Abraxis Bioscience (MM) (NASDAQ:ABBI)
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Abraxis BioScience, Inc. (NASDAQ:ABBI) today announced its intention to
separate the company's hospital-based product business -- Abraxis
Pharmaceutical Products (APP) -- from its proprietary product business
-- Abraxis Oncology and Abraxis Research (the new Abraxis BioScience) --
in a transaction that will result in two independent, highly focused
public companies. The transaction would enable each company to deliver
on their strategic visions and compete more effectively in their
specialized marketplaces with their differing capital requirements and
business mandates. The transaction is subject to obtaining a ruling from
the Internal Revenue Service that the separation will be tax-free to
Abraxis BioScience and its shareholders.
Following the separation of the businesses, each current shareholder
will own one share of Abraxis Pharmaceutical Products, which is expected
to be known as APP, Inc., and one share of the new Abraxis BioScience,
for each share previously held. It is currently expected that APP will
be traded on the NASDAQ Global Market under the ticker symbol �APPX�
and the new Abraxis BioScience, as a new publicly traded company, will
be traded on the NASDAQ Global Market under the company�s
current ticker symbol �ABBI.�
Abraxis has received commitments for $1.45 billion of senior credit
facilities comprised of a funded $1.3 billion term loan and an unfunded
$150 million revolving credit facility.�The funded financing is
anticipated to represent approximately 4.8 to 5.2x of APP's estimated
adjusted EBITDA for the previous four quarters prior to the close. APP
will be responsible for servicing the debt following the separation.�A
portion of the proceeds raised through the debt financing will be used
to repay the current company's existing indebtedness and approximately
$1.0 billion will be transferred to the new Abraxis BioScience
immediately prior to the separation.�The consolidated adjusted EBITDA as
set forth in the table attached for the current Abraxis BioScience was
$250.6 million for the fiscal year ended 2006.
Detailed information about the separation of the businesses will be
provided when the company files a Form 10 registration statement for the
new Abraxis BioScience, which is expected to be filed in the third
quarter of 2007.
Patrick Soon-Shiong, M.D., chairman and chief executive officer of
Abraxis BioScience, stated, "Strategic initiatives executed over the
past few years, including the acquisition of global rights to ABRAXANE
and the nab technology platform, the acquisition of the
AstraZeneca anesthesia/analgesic portfolio and the acquisition of the
Pfizer manufacturing facility in Puerto Rico, have accelerated the
growth of two robust businesses with more than 1,900 employees and
combined revenues that are expected to approach $1 billion by the end of
2007.
�By separating these unique business units
into two entities, we believe we will be able to unlock the intrinsic
value of both companies by allowing each company to pursue its unique
long-term strategic initiatives and address their diverse operational
and capital needs. Furthermore, the separation will permit each company
to focus on their respective pipelines, and business development
opportunities and compete more effectively in their individual
marketplaces,� continued Dr. Soon-Shiong. �APP,
with one of the most comprehensive injectable product portfolios in the
U.S. and one of the only companies that mirror the overall market demand
for injectable products, will be positioned to maximize its core
strength to enhance current product offerings and pursue new
opportunities including biosimilars. APP has demonstrated a remarkable
ability to remain flexible while continuing to aggressively pursue new
opportunities and products and, as a standalone entity, this ability to
respond rapidly to the needs in the generic marketplace will be enhanced.
�The proceeds provided to the new Abraxis
BioScience in this transaction will permit this entity to become a
highly focused biotechnology company, strategically concentrating on its nab
technology platform to deliver progressive therapeutics, such as
ABRAXANE, and develop core technologies that offer new and personalized
treatments to patients with life-threatening diseases. The era of
personalized medicine has arrived, and with the financial and scientific
resources created as a result of this transaction, the new Abraxis
BioScience will be uniquely positioned to forge new paradigms of drug
discovery and personalized drug development," said Dr. Soon-Shiong.
�APP has a strong, stable cash flow and has
established an impressive record of revenue growth and gross margins
which will adequately support the debt,� said
Lisa Gopala, chief financial officer of Abraxis BioScience. �With
a capital infusion of approximately $1.0 billion and 2007 net sales
expected in the range of $285 million to $305 million from ABRAXANE, the
new Abraxis BioScience will have the financial resources to maximize its
pipeline potential and capture opportunities that enhance
commercialization depth and establish Abraxis as a leader in
biotechnology.�
The transaction is expected to be completed in the fourth quarter of
2007, subject to customary closing conditions, obtaining of a private
letter ruling from the Internal Revenue Service, and other regulatory
approvals.
In connection with the transaction, Wachovia Securities and Merrill
Lynch & Co. are acting as financial advisors, and Fried, Frank, Harris,
Shriver and Jacobson, LLP and Morrison & Foerster, LLP, are acting as
legal advisors to Abraxis BioScience.
APP
Following the separation, APP will be one of the largest standalone
publicly traded companies focused on injectable pharmaceuticals and will
have approximately 1,400 employees. Pursuant to the guidance previously
provided, APP expects to generate revenue growth in 2007 in the mid
teens over the 2006 revenue of $583 million. The headquarters of APP
will remain in Schaumburg, Illinois.
APP will continue to focus on bringing to patients and their healthcare
providers one of the broadest injectable portfolios of products in the
U.S. The current injectable portfolio is comprised of anti-infectives,
critical care, oncology and anesthetic/analgesic products totaling over
400 dosage forms. In addition to its strong revenue base and broad
product offerings, APP also intends to leverage its expansive
manufacturing capabilities, operational strength, and solid
infrastructure to pursue growth opportunities as well as develop new
technologies to benefit the patients who use its products every day.
Dr. Soon-Shiong will remain as chairman and serve as chief executive
officer of APP. The operating management team that led to the growth of
APP in 2006 will remain in place and be further strengthened over time
to execute on its vision. Thomas H. Silberg will continue to lead APP as
president. Frank Harmon will remain as executive vice president and
chief operating officer of APP. Key executive officer positions, as well
as the Board of Directors, will be named prior to, or at the time of,
the close of the transaction.
In 2006, APP remained a market leader with 10 ANDA approvals. From 2001
to 2006, APP led the market with 55 ANDA approvals. Including the 29
ANDAs pending with the FDA, representing approximately $1.6 billion in
annual branded sales, APP currently has over 60 product candidates in
various stages of development.
The New Abraxis BioScience
The new Abraxis BioScience, as a standalone publicly traded company,
will have its headquarters in Los Angeles, California and employ more
than 500 people. The company will continue to market ABRAXANE and
accelerate the development of its pipeline which utilizes the nab�
(nanoparticle-albumin bound) technology platform.
The new Abraxis BioScience will combine the Abraxis Oncology and Abraxis
Research business units. Dr. Soon-Shiong will continue to serve as its
chairman and chief executive officer. The executive committee of Abraxis
BioScience will remain in their current positions. The new board of
directors for this business will be determined prior to, or at the close
of, the transaction.
ABRAXANE is marketed in the U.S. and Canada and posted revenue in 2006
of $175 million. For the first quarter of 2007, revenue increased 134
percent to $70.9 million versus the first quarter of 2006. Full year
2007 guidance for ABRAXANE net sales is $285 million to $305 million.
According to May 2007 IntrinsiQ data, ABRAXANE was the taxane market
leader in mestastatic breast cancer with a 36.4 percent share for
ABRAXANE compared to 35.9 percent for paclitaxel (Taxol�
and generic paclitaxel) and 27.7 percent for Taxotere�.
ABRAXANE is currently under active review in Australia, Russia and the
European Union by their respective regulatory agencies. In China,
ABRAXANE is in the final step in the regulatory approval process and in
Japan, ABRAXANE development is underway in partnership with Taiho
Pharmaceuticals, the leading domestic oncology company in that country.
The nab� tumor-targeting technology,
which harnesses the unique natural properties of the human protein
albumin to transport and deliver therapeutic agents to the site of
disease, was developed by Abraxis scientists. ABRAXANE, which was
approved in the U.S. in January 2005, was the first product developed
using the nab technology. In addition to the previously announced
initiation of clinical trials for nab-docetaxel (ABI-008),
studies are ongoing to evaluate several other therapeutic candidates
that employ the nab technology, including the mTOR inhibitor nab-rapamycin
(ABI-009) and the HSP90 inhibitor nab-17AAG (ABI-010), among
others. The IND for ABI-009, which was recently approved, is the third
investigational product based on the company�s
nab technology platform. Abraxis anticipates filing two
additional IND submissions over the next 12 to 18 months for ABI-010 and nab-thiocolchicine
dimer (ABI-011).
Conference Call Information
The company will host a conference call with interested parties today
beginning at 8:30 a.m. PDT/11:30 a.m. EDT to review the details of the
proposed separation. The conference call may be heard by interested
parties through a live audio Internet broadcast at www.abraxisbio.com
and www.earnings.com. For those
unable to listen to the live broadcast, a playback of the webcast will
be available at both websites for approximately six months beginning
shortly after the conclusion of the call.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical
company dedicated to meeting the needs of critically ill patients. The
company develops, manufactures and markets one of the broadest
portfolios of injectable products and leverages revolutionary technology
such as its nab� platform to discover
and deliver breakthrough therapeutics that transform the treatment of
cancer and other life-threatening diseases. The first FDA approved
product to use this nab platform, ABRAXANE�,
was launched in 2005 for the treatment of metastatic breast cancer.
Abraxis trades on the NASDAQ Global Market under the symbol ABBI. For
more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely
historical are forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking
statements in this press release include statements regarding our
expectations, beliefs, hopes, goals, intentions, initiatives or
strategies, including statements regarding the separation of the
proprietary product business from the hospital-based business and the
expected revenues of these businesses. Because these forward-looking
statements involve risks and uncertainties, there are important factors
that could cause actual results to differ materially from those in the
forward- looking statements. These factors include, but are not limited
to, the inability to obtain a private letter ruling from the IRS on the
tax-free nature of the transactions; the failure to obtain the necessary
debt financing arrangements; risks that the proposed transaction
disrupts current plans and operations and the potential difficulties in
employee retention; the inability to recognize the benefits of the
transactions contemplated by the separation of the businesses; the
continued market acceptance and demand of new and existing products for
the proprietary product and the hospital-based products businesses; the
difficulties or delays in developing, testing, obtaining regulatory
approval of, and producing and marketing of their products; the impact
of competitive products and pricing; the availability and pricing of
ingredients used in the manufacture of pharmaceutical products; and the
ability to successfully manufacture products in a time-sensitive and
cost effective manner. Additional relevant information concerning risks
can be found in Abraxis BioScience�s Form
10-K for the year ended December 31, 2006 and other documents it has
filed with the Securities and Exchange Commission. The information
contained in this press release is as of the date of this
release.�Abraxis assumes no obligations to update any forward-looking
statements contained in this press release as the result of new
information or future events or developments.
Abraxis BioScience, Inc.
Reconciliation of Net Income to Adjusted EBITDA(1)
For the Year Ended December 31, 2006
(unaudited, in thousands)
�
Net income
$
(46,897)
Depreciation and amortization
79,691
Interest expense (net of interest and other income)
9,971
Income tax expense
29,299
Merger related in-process research and development charge (2)
105,777
Stock-based compensation expense (3)
35,023
Merger costs (2)
17,954
Puerto Rico pre-launch costs (4)
11,246
Minority interests
11,383
Equity in net income of Drug Source Company, LLC
�
(2,847)
Adjusted EBITDA (1)
$
250,600
�
(1) We define Adjusted EBITDA as net income, excluding the impactof
depreciation and amortization, interest expense net of interestincome
and other income, income tax expense, stock-basedcompensation
expense, merger costs, merger related in-processresearch and
development charge, minority interests, equityinterests in
Drug Source Company, LLC and pre-launch costsassociated with
Puerto Rico manufacturing facility. We useadjusted EBITDA to
provide meaningful supplemental information toinvestors in
understanding the underlying operating performance ofthe
business and facilitate additional analysis by investors. Webelieve
that Adjusted EBITDA can assist management and investorsin
assessing the financial operating performance and underlyingstrength
of our core business. Adjusted EBITDA is not a recognizedterm
under GAAP and should not be considered in isolation of, oras
a substitute for, the information prepared and presented inaccordance
with GAAP. Because not all companies calculate AdjustedEBITDA
identically, our definition of Adjusted EBITDA may not becomparable
to similarly titled measures of other companies.
(2) Represents one-time costs, not including amortization,associated
with the 2006 merger.
(3) Amounts included in stock compensation expense could be settledin
cash.
(4) Represents pre-launch costs associated with Puerto Ricomanufacturing
facility acquired in March 2007.
Taxol� is a
registered trademark of Bristol-Myers Squibb Company.
Taxotere� is a
registered trademark of Sanofi-Aventis.