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8-K - Actavis, Inc. | v171894_8k.htm |
FOR
IMMEDIATE RELEASE
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CONTACTS:
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Investors:
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Patty
Eisenhaur
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Watson
Pharmaceuticals, Inc.
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(973)
355-8141
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Media:
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Charlie
Mayr
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Watson
Pharmaceuticals, Inc.
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(973)
355-8483
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WATSON
PROVIDES OVERVIEW OF GLOBAL OPERATIONS;
DELIVERS
OUTLOOK FOR CONTINUED GROWTH
Meeting
Highlights:
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Positioned
for continued growth in U.S.; Strong foundation in key markets and
opportunities in other international
markets
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Expanding
brand pipeline with near, mid-term opportunities; Urology and women’s
health opportunities are areas of key focus and anticipated
growth
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Expanded
global operations and supply chain supports increased efficiencies
in production; Continued opportunities to enhance profit and
support corporate growth
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Revenue
forecasted to be approximately $3.5 billion in 2010; $3.05 to $3.30 in
cash EPS and $760 million to $810 million in adjusted EBITDA projected for
2010
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Double-digit compounded annual
growth rate projected in
2010-2012
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New York,
NY, January 21, 2010 – Watson Pharmaceuticals, Inc. (NYSE: WPI) today provided a
detailed overview of its expanded global operations, enhanced supply chain
capabilities and commercial and pipeline developments in its Brand and Generics
businesses during an Investor Day meeting held in New York, NY. In
conjunction with the meeting, the company is providing its 2010 financial
forecast.
Watson
management predicted continued growth in its Generics, Brand and Distribution
businesses, with 2010 revenues expected to be approximately $3.5 billion and
double-digit annual cash earnings per share growth projected for
2010-2012.
“We have
been building the strategic foundation over the past two years that will serve
as the platform for Watson’s continued growth and expansion. While
there is more to accomplish, we continue to grow the Company and are pleased
with the results we have achieved to date,” said Paul Bisaro, Watson’s president
and chief executive officer.
“We have
strengthened our global supply chain, significantly enhanced our profits and
have refocused our generic development pipeline to maximize unique opportunities
and drive an enviable first-to-file portfolio. This year, we expanded
beyond our core U.S. business with the acquisition of Arrow that delivers a
global commercial footprint.”
“We have
also made substantive progress against our objective to realign our brand
business by capitalizing on our legacy strengths in women’s health and
maximizing our position with OB/Gyns, urologists and other targeted physician
groups,” Bisaro continued. “We have strengthened our brand pipeline
with many near and long-term commercial opportunities, and have taken measurable
and sustainable steps into biologics. We are in a strong position to
deliver sustainable adjusted EBITDA and cash earnings per share growth in 2010
and beyond by leveraging the strengths of our mixed generics and brand business
model.”
During
the Investor Day meeting, Watson showcased its global management team in a
review of the Company’s global businesses and operations, provided the first
extensive view into the assets provided by the acquisition of the Arrow Group
during 2009, and provided investors with business unit-based forecasts for
performance.
U.S.
Generics Business Complemented by Global Strengths and Significant Growth
Opportunities
”Our
acquisition of Arrow has enabled us to substantially reshape our generic
business. We enter 2010 with a larger product portfolio, an enhanced
pipeline of new products; and, access to established and emerging markets where
we can benefit from the increase in generic utilization,” said Tom Russillo,
Executive Vice President, Global Generics. “We have already begun to
maximize our new global opportunities for the near-term, while putting in place
the strategies that will deliver long-term opportunities. We are
investing in the future, to ensure generic growth across all markets in which we
now have a position.”
During
2009, Watson filed 36 Abbreviated New Drug Applications (ANDAs) with the U.S.
Food and Drug Administration (FDA), including a recently filed application for
Lidocaine Topical Patch 5%, a generic version of Endo Pharmaceutical’s Lidoderm®
product.
Watson
management noted that its U.S. generic portfolio has increased by approximately
20 products as a result of the Arrow acquisition, with such key products as
Ramipril, Isradipine, Ciprofloxacin and Acarbose. Sales and marketing
of U.S. generic products was transferred to Watson Sales/Customer Service at the
end of 2009, the Arrow marketing operations in Florida have been closed, and
transfer to the Watson label is underway. Watson currently markets
over 170 generic prescription product families in the U.S.
Watson
currently has more than 100 ANDAs on file in the U.S., with 38 potential
first-to-file or shared exclusivity products. The Company said that
it expects to submit more than 100 product applications worldwide in
2010.
Management
provided an overview of the key mature international markets where it has
operations, including:
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Canada,
where it ranks 8th
in the market with 49 products;
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The
U.K. where it ranks 5th
in the market with 250 products;
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France
where it where it ranks 7th
in the market with 320 products;
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Australia
where the Company markets 19
products.
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The
Company also noted that it has more than 30 molecules registered in a number of
additional European countries
The
company forecast 2010 Generics segment revenues to be approximately $2.3
billion, a record level which includes the addition of $600 million in
international revenue.
Brands
Poised to Expand Leadership Position in Urology;
Substantially Enhance Position in Women’s Health
Watson
management provided an update of market/payer acceptance of recently launched
Brand products, including RAPAFLO® for benign prostatic hyperplasia (BPH) and
GELNIQUE® for overactive bladder (OAB), noting a stronger managed care position
going into 2010. Management noted that the Company’s U.S. sales force
has been realigned to extend its reach and effectiveness in the urology, OB/Gyn
and targeted primary care markets. The new
structure recognizes the division’s near- and mid-term opportunities,
as it strengthens its position in urology and women’s health,
including:
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Two
novel and uniquely formulated oral contraceptives currently under FDA
review;
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Three
late-stage in-licensing opportunities for novel products in contraception,
infertility and labor and delivery;
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An
internally-developed, innovative drug delivery contraceptive in phase 3
development;
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Second
generation formulations of GELNIQUE® and ANDRODERM® that are currently in
late stage development;
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A
novel compound for cystitis in Phase 2
development.
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“As we
enter 2010, we have a strong product portfolio, a sales organization with
enhanced focus and reach into target physician groups, and a pipeline that will
create an expanded presence in both urology and women’s health care,” said Fred
Wilkinson, Watson’s executive vice president, Global Brands. “Our goal is to
leverage our current leadership position in urology and the OB/Gyn communities
and expand our women’s health marketplace with products that meet unmet needs or
provide enhanced benefits for consumers. In addition, we intend to
pursue biologic opportunities, as a result of our ownership relationship with
Eden Biodesign. We also are aggressively pursuing opportunities to
establish key brand franchises in international markets.”
The
company forecast Brand segment revenues to be approximately $460 million in
2010, reflecting continued growth of its current promoted products, a first half
launch of its six month formulation of Trelstar, the launch of a value brand
version of Ferrlecit® and the successful completion of a near-term business
development opportunity.
Global
Operations and Supply Chain Track Record for Continuous Performance
Improvement
Robert
Stewart, Watson’s senior vice president global operations told analysts,
“In 2009,
we realized savings of over $40 million via our Global Supply Chain Initiative
and additional savings through other supply chain cost initiatives. We will
continue to examine our operations in an effort to increase productivity,
streamline operations and reduce material costs. We expect to realize
these savings and more through expanded initiatives above and beyond what we
have already achieved.”
As a
result of the Arrow acquisition, Watson now has a total of 11 production
facilities around the world, with capacity for supporting the production of 20
billion pharmaceutical doses annually, supported by more than 3,100
employees. All of the Company’s facilities, with the exception of
Brazil, are FDA-approved, with the Company’s Florida and Toronto facilities
being additionally approved for Canadian distribution. The Company’s
facilities in Goa, Malta, Florida, Copiague and Brazil are either pending EMEA
approval, or have already received approval.
As part
of the Company’s continued emphasis on global supply chain efficiency, Stewart
noted that 2010 initiatives will include focusing on maximizing end-to-end
supply chain costs, as well as identifying opportunities to leverage the global
operations network to maximize capacity, tax, API and material synergy and
distribution costs. An increased emphasis will also be placed on
expanding internal production of Active Pharmaceutical Ingredients
(APIs).
2010
Financial Outlook
Watson
estimates total net revenue for 2010 will be approximately $3.5
billion.
— Total Generic segment revenue of
approximately $2.3 billion.
— Total Brand segment revenue of
approximately $460 million.
— Total Distribution segment revenue of
approximately $700 million.
Cash
earnings for 2010 is expected to be between $3.05 and $3.30 per diluted share
and adjusted EBITDA is expected to be between $760 million and $810
million.
Forward-Looking
Non-GAAP Financial Measures
Watson
presents GAAP and non-GAAP financial measures (and presentations derived from
these financial measures) as defined in Regulation G as promulgated on a
forward-looking basis. These non-GAAP measures should not be considered
replacements for GAAP results. We provide non-GAAP information
because we believe that such data provides useful information to
investors. However, investors are cautioned that, unlike financial
measures prepared in accordance with GAAP, non-GAAP measures may not be
comparable with the calculation of similar measures for by other
companies. The non-GAAP measures for years 2010-2012 are forward
looking statements for which the related GAAP measures are not available and
cannot be provided without undue effort and because we are unable to accurately
forecast the corresponding non-GAAP adjustments. We believe that the
corresponding GAAP measure is not likely to be significant to an understanding
of our non-GAAP adjustments. Such GAAP information may be materially
different from such forward-looking non-GAAP measures.
Watson’s
January 21st Investor Day meeting is being webcast live, and can be accessed by
logging onto http://www.watson.com
or the following link: http://www.videonewswire.com/event.asp?id=64988. A
replay of the webcast will also be available on Watson’s web site.
About
Watson Pharmaceuticals, Inc.
Watson
Pharmaceuticals, Inc. is a leading global specialty pharmaceutical
company. The Company is engaged in the development and distribution
of generic pharmaceuticals and specialized branded pharmaceutical products
focused on Urology and Women's Health. Watson has operations in many
of the world’s established and growing international markets.
In the
U.S., the Watson Brand portfolio includes RAPAFLOâ,
GELNIQUEâ,
Oxytrol®,
TRELSTAR® LA and
TRELSTAR® Depot
and INFeD®. In
addition, Watson markets the following brands under co-promotion agreements:
AndroGel®, with
Solvay Pharmaceuticals, Inc., and Femring®, with
Warner Chilcott Limited. The Watson Brand pipeline portfolio includes
a number of products, including a six-month formulation of TRELSTAR®, for the
treatment of advanced prostate cancer which is currently under review by the
FDA; URACYST®, under
development for cystitis; and a novel new oral contraceptive. All
other trademarks are property of their respective owners.
For press
release and other company information, visit Watson Pharmaceuticals' Web site at
http://www.watson.com.
Forward-Looking
Statement
Statements
contained in this press release that refer to Watson's estimated or anticipated
financial results or other non-historical facts are forward-looking statements
that reflect Watson's current perspective of existing trends and information as
of the date of this release. For instance, any statements in this press release
concerning prospects related to Watson's strategic initiatives, product
introductions and anticipated financial performance are forward-looking
statements. It is important to note that Watson's goals and expectations are not
predictions of actual performance. Watson's performance, at times, will differ
from its goals and expectations. Actual results may differ materially from
Watson's current expectations depending upon a number of factors affecting
Watson's business. These factors include, among others, the inherent uncertainty
associated with financial estimates; the possibility that the financial
estimates will change after further review by Watson’s management or outside
independent accountants; successful integration of the Arrow acquisition and the
ability to recognize the anticipated synergies and benefits of the Arrow
acquisition; the impact of competitive products and pricing; the difficulty of
predicting the timing or outcome of litigation and other claims; variability of
revenue mix between the Company's Brand, Generic and Distribution business
units; 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; timely and
successful consummation and implementation of strategic initiatives; the timing
and success of product launches; the difficulty of predicting the timing or
outcome of product development efforts and FDA or other regulatory agency
approvals or actions; the uncertainty associated with the identification and
successful consummation of external business development transactions; market
acceptance of and continued demand for Watson's products; 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 FDA and other governmental regulations
applicable to Watson's and its third party manufacturers' facilities, products
and/or businesses; changes in the laws and regulations, including Medicare and
Medicaid, affecting among other things, pricing and reimbursement of
pharmaceutical products; and such other risks and uncertainties detailed in
Watson's periodic public filings with the Securities and Exchange Commission,
including but not limited to Watson's annual report on Form 10-K for the year
ending December 31, 2008 and quarterly report on Form 10-Q for the period ended
September 30, 2009. Except as expressly required by law, Watson disclaims any
intent or obligation to update these forward-looking statements.
(Logo: http://www.newscom.com/cgi-bin/prnh/20100121/LA41294LOGO)