QuickLinks -- Click here to rapidly navigate through this document

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

FORM 10-Q


ý

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended June 30, 2010

OR

o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                                to                               

Commission File Number: 001-14956

BIOVAIL CORPORATION
(Exact name of registrant as specified in its charter)

Canada
(State or other jurisdiction of
incorporation or organization)
  98-0448205
(I.R.S. Employer Identification No.)

7150 Mississauga Road, Mississauga, Ontario
(Address of principal executive offices)

 

L5N 8M5
(Zip Code)

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

        Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  ý     No  o

        Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  ý     No  o

        Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of "large accelerated filer", "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

  Large accelerated filer  ý   Accelerated filer  o   Non-accelerated filer  o
(Do not check if a smaller
reporting company)
  Smaller reporting company  o

        Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  o     No  ý

        Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

        Common shares, no par value — 158,602,025 shares issued and outstanding at August 3, 2010


BIOVAIL CORPORATION
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2010
INDEX

Part I.   Financial Information        

Item 1.

 

Financial Statements (unaudited)

 

 

1

 

 

 

Consolidated Balance Sheets as at June 30, 2010 and December 31, 2009

 

 

1

 

 

 

Consolidated Statements of Income for the three months and six months ended June 30, 2010 and 2009

 

 

2

 

 

 

Consolidated Statements of Accumulated Deficit for the three months and six months ended June 30, 2010 and 2009

 

 

3

 

 

 

Consolidated Statements of Cash Flows for the three months and six months ended June 30, 2010 and 2009

 

 

4

 

 

 

Notes to the Consolidated Financial Statements

 

 

5

 

Item 2.

 

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

 

 

34

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

 

65

 

Item 4.

 

Controls and Procedures

 

 

65

 

Part II .

 

Other Information

 

 

 

 

Item 1.

 

Legal Proceedings

 

 

66

 

Item 1A.

 

Risk Factors

 

 

66

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

 

67

 

Item 3.

 

Defaults Upon Senior Securities

 

 

67

 

Item 4.

 

(Removed and Reserved)

 

 

67

 

Item 5.

 

Other Information

 

 

67

 

Item 6.

 

Exhibits

 

 

67

 

Signature

 

 

69

 

i


BIOVAIL CORPORATION
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2010
BASIS OF PRESENTATION

General

        Except where the context otherwise requires, all references in this Quarterly Report on Form 10-Q ("Form 10-Q") to the "Company", "Biovail", "we", "us", "our" or similar words or phrases are to Biovail Corporation and its subsidiaries, taken together.

        All dollar amounts in this report are expressed in United States ("U.S.") dollars.

Trademarks

        The following words are trademarks of our 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: ATTENADE™, A Tablet Design (Apex Down)®, A Tablet Design (Apex Up)®, APLENZIN®, ATIVAN®, ASOLZA™, BIOVAIL®, BIOVAIL CORPORATION INTERNATIONAL®, BIOVAIL & SWOOSH DESIGN®, BPI®, BVF®, CARDISENSE™, CARDIZEM®, CEFORM®, CRYSTAAL CORPORATION & DESIGN®, DITECH™, FLASHDOSE®, GLUMETZA®, INSTATAB™, ISORDIL®, JOVOLA™, JUBLIA™, MIVURA™, NITOMAN®, ONELZA™, ONEXTEN™, ORAMELT™, PALVATA™, RALIVIA®, SHEARFORM™, SMARTCOAT™, SOLBRI™, TESIVEE™, TIAZAC®, TITRADOSE®, TOVALT™, UPZIMIA™, VASERETIC®, VASOTEC®, VEMRETA™, VOLZELO™, XENAZINE®, XENAZINA®, and ZILERAN™.

        WELLBUTRIN®, WELLBUTRIN® SR, WELLBUTRIN® XL, WELLBUTRIN XL®, WELLBUTRIN® XR, ZOVIRAX® and ZYBAN® are trademarks of The GlaxoSmithKline Group of Companies and are used by us under license. ULTRAM® is a trademark of Ortho McNeil, Inc. (now known as PriCara, a division of Ortho McNeil Janssen Pharmaceuticals, Inc.) and is used by us under license. STACCATO® is a trademark of Alexza Pharmaceuticals, Inc. and is used by us under license. AMPAKINE® is a trademark of Cortex Pharmaceuticals, Inc. and is used by us under license.

        In addition, we have filed trademark applications for many of our other trademarks in Barbados, the U.S., Canada and in other jurisdictions and have implemented, on an ongoing basis, a trademark protection program for new trademarks.

FORWARD-LOOKING STATEMENTS

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

         To the extent any statements made in this Form 10-Q 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 defined under 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, including, without limitation:

    the proposed merger between Biovail and Valeant Pharmaceuticals International ("Valeant"), including future financial and operating results and the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts;

    closing of the proposed merger, including, but not limited to, our ability to satisfy the closing conditions and the timing thereof;

ii


    the impact of healthcare reform in the U.S. and elsewhere, including the healthcare reform legislation enacted in the U.S. in March 2010, which may adversely affect the amount of reimbursement we receive for our products;

    our intent and ability to implement and effectively execute plans and initiatives associated with our strategic focus on products targeting specialty central nervous system ("CNS") disorders and the anticipated impact of such strategy including, but not limited to, the amount and timing of expected contribution(s), from our product development pipeline;

    our intent to complete in-license agreements and acquisitions and to successfully integrate such in-license agreements and acquisitions into our business and operations and to achieve the anticipated benefits of such in-license agreements and acquisitions;

    our intent to deploy a specialty U.S. sales force to support our specialty CNS strategy, including our intent to develop a sales force to commercialize AZ-004 (Staccato® loxapine) and BVF-007 (AMPAKINE®) in the U.S., and the timing and amount of costs associated with establishing such sales force;

    the competitive landscape in the markets in which we compete, including, but not limited to, the prescription trends, pricing and the formulary or Medicare/Medicaid utilization and positioning for our products, the opportunities present in the market for therapies for specialty CNS disorders, the anticipated level of demand for our products and the availability or introduction of generic formulations of our products;

    our intent, timing and ability to close our Carolina, Puerto Rico manufacturing facility and operations and the anticipated impact of such closure;

    the expected impact on revenues and expenses relating to the disposition of non-core assets;

    anticipated level of demand for generic Tiazac® and generic Cardizem® CD products;

    our intent and related success or failure regarding the defence of our intellectual property against infringement;

    our views, beliefs and positions related to, results of, and costs associated with, certain litigation and regulatory proceedings and the timing, costs and expected impact of the resolution of certain litigation and regulatory proceedings;

    the timing, results and progress of research and development and regulatory approval efforts;

    our intent and ability to make future dividend payments or to repurchase our common shares under our share repurchase program;

    the sufficiency of cash resources, including those under the accordion feature of our senior secured revolving credit facility, to support future spending and business development requirements;

    the impact of market conditions on our ability to access additional funding at reasonable rates;

    our ability to manage exposure to foreign currency exchange rate changes and interest rate changes;

    our intent and ability to use a net share settlement approach upon conversion of our 5.375% Senior Convertible Notes due August 1, 2014 (the "Convertible Notes");

    additional expected charges and anticipated annual savings related to ongoing or planned efficiency initiatives;

    our expected capital expenditures; and

    expected impact of the adoption of new accounting guidance.

         Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "continue", "will", "may", "could", "would", "target", "potential" 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 may not be appropriate for other purposes. Although we have indicated above certain of these statements set out herein, all of the statements in this Form 10-Q that contain forward-looking statements are qualified by these cautionary statements. Although we believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks

iii


and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, including, but not limited to, factors and assumptions regarding the items outlined above. 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 following:

    the risk that the anticipated benefits and synergies from the proposed merger between Biovail and Valeant cannot be fully realized or may take longer to realize than expected, due to, among other things:

    the failure to receive, on a timely basis or otherwise, the required approvals by Valeant stockholders, Biovail shareholders and government or regulatory agencies;

    the risk that a condition to closing of the proposed merger may not be satisfied;

    the risk that the businesses will not be integrated successfully, or that the integration will be more costly or more time consuming and complex than anticipated;

    the risk that disruption from the proposed merger will make maintaining business and operational relationships more difficult; and

    the ability of the combined company to retain and hire key personnel and maintain relationships with customers, suppliers or other business partners;

    the uncertainties associated with the specific determinations necessary to implement certain provisions under the healthcare reform legislation enacted in the U.S.;

    the successful execution of our specialty CNS strategy, including our ability to successfully identify, evaluate, acquire, obtain regulatory approval for, develop, manufacture and commercialize pipeline products;

    the success of pre-clinical and clinical trials for our drug development pipeline or delays in clinical trials which adversely impact the timely commercialization of our pipeline products;

    the results of continuing safety and efficacy studies by industry and government agencies;

    the uncertainties associated with the development, acquisition and launch of new products, including, but not limited to, the acceptance and demand for new pharmaceutical products, and the impact of competitive products and pricing;

    our reliance on key strategic alliances, our ability to secure and maintain third-party research, development, manufacturing, marketing or distribution arrangements and securing other development partners for, and to share development costs associated with, certain product development programs;

    the availability of capital and our ability to generate operating cash flows to support our growth strategy;

    the continuation of the recent economic and market turmoil, which could result in fluctuations in currency exchange rates and interest rates;

    our eligibility for benefits under tax treaties and the continued availability of low effective tax rates for the business profits of our principal operating subsidiary;

    the difficulty of predicting the expense, timing and outcome within our legal and regulatory environment, including, but not limited to, U.S. Food and Drug Administration, Canadian Therapeutic Products Directorate and European regulatory approvals, legal and regulatory proceedings and settlements thereof, the protection afforded by our patents and other intellectual and proprietary property, successful challenges to our generic products, and infringement or alleged infringement of the intellectual property rights of others;

    our ability to establish or acquire a specialty U.S. sales force to support our specialty CNS strategy;

    our ability to attract and retain key personnel;

    the reduction in the level of reimbursement for, or acceptance of, pharmaceutical products by governmental authorities, health maintenance organizations or other third-party payors;

iv


    our ability to satisfy the financial and non-financial covenants of our credit facility and Convertible Notes indenture;

    our ability to repay or refinance the principal amount under the Convertible Notes indenture at maturity;

    the disruption of delivery of our products and the routine flow of manufactured goods across the U.S. border; and

    other risks detailed from time to time in our filings with the U.S. Securities and Exchange Commission (the "SEC") and the Canadian Securities Administrators (the "CSA"), 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 Form 10-Q, as well as under Item 1A "Risk Factors" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in the section entitled "Risk Factors" of our draft Registration Statement on Form S-4 filed with the SEC on July 21, 2010 and with the CSA on July 23, 2010. 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 our 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, except as may be required by law.

v



PART I.    FINANCIAL INFORMATION

Item 1.    Financial Statements


BIOVAIL CORPORATION

CONSOLIDATED BALANCE SHEETS

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)

 
  At
June 30
2010
  At
December 31
2009
 

ASSETS

             

Current

             

Cash and cash equivalents

  $ 176,566   $ 114,463  

Marketable securities

    6,238     9,566  

Accounts receivable

    114,409     119,919  

Inventories

    88,134     82,773  

Prepaid expenses and other current assets

    9,576     15,377  

Deferred tax assets, net of valuation allowance

    12,400      

Assets held for sale

    7,117     8,542  
           

    414,440     350,640  

Marketable securities

    9,660     11,516  

Property, plant and equipment, net

    96,480     103,848  

Intangible assets, net

    1,263,993     1,335,222  

Goodwill

    100,294     100,294  

Deferred tax assets, net of valuation allowance

    115,400     132,800  

Other long-term assets, net

    29,456     32,724  
           

  $ 2,029,723   $ 2,067,044  
           

LIABILITIES

             

Current

             

Accounts payable

  $ 41,880   $ 72,022  

Dividends payable

    15,064     14,246  

Accrued liabilities

    125,471     121,898  

Accrued legal settlements

    2,000     7,950  

Income taxes payable

    11,323     6,846  

Deferred revenue

    21,131     21,834  

Current portion of long-term obligations

    16,284     12,110  

Liabilities held for sale

    1,083      
           

    234,236     256,906  

Deferred revenue

    59,446     69,247  

Income taxes payable

    66,900     66,200  

Long-term obligations

    302,939     313,975  

Other long-term liabilities

    5,519     6,344  
           

    669,040     712,672  
           

SHAREHOLDERS' EQUITY

             

Common shares, no par value, unlimited shares authorized, 158,583,775 and 158,310,884 issued and outstanding at June 30, 2010 and December 31, 2009, respectively

    1,468,245     1,465,004  

Additional paid-in capital

    95,070     91,768  

Accumulated deficit

    (244,669 )   (245,974 )

Accumulated other comprehensive income

    42,037     43,574  
           

    1,360,683     1,354,372  
           

  $ 2,029,723   $ 2,067,044  
           

Commitments and contingencies (note 14)

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

1



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF INCOME

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

 
  Three Months Ended
June 30
  Six Months Ended
June 30
 
 
  2010   2009   2010   2009  

REVENUE

                         

Product sales

  $ 231,245   $ 187,716   $ 443,278   $ 353,109  

Research and development

    2,717     3,255     5,641     6,970  

Royalty and other

    4,809     2,564     9,487     6,775  
                   

    238,771     193,535     458,406     366,854  
                   

EXPENSES

                         

Cost of goods sold (exclusive of amortization of intangible assets shown separately below)

    63,850     50,057     122,805     94,897  

Research and development

    37,258     44,692     104,145     59,220  

Selling, general and administrative

    45,094     49,498     88,607     92,742  

Amortization of intangible assets

    33,299     21,778     66,599     37,281  

Restructuring costs

    2,881     11,367     3,494     12,715  

Acquisition-related costs

    7,577     5,596     7,577     5,596  

Legal settlements

                241  
                   

    189,959     182,988     393,227     302,692  
                   

Operating income

    48,812     10,547     65,179     64,162  

Interest income

    234     251     422     585  

Interest expense

    (9,952 )   (4,049 )   (19,779 )   (4,389 )

Foreign exchange gain

    667     314     44     721  

Impairment loss on debt securities

    (392 )   (1,617 )   (547 )   (4,324 )

Gain on auction rate security settlement

        22,000         22,000  

Gain on disposal of investments

        344         338  
                   

Income before provision for income taxes

    39,369     27,790     45,319     79,093  

Provision for income taxes

    5,400     3,700     14,500     16,000  
                   

Net income

  $ 33,969   $ 24,090   $ 30,819   $ 63,093  
                   

Basic and diluted earnings per share

  $ 0.21   $ 0.15   $ 0.19   $ 0.40  
                   

Weighted-average number of common shares outstanding (000s)

                         

Basic

    158,510     158,224     158,449     158,222  

Diluted

    161,019     158,331     160,115     158,301  
                   

Cash dividends declared per share

  $ 0.095   $ 0.090   $ 0.185   $ 0.465  
                   

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

2



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF ACCUMULATED DEFICIT

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)

 
  Three Months Ended
June 30
  Six Months Ended
June 30
 
 
  2010   2009   2010   2009  

Accumulated deficit, beginning of period

  $ (263,464 ) $ (340,356 ) $ (245,974 ) $ (319,909 )

Net income

    33,969     24,090     30,819     63,093  

Cash dividends declared and dividend equivalents

    (15,174 )   (14,243 )   (29,514 )   (73,693 )
                   

Accumulated deficit, end of period

  $ (244,669 ) $ (330,509 ) $ (244,669 ) $ (330,509 )
                   

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

3



BIOVAIL CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

In accordance with United States Generally Accepted Accounting Principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)

 
  Three Months Ended
June 30
  Six Months Ended
June 30
 
 
  2010   2009   2010   2009  

CASH FLOWS FROM OPERATING ACTIVITIES

                         

Net income

  $ 33,969   $ 24,090   $ 30,819   $ 63,093  

Adjustments to reconcile net income to net cash provided by operating activities

                         

Depreciation and amortization

    40,233     32,089     80,281     58,780  

Amortization of deferred revenue

    (4,776 )   (5,301 )   (9,551 )   (10,601 )

Amortization of discounts on long-term obligations

    2,837     564     5,638     564  

Amortization and write-down of deferred financing costs

    1,332     968     2,644     1,098  

Acquired in-process research and development

    10,242     30,414     61,245     30,414  

Deferred income taxes

    700     400     5,000     8,200  

Payment of accrued legal settlements

            (5,950 )   (6,158 )

Addition to accrued legal settlements

                241  

Stock-based compensation

    1,895     1,334     3,552     3,091  

Impairment charges

    392     9,674     547     12,381  

Gain on disposal of investments

        (344 )       (338 )

Other

    (154 )   192     (676 )   169  

Changes in operating assets and liabilities:

                         
 

Accounts receivable

    (11,397 )   (14,204 )   3,662     (7,365 )
 

Insurance recoveries receivable

                770  
 

Inventories

    9,036     (9,960 )   (5,822 )   (8,734 )
 

Prepaid expenses and other current assets

    2,961     2,770     5,236     5,980  
 

Accounts payable

    (566 )   6,223     (30,296 )   (10,111 )
 

Accrued liabilities

    17,803     20,512     3,000     11,736  
 

Income taxes payable

    3,676     (320 )   5,077     690  
 

Deferred revenue

    730     (2,020 )   (740 )   (9,847 )
                   

Net cash provided by operating activities

    108,913     97,081     153,666     144,053  
                   

CASH FLOWS FROM INVESTING ACTIVITIES

                         

Acquisition of intangible assets

    (10,242 )   (540,889 )   (60,245 )   (540,889 )

Proceeds from sale of property, plant and equipment

            8,542      

Additions to property, plant and equipment

    (2,860 )   (842 )   (6,494 )   (1,628 )

Proceeds from sales and maturities of marketable securities

    3,750     1,065     4,965     1,065  

Acquisition of business

        (200,000 )       (200,000 )

Proceeds from sale and leaseback of assets

        5,300         5,300  

Transfer to restricted cash

                (5,250 )

Additions to marketable securities

        (1,744 )       (2,763 )

Other

        357         370  
                   

Net cash used in investing activities

    (9,352 )   (736,753 )   (53,232 )   (743,795 )
                   

CASH FLOWS FROM FINANCING ACTIVITIES

                         

Cash dividends paid

    (14,256 )   (59,331 )   (28,502 )   (118,662 )

Repayment of other long-term obligations

    (12,500 )       (12,500 )    

Proceeds from exercise of stock options

    1,254     18     2,798     18  

Issuance of Convertible Notes

        350,000         350,000  

Advances under credit facility

        130,000         130,000  

Financing costs paid

        (26,274 )       (26,274 )

Other

        (393 )       (393 )
                   

Net cash provided by (used in) financing activities

    (25,502 )   394,020     (38,204 )   334,689  
                   

Effect of exchange rate changes on cash and cash equivalents

    (385 )   876     (127 )   424  
                   

Net increase (decrease) in cash and cash equivalents

    73,674     (244,776 )   62,103     (264,629 )

Cash and cash equivalents, beginning of period

    102,892     297,694     114,463     317,547  
                   

Cash and cash equivalents, end of period

  $ 176,566   $ 52,918   $ 176,566   $ 52,918  
                   

NON-CASH INVESTING AND FINANCING ACTIVITIES

                         

Cash dividends declared but unpaid

  $ (15,064 ) $ (14,240 ) $ (15,064 ) $ (14,240 )

Accrued acquisition of in-process research and development intangible assets

            (1,000 )    

Long-term obligation related to acquisition of business

        (26,768 )       (26,768 )

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

4



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

1.     DESCRIPTION OF BUSINESS

    The Company was formed under the Business Corporations Act (Ontario) on February 18, 2000, and was continued under the Canada Business Corporations Act on June 29, 2005. The Company is a specialty pharmaceutical company with a strategic focus on developing and commercializing products that address unmet medical needs in specialty central nervous system ("CNS") disorders.

2.     SIGNIFICANT ACCOUNTING POLICIES

    Basis of Presentation

    The accompanying unaudited consolidated financial statements have been prepared by the Company in United States ("U.S.") dollars and in accordance with U.S. generally accepted accounting principles ("U.S. GAAP") for interim financial reporting, which do not conform in all respects to the requirements of U.S. GAAP for annual financial statements. Accordingly, these condensed notes to the unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto prepared in accordance with U.S. GAAP that are contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2009. These interim consolidated financial statements have been prepared using accounting policies that are consistent with the policies used in preparing the Company's audited consolidated financial statements for the year ended December 31, 2009. There have been no material changes to the Company's significant accounting policies since December 31, 2009, except as described below under "Adoption of New Accounting Guidance". The consolidated financial statements reflect all normal and recurring adjustments necessary for the fair presentation of the Company's financial position and results of operations for the interim periods presented.

    Certain prior year amounts have been reclassified to conform to the presentation adopted in the current year.

    On June 20, 2010, the Board of Directors of Biovail and the Board of Directors of Valeant Pharmaceuticals International ("Valeant") unanimously approved an Agreement and Plan of Merger (the "merger agreement") under which the companies would merge to create a combined company. Biovail is both the legal and accounting acquirer in the merger. The merger is subject to approval by Biovail shareholders and Valeant stockholders, consummation of the financing contemplated by the commitment letter entered into among Biovail, Valeant and certain financial institutions or alternative financing, and the satisfaction or waiver (if permissible under applicable law) of customary closing conditions and regulatory approvals. While the Company has incurred costs associated with the transaction that are reflected in these consolidated financial statements, the results of operations of Valeant will not be included in the Company's consolidated financial statements until the completion of the merger. See note 16 for additional details regarding the proposed merger.

    Use of Estimates

    In preparing the Company's consolidated financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full year.

5



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

2.     SIGNIFICANT ACCOUNTING POLICIES (Continued)

    On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company's business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company's results of operations and financial position could be materially impacted.

    Adoption of New Accounting Guidance

    Effective January 1, 2010, the Company adopted the following new accounting guidance:

      Authoritative guidance requiring additional disclosure about the amounts of and reasons for significant transfers in and out of Level 1 and Level 2 fair value measurements. This guidance also clarifies existing disclosure requirements related to the level of disaggregation of fair value measurements for each class of assets and liabilities and disclosures about inputs and valuation techniques used to measure fair value for both recurring and nonrecurring Level 2 and Level 3 measurements. As the guidance only requires new disclosures, the adoption of this guidance did not impact the Company's financial position or results of operations. In addition, effective for interim and annual periods beginning after December 15, 2010, this guidance will require additional disclosure and require an entity to present disaggregated information about activity in Level 3 fair value measurements on a gross basis.

      Authoritative guidance for determining whether an entity is a variable interest entity ("VIE"). Under this guidance, an enterprise has a controlling financial interest when it has the power to direct the activities of a VIE that most significantly impact the entity's economic performance, and the obligation to absorb losses of the entity or the right to receive benefits from the entity that could potentially be significant to the VIE. Upon adoption of this guidance, the Company determined that none of its existing collaboration and license arrangements with other entities for various products under development represented arrangements with VIEs. Accordingly, the adoption of this guidance did not have any impact on the Company's consolidated financial statements.

    Recently Issued Accounting Guidance, Not Adopted as of June 30, 2010

    In March 2010, new authoritative guidance was issued recognizing the milestone method of revenue recognition as a valid application of the proportional performance model when applied to research and development arrangements. An entity may make an accounting policy election to recognize the receipt of a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. The guidance is effective for fiscal years, and interim periods within those years, beginning on or after June 15, 2010. The Company is currently evaluating the effect that the adoption of this guidance will have on its consolidated financial statements.

3.     ASSET ACQUISITIONS

    Istradefylline

    On June 2, 2010, the Company entered into a license agreement with Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") to acquire the U.S. and Canadian rights to develop and commercialize products containing istradefylline — a new chemical entity targeted for the treatment of Parkinson's disease.

6



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     ASSET ACQUISITIONS (Continued)

    Under the terms of the license agreement, the Company paid an upfront fee of $10,000,000, and could pay up to $20,000,000 in potential development milestones through U.S. Food and Drug Administration ("FDA") approval and up to an additional $35,000,000 if certain sales-based milestones are met. The Company will also make tiered royalty payments of up to 30% on net commercial sales of products containing istradefylline. In connection with this acquisition, the Company has also entered into an agreement with Kyowa Hakko Kirin for the supply of the istradefylline compound.

    This acquisition was accounted for as a purchase of in-process research and development ("IPR&D") intangible assets with no alternative future use. Accordingly, the $10,000,000 upfront payment, together with $242,000 of acquisition costs, was charged to research and development expenses at the acquisition date.

    AMPAKINE®

    On March 25, 2010, the Company acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex Pharmaceuticals, Inc. ("Cortex") for use in the field of respiratory depression, a brain-mediated breathing disorder. The acquired compounds include the Phase 2 compound CX717 in an oral formulation, the pre-clinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739.

    Under the terms of the asset purchase agreement, the Company paid an upfront fee of $9,000,000 and expects to pay an additional $1,000,000 upon the completion of a six-month transition period. In addition, the Company could pay up to $15,000,000 in potential milestones contingent on the successful demonstration of the utility of an intravenous formulation of CX717 in treating respiratory depression (BVF-007), the successful completion of a Phase 3 clinical program using an AMPAKINE® compound, and approval from the FDA of an AMPAKINE® compound. The Company may also owe certain development milestones and/or royalties on net sales to third parties of an AMPAKINE® compound.

    This acquisition was accounted for as a purchase of IPR&D intangible assets with no alternative future use. Accordingly, the $9,000,000 upfront payment and the $1,000,000 accrued transition payment, together with $686,000 of acquisition costs, were charged to research and development expenses at the acquisition date.

    Staccato® Loxapine

    On February 9, 2010, the Company entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc. ("Alexza") to acquire the U.S. and Canadian development and commercialization rights to AZ-004 for the treatment of psychiatric and/or neurological indications and the symptoms associated with these indications, including the initial indication of treating agitation in schizophrenia and bipolar patients. AZ-004 combines Alexza's proprietary Staccato® drug-delivery system with the antipsychotic drug loxapine. In December 2009, Alexza submitted a New Drug Application ("NDA") to the FDA for Staccato® loxapine. The FDA has accepted the NDA for filing and has indicated a Prescription Drug User Fee Act goal date of October 11, 2010.

    Under the terms of the agreement, the Company paid an upfront fee of $40,000,000, and could pay up to $90,000,000 in potential milestones in connection with the initial indication contingent on the successful approval of the first AZ-004 NDA, successful commercial manufacturing scale-up, and the first commercial sale on an inpatient and on an outpatient basis, which may require the successful completion of additional clinical trials, regulatory submissions, and/or approval of a supplemental NDA. The Company will also

7



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

3.     ASSET ACQUISITIONS (Continued)


    make tiered royalty payments of 10% to 25% on net commercial sales of Staccato® loxapine. Alexza will supply Staccato® loxapine to the Company for commercialization and will receive a per-unit transfer price, based on annual product volume.

    This acquisition was accounted for as a purchase of IPR&D intangible assets with no alternative future use. Accordingly, the $40,000,000 upfront payment, together with $317,000 of acquisition costs, was charged to research and development expenses at the acquisition date.

4.     RESTRUCTURING

    In May 2008, the Company initiated restructuring measures that were intended to rationalize its manufacturing operations, pharmaceutical sciences operations, and general and administrative expenses.

    Manufacturing Operations

    On January 15, 2010, the Company completed the sale of its Dorado, Puerto Rico manufacturing facility for net cash proceeds of $8,542,000. The related property, plant and equipment was classified as assets held for sale on the consolidated balance sheet at December 31, 2009. The Company occupied the Dorado facility until March 31, 2010, pursuant to a short-term lease agreement with the buyer. The Company is continuing to actively market its manufacturing facility located in Carolina, Puerto Rico.

    The Company expects to incur employee termination costs of approximately $9,800,000 in total for severance and related benefits payable to the approximately 240 employees who have been, or will be, terminated as a result of the closure of the Dorado and Carolina facilities. As these employees are required to provide service during the shutdown period in order to be eligible for termination benefits, the Company is recognizing the cost of those termination benefits ratably over the estimated future service period. On a cumulative basis to June 30, 2010, the Company has recognized $9,292,000 of these costs, of which $5,564,000 have been paid.

    Pharmaceutical Sciences Operations

    On April 30, 2010, the Company entered into an asset purchase agreement to sell its contract research division ("CRD") to Lambda Therapeutic Research Inc. ("Lambda"). The Company no longer considered CRD a strategic fit as a result of the Company's transition from reformulation programs to the in-licensing, acquisition and development of specialty CNS products. CRD has not been treated as a discontinued operation for accounting purposes, on the basis that its operations were immaterial and incidental to the Company's core specialty pharmaceutical business.

8



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

4.     RESTRUCTURING (Continued)

    The following assets and liabilities of CRD were reported as held for sale in the consolidated balance sheet at June 30, 2010:

   
  At
June 30
2010
 
 

Accounts receivable

  $ 1,800  
 

Other current assets

    566  
 

Property, plant and equipment

    4,751  
         
 

Total assets held for sale

    7,117  
         
 

Accounts payable and accrued liabilities

    870  
 

Other current liabilities

    213  
         
 

Total liabilities held for sale

    1,083  
         
 

Net assets held for sale

  $ 6,034  
         

    For the three-month and six-month periods ended June 30, 2010 and 2009, CRD reported the following revenue and expenses, which, as described above, have not been segregated from continuing operations in the consolidated statements of income:

   
  Three Months Ended
June 30
  Six Months Ended
June 30
 
   
  2010   2009   2010   2009  
 

Research and development revenue

  $ 2,309   $ 2,953   $ 5,233   $ 6,255  
                     
 

Research and development expenses

    3,372     3,563     6,679     6,984  
 

Selling, general and administrative expenses

    859     948     1,678     1,761  
                     
 

Total operating expenses

    4,231     4,511     8,357     8,745  
                     
 

Operating loss

    (1,922 )   (1,558 )   (3,124 )   (2,490 )
 

Foreign exchange gain (loss)

    (25 )   (32 )   (108 )   161  
                     
 

Net loss

  $ (1,947 ) $ (1,590 ) $ (3,232 ) $ (2,329 )
                     

    In the three-month period ended June 30, 2010, the Company recognized employee termination costs of $1,924,000 for the approximately 70 CRD employees not expected to be offered employment by Lambda. On July 23, 2010, the Company completed the sale of CRD to Lambda for net cash proceeds of approximately $6,000,000.

    Prior to December 31, 2009, the Company completed the closure of its research and development facilities in Dublin, Ireland and Mississauga, Ontario, and the consolidation of its research and development operations in Chantilly, Virginia.

9



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)

4.     RESTRUCTURING (Continued)

    The following table summarizes the major components of restructuring costs recognized through June 30, 2010:

   
  Asset Impairments   Employee Termination Benefits    
   
 
   
  Contract
Termination
and Other
Costs
   
 
   
  Manufacturing   Pharmaceutical
Sciences
  Manufacturing   Pharmaceutical
Sciences
  Total  
 

Balance, January 1, 2008

  $   $   $   $   $   $  
 

Costs incurred and charged to expense

    42,602     16,702     3,309     2,724     4,865     70,202  
 

Cash payments

                (2,724 )   (333 )   (3,057 )
 

Non-cash adjustments

    (42,602 )   (16,702 )           (1,186 )   (60,490 )
                             
 

Balance, December 31, 2008

            3,309         3,346     6,655  
                             
 

Costs incurred and charged to expense

    7,591     2,784     4,942     1,441     2,307     19,065  
 

Cash payments

            (2,041 )   (1,278 )   (1,321 )   (4,640 )
 

Non-cash adjustments

    (7,591 )   (2,784 )       71         (10,304 )
                             
 

Balance, December 31, 2009

            6,210     234     4,332     10,776  
                             
 

Costs incurred and charged to expense

            333         280     613  
 

Cash payments

            (2,703 )   (195 )   (429 )   (3,327 )
 

Non-cash adjustments

                6         6  
                             
 

Balance, March 31, 2010

            3,840     45     4,183     8,068  
                             
 

Costs incurred and charged to expense

            708     1,924     249     2,881  
 

Cash payments

            (820 )       (435 )   (1,255 )
 

Non-cash adjustments

                (46 )       (46 )
                             
 

Balance, June 30, 2010

  $   $   $ 3,728   $ 1,923   $ 3,997   $ 9,648  
                             

10



BIOVAIL CORPORATION

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (Continued)

In accordance with United States Generally Accepted Accounting Principles
(All tabular dollar amounts expressed in thousands of U.S. dollars, except per share data)
(Unaudited)