Download FORM 6-K - Morningstar Document Research

Form 6-K
Valeant Pharmaceuticals International, Inc. - N/A
Filed: May 26, 2009 (period: May 16, 2009)
Report of foreign issuer rules 13a-16 and 15d-16 of the Securities Exchange Act
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user
assumes all risks for any damages or losses arising from any use of this information, except to the extent such damages or losses cannot be
limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Table of Contents
6-K - 6-K
SIGNATURES
EX-99.1 (EX-99.1)
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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 26, 2009
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
Form 40-F
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
No
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
No
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
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
No
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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
Material Change Report dated May 26, 2009
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 26, 2009
By:
/ s / Jennifer Tindale
Jennifer Tindale
Vice President &
Associate General Counsel
i
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Exhibit 99.1
MATERIAL CHANGE REPORT
FORM 51-102F3
ITEM 1
NAME AND ADDRESS OF COMPANY
Biovail Corporation
7150 Mississauga Road
Mississauga, Ontario L5N 8M5
ITEM 2
DATE OF MATERIAL CHANGE
May 16, 2009
ITEM 3
NEWS RELEASE
The news release attached hereto as Exhibit “A” was issued by Biovail Corporation (“Biovail” or the “Company”) on
May 18, 2009. The news release was distributed in Canada and the United States through Business Wire and was
filed with the Toronto Stock Exchange and with each of the Canadian provincial securities regulatory authorities via
the System for Electronic Document Analysis and Retrieval (“SEDAR”). The release has been filed as part of the
Company’s Form 6-K via the Electronic Data Gathering Analysis and Retrieval system (“EDGAR”) with the U.S.
Securities and Exchange Commission (“SEC”) and the New York Stock Exchange. A copy of the press release was
posted to the Company’s website at www.biovail.com.
ITEM 4
SUMMARY OF MATERIAL CHANGE
On May 18, 2009, Biovail announced that its wholly owned subsidiary, Biovail Laboratories International (Barbados)
SRL, had entered into an agreement to acquire the worldwide development and commercialization rights to the entire
portfolio of tetrabenazine products held by Cambridge Laboratories (Ireland) Limited and its affiliates, for a total
purchase price of US$230 million.
ITEM 5
FULL DESCRIPTION OF MATERIAL CHANGE
On May 18, 2009, Biovail announced that its wholly owned subsidiary, Biovail Laboratories International (Barbados)
SRL, had entered into a definitive agreement, dated May 16, 2009, to acquire the worldwide development and
commercialization rights to the entire portfolio of tetrabenazine, including Xenazine ® /Nitoman ® (tetrabenazine
tablets), and the associated intellectual property rights held by Cambridge Laboratories (Ireland) Limited and its
affiliates (collectively, “Cambridge”). The transaction is anticipated to close within 90 days, subject to customary
closing conditions.
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Under the terms of the agreement, Biovail will make a payment of $200 million upon closing of the transaction and
will pay an additional $30 million in two tranches over the subsequent 24 months to acquire these worldwide
development, manufacturing, and commercialization rights to the tetrabenazine product portfolio, including a
controlled-release formulation of tetrabenazine in development for Tourette Syndrome (BVF-018), as well as a
tetrabenazine-derived new chemical entity (NCE), RUS350 — a next-generation molecule that may enter Phase 2
clinical development in the next 12 months. In addition, Biovail will obtain a broad range of intellectual property for
the product portfolio, including issued and pending patents.
In November 2008, Xenazine was launched in the United States, where it has orphan drug status through
August 2015 for the treatment of chorea associated with Huntington’s disease. In Canada, Nitoman has been
available since 1996 and is indicated for a number of hyperkinetic movement disorders, including Huntington’s
chorea, Tourette Syndrome and tardive dyskinesia. Tetrabenazine is marketed through distribution agreements in a
number of other countries, including Australia, Denmark, France, Germany, Ireland, Israel, Italy, New Zealand,
Portugal, Spain, Switzerland and the United Kingdom, with license applications pending in several European
territories. Biovail anticipates seeking marketing approval in countries where treatment for chorea associated with
Huntington’s disease will be commercially viable.
Upon closing of the transaction, Biovail will earn revenue from the worldwide sales that have been established
through Cambridge’s network of marketing partners in approved territories. In addition, tetrabenazine tablets are
marketed in Canada under the Nitoman brand name by the Biovail Pharmaceuticals Canada sales force. In the
United States, Biovail supplies Xenazine tablets to its commercialization partner for a variable percentage of the
product’s annual net sales. For net sales up to $125 million, Biovail’s supply price is 72% of net sales and, beyond
$125 million, Biovail’s supply price is 65% of net sales. This transaction will enable Biovail to capture the gross
margin earned by Cambridge on its supply of product for the US and Canadian markets. Biovail will assume a
royalty obligation to a third party.
The transaction is immediately accretive to revenues and margins, and is expected to provide minimal operating
cash flows in 2009 and in the range of $23 million to $26 million in 2010.
ITEM 6
RELIANCE ON SUBSECTION 7.1(2) OF NATIONAL INSTRUMENT 51-102
N/A
ITEM 7
OMITTED INFORMATION
N/A
ITEM 8
EXECUTIVE OFFICER
For further information, contact Nelson F. Isabel at 905-286-3250.
ITEM 9
DATE OF REPORT
May 26, 2009
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
EXHIBIT “A”
NEWS RELEASE
CONTACT: Nelson F. Isabel
Vice-President, Investor Relations
& Corporate Communications
(905) 286-3000
For Immediate Release:
BIOVAIL ANNOUNCES ACQUISITION OF
WORLDWIDE RIGHTS TO TETRABENAZINE
Transaction Directly Aligned with Specialty CNS Strategy;
Immediately Accretive To Revenues, Margins & Cash Flows
TORONTO, Canada, May 18, 2009 — Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced a wholly owned subsidiary
has entered into a definitive agreement to acquire worldwide development and commercialization rights to the entire portfolio of
tetrabenazine products, including Xenazine ® /Nitoman ® (tetrabenazine tablets), and the associated intellectual property rights held
by Cambridge Laboratories (Ireland) Ltd and its affiliates. The transaction is anticipated to close within 90 days, subject to customary
closing conditions. In November 2008, Xenazine was launched in the United States, where it has orphan drug status through
August 2015 for the treatment of chorea associated with Huntington’s disease. In Canada, Nitoman has been available since 1996 and
is indicated for a number of hyperkinetic movement disorders, including Huntington’s chorea, Tourette Syndrome and tardive
dyskinesia. Tetrabenazine is marketed through distribution agreements in a number of countries, including Australia, Denmark,
France, Germany, Ireland, Israel, Italy, New Zealand, Portugal, Spain, Switzerland and the United Kingdom, with license applications
pending in several European territories.
“This acquisition will be immediately accretive to revenues, margins and operating cash flows, and is anticipated to be moderately
accretive to GAAP earnings per share in 2010. The transaction represents another solid step in our transformation to a leading
specialty CNS company,” said Bill Wells, Chief Executive Officer of Biovail. “Xenazine is showing strong
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
commercial success in the U.S. in treating chorea associated with Huntington’s disease. By acquiring these worldwide rights, we
believe we will be able to maximize the value of this asset in the near term for shareholders. In addition, the acquisition further
expands our specialty CNS pipeline, which bolsters our long-term revenue growth outlook.”
Under the terms of the agreement, Biovail will make a payment of $200 million upon closing of the transaction and will pay an
additional $30 million in two tranches over the subsequent 24 months to acquire these worldwide development, manufacturing, and
commercialization rights to the tetrabenazine product portfolio. This includes a controlled-release formulation of tetrabenazine in
development for Tourette Syndrome (BVF-018), as well as a tetrabenazine-derived new chemical entity (NCE), RUS350 — a
next-generation molecule that may enter Phase 2 clinical development in the next 12 months.
In addition, Biovail will obtain a broad range of intellectual property for the product portfolio, including issued and pending patents.
The agreement enables Biovail to capture the gross margin earned by Cambridge on its supply of product for the US and Canadian
markets. Biovail will assume a royalty obligation to a third party.
Tetrabenazine tablets in Canada are marketed under the Nitoman brand name by the Biovail Pharmaceuticals Canada sales force. In
the United States, Biovail supplies Xenazine tablets to its commercialization partner for a variable percentage of the product’s annual
net sales. For net sales up to $125 million, Biovail’s supply price is 72% of net sales. Beyond $125 million, Biovail’s supply price is
65% of net sales. Upon closing of the transaction, Biovail will earn revenue from the worldwide sales that have been established
through Cambridge’s network of marketing partners in approved territories. Biovail anticipates seeking marketing approval in
countries where treatment for chorea associated with Huntington’s disease will be commercially viable.
The transaction is immediately accretive to revenues and margins, and is expected to provide minimal operating cash flows in 2009
and in the range of $23 million to $26 million in 2010.
About Xenazine/Nitoman (tetrabenazine)
Tetrabenazine is a highly selective and reversible centrally-acting dopamine depleting drug that works by inhibiting a molecule known
as vesicular monoamine transporter 2 (VMAT2).
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Xenazine was approved by the FDA on August 15, 2008, for the treatment of chorea associated with Huntington’s disease, based on
the results of a double-blind, placebo-controlled, Phase 3 study that found Xenazine significantly reduced patients’ chorea burden,
improved global outcome scores, and was generally safe and well tolerated. Additional post-marketing preclinical studies further
elucidating the safety profile of the product are being conducted. Tetrabenazine has been available in Europe for more than 30 years
and in Canada since 1996. Full prescribing information is available on the Investor Relations page of Biovail’s website at
www.biovail.com.
About Huntington’s Disease
Affecting an estimated 25,000 Americans, Huntington’s disease is a devastating neurodegenerative disease that causes progressive
movement disorders, cognitive dysfunction and behavioral changes and is ultimately a fatal condition. Chorea is the most common
symptom, affecting approximately 90% of Huntington’s disease patients, and is characterized by excessive, involuntary and repetitive
movements, which are the most visible and dangerous manifestations of Huntington’s disease and interfere with patients’ abilities to
perform activities of daily living, including dressing, bathing and caring for themselves. For more information about Huntington’s
disease, please visit http://www.hdfoundation.org or http://www.hdsa.org.
Important Safety Information
The most frequent adverse events reported with Xenazine include sedation/somnolence, fatigue, insomnia, depression, akathisia and
nausea. Xenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s
disease and the drug is therefore contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately
treated depression. Xenazine is also contraindicated in patients with impaired hepatic function and in patients taking monoamine
oxidase inhibitors or reserpine. Xenazine was approved with a required Risk Evaluation and Mitigation Strategy (REMS) to ensure
that the benefits of the drug outweigh its risks, particularly the risks of depression and suicidal thoughts and actions. REMS is a
strategy to manage a known or potential serious risk associated with a drug or biological product.
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,
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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 terms of the transaction, including the
terms for such supply and promotion, anticipated clinical development and the anticipated impact of the transaction on our revenues,
margins, earnings per share and cash flows, 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, 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 satisfaction of certain closing conditions by the parties to the transaction, acceptance and demand for pharmaceutical products, the
impact of competitive products and pricing, uncertainties associated with the development, launch and commercialization of new
products, reliance on key strategic alliances, contractual disagreements with third parties, availability of raw materials and finished
products, the difficulty of predicting the impact of post-marketing studies on U.S. Food and Drug Administration approvals, the
regulatory environment generally, 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.
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
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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 [email protected].
Source: Valeant Pharmaceuticals International, Inc., 6-K, May 26, 2009
Powered by Morningstar Document Research.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.