-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, P7aIMh1Q67lyb0bBDYbh45Dg4AFiwXVXDVZkrnToK7j8cpIp+gzM7sfvj4UAjLy2 +3jBfFwW1NZq0wNJrqpJJQ== 0001104659-08-052670.txt : 20080813 0001104659-08-052670.hdr.sgml : 20080813 20080813172624 ACCESSION NUMBER: 0001104659-08-052670 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20080813 FILED AS OF DATE: 20080813 DATE AS OF CHANGE: 20080813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOVAIL CORP INTERNATIONAL CENTRAL INDEX KEY: 0000885590 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A6 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14956 FILM NUMBER: 081014456 BUSINESS ADDRESS: STREET 1: 7150 MISSISSAUGA ROAD STREET 2: MISSISSAUGA CITY: ONTARIO STATE: A6 ZIP: 00000 BUSINESS PHONE: 905 286-3000 MAIL ADDRESS: STREET 1: 7150 MISSISSAUGA ROAD STREET 2: MISSISSAUGA CITY: ONTARIO STATE: A6 ZIP: 00000 6-K 1 a08-21629_26k.htm 6-K

 

 

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

 

August 13, 2008

 

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 x                        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 x

 

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 x

 

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 x

 

 

 



 

BIOVAIL CORPORATION

 

This Report of Foreign Private Issuer on Form 6-K is incorporated by reference into the registration statements on Form S-8 (Registration Nos. 333-92229 and 333-138697) of Biovail Corporation.

 

INDEX

 

Exhibit 99.1                                    News Release dated August 13, 2008:  Biovail Declares Quarterly Dividend

Exhibit 99.2                                    News Release dated August 13, 2008:  Biovail Reports Second-Quarter 2008 Financial Results

 

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:

August 13, 2008

By:

/ s / Jennifer Tindale

 

 

 

Jennifer Tindale

 

 

 

Vice President &

 

 

 

Associate General Counsel

 

2


EX-99.1 2 a08-21629_2ex99d1.htm EX-99.1

Exhibit 99.1

 

 

CONTACT: Nelson F. Isabel

Vice-President, Investor Relations

& Corporate Communications

(905) 286-3000

 

For Immediate Release:

 

BIOVAIL DECLARES QUARTERLY DIVIDEND

Total Dividends Declared Since December 2005 of $4.125 per share

 

TORONTO, Canada, August 13, 2008 – Biovail Corporation (NYSE, TSX: BVF) today announced that the Company’s Board of Directors has declared a quarterly cash dividend of US$0.375 per share payable on September 3, 2008, to shareholders of record at the close of business August 25, 2008. The ex-dividend date is August 21, 2008.

 

Upon payment of this dividend, Biovail will have distributed US$4.125 per share to shareholders since implementing its dividend program in December 2005.

 

Important Income-Tax Information for Canadian Resident Shareholders

 

Biovail Corporation designates the entire amount of this taxable dividend to be an “eligible dividend” for purposes of the Income Tax Act (Canada), as amended from time to time. This notice meets the requirements of the Income Tax Act (Canada). Please contact your tax advisor if you have any questions with regard to the designation of the eligible dividend.

 

About Biovail Corporation

 

Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products. The Company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets. For more information about Biovail, visit the Company’s Web site at www.biovail.com.

 



 

For further information, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to ir@biovail.com.

 

Source: Biovail Corporation

 


EX-99.2 3 a08-21629_2ex99d2.htm EX-99.2

Exhibit 99.2

 

 

CONTACT: Nelson F. Isabel

Vice-President, Investor Relations

& Corporate Communications

(905) 286-3000

 

For Immediate Release:

 

BIOVAIL REPORTS SECOND-QUARTER 2008 FINANCIAL RESULTS

 

Company Records Total Revenues of $186 Million;
U.S. GAAP Loss Per Share of $0.16, Including Net Negative Impact

From Specific Items of $0.53;

Implementation of New Strategic Focus on Track

 

TORONTO, Canada, August 13, 2008 – Biovail Corporation (NYSE/TSX: BVF) today announced financial results for the three-month and six-month periods ended June 30, 2008. To the extent that this news release contains forward-looking statements, investors are cautioned that these are based on the Company’s current views, and actual outcomes are not certain. For more information, see the note on forward-looking information following the conference call details in this news release.

 

“We have made progress in the implementation of our New Strategic Focus and the transformation of Biovail,” said Biovail Chief Executive Officer Bill Wells. “Our cost-efficiency initiatives are beginning to produce results, our business-development efforts are extremely active, and Biovail’s balance sheet and cash balances are robust. Operating cash flows are also strong. Across all levels of the organization, Biovail’s employees are eager to do their part to implement the Company’s new strategy.”

 

Financial Results

 

Total revenues for the three months ended June 30, 2008 were $186.1 million, compared with $203.0 million for the second quarter of 2007. Total revenues for the six months ended June 30,

 

1



 

2008 were $394.6 million, compared with $450.0 million for the first six months of 2007. Second-quarter 2008 net income, in accordance with United States Generally Accepted Accounting Principles (GAAP), was a loss of $25.3 million, compared with net income of $67.8 million for the corresponding 2007 period. Net income for the first half of 2008 was $31.1 million, compared with $161.6 million in the same period a year earlier. On a per-share basis, Biovail recorded a GAAP diluted loss per share of $0.16 for the second quarter of 2008, compared with earnings per share (EPS) of $0.42 for the second quarter of 2007. In the first half of 2008, GAAP EPS were $0.19, compared with EPS of $1.01 for the first half of 2007.

 

Specific Items Affecting Operations

 

The following table displays specific items that affected results in the second quarter and first half of 2008 and 2007, respectively, and the impact of each individual item on diluted EPS.

 

 

 

Three Months Ended June 30

 

Six Months Ended June 30

 

[$ in 000s, except per share data;

 

2008

 

2007

 

2008

 

2007

 

Income (Expense)]

 

Amount

 

EPS Impact

 

Amount

 

EPS Impact

 

Amount

 

EPS Impact

 

Amount

 

EPS Impact

 

Restructuring costs

 

$

(51,760

)

$

(0.32

)

$

(887

)

$

(0.01

)

$

(51,760

)

$

(0.32

)

$

(1,532

)

$

(0.01

)

Legal settlement

 

(24,648

)

$

(0.15

)

 

$

 

(24,648

)

$

(0.15

)

 

$

 

Management succession costs

 

(6,052

)

$

(0.04

)

 

$

 

(6,052

)

$

(0.04

)

 

$

 

Proxy contest costs

 

(5,414

)

$

(0.03

)

 

$

 

(5,414

)

$

(0.03

)

 

$

 

Gain on disposal of investments

 

3,461

 

$

0.02

 

15,716

 

$

0.10

 

3,461

 

$

0.02

 

15,716

 

$

0.10

 

Loss on impairment of investments

 

(489

)

$

 

 

$

 

(4,105

)

$

(0.03

)

 

$

 

Equity loss

 

 

$

 

(469

)

$

 

(1,195

)

$

(0.01

)

(893

)

$

(0.01

)

Loss on early extinguishment of debt

 

 

$

 

(12,463

)

$

(0.08

)

 

$

 

(12,463

)

$

(0.08

)

Contract recoveries

 

 

$

 

1,612

 

$

0.01

 

 

$

 

1,612

 

$

0.01

 

Total

 

$

(84,902

)

(0.53

)

$

3,509

 

0.02

 

$

(89,713

)

(0.56

)

$

2,440

 

0.02

 

 

In the second quarter of 2008, Biovail accrued a $51.8-million charge related to the planned closure of the Company’s Puerto Rico manufacturing facilities and the pending closure of its research and development facility in Dublin, Ireland. In addition, Biovail incurred a charge of $24.6 million related to an agreement-in-principle with the U.S. Department of Justice related to their investigation into the 2003 commercial launch of Cardizem® LA. Biovail also incurred costs of $6.1 million in expenses in the second quarter of 2008 related to management succession; $5.4 million associated with the recently resolved proxy contest regarding the election of the Board of Directors; and a $0.5-million loss on impairment of investments, relating primarily to the Company’s portfolio of auction rate securities. These charges were partially offset by a $3.5-million gain on the sale of Biovail’s investment in Financière Verdi (formerly Ethypharm S.A.). These specific items had an aggregate negative impact of $84.9 million in the second quarter of 2008, or $0.53 per common share.

 

2



 

In the second quarter of 2007, Biovail incurred a charge of $0.9 million associated with the December 2006 restructuring of the Company’s U.S. commercial operations, and a loss of $12.5 million on the extinguishment of the Company’s Senior Subordinated Notes, which includes a $7.9-million premium for the early redemption, and the write-off of $4.6 million in deferred financing and other associated costs. Biovail also recorded a $0.5-million equity loss in the second quarter of 2007 relating to the Company’s investment in Western Life Sciences Venture Fund. Offsetting these items was a $15.7-million gain associated with the April 2007 sale of a portion of the Company’s investment in Ethypharm S.A., and a $1.6-million reversal in accrued contract-cost provisions, primarily related to the Wellbutrin XL® agreement as a result of additional sample purchases by GlaxoSmithKline plc (GSK) in the second quarter of 2007. These specific items had an aggregate positive impact to net income of $3.5 million, or $0.02 per common share.

 

New Strategic Focus

 

In May 2008, Biovail announced a New Strategic Focus – one that leverages the Company’s existing strengths to target unmet medical needs in the therapeutic area of specialty central nervous system (CNS) disorders. This shift in strategy was necessary given ongoing changes in the global pharmaceutical marketplace, including heightened cost-containment pressures and intellectual-property regulations, and shorter product lifecycles. Since then, the Company has made progress in its product-procurement activities targeted towards specialty CNS disorders, and is currently reviewing a number of in-licensing or acquisition opportunities. Biovail is also assessing a number of private and public pharmaceutical companies active in the specialty CNS market for potential acquisition.

 

Biovail is enhancing its senior management team and internal expertise in CNS disorders, as it implements its New Strategic Focus. In June 2008, the Company appointed Dr. Robert Butz as Vice-President, Medical and Scientific Affairs. Dr. Butz brings over 30 years of experience in the pharmaceutical industry, including tenures at Burroughs Wellcome, Quintiles Transnational, Amylin Pharmaceuticals, Sensus Drug Development Corporation and MDS Pharma Services. Throughout his career, Dr. Butz has been involved in the development of over a dozen CNS programs.

 

Biovail is currently recruiting a Chief Scientific Officer, and has met with a number of qualified candidates to fill the role. Biovail is also active in its efforts to establish a Scientific Advisory Board to provide oversight to its product-development pipeline.

 

3



 

Operating-Efficiency Initiatives

 

Also in May, Biovail announced it was taking steps to close the Company’s two Puerto Rico manufacturing facilities and transfer certain manufacturing processes to its Steinbach, Manitoba facility. These closures, which are expected to take 18 to 24 months to complete, are intended to reduce the Company’s cost infrastructure and increase available capital. Biovail is also planning the closure of its research-and-development facility in Dublin, Ireland, and the consolidation of the activities conducted therein to the Company’s R&D site in Chantilly, Virginia. A consultation process with employees in Ireland in respect of this closure is ongoing.

 

Biovail has begun the sale process relating to its Puerto Rican facilities and will initiate similar efforts for the Company’s Irish facility upon confirmation of its closure. The closure of these three facilities will result in a reduction of headcount of about 300 employees – representing approximately 20% of Biovail’s total headcount – without any anticipated impact to the Company’s existing revenue base.

 

Non-Core Asset Sales

 

In June 2008, Biovail sold its economic interest (common shares and convertible securities) in Financière Verdi for proceeds of $12.2 million. Biovail is exploring the divestiture and/or monetization of other non-core assets, including its facilities in Puerto Rico and Ireland, which the Company believes could, in aggregate, result in cash proceeds in excess of $100 million.

 

Share Repurchase Program

 

Under the Company’s ongoing share repurchase program, 2.3 million shares were purchased and cancelled from June 2, 2008 to June 23, 2008 at a cost of $25.5 million. Biovail’s Board has approved the purchase of up to 14 million shares, subject to regulatory filings and approvals, under the program, which expires June 1, 2009. Biovail’s credit facility currently restricts any share purchases to $50 million per calendar year and any purchases beyond this threshold require lender consent.

 

4



 

Second-Quarter 2008 Financial Performance

 

The following table summarizes Biovail’s product revenue performance in the second quarter and first half of 2008:

 

($ 000s)

 

Q2/08 Revenues

 

Q2/07 Revenues

 

Change

 

H1/08 Revenues

 

H1/07 Revenues

 

Change

 

Wellbutrin XL®

 

30,420

 

53,048

 

(43

)%

89,276

 

114,453

 

(22

)%

Ultram® ER

 

19,166

 

19,562

 

(2

)%

43,270

 

49,581

 

(13

)%

Zovirax®

 

37,525

 

35,217

 

7

%

74,655

 

72,500

 

3

%

Biovail Pharmaceuticals Canada

 

18,413

 

14,071

 

31

%

34,653

 

27,897

 

24

%

Cardizem® LA

 

10,485

 

22,686

 

(54

)%

20,692

 

46,635

 

(56

)%

Legacy Products

 

40,191

 

34,917

 

15

%

73,338

 

70,557

 

4

%

Generics

 

18,937

 

11,265

 

68

%

36,167

 

47,145

 

(23

)%

Glumetza® - US

 

529

 

 

N/A

 

529

 

 

N/A

 

Total Product Revenues

 

175,666

 

190,766

 

(8

)%

372,580

 

428,768

 

(13

)%

 

Product revenues for the second quarter of 2008 were $175.7 million, compared with $190.8 million in the second quarter of 2007, an 8% decrease that primarily reflects the introduction of generic competition for the 150mg dosage strength of Wellbutrin XL® and lower revenues for Cardizem® LA. Partially offsetting these declines were increases in revenues from the Company’s portfolio of generic products, Legacy products, Biovail Pharmaceuticals Canada (BPC) and, Zovirax®. Product revenues for the six months ended June 30, 2008 were $372.6 million compared with $428.8 million for the six months ended June 30, 2007.

 

Product revenues for Wellbutrin XL® were $30.4 million in the second quarter of 2008, and $89.3 million in the first half of 2008, compared with $53.0 million and $114.5 million in corresponding periods in 2007, respectively. These decreases reflect the December 2006 and May 2008 introduction of generic competition for the 300mg and 150mg dosage strengths, respectively, of the product.

 

Biovail recorded revenues of $19.2 million for Ultram® ER in the second quarter of 2008, compared with $19.6 million in the corresponding period in 2007. In the first half of 2008, Ultram® ER generated revenues of $43.3 million, compared to $49.6 million in the corresponding period in 2008. Year-over-year performance reflects a reduction in inventory levels and the timing of sample shipments, partially offset by a price increase in the first quarter of 2008. In the second quarter of 2008, Ultram® ER captured 5.6% of total prescription volume of the tramadol market (including generics).

 

5



 

Revenues for Biovail’s Zovirax® franchise were $37.5 million in the second quarter of 2008, and $74.7 million in the first half of 2008, representing increases of 7% and 3%, respectively, when compared with $35.2 million and $72.5 million in the prior-year periods. The increases reflect the timing of wholesaler inventory purchases and a January 2008 price increase. In the second quarter of 2008, Zovirax® Ointment and Zovirax® Cream held a combined 75.1% share of the topical herpes market.

 

Second-quarter 2008 revenues for BPC were $18.4 million, compared with $14.1 million in the prior-year period. First-half 2008 revenues for BPC were $34.7 million, compared with $27.9 million in the first half of 2007. The increases reflect higher sales of Wellbutrin® XL, Tiazac® XC, Glumetza® and Ralivia™ which was launched in November 2007. Wellbutrin® XL continues to gain market share, capturing 46% of total prescriptions written for the Wellbutrin® brand in the second quarter of 2008. Tiazac® XC continues to gain market share, capturing 39% of total prescriptions written for the Tiazac® brand in the second quarter of 2008. Partially offsetting factors were lower sales of Tiazac®, Zyban® and Wellbutrin® SR.

 

In the second quarter of 2008, Cardizem® LA generated revenues of $10.5 million, compared with $22.7 million for the corresponding period in 2007. In the first half of 2008, Cardizem® LA generated revenues of $20.7 million, compared with $46.6 million in the first half of 2007. The decreases in sales for the three and six months ended June 2008 reflects lower prescription volumes for the product, partially offset by price increases. In addition, sales were unusually high in the first six months of 2007 due to the fulfillment of backorders for the 120mg and 180mg strength tablets of the product in the first quarter of 2007.

 

Legacy products generated revenues of $40.2 million in the second quarter of 2008 and $73.3 million in the first half of 2008, compared with $34.9 million and $70.6 million in the corresponding periods in 2007, respectively. This performance primarily reflects the impact of price increases, partially offset by lower prescription volumes.

 

Product revenue for Biovail’s portfolio of generic products, distributed by Teva Pharmaceutical Industries Ltd. (Teva), was $18.9 million in the second quarter of 2008, compared with $11.3 million in the second quarter of 2007, which was impacted by a higher-than-expected level of charge-backs processed by Teva. In the first half of 2008, Biovail’s generic products generated revenues of $36.2 million, compared with $47.1 million in the first half of 2007, reflecting lower sales of Biovail’s generic formulations of Adalat CC and Procardia XL.

 

6



 

Research-and-development revenue was $5.7 million in the second quarter of 2008, compared with $7.4 million in the prior-year period, a decrease of 23% that reflects a $1.9-million payment from Kos in the second quarter of 2007 related to development activity for Vasocard™ prior to the project’s termination. Revenues for the first half of 2008 increased 7% compared with the corresponding period of 2007, which reflects increased activity levels at Biovail’s Contract Research Division.

 

Royalty and other revenue was $4.7 million in the second quarter of 2008 and $9.0 million in the first half of 2008, compared with $4.9 million and $9.0 million in the corresponding periods in 2007, respectively.

 

Cost of goods sold for the second quarter of 2008 was $43.9 million, compared with $54.5 million in the second quarter of 2007. Gross margins based on product sales were 75.0% and 73.8% in the second quarter and first half of 2008, respectively, compared with 71.4% and 74.1% in the corresponding 2007 periods. Gross margins in the second quarter of 2008 were positively impacted by price increases and a reduction in inventory reserves. In the second quarter of 2007, gross margins were negatively impacted by a higher-than-expected level of charge-backs processed by Teva (described above).

 

Research-and-development expenditures were $21.8 million for the second quarter of 2008 and $58.1 million for the first half of 2008, compared with $28.4 million and $58.2 million for the corresponding periods in 2007, respectively. The year-over-year changes reflect decreased spending for BVF-146 (tramadol/NSAID combination), which was recently discontinued, and Aplenzin™ (bupropion salt), which received FDA approval in April 2008. Biovail is in active discussions with potential partners for the commercialization of Aplenzin™ in the United States. The Company is also evaluating other commercialization options for the product, including co-promotion opportunities and the use of a contract sales organization.

 

Selling, general and administrative (SG&A) expenses for the second quarter of 2008 were $56.6 million, compared with $46.3 million in the second quarter of 2007. SG&A expenses for the first half of 2008 were $100.2 million, compared with $95.9 million in the corresponding period in 2007. These increases reflect expenses of $5.4 million associated with the recent proxy contest and $6.1 million in expenses related to management succession, which includes $2.1 million in

 

7



 

non-cash expenses associated with the accounting for stock-based compensation. Also contributing to the increase were higher payments to Sciele Pharma, Inc. ($5.5 million in the second quarter of 2008, compared with $3.7 million in the prior-year period), related to their promotional efforts for Zovirax® and an increase in advertising and promotional expenses ($5.6 million in the second quarter of 2008, compared with $3.2 million in the prior-year period), primarily related to the launch of Ralivia™ in Canada. Partially offsetting factors include lower legal costs, which totaled $9.1 million in the second quarter of 2008, compared with $13.9 million in the prior-year period.

 

Amortization expense was $11.7 million in the second quarter of 2008 and $23.4 million in the first half of 2008, compared with $12.0 million and $24.0 million in the second quarter and first half of 2007, respectively.

 

Balance Sheet & Cash Flow

 

At June 30, 2008, Biovail had cash balances of $354.1 million and marketable securities of $23.1 million. The Company has no long-term debt and no outstanding borrowings against its $250-million credit facility.

 

Biovail currently has $26.8 million of principal invested in auction-rate securities (ARS), all of which were rated Aaa/AAA at the time of purchase. However, given declines in underlying collateral values, several of these holdings have had their ratings downgraded since the fourth quarter of 2007. Although these securities continue to pay cash interest, Biovail has been unable to liquidate its ARS portfolio. As such, the Company has recorded this portfolio at its estimated fair value of $13.5 million as at June 30, 2008 and has recorded a further impairment charge of $0.3 million in the second quarter of 2008. To date, the Company has recorded cumulative impairment charges of $9.2 million in respect of these securities. In addition, the Company has recorded a cumulative amount of $4.1 million as an unrealized loss in other comprehensive income.

 

Cash flow from operations was $67.1 million in the second quarter of 2008, compared with $98.3 million in the second quarter of 2007, which reflects changes in working capital, increased costs related to the proxy contest and management succession and a modest decline in gross profit due primarily to the genericization of the 150mg strength of Wellbutrin XL® product in May 2008. Net capital expenditures in the second quarter of 2008 amounted to $7.7 million, compared with $7.4 million in the prior-year period. Capital expenditures are expected to decrease going forward, with the closure of the Company’s Puerto Rico manufacturing facilities.

 

8



 

Outlook

 

Biovail is making progress in the implementation of its New Strategic Focus. Over the next several quarters, the Company’s ongoing and planned efficiency initiatives are expected to result in additional charges to earnings. Cumulatively, these charges, including those recorded in the second quarter of 2008, are expected to be in the range of $80 million to $100 million, of which the cash component is expected to be $30 million to $40 million. Cost-efficiency initiatives, which should gradually lower expenses, include the previously disclosed closure of the Company’s two manufacturing facilities in Puerto Rico and the potential closure of our research-and-development site in Dublin, Ireland. In addition, the Company’s recent resolution of several legacy litigation matters should also contribute to lower overall expenses. Biovail anticipates total annual savings of $30 million to $40 million once all initiatives are completed.

 

Biovail expects year-over-year decreases in its product sales for the next several quarters, mainly as a result of the second-quarter 2008 introduction of generic competition on the 150mg strength of Wellbutrin XL®. Biovail does not anticipate meaningful revenue contribution from its development pipeline until the 2010-2011 timeframe.

 

Biovail plans to invest over $600 million in research and development through 2012, targeting unmet medical needs in specialty CNS markets. Business-development efforts to in-license or acquire products targeting specialty CNS markets are active with a number of U.S. and international companies.

 

Conference Call

 

Biovail management will host a conference call and Webcast on Wednesday, August 13, 2008, at 8:30a.m. EDT, for Company executives to discuss second-quarter 2008 financial and operational results. Following the discussion, Biovail executives will address inquiries from research analysts.

 

A live Webcast of this call will be available through the Investor Relations section of Biovail’s Web site at www.biovail.com. To access the call live, please dial 416-695-6617 (Toronto and International callers) and 1-800-952-6845 (U.S. and Canada). Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays.

 

9



 

A replay of the conference call will be available until 7 p.m. EDT on Wednesday, August 20, 2008, by dialing 416-695-5800 (Toronto and International callers) and 1-800-408-3053 (U.S. and Canada), using access code, 3266755#.

 

Caution Regarding Forward-Looking Information and “Safe Harbor” Statement

 

To the extent any statements made in this release 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 under applicable Canadian provincial securities legislation (collectively, “forward-looking statements”).  These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, statements concerning the Company’s New Strategic Focus, including the Company’s intention and ability to implement and effectively execute elements of its New Strategic Focus and the anticipated impact of the Company’s New Strategic Focus, the intent, timing and associated costs of the proposed closure of the Company’s Puerto Rico and Ireland facilities and other efficiency initiatives, the Company’s intent and ability to make purchases under its share repurchase program, the outcome of business development efforts, the expected impact of the introduction of generic competition on the 150mg strength of Wellbutrin XL®, the amount and timing of expected contribution from the Company’s development pipeline and the amount and timing of investment in research and development 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 Biovail believes 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, including, but not limited to, factors and assumptions regarding prescription trends, pricing and the formulary and/or Medicare/Medicaid positioning for our products, the competitive landscape in the markets in which we compete, including, but not limited to, the availability or introduction of generic formulations of our products, timelines associated with the development of, and receipt of regulatory approval for, our new products, and actual results may differ materially from those expressed or implied in such statements. Important

 

10



 

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, uncertainties associated with the development, acquisition and launch of new products, reliance on key strategic alliances, contractual disagreements with third parties, availability of raw materials and finished products, the regulatory environment, the expense, timing and uncertain outcome of legal and regulatory proceedings and settlements thereto, market liquidity for our common shares and our satisfaction of applicable laws for the repurchase of our common shares, the results of the upcoming U.S. presidential election, consolidated tax rate assumptions, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission and the Canadian Securities Administrators, as well as the Company’s 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 news release, as well as under the heading “Risk Factors” contained in Item 3(D) of Biovail’s most recent Annual Report on Form 20-F/A.

 

The Company cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Biovail’s 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. Biovail undertakes no obligation to update or revise any forward-looking statement.

 

About Biovail Corporation

 

Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products. The Company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets. For more information about Biovail, visit the Company’s Web site at www.biovail.com.

 

For further information, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to ir@biovail.com.

 

11



 

BIOVAIL CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)

(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

 

 

 

2008

 

2007

 

2008

 

2007

 

REVENUE

 

 

 

 

 

 

 

 

 

Product sales

 

$

175,666

 

$

190,766

 

$

372,580

 

$

428,768

 

Research and development

 

5,704

 

7,378

 

13,057

 

12,219

 

Royalty and other

 

4,725

 

4,883

 

8,956

 

9,045

 

 

 

186,095

 

203,027

 

394,593

 

450,032

 

EXPENSES

 

 

 

 

 

 

 

 

 

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

 

43,877

 

54,534

 

97,612

 

110,950

 

Research and development

 

21,759

 

28,447

 

58,091

 

58,169

 

Selling, general and administrative

 

56,633

 

46,329

 

100,230

 

95,923

 

Amortization

 

11,691

 

11,982

 

23,385

 

23,963

 

Restructuring costs

 

51,760

 

887

 

51,760

 

1,532

 

Legal settlement

 

24,648

 

 

24,648

 

 

Contract recoveries

 

 

(1,612

)

 

(1,612

)

 

 

210,368

 

140,567

 

355,726

 

288,925

 

Operating income (loss)

 

(24,273

)

62,460

 

38,867

 

161,107

 

Interest income

 

3,412

 

6,070

 

6,880

 

15,831

 

Interest expense

 

(236

)

(453

)

(478

)

(9,130

)

Foreign exchange gain (loss)

 

(1,564

)

763

 

(1,343

)

475

 

Equity loss

 

 

(469

)

(1,195

)

(893

)

Gain on disposal of investments

 

3,461

 

15,716

 

3,461

 

15,716

 

Loss on impairment of investments

 

(489

)

 

(4,105

)

 

Loss on early extinguishment of debt

 

 

(12,463

)

 

(12,463

)

Income (loss) before provision for income taxes

 

(19,689

)

71,624

 

42,087

 

170,643

 

Provision for income taxes

 

5,600

 

3,800

 

11,000

 

9,000

 

Net income (loss)

 

$

(25,289

)

$

67,824

 

$

31,087

 

$

161,643

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted earnings (loss) per share

 

$

(0.16

)

$

0.42

 

$

0.19

 

$

1.01

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding (000s)

 

 

 

 

 

 

 

 

 

Basic

 

160,709

 

160,847

 

160,866

 

160,654

 

Diluted

 

160,709

 

160,988

 

160,866

 

160,724

 

 

 

 

 

 

 

 

 

 

 

Cash dividends declared per share

 

$

0.375

 

$

0.375

 

$

0.750

 

$

0.750

 

 

12



 

BIOVAIL CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

 

 

 

At
June 30
2008

 

At
December 31
2007

 

ASSETS

 

 

 

 

 

Cash and cash equivalents

 

$

354,056

 

$

433,641

 

Other current assets

 

310,000

 

273,376

 

 

 

664,056

 

707,017

 

Marketable securities

 

23,065

 

24,417

 

Long-term investments

 

14,609

 

24,834

 

Property, plant and equipment, net

 

182,298

 

238,457

 

Intangible assets, net

 

602,542

 

630,514

 

Goodwill

 

100,294

 

100,294

 

Deferred tax assets, net of valuation allowance

 

18,200

 

20,700

 

Other long-term assets, net

 

34,541

 

35,882

 

 

 

$

1,639,605

 

$

1,782,115

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

$

350,975

 

$

367,578

 

Long-term liabilities

 

105,475

 

116,718

 

Shareholders’ equity

 

1,183,155

 

1,297,819

 

 

 

$

1,639,605

 

$

1,782,115

 

 

BIOVAIL CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

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

(Unaudited)

 

 

 

Three Months Ended
June 30

 

Six Months Ended
June 30

 

 

 

2008

 

2007

 

2008

 

2007

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(25,289

)

$

67,824

 

$

31,087

 

$

161,643

 

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

25,345

 

24,376

 

50,418

 

46,261

 

Amortization and write-down of deferred financing costs

 

130

 

4,043

 

260

 

4,574

 

Amortization and write-down of discounts on long-term obligations

 

 

761

 

 

962

 

Accrued legal settlements

 

24,648

 

 

14,648

 

 

Stock-based compensation

 

3,744

 

2,811

 

5,173

 

7,037

 

Gain on disposal of investment

 

(3,461

)

(15,716

)

(3,461

)

(15,716

)

Impairment charges

 

51,974

 

 

55,590

 

 

Equity loss

 

 

469

 

1,195

 

893

 

Premium paid on early extinguishment of debt

 

 

7,854

 

 

7,854

 

Contract recoveries

 

 

(1,612

)

 

(1,612

)

Other

 

(1,621

)

383

 

(1,053

)

1,079

 

Changes in operating assets and liabilities

 

(8,414

)

7,084

 

5,875

 

5,130

 

Net cash provided by operating activities

 

67,056

 

98,277

 

159,732

 

218,105

 

Net cash provided by (used in) investing activities

 

1,796

 

30,402

 

(92,483

)

24,672

 

Net cash used in financing activities

 

(146,320

)

(529,837

)

(146,458

)

(608,331

)

Effect of exchange rate changes on cash and cash equivalents

 

(13

)

441

 

(376

)

472

 

Net decrease in cash and cash equivalents

 

(77,481

)

(400,717

)

(79,585

)

(365,082

)

Cash and cash equivalents, beginning of period

 

431,537

 

870,175

 

433,641

 

834,540

 

Cash and cash equivalents, end of period

 

$

354,056

 

$

469,458

 

$

354,056

 

$

469,458

 

 

13


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