Successes in 2001 trigger strategic investments in 2002
for AMEVIVE(R) (alefacept), ANTEGREN(R) (natulizumab) and robust pipeline
- - -
Management forecasts modest growth for 2002,
accelerated earnings growth to 20 percent for 2003 and beyond
CAMBRIDGE, Mass., Nov. 1 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN) today
reviewed with members of the investment community its strategic and
operational plans for continued revenue growth through 2005. Management
projects earnings growth in the low single digits for 2002 followed by 20
percent for 2003 and beyond.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
2001 -- A Year of Strong AVONEX(R) (Interferon beta-1a) Growth, Pipeline
Progress
Meeting today with the investment community, Jim Mullen, President and
Chief Executive Officer, said, "During 2001 we've had tremendous successes in
advancing our pipeline. On the basis of those results, we are investing now -
for the launch of AMEVIVE in psoriasis, and for the advancement of numerous
other pipeline opportunities. We firmly believe our pipeline investments will
generate accelerated earnings growth rates of more than 20 percent for 2003
and beyond."
Mullen cited continued robust momentum for AVONEX, with year-to-date
AVONEX sales up 28% for 2001. Biogen expects 2002 AVONEX growth in the upper
teens; 2003 AVONEX growth projections are in the high single digit range.
The Company reiterated confidence in the First Call consensus for
projected operating earnings of $1.90 diluted earnings per share for the full
year 2001, excluding the $8 million upfront fee paid upon initiation of its
collaboration with ICOS.
2002 -- Preparing to Capitalize on Opportunities
At today's meeting, Biogen highlighted the substantial progress in its
late-stage pipeline and the strategic investments that are flowing from these
pipeline successes:
-- AMEVIVE is in registration in both the US and Europe for its first
indication -- moderate-severe psoriasis. On August 6, 2001, regulatory
filings for AMEVIVE were submitted in the US and Europe and have been
formally accepted for review by the FDA and EMEA.
Since AMEVIVE may be the first biologic to be approved for the
treatment of psoriasis, Biogen will initiate the build out of necessary
infrastructure, including sales force and customer service, to maximize
this potential first-mover advantage. AMEVIVE's therapeutic profile may
potentially address patient needs not addressed by current therapies.
The global moderate-severe psoriasis market exceeds $2 billion.
-- ANTEGREN is planned to start Phase III trials in MS and Crohn's Disease
this quarter. The Phase III trials for mono and combination therapy in
MS will be the largest trials ever conducted in MS. The worldwide MS
market today is about $2 billion, but Biogen estimates the ultimate
scale of the global MS market to be greater than $4 billion. ANTEGREN
has the potential to fulfill patient needs not addressed by current
therapies. In September, Biogen and Elan Corporation, plc (NYSE: ELN)
presented promising Phase II data for ANTEGREN at the ECTRIMS
Conference in Dublin.
"We are on the cusp of an exceptional new growth scenario driven by
AVONEX, AMEVIVE and ANTEGREN," said Mullen. "Biogen is poised to become a
two-product company -- and our evolution into a three-product organization is
soon to follow.
For the full year 2002, Biogen expects that:
-- Operating earnings per share will be $1.90 - $2.00 for the full year.
-- AVONEX revenues will increase by 15% to 18%.
-- Royalty revenue will be in the range of $70 - 85 million. The low end
of this range reflects a scenario with non-resumption of royalties from
Schering Plough in 2002. The high-end figure reflects a scenario where
these revenues do resume in 2002.
-- Cost of Sales will be in the range of 13% to 14% of total revenues.
-- Research and Development expense, excluding any upfront payments for
in-licensing agreements, will be 30% to 32% of total revenues.
-- Selling, general and administrative expenses will be approximately 23-
25% of total revenues.
-- The effective tax rate will be approximately 28%.
2003 and Beyond -- Significantly Higher Growth
Biogen cited its goal of surpassing $2 billion in revenues in 2005.
Supporting this goal, Biogen projects a revenue growth rate in the high teens,
and earnings growth of 20 percent in 2003, 2004, 2005, and beyond.
Also at today's investment meeting, Biogen reviewed the balance of its
clinical pipeline:
-- ADENTRI -- This highly selective A1 Adenosine Antagonist blocks
clinically relevant receptors for the treatment of Congestive Heart
Failure. A small molecule compound, ADENTRI, is being developed as
both oral and intravenous formulations. This program is currently in
Phase I and is planned to enter Phase II trials by year end 2001.
-- LTBR -- Lymphotoxin Beta Receptor is currently in Phase I trials. The
compound may offer a novel approach to autoimmune diseases by
disrupting an early event in the autoimmune cascade.
-- LFA1 -- In July, Biogen and ICOS Corporation (NASDAQ: ICOS) finalized
their agreement to collaborate worldwide on the development and
commercialization of orally active, small molecule LFA-1 antagonists
(including IC747, currently in a Phase I clinical trial) as oral
therapeutics for the treatment of inflammatory conditions.
-- Interferon Beta Gene Therapy -- This program is planned to start Phase
I/II clinical trials in glioma, an aggressive form of brain cancer.
The adenovirus vector encoding the human IFNbeta gene has a multi-
pronged mechanism of action.
Supplemental Financial Information
This news release is provided as a convenience to investors, and inclusion
of any information herein is not a determination by Biogen that such
information is material. Biogen is providing this information as of November
1, 2001 and disclaims any duty to update information contained in this
summary.
Webcast
The Webcast of the Biogen Analyst & Investor meeting is accessible through
the Investor Relations section of Biogen's homepage, http://www.biogen.com.
The webcast will be available for replay through November 9, 2001.
Forward Looking Statements
In addition to historical facts, this press release contains forward-
looking statements that involve risks and uncertainties that could cause
actual results to differ materially from those reflected in the forward-
looking statements. Reference is made in particular to projections regarding
anticipated revenues growth, range of earnings per share, royalty amounts,
expense levels and other forecasted financial results for 2002, projections
for earnings growth, AVONEX growth, revenue amounts, market size, number of
marketed products, and other financial results targeted for 2003-2005, and
statements regarding the Company's expectations as to the commencement of
Phase III trials of ANTEGREN and commencement of earlier stage clinical trials
of its other development-stage products, the therapeutic potential of the
Company's development-stage products, and the Company's expectations regarding
AMEVIVE approval and launch.
Factors which could cause actual financial results to differ from the
Company's current expectations include, without limitation, the impact of
competitive products on AVONEX sales, any change in market acceptance for
AVONEX in key markets worldwide, any unexpected negative results related to
AVONEX, any unanticipated increase in expenses including in the areas of
research and development, any unexpected costs related to commercialization
activities, the impact and cost of litigation, the impact and cost of in-
licensing opportunities and the other risks and uncertainties associated with
drug development and commercialization described in the Company's periodic
reports filed with the Securities and Exchange Commission. In addition,
financial projections for 2003 and beyond assume that there will be no
significant delays in Amevive approval or launch. Factors which could cause
actual results related to AMEVIVE approval and launch timelines to differ
materially from the Company's current expectations include the risk that
unexpected concerns may arise from additional data analysis or from additional
data or that obstacles may arise or issues be identified in connection with
review of data with regulatory authorities or that regulatory authorities may
disagree with the Company's view of the data or may require additional data or
information or additional studies. In addition, the Company's expectations
with respect to AMEVIVE may be affected by other risks inherent in the
biotechnology industry, including other actions by the Food and Drug
Administration on regulatory matters, actions by the U.S. Patent and Trademark
Office, and uncertainties regarding the status of biotechnology patents and
litigation. If AMEVIVE is approved by the FDA, other risks include
reimbursement and pricing decisions and the introduction of competitive
products, as well as the other risks and uncertainties described from time to
time in the Company's periodic reports filed with the Securities and Exchange
Commission.
Factors which could cause actual results regarding clinical trials to
differ from the Company's current expectations include the risk that the
Company will encounter one or more technical hurdles associated with new drug
development or that problems or delays may arise during preparations for or
the conduct of clinical trials, as well as the other risks and uncertainties
associated with drug development described in the Company's periodic reports
filed with the Securities and Exchange Commission. Drug development involves a
high degree of risk. Success in early stage clinical trials or preclinical
work does not ensure that later stage or larger scale clinical trials will be
successful.
About Biogen
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biopharmaceutical company principally engaged in discovering and developing
drugs for human healthcare through genetic engineering. Headquartered in
Cambridge, MA, the Company's revenues are generated from international sales
of AVONEX for treatment of relapsing forms of multiple sclerosis, and from the
worldwide sales by licensees of a number of products, including alpha
interferon and hepatitis B vaccines and diagnostic products. (Please see full
prescribing information at http://www.avonex.com) Biogen's research and
development activities are focused on novel products to treat inflammatory and
autoimmune diseases, neurological diseases, cancer, fibrosis and congestive
heart failure. For copies of press releases and additional information about
the Company, please consult Biogen's Homepage on the World Wide Web at
http://www.biogen.comAVONEX(R) (Interferon beta-1a) is a registered trademark
of Biogen, Inc. AMEVIVE(R) (alefacept) is a registered trademark of Biogen,
Inc. ANTEGREN(R) (natalizumab) is a registered trademark of Elan Corporation.
SOURCE Biogen, Inc.
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Related links:
http://www.biogen.com.
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CONTACT:
Media Contact: Kathleen O'Donnell, Associate
Director, Public Affairs, +1-617- 679-2837, or Investment
Community Contact: Elizabeth Woo, Associate Director, Investor
Relations, +1-617-679-2822, both of Biogen, Inc.
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