PARSIPPANY, N.J. and
DUBLIN, Sept. 27, 2013 /PRNewswire/ -- Actavis, Inc.
(NYSE: ACT) and Warner Chilcott plc
(NASDAQ: WCRX) today announced that the U.S. Federal Trade
Commission (FTC) has voted to approve Actavis' proposed acquisition
of Warner Chilcott. The vote
in support of the transaction follows Actavis' agreement to a
proposed consent order, pursuant to which Actavis has agreed to
divest certain products as a condition to obtaining FTC
approval. The closing of the transaction remains subject to
approval by the Irish High Court and other customary closing
conditions, and is expected to occur as soon as practicable after
satisfaction of those conditions.
Under the terms of the consent order with the FTC and subject to
the consummation of the transaction between Actavis and
Warner Chilcott, Actavis will divest
four products to Amneal Pharmaceuticals. Terms of the
divestitures were not disclosed. The divested products
are:
- Actavis' Zenchent Fe™ (norethindrone acetate/ethinyl
estradiol), a generic version of Femcon Fe™
- Actavis' pending application for norethindrone acetate/ethinyl
estradiol, a generic version of Lo Loestrin® Fe. This product
application remains subject to pending patent litigation pursuant
to the provisions of the Hatch Waxman Act
- Actavis' pending application for risedronate sodium, a generic
version of Atelvia®. This product application remains subject to
pending patent litigation pursuant to the provisions of the Hatch
Waxman Act
- Actavis' approved application for norethindrone acetate/ethinyl
estradiol, a generic version of Loestrin® 24 Fe. This
product is the subject of a settlement agreement that resolved
patent litigation, pursuant to which the product may be launched in
January 2014.
About Actavis
Actavis, Inc. (NYSE: ACT) is a global, integrated specialty
pharmaceutical company focused on developing, manufacturing and
distributing generic, brand and biosimilar products. Actavis
has global headquarters in Parsippany,
New Jersey, USA.
Operating as Actavis Pharma, Actavis markets generic, branded
generic, legacy brands and Over-the-Counter (OTC) products in more
than 60 countries. Actavis Specialty Brands is Actavis'
global branded specialty pharmaceutical business focused in the
Women's Health and Urology therapeutic categories. Actavis
Specialty Brands also has a portfolio of five biosimilar products
in development in Women's Health and Oncology. Actavis Global
Operations has more than 30 manufacturing and distribution
facilities around the world, and includes Anda, Inc., a U.S.
pharmaceutical product distributor.
For press release and other company information, visit Actavis'
Web site at http://www.actavis.com.
About Warner Chilcott
Warner Chilcott is a leading
specialty pharmaceutical company currently focused on the women's
healthcare, gastroenterology, urology and dermatology segments of
the branded pharmaceuticals market, primarily in North America. Warner
Chilcott is a fully integrated company with internal
resources dedicated to the development, manufacture and promotion
of its products.
Actavis Cautionary Statement Regarding Forward-Looking
Statements
Statements contained in this press release that refer to
non-historical facts are forward-looking statements that reflect
Actavis' current perspective of existing information as of the date
of this release. It is important to note that Actavis' goals
and expectations are not predictions of actual performance. Actual
results may differ materially from Actavis' current expectations
depending upon a number of factors, risks and uncertainties
affecting Actavis' business. These factors include, among others,
the inherent uncertainty associated with financial projections;
restructuring in connection with, and successful close of, Actavis'
acquisition of Warner Chilcott (the
"Acquisition"); subsequent integration of the Acquisition and the
ability to recognize the anticipated synergies and benefits of the
Acquisition; the receipt of required regulatory approvals for the
Acquisition (including the approval of antitrust authorities
necessary to complete the Acquisition); the difficulty of
predicting the timing and outcome of the pending patent litigation
concerning certain of the products to be divested pursuant to
Actavis' agreement with the U.S. Federal Trade Commission; the
anticipated size of the markets and continued demand for Actavis'
and Warner Chilcott's products; the
impact of competitive products and pricing; access to available
financing (including financing for the Acquisition or refinancing
of Actavis or Warner Chilcott debt)
on a timely basis and on reasonable terms; maintaining a position
in the Standard & Poor's 500; the risks of fluctuations in
foreign currency exchange rates; the risks and uncertainties
normally incident to the pharmaceutical industry, including product
liability claims and the availability of product liability
insurance on reasonable terms; the difficulty of predicting the
timing or outcome of pending or future litigation or government
investigations; periodic dependence on a small number of products
for a material source of net revenue or income; variability of
trade buying patterns; changes in generally accepted accounting
principles; risks that the carrying values of assets may be
negatively impacted by future events and circumstances; the timing
and success of product launches; the difficulty of predicting the
timing or outcome of product development efforts and regulatory
agency approvals or actions, if any; costs and efforts to defend or
enforce intellectual property rights; difficulties or delays in
manufacturing; the availability and pricing of third party sourced
products and materials; successful compliance with governmental
regulations applicable to Actavis' and Warner Chilcott's manufacturers, facilities,
products and/or businesses; changes in the laws and regulations
affecting, among other things, pricing and reimbursement of
pharmaceutical products; changes in tax laws or interpretations
that could increase Actavis' consolidated tax liabilities; the loss
of key senior management or scientific staff; and such other risks
and uncertainties detailed in Actavis' periodic public filings with
the SEC including but not limited to Actavis' Quarterly Reports on
Form 10-Q for the quarters ended March 31,
2013 and June 30, 2013 and
Actavis' Annual Report on Form 10-K for the year ended December 31, 2012 (as revised pursuant to
Actavis' Current Report on Form 8-K dated as of June 17, 2013, which was filed with the SEC on
June 18, 2013), as well as the Form
S-4. Except as expressly required by law, Actavis disclaims
any intent or obligation to update these forward-looking
statements.
Warner Chilcott Cautionary Statement Regarding
Forward-Looking Statements
This press release contains forward-looking statements,
including statements concerning the proposed transaction with
Actavis, Warner Chilcott's industry,
Warner Chilcott's operations,
Warner Chilcott's anticipated
financial performance and financial condition and Warner Chilcott's business plans, growth
strategy and product development efforts. These statements
constitute forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. The words "may," "might," "will," "should,"
"estimate," "project," "plan," "anticipate," "expect," "intend,"
"outlook," "believe" and other similar expressions are intended to
identify forward-looking statements. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of their dates. These forward-looking statements are
based on estimates and assumptions by Warner Chilcott's management that, although
Warner Chilcott believes to be
reasonable, are inherently uncertain and subject to a number of
risks and uncertainties. The following represent some, but not
necessarily all, of the factors that could cause actual results to
differ from historical results or those anticipated or predicted by
Warner Chilcott's forward-looking
statements: the timing to consummate the proposed transaction with
Actavis; the risk that a condition to closing of the proposed
transaction with Actavis may not be satisfied; the risk that a
regulatory approval that may be required for the proposed
transaction with Actavis is delayed, is not obtained or is obtained
subject to conditions that are not anticipated; New Actavis'
ability to achieve the synergies and value creation contemplated by
the proposed acquisition; New Actavis' ability to promptly and
effectively integrate Actavis' and Warner
Chilcott's businesses; the diversion of management time on
transaction-related issues; Warner
Chilcott's substantial indebtedness, including increases in
the LIBOR rates on its variable-rate indebtedness above the
applicable floor amounts; competitive factors and market conditions
in the industry in which Warner
Chilcott operates, including the approval and introduction
of generic or branded products that compete with its products;
Warner Chilcott's ability to protect
its intellectual property; a delay in qualifying any of
Warner Chilcott's manufacturing
facilities that produce its products, production or regulatory
problems with either its own manufacturing facilities or those of
third party manufacturers, packagers or API suppliers upon whom
Warner Chilcott may rely for some of
its products or other disruptions within Warner Chilcott's supply chain; pricing
pressures from reimbursement policies of private managed care
organizations and other third party payors, government sponsored
health systems and regulatory reforms, and the continued
consolidation of the distribution network through which
Warner Chilcott sells its products;
changes in tax laws or interpretations that could increase
Warner Chilcott's consolidated tax
liabilities; government regulation, including U.S. and foreign
health care reform, affecting the development, manufacture,
marketing and sale of pharmaceutical products, including
Warner Chilcott's ability and the
ability of companies with whom it does business to obtain necessary
regulatory approvals; adverse outcomes in Warner Chilcott's outstanding litigation,
regulatory investigations or arbitration matters or an increase in
the number of such matters to which it is subject; the loss of key
senior management or scientific staff; Warner Chilcott's ability to manage the growth
of its business by successfully identifying, developing, acquiring
or licensing new products at favorable prices and marketing such
new products; Warner Chilcott's
ability to obtain regulatory approval and customer acceptance of
new products, and continued customer acceptance of its existing
products; and the other risks identified in Warner Chilcott's periodic filings, including
its Annual Report on Form 10-K for the year ended December 31, 2012 and its Quarterly Reports on
Form 10-Q for the quarters ended March 31,
2013 and June 30, 2013, and
from time-to-time in its other investor communications.
Warner Chilcott cautions you that
the foregoing list of important factors is not exclusive. In
addition, in light of these risks and uncertainties, the matters
referred to in Warner Chilcott's
forward-looking statements may not occur. Warner Chilcott undertakes no obligation to
publicly update or revise any forward-looking statement as a result
of new information, future events or otherwise, except as may be
required by law.
Statement Required by the Irish Takeover Rules
The directors of Actavis accept responsibility for the
information contained in this announcement other than that relating
to Warner Chilcott and its
Associates and the directors of Warner
Chilcott and members of their immediate families, related
trusts and persons connected with them. To the best of the
knowledge and belief of the directors of Actavis (who have taken
all reasonable care to ensure that such is the case), the
information contained in this announcement for which they accept
responsibility is in accordance with the facts and does not omit
anything likely to affect the import of such information.
The directors of Warner Chilcott
accept responsibility for the information contained in this
announcement relating to Warner
Chilcott and its Associates and the directors of
Warner Chilcott and members of their
immediate families, related trusts and persons connected with them.
To the best of the knowledge and belief of the directors of
Warner Chilcott (who have taken
all reasonable care to ensure such is the case), the information
contained in this announcement for which they accept responsibility
is in accordance with the facts and does not omit anything likely
to affect the import of such information.
BofA Merrill Lynch and Greenhill & Co. are acting
exclusively for Actavis and no one else in connection with the
matters referred to in this announcement and will not be
responsible to anyone other than Actavis for providing the
protections afforded to clients of BofA Merrill Lynch or Greenhill
& Co and for providing advice in relation to the acquisition of
Warner Chilcott, the contents of
this announcement or any transaction or arrangement referred to
herein.
Deutsche Bank Securities Inc. is acting for Warner Chilcott as financial advisor and is not
acting as financial advisor to anyone else in connection with the
matters referred to in this announcement and will not be
responsible to anyone other than Warner
Chilcott in connection therewith for providing advice in
relation to the matters referred to in this announcement. Deutsche
Bank Securities Inc. has delegated certain of its financial
advisory functions and responsibilities to Deutsche Bank AG, acting
through its London branch.
Deutsche Bank AG, acting through its London branch is performing such delegated
functions and responsibilities exclusively for Warner Chilcott and is not acting as a financial
adviser for any other person in connection with the matters
referred to in this announcement and will not be responsible to any
such other person for providing advice in relation to the matters
referred to in this announcement. Deutsche Bank AG is authorised
under German Banking Law (competent authority: BaFin – Federal
Financial Supervisory Authority) and authorised and subject to
limited regulation by the Financial Conduct Authority. Details
about the extent of Deutsche Bank AG's authorization and regulation
by the Financial Conduct Authority are available on request.
Dealing Disclosure Requirements
Under the provisions of Rule 8.3 of the Irish Takeover Panel
Act, 1997, Takeover Rules 2007, as amended (the "Irish Takeover
Rules"), if any person is, or becomes, 'interested' (directly or
indirectly) in, 1% or more of any class of 'relevant securities' of
Warner Chilcott or Actavis, all
'dealings' in any 'relevant securities' of Warner Chilcott or Actavis (including by means
of an option in respect of, or a derivative referenced to, any such
'relevant securities') must be publicly disclosed by not later than
3:30 p.m. (Dublin time) on the business day following the
date of the relevant transaction. This requirement will continue
until the date on which the Scheme becomes effective or on which
the 'offer period' otherwise ends. If two or more persons
co-operate on the basis of any agreement, either express or tacit,
either oral or written, to acquire an 'interest' in 'relevant
securities' of Warner Chilcott or
Actavis, they will be deemed to be a single person for the purpose
of Rule 8.3 of the Irish Takeover Rules.
Under the provisions of Rule 8.1 of the Irish Takeover Rules,
all 'dealings' in 'relevant securities' of Warner Chilcott by Actavis or 'relevant
securities' of Actavis by Warner
Chilcott, or by any of their respective 'associates' must
also be disclosed by no later than 12 noon (Dublin time) on the 'business' day following
the date of the relevant transaction.
A disclosure table, giving details of the companies in whose
'relevant securities' 'dealings' should be disclosed, can be found
on the Irish Takeover Panel's website at
www.irishtakeoverpanel.ie.
'Interests in securities' arise, in summary, when a person has
long economic exposure, whether conditional or absolute, to changes
in the price of securities. In particular, a person will be treated
as having an 'interest' by virtue of the ownership or control of
securities, or by virtue of any option in respect of, or derivative
referenced to, securities.
Terms in quotation marks are defined in the Irish Takeover
Rules, which can also be found on the Irish Takeover Panel's
website. If you are in any doubt as to whether or not you are
required to disclose a dealing under Rule 8, please consult the
Irish Takeover Panel's website at www.irishtakeoverpanel.ie or
contact the Irish Takeover Panel on telephone number +353 1 678
9020 or fax number +353 1 678 9289.
CONTACTS:
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Actavis:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Charlie
Mayr
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(862)
261-8030
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Warner
Chilcott:
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Rochelle
Fuhrmann
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SVP,
Finance
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(973)
442-3281
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Kevin
Crissey
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Director, Investor
Relations
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(973)
907-7084
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http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )
SOURCE Actavis, Inc.