-----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, F2Lzo25l9WOi0f0xrBNItC2c/TyC1KLhxej1lQmREbEOWLfNZZ2Kop+RukbGEXFY AR8hGDu5DdP/QbdK2ena1A== 0001104659-08-031789.txt : 20080509 0001104659-08-031789.hdr.sgml : 20080509 20080509144741 ACCESSION NUMBER: 0001104659-08-031789 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20080508 FILED AS OF DATE: 20080509 DATE AS OF CHANGE: 20080509 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: 08817841 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 a08-13797_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

 

May 9, 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 May 8, 2008 – Biovail Reports First-Quarter 2008 Financial Results

Exhibit 99.2            News Release dated May 8, 2008 – Biovail Announces New Strategic Focus

Exhibit 99.3            News Release dated May 8, 2008 – Biovail Announces Normal Course Issuer Bid

Exhibit 99.4            News Release dated May 8, 2008 – Biovail Declares Quarterly Dividend

 

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 9, 2008

By:

/s/ Jennifer Tindale

 

 

Jennifer Tindale

 

 

Vice President &

 

 

 

Associate General Counsel

 

i


EX-99.1 2 a08-13797_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 REPORTS FIRST-QUARTER 2008 FINANCIAL RESULTS

 

TORONTO, Canada, May 8, 2008 – Biovail Corporation (NYSE/TSX: BVF) today announced its financial results for the three-month period ended March 31, 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 below.

 

Total revenues for the three months ended March 31, 2008 were $208.5 million, compared with $247.0 million for the first quarter of 2007. First-quarter 2008 net income, in accordance with United States Generally Accepted Accounting Principles (GAAP), was $56.4 million, compared with $93.8 million for the corresponding 2007 period. GAAP diluted earnings per share (EPS) for the first quarter of 2008 were $0.35, versus $0.58 for the first quarter of 2007.

 

GAAP net income and EPS figures for the first quarter of 2008 were negatively impacted by a $3.6-million loss on the impairment of investments primarily related to the Company’s investments in auction-rate securities, a $1.2-million equity loss related to an investment in Western Life Sciences Venture Fund and an accrual of $7.9 million for the estimated contractual obligations to terminate the long-term safety study for BVF-146 (combination of once-daily tramadol with an anti-inflammatory agent). First-quarter 2007 net income and EPS figures were

 

1



 

negatively impacted by a $0.6-million restructuring charge related to the December 2006 restructuring of the Company’s U.S. commercial operations, and a $0.4 million equity loss.

 

Product revenues for the first quarter of 2008 were $196.9 million, compared with $238.0 million in the first quarter of 2007, primarily due to lower revenues from the Company’s generics portfolio, Cardizem® LA and Ultram® ER.

 

Product revenues for Wellbutrin XL® were $58.9 million in the first quarter of 2008, compared with $61.4 million in the first quarter of 2007. Wellbutrin XL® revenues in each of the first quarters of 2007 and 2008 reflected the December 2006 launch of a generic formulation of the 300mg strength of the product. In the first quarter of 2008, the generic formulation captured 88% of the 300mg dosage strength’s total prescription volume. Pursuant to the terms of a comprehensive settlement agreement entered into with a number of generic pharmaceutical companies, a generic version of the 150mg strength of Wellbutrin XL® could be launched commencing the earlier of May 30, 2008 or upon an adverse decision of Biovail’s appeal of the non-infringement summary judgment previously granted to Anchen Pharmaceuticals, Inc.

 

Ultram® ER generated revenues of $24.1 million in the first quarter of 2008, compared with $30.0 million in the first quarter of 2007. Ultram® ER’s performance in the first quarter of 2008 reflects a decrease in inventory levels by Biovail’s marketing partner Ortho-McNeil, Inc. (OMI), which was partially offset by higher prescription volumes and a price increase. In the first quarter of 2008, Ultram® ER captured 5.9% of total prescription volume for the Ultram® brand (including generics).

 

First-quarter 2008 revenues for Biovail’s Zovirax® franchise were $37.1 million, consistent with the level of the prior-year period, reflecting the impact of price increases offset by a 4% decline in prescription demand and a decrease in inventories at the wholesaler level from 1.5 months to 1.2 months. In the first quarter of 2008, Zovirax® Ointment and Zovirax® Cream held a combined 73.9% share of the topical herpes market, an increase of 1.5 percentage points in market share versus first-quarter 2007 levels.

 

Revenues from BPC were $16.2 million in the first quarter of 2008, compared with $13.8 million in the first quarter of 2007, an increase of 17% that reflects the impact of a stronger Canadian dollar and continued growth of Tiazac® XC and Wellbutrin® XL in Canada. Total prescription

 

2



 

volume for Tiazac® XC and Wellbutrin® XL in the first quarter of 2008 increased 34% and 80%, respectively, compared with the corresponding period in 2007.

 

In the first quarter of 2008, Cardizem® LA generated revenues of $10.2 million, compared with $23.9 million for the corresponding period in 2007. This decrease reflects lower prescription volumes and the first-quarter 2007 fulfillment of back orders for the 120mg and 180mg strengths of the product. The amortization of deferred revenues associated with the May 2005 Kos transaction positively impacted Cardizem® LA revenues by $3.8 million in the first quarters of both 2007 and 2008.

 

Legacy products generated revenues of $33.1 million for the first quarter of 2008, compared with $35.6 million in the first quarter of 2007. This performance reflects lower prescription volumes for these mature products and lower pricing on Tiazac® branded and generic products, partially offset by the positive impact of price increases implemented in 2007 and the first quarter of 2008.

 

Product revenue for Biovail’s portfolio of generic products was $17.2 million in the first quarter of 2008, compared with $35.9 million in the first quarter of 2007. This performance reflects lower prescription volumes and a decrease in pricing to remain competitive in the market.

 

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

 

($ 000s)

 

Q1/08 Revenues

 

Q1/07 Revenues

 

Change (%)

 

Wellbutrin XL®

 

58,856

 

61,405

 

(4

)

Ultram® ER

 

24,104

 

30,019

 

(20

)

Zovirax®

 

37,130

 

37,283

 

(—

)

Biovail Pharmaceuticals Canada

 

16,240

 

13,826

 

17

 

Cardizem® LA

 

10,207

 

23,949

 

(57

)

Legacy

 

33,147

 

35,640

 

(7

)

Generics

 

17,230

 

35,880

 

(52

)

Total Product Revenues

 

196,914

 

238,002

 

(17

)

 

Research-and-development revenue was $7.4 million in the first quarter of 2008, compared with $4.8 million in the corresponding period in 2007, an increase of 52% that reflects the higher volume of clinical research and laboratory testing services provided to external customers by Biovail’s Contract Research Division (CRD).

 

3



 

Royalty and other revenue was $4.2 million in the first quarter of 2008, which is consistent with the level of the first quarter of 2007.

 

Cost of goods sold for the first quarter of 2008 was $53.7 million, compared with $56.4 million in the first quarter of 2007. Gross margins on product revenues were 73% in the first quarter of 2008, compared with 76% in the first quarter of 2007, reflecting higher unabsorbed overhead costs as a result of lower production volumes, lower pricing for the Company’s portfolio of generic pharmaceuticals, an increase in amortization expense associated with the Zovirax® supply-price agreement with GlaxoSmithKline plc (GSK) and higher costs associated with Biovail’s one-third share of the costs associated with GSK’s license agreement with Watson Pharmaceuticals, Inc. related to Wellbutrin XL® 150mg. These items were partially offset by price increases across other product lines.

 

Total research-and-development (R&D) expenditures for the first quarter of 2008 were $36.3 million, compared with $29.7 million for the first quarter of 2007. Excluding expenses associated with CRD, R&D expenses were $30.2 million in the first quarter of 2008, compared with $25.9 million in the first quarter of 2007. This 17% year-over-year increase reflects an accrual of $7.9 million for the estimated contractual obligations to terminate the long-term safety study for BVF-146.

 

Selling, general and administrative (SG&A) expenses for the first quarter of 2008 were $43.6 million, compared with $49.6 million in the first quarter of 2007, a decrease of 12% that reflects lower legal costs and lower stock-based compensation expense; partially offset by higher payments to Sciele Pharma, Inc. related to their promotional efforts for Zovirax® and an increase in promotional expenses, primarily related to the launch of Ralivia™ in Canada. Legal expenses related to legacy litigation and regulatory matters arising from issues in 2001 to May 2004 were $3.2 million in the first quarter of 2008, compared with $9.5 million in the prior-year period. SG&A expenses in the second quarter of 2008 will include approximately $5.0 million in expenses related to management succession planning.

 

Amortization expense in the first quarter of 2008 was $11.7 million, compared with $12.0 million in the first quarter of 2007, a decrease of 2% that reflects the write-down of certain intangible assets in December 2007.

 

4



 

Balance Sheet & Cash Flow

 

At the end of the first quarter of 2008, Biovail had cash, cash equivalents and short-term investments of $511.3 million, and marketable securities of $25.3 million. 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 in either or both of the fourth quarter of 2007 and the first quarter of 2008. 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 $14.8 million as at March 31, 2008 and has recorded a further impairment charge of $2.9 million in the first quarter of 2008 (a charge of $6.0 million was recorded in the fourth quarter of 2007). In addition, the Company recorded an unrealized loss in other comprehensive income of $0.3 million in the first quarter of 2008 and $2.8 million in the fourth quarter of 2007.

 

Cash flow from operations was $92.7 million in the first quarter of 2008, compared with $119.8 million in the first quarter of 2007, which reflects lower net income in 2008. Net capital expenditures in the first quarter of 2008 amounted to $9.7 million, compared with $5.7 million in the prior-year period.

 

Conference Call

 

Biovail management will host a conference call and Webcast on Thursday, May 8, 2008, at 8:30 a.m. EDT for Company executives to discuss 2008 first-quarter financial results and the Company’s new strategic plan. For further information on the new strategic plan, see separate news release issued May 8, 2008 – Biovail Announces New Strategic Focus. 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 416-641-6136 (Toronto and International callers) and 1-866-225-9256 (U.S. and Canada). Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays.

 

A replay of the conference call will be available until 7 p.m. EDT on Thursday, May 15, 2008, by dialing 416-695-5800 (Toronto and International callers) and 1-800-408-3053 (U.S. and Canada), using access code, 3259219#.

 

5



 

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, outlook and guidance, including, without limitation, statements concerning the Company’s objectives, goals, strategies, beliefs, intentions, plans, estimates and outlook, including, without limitation, the timing of the launch of a generic version of the 150mg strength of Wellbutrin XL®,, and can generally be identified by the use of words such as “guidance”, “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, 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, Canadian Therapeutic Products Directorate and European regulatory 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, infringement and alleged infringement of our intellectual property rights and those of others, the regulatory environment, tax rate assumptions, the outcome of legal proceedings and settlements thereto, the anticipated proxy contest in connection with the election of the Board of Directors at the Company’s upcoming annual meeting of shareholders,  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 Ontario Securities Commission, 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.

 

6



 

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 utilizing advanced drug-delivery technologies. 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

 

7



 

BIOVAIL CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

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

(Unaudited)

 

 

 

Three Months Ended
March 31

 

 

 

2008

 

2007

 

REVENUE

 

 

 

 

 

Product sales

 

$

196,914

 

$

238,002

 

Research and development

 

7,353

 

4,841

 

Royalty and other

 

4,231

 

4,162

 

 

 

208,498

 

247,005

 

EXPENSES

 

 

 

 

 

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

 

53,735

 

56,416

 

Research and development

 

36,332

 

29,722

 

Selling, general and administrative

 

43,597

 

49,594

 

Amortization

 

11,694

 

11,981

 

Restructuring costs

 

 

645

 

 

 

145,358

 

148,358

 

Operating income

 

63,140

 

98,647

 

Interest income

 

3,468

 

9,761

 

Interest expense

 

(242

)

(8,677

)

Foreign exchange gain (loss)

 

221

 

(288

)

Equity loss

 

(1,195

)

(424

)

Loss on impairment of investments

 

(3,616

)

 

Income before provision for income taxes

 

61,776

 

99,019

 

Provision for income taxes

 

5,400

 

5,200

 

Net income

 

$

56,376

 

$

93,819

 

 

 

 

 

 

 

Basic and diluted earnings per share

 

$

0.35

 

$

0.58

 

 

 

 

 

 

 

Basic and diluted weighted average number of common shares outstanding (000s)

 

161,024

 

160,458

 

 

 

 

 

 

 

Cash dividends declared per share

 

$

0.375

 

$

0.375

 

 

8



 

BIOVAIL CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

 

 

 

At
March 31
2008

 

At
December 31
2007

 

ASSETS

 

 

 

 

 

Cash and cash equivalents

 

$

431,537

 

$

433,641

 

Short-term investments

 

79,725

 

 

Other current assets

 

223,954

 

273,376

 

 

 

735,216

 

707,017

 

Marketable securities

 

23,758

 

24,417

 

Long-term investments

 

23,637

 

24,834

 

Property, plant and equipment, net

 

233,799

 

238,457

 

Intangible assets, net

 

616,526

 

630,514

 

Goodwill

 

100,294

 

100,294

 

Deferred tax assets, net of valuation allowance

 

18,000

 

20,700

 

Other long-term assets, net

 

38,506

 

35,882

 

 

 

$

1,789,736

 

$

1,782,115

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

$

390,225

 

$

367,578

 

Long-term liabilities

 

108,887

 

116,718

 

Shareholders’ equity

 

1,290,624

 

1,297,819

 

 

 

$

1,789,736

 

$

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
March 31

 

 

 

2008

 

2007

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

Net income

 

$

56,376

 

$

93,819

 

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

 

 

 

 

 

Depreciation and amortization

 

25,073

 

21,885

 

Amortization of deferred financing costs

 

130

 

531

 

Amortization of discounts on long-term obligations

 

 

201

 

Accrued legal settlements

 

(10,000

)

 

Impairment charges

 

3,616

 

 

Stock-based compensation

 

1,429

 

4,226

 

Equity loss

 

1,195

 

424

 

Other

 

568

 

696

 

Changes in operating assets and liabilities

 

14,289

 

(1,954

)

Net cash provided by operating activities

 

92,676

 

119,828

 

Net cash used in investing activities

 

(94,279

)

(5,730

)

Net cash used in financing activities

 

(138

)

(78,494

)

Effect of exchange rate changes on cash and cash equivalents

 

(363

)

31

 

Net increase (decrease) in cash and cash equivalents

 

(2,104

)

35,635

 

Cash and cash equivalents, beginning of period

 

433,641

 

834,540

 

Cash and cash equivalents, end of period

 

$

431,537

 

$

870,175

 

 

9


EX-99.2 3 a08-13797_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 ANNOUNCES NEW STRATEGIC FOCUS

 

Focus on High-Growth Central Nervous System Disorder Specialty Markets;

Board of Directors Confirms Annual Dividend Policy of $1.50 per Share;

Board of Directors Approves Filing of Normal Course

Issuer Bid For up to 14 Million Shares;

Company to Close Puerto Rico Operations, Reduce R&D Overhead Costs;

Targets Investment in R&D of Over $600 Million Through 2012;

Targets Cash From Non-Core Asset Sales of Over $100 Million;

Five New Director Nominees Approved by Board of Directors

 

TORONTO, Canada, May 8, 2008 – Biovail Corporation (NYSE/TSX: BVF) today announced several new initiatives stemming from its strategic review, including a new strategic focus on developing specialty products targeted towards central nervous system (CNS) disorders intended to drive sustainable growth. The Company also announced Board approval for the filing of a Normal Course Issuer Bid for up to 14 million shares and the addition of five new nominees to the Company’s proposed slate of Directors for the upcoming annual meeting of shareholders.

 

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 below.

 

1



 

“After an extensive review of all aspects of Biovail’s business and of the strategic options available to the Company, Biovail’s Board of Directors has considered and approved a new strategic focus that we believe will create significant value for shareholders,” said Biovail Chief Executive Officer Bill Wells. “We will leverage Biovail’s existing core capabilities in drug delivery and formulation for the therapeutic area of CNS disorders – a large market where unmet medical needs and growth potential are high. We intend to invest over $600 million in research-and-development through 2012, exploring niche in-licensed and acquired late-stage new chemical entities (NCEs), new indications and in-house reformulation opportunities. We intend to optimize operating efficiencies across all functional areas of the Company, and will return capital in excess of our business needs through ongoing dividend payments to shareholders and stock buyback programs.”

 

As disclosed in March 2008, an Independent Committee of the Company’s Board of Directors was established to consider a number of strategic alternatives to increase shareholder value. Under the direction of the Independent Committee, management also explored operational strategies that would allow the Company to create sustainable growth, more effectively capitalize on its core capabilities and continue to return capital to shareholders. The result of these activities formed the basis for the Company’s new strategic focus.

 

The key features of Biovail’s new strategic focus will be presented in detail in its Proxy Circular, which will be mailed to all shareholders shortly, and made available on the Company’s website. Highlights of the new strategic focus include the following:

 

·                  By focusing its pipeline-development and business-development efforts on niche CNS disorders, Biovail believes it can build upon its expertise within the category and, where appropriate, reach key prescribing physicians with a small in-house sales organization. The Company believes CNS disorders represent a $70 billion global market, with growth expected in the low-to-mid double digits in niche specialty CNS markets, such as Parkinson’s disease and multiple sclerosis.

 

·                  The Company will take steps to rationalize its (i) manufacturing operations, (ii) pharmaceutical sciences operations, and (iii) general and administrative expenses.

 

·                  The Company is committed to exercising financial discipline in its capital allocation strategies and in distributing capital to shareholders through ongoing dividend payments and, when appropriate, buying back stock.

 

2



 

Operating Efficiency Initiatives

 

To improve operating efficiencies, Biovail is taking steps to close the Company’s two Puerto Rico manufacturing facilities and transfer certain manufacturing processes to its Steinbach, Manitoba facility. Biovail believes these closures, which are expected to take 18 to 24 months to complete, should not result in any supply disruptions, and are intended to reduce the Company’s cost infrastructure and increase available capital.

 

In other functional areas, Biovail intends to enhance efficiencies in its research-and-development group, while continuing to invest heavily in the Company’s product-development pipeline which will be focused on high-growth niche CNS markets. Biovail intends to invest over $600 million in research and development through 2012.

 

Financial Impact

 

Biovail believes that the implementation of its new strategic focus, including the closure of its manufacturing facilities in Puerto Rico and the implementation of other operating-efficiency initiatives described above will result in charges of approximately $80 million to $100 million, which will be recognized in the coming quarters. Of these amounts, it is expected that the cash component will be in the range of $30 million to $40 million.

 

Biovail anticipates that these efficiency initiatives, once fully implemented, will result in annual savings of $30 million to $40 million.

 

Other Initiatives

 

Biovail will continue its ongoing efforts to resolve various legal, regulatory and criminal matters arising from allegations of conduct in the period from 2001 to May 2004. Resolution of these matters will materially reduce associated expenses and increase available capital. To date, Biovail has incurred cumulative legal expenses and penalties of over $230 million (approximately $150 million net of insurance recoveries) relating to these legacy matters.

 

The Company is also exploring the divestiture and/or monetization of certain non-core assets, which the Company believes could result in cash proceeds in excess of $100 million.

 

The Company intends to utilize capital generated from these initiatives to support: 1) the transition to the new strategic focus, 2) R&D investments, 3) focused business development activities and 4) the return of capital to shareholders.

 

3



 

Normal Course Issuer Bid

 

Biovail today announced its intention to file a normal course issuer bid with Canadian securities regulators, pursuant to which the Company may repurchase, subject to regulatory approval, up to 14 million of its common shares during a one-year period. Any common shares purchased by the Company under the issuer bid will be cancelled. Biovail intends to begin purchasing its common shares following receipt of regulatory approval. For further information, see the separate news release issued May 8, 2008, Biovail Announces Normal Course Issuer Bid.

 

New Board Nominees

 

Biovail also announced today that five new independent candidates have agreed to be included in the Company’s proposed slate of Directors for consideration at its annual meeting of shareholders, which is scheduled for June 25, 2008 at 10:00am EDT at The Suites at King West in Toronto, Canada. The nominees are listed in the table below:

 

Name

 

Experience

Serge Gouin

 

Chairman of Quebecor Media Inc.

David H. Laidley

 

Retired partner and former Chairman of Deloitte & Touche LLP

J. Spencer Lanthier

 

Retired partner and former Chairman and Chief Executive of KPMG Canada

Mark Parrish

 

Former CEO of Healthcare Supply Chain Services, (Cardinal Health, Inc.)

Robert N. Power

 

Former Executive Vice-President of Global Business Operations of Wyeth

 

Additional information on these nominees will be provided in the Company’s Proxy Circular which will be mailed to shareholders shortly.

 

Conference Call

 

Biovail management will host a conference call and Webcast on Thursday, May 8, 2008, at 8:30 a.m. EDT for Company executives to discuss the Company’s new strategic plan and 2008 first-quarter financial 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 416-641-6136 (Toronto and International callers) and 1-866-225-9256 (U.S. and Canada). Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays.

 

4



 

A replay of the conference call will be available until 7 p.m. EDT on Thursday, May 15, 2008, by dialing 416-695-5800 (Toronto and International callers) and 1-800-408-3053 (U.S. and Canada), using access code, 3259219#.

 

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, outlook and guidance, including, without limitation, statements concerning the Company’s expectations regarding operations through 2012, proceeds from the sale of non-core assets, savings from the closure of the Company’s Puerto Rico operations and other efficiency initiatives, research-and-development expenses through 2012, intentions to optimize operating efficiencies across all functional areas of the Company, intentions to return capital in excess of business needs to shareholders, and can generally be identified by the use of words such as “targets”, “guidance”, “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, 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: availability of capital and satisfaction of applicable laws for dividend payments, the difficulty of predicting U.S. Food and Drug Administration, Canadian Therapeutic Products Directorate and European regulatory 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, infringement and alleged infringement of our intellectual property rights and those of others, the regulatory environment, tax rate assumptions, the outcome of legal proceedings and settlements thereto, fluctuations in operating results and other risks

 

5



 

detailed from time to time in the Company’s filings with the Securities and Exchange Commission and the Ontario Securities Commission, 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.

 

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 utilizing advanced drug-delivery technologies. 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

 

6


EX-99.3 4 a08-13797_2ex99d3.htm EX-99.3

Exhibit 99.3

 

 

CONTACT: Nelson F. Isabel

Vice-President, Investor Relations

& Corporate Communications

(905) 286-3000

 

BIOVAIL ANNOUNCES NORMAL COURSE ISSUER BID

 

TORONTO, Canada, May 8, 2008 – Biovail Corporation (NYSE, TSX: BVF) today announced that its Board of Directors has authorized a share repurchase program of up to 14,000,000 common shares, representing up to approximately 10% of its public float. As of the date hereof, Biovail has 161,023,729 common shares issued and outstanding. Biovail intends to begin purchasing its common shares by means of a normal course issuer bid (NCIB) on the open market, through the facilities of the Toronto Stock Exchange (TSX) and the New York Stock Exchange, in accordance with their rules and guidelines, subject to receipt of regulatory approval. Biovail intends to file a notice of intention with the TSX and Ontario Securities Commission regarding the proposed share repurchase program in the near future. The NCIB will terminate not more than one year after the commencement of the bid, or upon such time as Biovail completes its purchases.

 

The Board also reconfirmed that, at this time, it does not intend to change its dividend policy, which currently contemplates the payment of an annual dividend of $1.50 per common share, paid in quarterly increments of $0.375 per share.

 

Under the proposed share repurchase program approved by the Board of Directors, Biovail may repurchase shares for cash on the open market from time to time, if it is considered advisable, and the specific timing and amount of share repurchases will vary based on market conditions, regulatory requirements and other factors. The share repurchases will be funded using Biovail’s existing cash resources. The program does not require Biovail to repurchase a minimum number of shares, and it may be modified, suspended or terminated at any time without prior notice. All common shares purchased by

 



 

Biovail under this program will be cancelled. Biovail’s Board of Directors believes that the proposed purchases are in the best interests of the Company and are a desirable use of corporate funds.

 

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, outlook and guidance, including, without limitation, statements concerning the Company’s intentions to commence a normal course issuer bid and repurchase its common shares and the Company’s intentions regarding its dividend policy, and can generally be identified by the use of words such as “targets”, “guidance”, “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, 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: availability of capital and satisfaction of applicable laws for dividend payments, market liquidity of our common shares and our satisfaction of applicable laws for the acquisition of our common shares, the difficulty of predicting U.S. Food and Drug Administration, Canadian Therapeutic Products Directorate and European regulatory 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, infringement and alleged infringement of our intellectual property rights and those of others, the regulatory environment, tax rate assumptions, the outcome of legal proceedings and settlements thereto, 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 Ontario Securities Commission, 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.

 

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 utilizing advanced drug-delivery technologies. For more information about us, visit our website at www.biovail.com.

 

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

 


EX-99.4 5 a08-13797_2ex99d4.htm EX-99.4

Exhibit 99.4

 

 

CONTACT: Nelson F. Isabel

Vice-President, Investor Relations

& Corporate Communications

 (905) 286-3000

 

For Immediate Release:

 

BIOVAIL DECLARES QUARTERLY DIVIDEND

 

TORONTO, Canada, May 8, 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 May 30, 2008, to shareholders of record at the close of business May 22, 2008.

 

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 utilizing advanced drug-delivery technologies. 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

 


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