings (loss) per share

 

 

 

 

 

 

 

 

 

 
Income (loss) from continuing operations   $ 0.43   $ 0.08   $ (0.08 )
Loss from discontinued operation     (0.03 )   (0.01 )    
   
 
 
 
Net income (loss)   $ 0.40   $ 0.07   $ (0.08 )
   
 
 
 

Weighted average number of common shares
outstanding (000s)

 

 

 

 

 

 

 

 

 

 
Basic     159,663     159,385     159,385  
   
 
 
 
Diluted     159,737     159,447     159,385  
   
 
 
 

27


 
  Three Months Ended March 31
 
 
  2006
  2005
  2005
 
 
  (U.S. GAAP)
  (U.S. GAAP)
  (CDN GAAP)
 
CASH FLOWS FROM OPERATING ACTIVITIES                    
Income (loss) from continuing operations   $ 68,606   $ 12,059   $ (12,592 )
Adjustments to reconcile income (loss) from continuing operations to net cash provided by continuing operating activities                    
Depreciation and amortization     25,115     22,564     47,092  
Amortization of deferred financing costs     622     812     812  
Amortization of discounts on long-term obligations     491     784     691  
Stock-based compensation     6,873         216  
Equity loss     318     270     270  
Receipt of leasehold inducements     211          
Other     (196 )   (221 )   (221 )
Changes in operating assets and liabilities:                    
  Accounts receivable     25,991     32,332     32,332  
  Inventories     (2,201 )   (8,286 )   (8,286 )
  Deposits and prepaid expenses     3,087     4,691     4,691  
  Accounts payable     (22,918 )   (2,970 )   (2,970 )
  Accrued liabilities     966     9,937     9,937  
  Income taxes payable     886     (1,833 )   (1,833 )
  Deferred revenue     (13,159 )   (2,343 )   (2,343 )
   
 
 
 
Net cash provided by continuing operating activities     94,692     67,796     67,796  
   
 
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 

 

 

 
Additions to property, plant and equipment, net     (17,913 )   (5,095 )   (5,095 )
Purchases of marketable securities     (1,152 )   (4,144 )   (4,144 )
Proceeds from sales and maturities of marketable securities     853     3,258     3,258  
   
 
 
 
Net cash used in continuing investing activities     (18,212 )   (5,981 )   (5,981 )
   
 
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

 

 
Repayments of other long-term obligations     (11,352 )   (11,722 )   (11,722 )
Issuance of common shares     2,995     7     7  
   
 
 
 
Net cash used in continuing financing activities     (8,357 )   (11,715 )   (11,715 )
   
 
 
 

CASH FLOWS FROM DISCONTINUED OPERATION

 

 

 

 

 

 

 

 

 

 
Net cash used in operating activities     (580 )   (408 )   (408 )
Net cash used in investing activities         (45 )   (45 )
   
 
 
 
Net cash used in discontinued operation     (580 )   (453 )   (453 )
   
 
 
 
Effect of exchange rate changes on cash and cash equivalents     (13 )   (49 )   (49 )
   
 
 
 
Net increase in cash and cash equivalents     67,530     49,598     49,598  
Cash and cash equivalents, beginning of period     445,289     34,324     34,324  
   
 
 
 
Cash and cash equivalents, end of period   $ 512,819   $ 83,922   $ 83,922  
   
 
 
 

28


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

In accordance with United States 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 United States ("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, 2005.

        The discussion and analysis contained in this MD&A are as of May 15, 2006.

FORWARD-LOOKING STATEMENTS

        A MD&A by its nature has many forward-looking statements. Although, in several instances, we have noted that a section may contain forward-looking statements, we note that this whole MD&A should be read in light of this caution. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the Forward-Looking Statements caution contained on page (ii) of this Form 6-K and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement.

COMPANY PROFILE

        We are a specialty pharmaceutical company that is engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. Our main therapeutic areas of focus are central nervous system, pain management, and cardiovascular (including Type II diabetes). Our key product lines that we market directly through our internal commercial operations in Canada and the U.S. and/or through strategic commercial alliances with other pharmaceutical companies are as follows:

        We have various research and development, clinical testing, manufacturing and commercial operations located in Barbados, Canada, the U.S., Puerto Rico and Ireland.

RESTRUCTURING

        In May 2005, we sold the distribution rights to our cardiovascular product Cardizem® LA in the U.S. and Puerto Rico to Kos Pharmaceuticals, Inc. ("Kos"). We are the exclusive manufacturer and supplier of Cardizem® LA to Kos at contractually determined prices over an initial seven-year supply term. In addition, we transferred to Kos all of our product rights and certain inventories related to our anti-hypertension drugs, Teveten and Teveten HCT.

        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. Our maximum potential exposure under this indemnity is $25 million until December 31,

29



2006. Between January 1, 2007 and December 31, 2008, this amount is reduced monthly on a straight-line basis to zero. We are aware that Andrx Corporation is seeking U.S. Food and Drug Administration ("FDA") approval for a generic version of Cardizem® LA in multiple dosage formats. We continually assess the probability, amount, and timing of future payments, if any, that we may be required to make to Kos under this indemnity. We believe that we can make reasonable estimates for any potential obligation that may exist. We currently estimate that no obligation will become payable under this indemnity.

        Concurrent with the Kos transaction, we restructured our commercial operations in the U.S., including a reduction of our primary-care and cardiovascular specialty sales forces. We retained 85 specialty sales representatives who are focusing on the promotion of Zovirax® Ointment and Zovirax® Cream to dermatologists and women's health-care practitioners, as well as providing co-promotion services to Ortho-McNeil, Inc. ("OMI") related to Ultram® ER. In addition, commencing in May 2006, these representatives are also promoting AstraZeneca Pharmaceuticals LP's Zoladex® 3.6 mg (goserelin acetate implant) to women's health-care practitioners for the treatment of endometriosis in the U.S. and Puerto Rico.

        The Kos transaction and restructuring activities had a material positive impact on our consolidated results of operations, financial position and cash flows in the first quarter of 2006, compared with the first quarter of 2005, due to 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. These factors were partially offset by lower gross profit on revenue from sales of Cardizem® LA product to Kos and the elimination of Teveten and Teveten HCT product sales.

DISCONTINUED OPERATION

        On May 2, 2006, we completed the sale of our Nutravail division to Futuristic Brands USA, Inc. ("Futuristic"). In consideration for Nutravail's inventory, long-lived assets and intellectual property, we are entitled to future payments based on the net revenues generated from those assets by Futuristic for a period of 10 years.

        At March 31, 2006, we estimated that the net realizable value of the Nutravail's inventory and fair value of Nutravail's long-lived assets were zero, as no consideration was received at the date of sale, and we did not attribute any value to the future payments. As a result, we recorded a write-down of $1.7 million to cost of goods sold to adjust Nutravail's inventory, and an additional write-down of $1.1 million to the carrying values of Nutravail's long-lived assets. We do not have a reasonable basis to estimate the amount of the future payments we may receive because we do not have any significant continuing involvement in the operations of Nutravail. We will recognize any future payments as revenue once each payment is determinable and collection is reasonably assured, which generally will be upon receipt of the cash payment.

        Nutravail's operations and direct cash flows have been eliminated from our ongoing operations as a result of the sale transaction. The extent to which we are involved in the operations of Nutravail is limited to our ability to receive indirect cash flows from the future payments. We have no continuing obligations in connection with the receipt of these payments, and these payments are not expected to be significant to our continuing operations or those of Nutravail. Accordingly, Nutravail has been reported as a discontinued operation in our consolidated statements of income and cash flows, for the current and prior periods.

30



        For the first quarters of 2006 and 2005, the following revenue and expenses of Nutravail have been reclassified from continuing operations to loss from discontinued operation:

 
  Three Months Ended March 31
 
($ in 000s)
  2006
  2005
 

REVENUE

 

 

 

 

 

 

 
Product sales   $ 519   $ 637  
Research and development     59     326  
Royalty and other     162     612  
   
 
 
      740     1,575  
   
 
 

EXPENSES

 

 

 

 

 

 

 
Cost of goods sold (including write-down of inventory of $1,711)     2,207     990  
Research and development     861     533  
Selling, general and administrative     708     911  
Amortization         68  
   
 
 
      3,776     2,502  
   
 
 
Loss from discontinued operation before write-down of assets     (3,036 )   (927 )
Write-down of assets     (1,084 )    
   
 
 
Loss from discontinued operation   $ (4,120 ) $ (927 )
   
 
 

STOCK-BASED COMPENSATION

        Effective January 1, 2006, we adopted Statement of Financial Accounting Standards ("SFAS") No. 123 (revised 2004), "Share-Based Payment" ("SFAS No. 123R"), which 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. Prior to January 1, 2006, we recognized employee stock-based compensation cost under the intrinsic value-based method of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees". Accordingly, no compensation expense for stock options granted to employees at fair market value was included in the determination of net income or loss prior to January 1, 2006. We elected to use the modified-prospective transition method of adoption. This method requires that compensation expense be recorded for all share-based payments granted, modified or settled after the date of adoption and for all unvested stock options at the date of adoption. Prior periods have not been restated to recognize stock-based compensation expense.

        In the first quarter of 2006, we recognized total stock-based compensation expense, net of estimated forfeitures, related to stock options in the amount of $6.9 million, of which $0.5 million was recorded in cost of goods sold, $0.9 million was recorded in research and development expenses, and $5.5 million was recorded in selling, general and administrative expenses. Approximately 40 to 45 percent of the annual cost of stock-based compensation will generally be recognized in the first quarter of each year due to the timing of the grants of stock option awards. We estimate that stock-based compensation expense related to currently outstanding stock options will be approximately $3.0 million in each of the remaining three quarters of 2006, though this estimate could be affected by the approval of additional grants of stock options, unanticipated forfeitures, as well as other factors (see — Forward-Looking Statements).

31



OVERVIEW

Revenue

        Revenue increased 27% from $173.7 million in the first quarter of 2005 to $220.5 million in the first quarter of 2006, due mainly to higher revenue from sales of Wellbutrin XL® in the U.S. by GlaxoSmithKline plc ("GSK") and revenue generated from sales of Ultram® ER, which was launched by OMI in the U.S. in February 2006. These factors were partially offset by lower product sales in Canada, due mainly to generic competition to Tiazac® and Wellbutrin® SR, and the elimination of Teveten and Teveten HCT product sales following the Kos transaction.

Results of operations

        Income from continuing operations increased 469% from $12.1 million (basic and diluted earnings per share of $0.08) in the first quarter of 2005 to $68.6 million (basic and diluted earnings per share of $0.43) in the first quarter of 2006. Net income increased 479% from $11.1 million (basic and diluted earnings per share of $0.07) in the first quarter of 2005 to $64.5 million (basic and diluted earnings per share of $0.40) in the first quarter of 2006.

        In the first quarter of 2006, income from continuing operations and net income were impacted by the inclusion of stock-based compensation expense of $6.9 million (basic and diluted impact per share of $0.04). Impacting net income in the first quarter of 2006 was the loss from discontinued operation, which included the write-downs of Nutravail's inventory and long-lived assets of $2.8 million in the aggregate (basic and diluted impact per share of $0.02).

Cash dividends

        In March 2006, our Board of Directors declared a cash dividend of $0.125 per share (or $20.0 million in the aggregate), which was paid to our shareholders in April 2006. On May 10, 2006, our Board of Directors declared a cash dividend of $0.125 per share, payable on May 31, 2006.

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.

        Figures for the first quarter of 2005 reflect the reclassification of Nutravail's revenue and expenses to discontinued operations.

REVENUE

        Our revenue is derived primarily from the following sources:

32


The following table displays the dollar amount of each source of revenue in the first quarters of 2006 and 2005, 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 March 31
   
   
 
($ in 000s)
  2006
  2005
  Change
 
Product sales   $ 209,705   95 % $ 160,531   92 % $ 49,174   31 %
Research and development     4,909   2     7,200   4     (2,291 ) (32 )
Royalty and other     5,909   3     5,955   3     (46 ) (1 )
   
 
 
 
 
     
    $ 220,523   100 % $ 173,686   100 % $ 46,837   27 %
   
 
 
 
 
 
 

Product sales

        The following table displays product sales by reporting category in the first quarters of 2006 and 2005, 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 March 31
   
   
 
($ in 000s)
  2006
  2005
  Change
 
Wellbutrin XL®   $ 65,004   31 % $ 36,756   23 % $ 28,248   77 %
Zovirax®     24,474   12     27,120   17     (2,646 ) (10 )
Cardizem® LA     16,210   8     11,380   7     4,830   42  
Ultram® ER     15,111   7           15,111   NM  
Biovail Pharmaceuticals Canada     19,780   9     25,039   16     (5,259 ) (21 )
Legacy     35,529   17     29,780   19     5,749   19  
Generic     33,597   16     24,975   16     8,622   35  
Teveten           5,481   3     (5,481 ) (100 )
   
 
 
 
 
     
    $ 209,705   100 % $ 160,531   100 % $ 49,174   31 %
   
 
 
 
 
 
 

NM — Not meaningful

Wholesaler Distribution Services Agreements ("DSAs")

        In the U.S., we sell our Zovirax® and Legacy products, as well as our Cardizem® LA and Teveten products prior to the Kos transaction, directly to drug wholesalers and warehousing chains. Three national drug wholesalers, Cardinal Health, Inc. ("Cardinal"), McKesson Corporation ("McKesson") and AmerisourceBergen Corporation ("ABC"), dominate the drug wholesale market in the U.S. These wholesalers account for the majority of our direct product sales in the U.S. We believe that, prior to 2004, these wholesalers relied largely on cash discounts on purchases and price arbitrage to generate income. This industry business model resulted in forward buying (purchases of inventory not tied to demand) on the part of these wholesalers in anticipation of possible price increases. At times, this led to elevated inventory levels in the wholesale distribution channel. In late 2004 and early 2005, we entered into DSAs with these wholesalers, which has fundamentally changed the way we conduct business with them. In exchange for a fee-for-service, these agreements limit the amount of inventory these wholesalers can own to between 1/2 to 11/2 months of supply. These agreements also require these wholesalers to provide us with more timely and complete information with respect to inventory levels held and better data regarding sales and marketplace activity.

33



        In anticipation of the transition to DSAs, we took steps together with Cardinal, McKesson and ABC to reduce their inventories of our products, which resulted in lower purchases and/or increased returns by these wholesalers. This process was substantially completed during the first quarter of 2005. As a result, the reported sales of certain of our products sold directly to these wholesalers during the first quarter of 2005 were adversely affected by this reduction, and not necessarily reflective of prescription demand. We believe, however, that our product sales to these wholesalers in the first quarter of 2006 more closely reflected demand-based sales.

        As displayed in the following table, at March 31, 2006, Cardinal, McKesson and ABC owned overall 1.2 months of supply of our products, of which only $128,000 had less than 12 months remaining shelf life.

 
   
  At March 31, 2006
  At December 31, 2005
($ in 000s)
  Original
Shelf Life
(In Months)

  Total
Inventory

  Months
On Hand
(In Months)

  Inventory
With
Less Than
12 Months
Remaining
Shelf Life

  Total
Inventory

  Months
On Hand
(In Months)

  Inventory
With
Less Than
12 Months
Remaining
Shelf Life

Zovirax®   36-48   $ 8,757   1.2   $ 58   $ 7,858   1.0   $ 59
Cardizem®   36     5,027   1.1     44     5,525   1.0     45
Ativan®   24     2,209   1.2     9     2,059   1.0     14
Vasotec® and Vaseretic®   24     1,989   1.1     13     2,182   1.1     15
Isordil®   36-60     372   1.5     1     508   1.7     2
Cardizem® Tabs   48     343   1.7     3     433   1.7     3
   
 
 
 
 
 
 
Total   24-60   $ 18,697   1.2   $ 128   $ 18,565   1.0   $ 138
   
 
 
 
 
 
 

Wellbutrin XL®

        We are the exclusive manufacturer and supplier of Wellbutrin XL® to GSK for marketing and distribution in the U.S. Our contractually determined supply price for Wellbutrin XL® is based on an increasing tiered percentage of revenue generated on GSK's net sales (after taking into consideration GSK's provisions for estimated discounts, returns, rebates and chargebacks). The supply price is reset to the lowest tier at the start of each calendar year and the sales thresholds to achieve the second and third tier supply prices generally increase each year. Our revenue from sales of Wellbutrin XL® increased 77% in the first quarter of 2006, compared with the first quarter of 2005, due to higher volumes sold by GSK, as well as price increases effected by GSK during 2005 that positively impact our supply price to them. In addition, our revenue from sales of Wellbutrin XL® in the first quarter of 2005 was impacted by a planned reduction in the level of GSK's safety stock in that quarter. During 2004, GSK had increased its safety stock in anticipation of our need to shift production in 2005 from Wellbutrin XL® to scale-up activities for various products under development, including Tramadol ER (Ultram® ER).

        A number of companies are seeking FDA approval for generic versions of Wellbutrin XL®. As a result, a generic version of Wellbutrin XL® could be launched in 2007 or sooner, at which point we would anticipate losing a substantial portion of the pre-genericization revenue from Wellbutrin XL® product sales within a short period of time. There are certain risks associated with predicting the timing of FDA approvals (see — Forward-Looking Statements).

Zovirax®

        We currently promote Zovirax® Ointment and Zovirax® Cream directly to specialist practitioners in the U.S. Combined sales of Zovirax® Ointment and Zovirax® Cream declined 10% in the first quarter of 2006,

34



compared with the first quarter of 2005. The decline in Zovirax® product sales was due mainly to additional purchases made by wholesalers in anticipation of a price increase for Zovirax® in the first quarter of 2005.

Cardizem® LA

        We are the exclusive manufacturer and supplier of Cardizem® LA to Kos for marketing and distribution in the U.S. and Puerto Rico. Since May 2, 2005 (the date of the Kos transaction), we sell Cardizem® LA to Kos at contractually determined prices that are lower than what we historically charged for this product when we sold it directly to wholesalers. In the first quarter of 2006, we recognized $3.8 million related to the amortization of the deferred revenue associated with the Kos transaction. Our revenue from sales of Cardizem® LA increased 42% in the first quarter of 2006, compared with the first quarter of 2005, partially due to unanticipated returns of slow-moving 90-tablet bottles of Cardizem® LA in the first quarter of 2005.

Ultram® ER

        In November 2005, we entered into a 10-year supply agreement with OMI for the distribution of our extended-release and orally disintegrating formulations of tramadol. We currently manufacture and supply Ultram® ER to OMI for distribution in the U.S. and Puerto Rico. Our contractually determined supply prices are based on 27.5% to 37.5% of OMI's net selling price for Ultram® ER, depending on the year of sale. In the fourth quarter of 2005, OMI paid us a supply prepayment of $60 million, which will be reduced to zero through credits against one-third of the aggregate amount of our future invoices for Ultram® ER manufactured and supplied to OMI.

        OMI launched Ultram® ER in the U.S. in February 2006. Our revenue from sales of Ultram® ER by OMI amounted to $15.1 million in the first quarter of 2006. We currently anticipate that OMI will launch Ultram® ODT in the latter part of 2006, though there are certain risks associated with this timing (see — Forward-Looking Statements).

Biovail Pharmaceuticals Canada ("BPC") products

        BPC products are Glumetza™, Monocor, Retavase, Tiazac®, Tiazac® XC, Wellbutrin® SR, Wellbutrin® XL (since March 2006) and Zyban®, which are sold in Canada to drug wholesalers, retail pharmacies and hospitals. We currently promote Glumetza™, Tiazac® XC and Wellbutrin® XL directly to Canadian physicians. Sales of BPC products declined 21% in the first quarter of 2006, compared with the first quarter of 2005. The decline in BPC product sales reflected lower sales of Tiazac® and Wellbutrin® SR due to the introduction of generic competition, partially offset by our launches of Tiazac® XC and Glumetza™ in January 2005 and November 2005, respectively, and the introduction of Wellbutrin® XL in March 2006. We formally launched Wellbutrin® XL in Canada in April 2006.

Legacy products

        Our key Legacy products are Ativan®, Cardizem® CD, Isordil®, Tiazac®, Vasotec® and Vaseretic®, which are sold primarily in the U.S. We do not actively promote these products as they have been genericized. We sell Tiazac® (branded and generic) to Forest Laboratories, Inc. for distribution in the U.S. Our other Legacy products are primarily sold directly to drug wholesalers and warehousing chains. Sales of our Legacy products increased 19% overall in the first quarter of 2006, compared with the first quarter of 2005. The increase in overall sales of our Legacy products, despite declines in prescription volumes for these products, reflected the effect of price increases for certain of these products in the first quarter of 2006, and reductions in wholesaler inventories of these products in the first quarter of 2005.

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        In November 2005, we announced our intention to spin-off substantially all of our off-patent branded pharmaceutical products. These products comprise substantially all of our Legacy products. These products are not considered strategic to our business and are in decline (in terms of prescription volumes) due to generic competition. Should the spin-off transaction be effected, it would involve: the creation of an independent company, to be known as Crystaal Pharmaceuticals Corporation ("Crystaal"); the transfer of the assets associated with these products to Crystaal; and the distribution of Crystaal's shares to our shareholders either as a dividend in kind or as a return of capital. We hope to complete this spin-off transaction in 2006; however, this transaction is 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.

        We believe that a spin-off of our off-patent products will allow us to better focus on achieving long-term growth through our drug development efforts, as well as allow for the underlying value of these products to be better realized through the dedicated efforts of Crystaal. Should the spin-off transaction be effected, it would have a significant impact on our future consolidated results of operations, financial position and cash flows.

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 Pharmaceuticals Industries Ltd. ("Teva") for distribution in the U.S., as well as an authorized generic version of Tiazac®, which we manufacture and sell to Novopharm Limited ("Novopharm"), also a subsidiary of Teva, for distribution in Canada. Sales of our Generic products increased 35% overall in the first quarter of 2006, compared with the first quarter of 2005. The increase in our Generic product sales reflected changes in inventory levels of these products owned by Teva and increased prescription volumes for these products, as well as Novopharm's introduction of generic Tiazac® in Canada in January 2006.

Teveten products

        Since May 2, 2005 (the date of the Kos transaction), we no longer have an ongoing financial interest in Teveten and Teveten HCT.

Research and development revenue

        Research and development revenue declined 32% in the first quarter of 2006, compared with the first quarter of 2005, reflecting a lower level of clinical research and laboratory testing services provided to external customers by our contract research operation, due to the postponement of certain studies.

Royalty and other revenue

        Royalty and other revenue declined 1% in the first quarter of 2006, compared with the first quarter of 2005. In the first quarter of 2006, other revenue included $0.4 million received from OMI related to our co-promotion of Ultram® ER.

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OPERATING EXPENSES

        The following table displays the dollar amount of each operating expense item in the first quarters of 2006 and 2005, 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 March 31
   
   
 
($ in 000s)
  2006
  2005
  Change
 
Cost of goods sold   $ 49,329   22 % $ 41,101   24 % $ 8,228   20 %
Research and development     22,328   10     19,954   11     2,374   12  
Selling, general and administrative     56,550   26     74,694   43     (18,144 ) (24 )
Amortization     14,824   7     15,966   9     (1,142 ) (7 )
   
 
 
 
 
     
    $ 143,031   65 % $ 151,715   87 % $ (8,684 ) (6 )%
   
 
 
 
 
 
 

Cost of goods sold and gross margins

        In first quarter of 2006, cost of goods sold included $2.0 million related to the amortization of the Cardizem® LA intangible asset associated with the Kos transaction, and $2.1 million related to the amortization of the asset associated with a reduction in the Zovirax® supply price to be paid to GSK.

        Gross margins based on product sales were 76% and 74% overall in the first quarters of 2006 and 2005, respectively. The increase in overall gross margins reflected higher volumes of Wellbutrin XL® sold to GSK, as well as the positive impact that the price increases effected by GSK in 2005 had on our supply price. In addition, we experienced a lower overall level of product returns in the first quarter of 2006, compared with the first quarter of 2005. These factors were partially offset by the lower margin realized on Cardizem® LA product sales to Kos and start-up manufacturing inefficiencies related to Ultram® ER.

Research and development expenses

        Research and development expenses increased 12% in the first quarter of 2006, compared with the first quarter of 2005. We invested 10% of total revenue in research and development activities in the first quarter of 2006, compared with 11% in the first quarter of 2005. Research and development expenses include employee compensation costs, overhead and occupancy costs, clinical trial, clinical manufacturing and scale-up costs, contract research services and other third-party development costs. Research and development expenses also include costs associated with providing contract research services to external customers.

        Research and development activities in the first quarter of 2006 included line-extension and enhanced-formulation programs including:

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There are certain risks associated with predicting the timing of NDA filings and the receipt of FDA approvals, as well as our ability to successfully commercialize our pipeline products referred to above (see — Forward-Looking Statements).

Selling, general and administrative expenses

        Selling, general and administrative expenses declined by 24% in the first quarter of 2006, compared with the first quarter of 2005. As a percentage of total revenue, selling, general and administrative expenses were 26% and 43% in the first quarters of 2006 and 2005, respectively. The decline in selling, general and administrative expenses reflected the positive impact of the Kos transaction and concurrent restructuring of our U.S. commercial operations in May 2005. 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 increased professional fees related to ongoing regulatory and legal matters, and costs associated with our corporate governance and Sarbanes-Oxley Act of 2002 compliance initiatives, as well as the inclusion of stock-based compensation. In addition, we incurred initial marketing costs in Canada associated with Glumetza™ and Wellbutrin® XL.

Amortization expense

        Amortization expense declined 7% in the first quarter of 2006, compared with the first quarter of 2005. As a percentage of total revenue, amortization expense was 7% and 9% in the first quarters of 2006 and 2005, respectively. The decline in amortization expense in the first quarter of 2006 reflected the discontinuance of the amortization of the Teveten and Teveten HCT product rights following the Kos transaction, as well as the final amortization of certain other intangible assets during 2005, partially offset by the inclusion of amortization associated with the Glumetza™ intangible asset.

OPERATING INCOME

        We recorded operating income of $77.5 million in the first quarter of 2006, compared with $22.0 million in the first quarter of 2005. The increase in operating income reflected higher product sales and an improved overall gross margin on those sales, as well as lower sales force and marketing costs. These factors were partially offset by increased research and development spending and higher corporate expenses, as well as the inclusion of stock-based compensation.

NON-OPERATING ITEMS

Interest income

        Interest income was $5.2 million in the first quarter of 2006, compared with $0.4 million in the first quarter of 2005. The increase in interest income reflected a higher amount of surplus cash available for investment.

Interest expense

        Interest expense was $9.0 million in the first quarter of 2006, compared with $8.9 million in the first quarter of 2005. Interest expense mainly comprised interest on our 77/8% Senior Subordinated Notes due April 1, 2010 ("Notes").

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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 $4.2 million and $0.6 million in the first quarters of 2006 and 2005, respectively.

SUMMARY OF QUARTERLY RESULTS

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

 
  2006
  2005
($ in 000s, except per share data)
  Q1
  Q4
  Q3
  Q2
Revenue   $ 220,523   $ 287,614   $ 258,058   $ 216,178
Income from continuing operations     68,606     120,516     109,299     4,922
Net income     64,486     119,719     101,663     3,707

Basic and diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 
Income from continuing operations   $ 0.43   $ 0.75   $ 0.69   $ 0.03
Net income   $ 0.40   $ 0.75   $ 0.64   $ 0.02
   
 
 
 
Net cash provided by continuing operating activities   $ 94,692   $ 223,390   $ 122,446   $ 88,247
   
 
 
 
 
 
  2005
  2004
($ in 000s, except per share data)
  Q1
  Q4
  Q3
  Q2
Revenue   $ 173,686   $ 275,350   $ 213,618   $ 204,886
Income from continuing operations     12,059     46,582     50,645     45,784
Net income     11,132     46,045     49,635     44,208

Basic and diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 
Income from continuing operations   $ 0.08   $ 0.29   $ 0.32   $ 0.29
Net income   $ 0.07   $ 0.29   $ 0.31   $ 0.28
   
 
 
 
Net cash provided by continuing operating activities   $ 67,796   $ 112,153   $ 58,640   $ 44,356
   
 
 
 

Results of operations

        The declines in revenue, income from continuing operations and net income in the first quarter of 2006, compared with the fourth quarter of 2005, 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, as well as the introduction of generic competition to Tiazac® in Canada. The factors were partially offset by the positive impact of the Wellbutrin XL® price increases effected by GSK during 2005, as well as revenue generated from sales of Ultram® ER following its launch by OMI in February 2006.

Cash flows

        The decline in net cash provided by continuing operating activities in the first quarter of 2006, compared with the fourth quarter of 2005, reflected lower gross profit on Wellbutrin XL® product sales in the first quarter of 2006 due to the tiered supply price, as well as the receipt of the $60 million supply prepayment from OMI for Ultram® ER in the fourth quarter of 2005.

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FINANCIAL CONDITION

        The following table presents a summary of our financial condition at March 31, 2006 and December 31, 2005:

($ in 000s)
  At
March 31
2006

  At
December 31
2005

Working capital   $ 458,394   $ 411,226
Long-lived assets     1,260,212     1,269,643
Long-term obligations     426,118     436,868
Shareholders' equity     1,276,052     1,220,356
   
 

Working capital

        The $47.2 million increase in working capital from December 31, 2005 to March 31, 2006 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 $9.4 million decrease in long-lived assets from December 31, 2005 to March 31, 2006 was primarily due to:

        Partially offset by:

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Long-term obligations

        The $10.8 million decrease in long-term obligations, including the current portion thereof, from December 31, 2005 to March 31, 2006 reflected primarily the payment of $11.3 million to GSK related to the October 2002 amendments to the Zovirax® distribution agreement.

Shareholders' equity

        The $55.7 million increase in shareholders' equity reflected primarily net income of $64.5 million (including $6.9 million of stock-based compensation recorded in additional paid-in capital), partially offset by the dividends declared in March 2006.

CASH FLOWS

        Our primary source of cash is the collection of accounts receivable related to product sales. Our primary uses of cash include salaries and benefits, inventory purchases, research and development programs, sales and marketing activities, capital expenditures, loan repayments and dividend payments. At March 31, 2006, we had cash and cash equivalents of $512.8 million, compared with $445.3 million at December 31, 2005. The following table displays cash flow information for the first quarters of 2006 and 2005:

 
  Three Months Ended
March 31

 
($ in 000s)
  2006
  2005
 
Net cash provided by continuing operating activities   $ 94,692   $ 67,796  
Net cash used in continuing investing activities     (18,212 )   (5,981 )
Net cash used in continuing financing activities     (8,357 )   (11,715 )
Net cash used in discontinued operation     (580 )   (453 )
Effect of exchange rate changes on cash and cash equivalents     (13 )   (49 )
   
 
 
Net increase in cash and cash equivalents   $ 67,530   $ 49,598  
   
 
 

Operating activities

        Net cash provided by continuing operating activities increased $26.9 million from the first quarter of 2005 to the first quarter of 2006, primarily due to:

Partially offset by:

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Investing activities

        Net cash used in continuing investing activities increased $12.2 million from the first quarter of 2005 to the first quarter of 2006 primarily due to an increase of $12.8 million in capital expenditures on property, plant and equipment.

Financing activities

        Net cash used in continuing financing activities declined by $3.4 million from the first quarter of 2005 to the first quarter of 2006 primarily due to an increase of $3.0 million in proceeds received on the exercise of stock options.

Outlook

        We intend to use 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, as well as to finance our contemplated quarterly dividend of $0.125 per share (or approximately $20 million per quarter). We also anticipate capital expenditures of approximately $50 million to $60 million in 2006. Major projects planned include the completion of the expansion of our Steinbach manufacturing facility (anticipated in the coming months), the addition of equipment related to the manufacture of orally disintegrating products, and upgrades to our computer information systems. However, certain factors could alter our intentions and anticipations (see — Forward-Looking Statements).

LIQUIDITY AND CAPITAL RESOURCES

        At March 31, 2006, we had total long-term obligations of $426.1 million, including the current portion thereof, which included the carrying value of our Notes of $400.5 million and obligations related to past acquisitions of intangible assets of $24.7 million.

        At March 31, 2006, we had no outstanding borrowings under our revolving term credit facility; however, we had a letter of credit of $17.6 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®. In May 2006, the lenders consented to an extension of this credit facility at $250 million for a further 364-day term until May 23, 2007. This facility is renewable for additional 364-day 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 March 31, 2006, 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 as follows:

 
  S&P
  Moody's
Overall   BB+   Ba3
Revolving term credit facility   BBB-   NR
Senior Subordinated Notes   BB-   B2
Outlook   Stable   Negative
   
 

NR — Not rated

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        We believe that our existing balance of cash and cash equivalents, together with cash expected to be generated by operations and existing funds available under our revolving term credit facility, will be sufficient to support our operational, capital expenditure and interest requirements, as well as to meet our obligations as they become due, for at least the next 12 months. 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. There are certain risks to our business that could negatively affect our expected cash flows and liquidity (see — Forward-Looking Statements).

CONTRACTUAL OBLIGATIONS

        The following table summarizes our fixed contractual obligations at March 31, 2006:

 
  Payments Due by Period
($ in 000s)
  Total
  2006
  2007 and
2008

  2009 and
2010

  Thereafter
Long-term obligations   $ 425,261   $ 14,011   $ 11,250   $ 400,000   $
Operating lease obligations     37,551     4,389     10,342     8,069     14,751
Purchase obligations     24,089     24,089            
   
 
 
 
 
Total contractual obligations   $ 486,901   $ 42,489   $ 21,592   $ 408,069   $ 14,751
   
 
 
 
 

        The above purchase obligations are in connection with the manufacture and supply to us of Cardizem® products by Aventis Pharmaceuticals Inc. and diltiazem (the active ingredient in Cardizem® and Tiazac®) by an affiliate of Teva. We are obligated to purchase approximately $12.5 million-worth of Cardizem® products and approximately $8.0 million-worth of diltiazem in 2006. We are also obligated to make payments totaling $3.6 million in 2006 to Merck for minimum quantities of Vasotec® and Vaseretic® (regardless of the actual product supplied).

        The above table does not reflect any milestone payments in connection with research and development collaborations with third parties. In the event that all research and development projects are successful, we would have to make aggregate milestone payments of approximately $70 million. 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. We do not anticipate that we will be required to make any material milestone payments in 2006 related to currently existing research and development collaborations.

OFF-BALANCE SHEET ARRANGEMENTS

        We did not have any off-balance sheet arrangements at March 31, 2006, other than operating leases, purchase obligations and contingent milestone payments, which are disclosed above under Contractual Obligations.

OUTSTANDING SHARE DATA

        At May 10, 2006, we had 159,988,010 issued and outstanding common shares, as well as outstanding options to purchase 9,221,632 common shares under our stock option plans.

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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        We are exposed to financial market risks, including changes in foreign currency exchange rates, interest rates on investments and debt obligations, and equity market prices on long-term investments. We use derivative financial instruments 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 consolidated 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. 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.

        The eventual payment of our Notes will likely result in a foreign exchange gain or loss for Canadian income tax purposes. The amount of this gain or loss will depend on the exchange rate between the U.S. and Canadian dollars at the time the Notes are paid. At March 31, 2006, the unrealized foreign exchange gain on the translation of the Notes to Canadian dollars for Canadian income tax purposes was approximately $146 million. If the Notes had been paid at March 31, 2006, one-half of this foreign exchange gain would be included in our taxable income for 2006, which would result in a corresponding reduction in our available Canadian operating losses and tax credit carryforward balances (with an offsetting reduction to the valuation allowance provided against those balances). However, the eventual payment of our Notes will not result in a foreign exchange gain or loss being recognized in our consolidated financial statements, as these statements are prepared in U.S. dollars.

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, but typically less than 90 days. As it is our intent and policy to hold these investments until maturity, we do not have a material exposure to interest rate risk.

        We are exposed to interest rate risk on borrowings under our 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 also affected by changes in interest rates. Currently, we do not utilize interest rate swap contracts to hedge against interest rate risk; however, 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

44



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.

UNRESOLVED U.S. SECURITIES AND EXCHANGE COMMISSION ("SEC") STAFF COMMENTS

        The SEC has advised us that it has reviewed the financial statements and related disclosures of our Form 20-F for the fiscal year ended December 31, 2004. Based on its review of this document, the SEC provided comments and questions regarding certain accounting disclosures and methods, including but not limited to inquiries regarding our accounting methodologies related to product returns, and requested additional disclosures related to these filings. We incorporated additional disclosure items requested for these past filings into our Form 20-F for the fiscal year ended December 31, 2005, and related audited consolidated financial statements. Discussions regarding the Form 20-F for the fiscal year ended December 31, 2004 are ongoing and may result in modifications to previously filed SEC documents. We will provide an update as material developments in these matters occur.

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. Since December 31, 2005, none of our critical accounting policies or estimates (as more fully described in the MD&A contained in our Annual Report on Form 20-F for the fiscal year ended December 31, 2005) have changed significantly, except as follows:

Stock-based compensation

        Effective January 1, 2006, we adopted the fair value-based method for recognizing employee stock-based compensation. Prior to 2006, we did not recognize stock-based compensation expense for stock options granted to employees at fair market value. We use the Black-Scholes option-pricing model to calculate stock option values, which requires certain assumptions related to the expected life of the option, future stock price volatility, risk-free interest rate, and dividend yield. The expected life of the option is based on historical exercise and forfeiture patterns. Future stock price volatility is based on historical volatility of our common shares over the expected life of the option. The risk-free interest rate is based on the rate at the time of grant for zero-coupon Canadian government bonds with a remaining term equal to the expected life of the option. Dividend yield is based on the option's exercise price and expected annual dividend rate at the time of grant. Changes to any of these assumptions, or the use of a different option-pricing model (such as the lattice model) could produce a different fair value for stock-based compensation expense, which could have a material impact on our results of operations. As we develop detailed data about our employees' stock option exercise patterns, we will evaluate the use of the lattice model to determine if that model might be expected to produce a better estimate of fair value.

CONTROLS AND PROCEDURES

        We performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that the material financial and non-financial information required to be disclosed in filings with the SEC is recorded, processed, summarized and reported in a timely manner. Based on our evaluation, our management, including the Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO"), have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the

45



Exchange Act) as of the end of the period covered by this report are effective. Notwithstanding the foregoing, there can be no assurance that our disclosure controls and procedures will detect or uncover all failures of persons within the Company to disclose material information otherwise required to be set forth in our reports.

        There were no changes in our internal controls over financial reporting during the three-month period ended March 31, 2006 identified in connection with the evaluation thereof by our management, including the CEO and CFO, that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

CANADIAN GAAP SUPPLEMENTAL INFORMATION

        The following supplemental information is provided to summarize the significant differences that would have resulted in the MD&A had it been prepared in accordance with Canadian GAAP. Material differences between U.S. GAAP and Canadian GAAP related to recognition, measurement and presentation, are explained in note 14 to the accompanying unaudited consolidated financial statements.

Results of operations

 
  Three Months
Ended
March 31

 
($ in 000s, except per share data)
  2006
  2005
 
Income from continuing operations — U.S. GAAP   $ 68,606   $ 12,059  
Income (loss) from continuing operations — Canadian GAAP     56,198     (12,592 )
Net income — U.S. GAAP     64,486     11,132  
Net income (loss) — Canadian GAAP     52,078     (13,519 )

Basic and diluted earnings (loss) per share

 

 

 

 

 

 

 
Income from continuing operations — U.S. GAAP   $ 0.43   $ 0.08  
Income (loss) from continuing operations — Canadian GAAP   $ 0.35   $ (0.08 )
Net income — U.S. GAAP   $ 0.40   $ 0.07  
Net income (loss) — Canadian GAAP   $ 0.33   $ (0.08 )
   
 
 

        In the first quarter of 2006, income from continuing operations and net income under Canadian GAAP would each have been $12.4 million lower than income from continuing operations and net income reported under U.S. GAAP. In the first quarter of 2005, loss from continuing operations and net loss under Canadian GAAP would have been $24.7 million lower than income from continuing operations and net income reported under U.S. GAAP.

        The principal reconciling difference that affects results of operations under Canadian GAAP relates to the treatment of acquired research and development assets. Under Canadian GAAP, additional amortization expense of $12.3 million and $24.5 million would have been recognized in the first quarters of 2006 and 2005, respectively, related to acquired research and development assets that were capitalized at the time of acquisition. Under U.S. GAAP, these assets were written-off at the time of acquisition.

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Financial condition

($ in 000s)
  At
March 31
2006

  At
December 31
2005

Long-lived assets — U.S. GAAP   $ 1,260,212   $ 1,269,643
Long-lived assets — Canadian GAAP     1,423,508     1,445,161
Shareholders' equity — U.S. GAAP     1,276,052     1,220,356
Shareholders' equity — Canadian GAAP     1,420,447     1,379,549
   
 

        At March 31, 2006 and December 31, 2005, long-lived assets under Canadian GAAP would have been higher by $163.3 million and $175.5 million, respectively, than long-lived assets reported under U.S. GAAP. The principal reconciling difference that affects long-lived assets under Canadian GAAP relates to the unamortized carrying value of capitalized acquired research and development assets. The carrying value of these assets amounted to $162.8 million and $175.1 million at March 31, 2006 and December 31, 2005, respectively.

        At March 31, 2006 and December 31, 2005, shareholders' equity under Canadian GAAP would have been higher by $144.4 million and $159.2 million, respectively, than shareholders' equity reported under U.S. GAAP. The principal reconciling differences that affect shareholders' equity under Canadian GAAP relate to the unamortized carrying value of capitalized acquired research and development assets, partially offset by unrealized holding gains on available-for-sale investments that are reported at cost under Canadian GAAP. Under U.S. GAAP unrealized gains on available-for-sale investments are recorded in the accumulated other comprehensive income component of shareholders' equity. At March 31, 2006 and December 31, 2005, the cost of available-for-sale investments under Canadian GAAP would have been lower by $18.8 million and $16.2 million, respectively, than the fair values of these investments reported under U.S. GAAP.

Cash flows

        There were no material differences between our cash flows as reported under U.S. GAAP and our cash flows that would have been reported under Canadian GAAP.

47



BIOVAIL CORPORATION

FORM 6-K

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006


PART II — OTHER INFORMATION

1.     LEGAL PROCEEDINGS

2.     EXHIBITS

        Exhibit 99.1 Certifications of the Chief Executive Officer and Chief Financial Officer

48



BIOVAIL CORPORATION

FORM 6-K

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006


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 15, 2006

 

By:

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

49




QuickLinks

BIOVAIL CORPORATION FORM 6-K FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006
INDEX
BASIS OF PRESENTATION
FORWARD-LOOKING STATEMENTS
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 FORM 6-K FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006
PART II — OTHER INFORMATION
BIOVAIL CORPORATION FORM 6-K FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006
SIGNATURES