2001 REVENUES EXCEED $1 BILLION
AVONEX(R) (Interferon beta-1a) sales up 28 percent year-over-year
- - -
AMEVIVE(R) (Alefacept) more than 5 months into review
with U.S. and European regulators
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Major pipeline advances in 2001
with 4 new projects added to clinical development
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CAMBRIDGE, Mass., Jan. 24 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today reported that revenues for the year ended
December 31, 2001 increased 13 percent, to $1,043 million from $926 million in
2000. Net income for 2001 was $273 million, or $1.78 per share, which includes
$0.12 per share of net one-time charges. This resulted in full year 2001
operating earnings per share of $1.90. On an operating basis, earnings per
share increased eight percent over 2000 earnings per share of $1.75.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
For the three months ending December 31, 2001, the Company reported total
revenues, including royalties, of $280 million compared to $245 million for
the same quarter last year. Net income for the fourth quarter of 2001 was $59
million, or $0.39 per share, and included one-time charges of $20 million, or
$0.09 per share. Excluding these one-time charges, fourth quarter earnings per
share were $0.48 compared to $0.47 for the same period last year.
The one-time charges in 2001 are:
-- A $2.5 million, or $0.01 per share gain, as a result of gains on the
sale of marketable securities in the first quarter.
-- An $8 million, or $0.04 per share, upfront fee paid upon initiation of
the ICOS collaboration which began in the third quarter.
-- A $20 million, or $0.09 per share charge, in the fourth quarter as part
of a settlement of the ongoing patent infringement dispute with Berlex.
(NOTE: Please see Biogen's statement, released today - January 24.)
-- Also in the fourth quarter, Biogen marked to market certain publicly
traded securities that were determined to be impaired on an other than
temporary basis. This created a loss of $27.9 million, largely offset
by gains of $27.8 million on the sale of other marketable securities.
In 2000, the Company reported net income of $334 million, or $2.16 per
share, which included gains on the sale of marketable securities of $101
million, or $0.41 per share. Excluding these gains, full year 2000 operating
earnings were $271 million, or $1.75 operating earnings per share.
"Biogen wrapped up a successful year with four quarters of solid results.
Our AVONEX(R) business continued its strong growth. We completed the filing
for market approval of AMEVIVE(R) in both the U.S. and Europe in record time.
Our pipeline made major advances. We expanded our global commercial presence
and restructured the management team. And our revenues exceeded $1 billion -
a milestone in this Company's history," said James C. Mullen, Biogen's
President and CEO.
For the fourth quarter and full year 2001, AVONEX growth accelerated to 28
percent year-over-year. For the quarter ended December 31, 2001, sales
reached a record $259 million. AVONEX sales in 2001 were $972 million versus
$761 million in 2000. At the end of 2001, more than 118,000 patients were on
AVONEX, which remains the number one therapy worldwide for patients with
multiple sclerosis (MS).
2001 also was a watershed year for Biogen's pipeline, which has increased
its momentum entering 2002:
-- AMEVIVE successfully completed Phase 3 trials in psoriasis, and now is
more than five months into the review process with U.S. and European
regulators.
-- Biogen and its partner Elan Corporation, plc successfully completed
ANTEGREN(R) (natalizumab) Phase 2 trials. The companies are now
enrolling patients in Phase 3 trials in MS and Crohn's disease.
-- ADENTRI(TM) (Adenosine receptor antagonist), a compound for acute and
chronic congestive heart failure, entered Phase 2 trials.
-- Lymphotoxin Beta Receptor, a biologic for various autoimmune diseases,
began Phase 1 safety trials and is expected to enter Phase 2 trials in
the second half of 2002.
Initial trials in beta interferon gene therapy are actively recruiting
glioma patients.
Three compounds entered the clinic in 2001 -- and Biogen added another
with its collaboration with ICOS Corporation on small molecule LFA-1
antagonists, an exciting opportunity for an oral product with potential
applications in autoimmune diseases such as psoriasis and MS.
Biogen's R&D expenditures in 2001 were 30 percent of total revenue -- one of
the highest rates in the industry. Currently, Biogen has more than 20 project
areas in its research pipeline, each of which is designed to focus on a large,
underserved yet focused market.
For the full year 2002, the Company reaffirmed guidance (originally
announced on November 1, 2001) of $1.90 - $2.00 for operating earnings per
share. Operating earnings per share for the first quarter of 2002 are
expected to fall within the $0.45 - $0.48 range.
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 statements regarding
future financial results, including the anticipated ranges of revenues and
earnings per share and the Company's expectations regarding the completion or
commencement of clinical trials for the Company's pipeline products.
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(R) sales, the timing of the approval of
Rebif(R) in the United States, 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, the impact of litigation and patent-related events, 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.
Factors which could cause actual results regarding clinical trials to
differ from the Company's current expectations include, without limitation,
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 U.S. and European
sales of AVONEX(R) (Interferon beta-1a) 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. The Company maintains active clinical
research programs in protein therapeutics, small molecules, genomics and gene
therapy. 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.com.
AVONEX(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. ADENTRI(TM) is a
trademark of Biogen, Inc.
NOTE: The Company's earnings conference call for the fourth quarter will
be broadcast via the Internet at 8:30 a.m. EST on Thursday, January 24, 2002,
and will be accessible through the investor relations section of Biogen's
homepage, http://www.biogen.com.
Financial Results For The Fourth Quarter and Full
Year of 2001
Condensed Consolidated Statements Of Income
(in thousands, except per share amounts)
Three Months Ended Full Year Ended
December 31, December 31,
2001 2000 2001 2000
REVENUES
Product $259,177 $203,232 $971,594 $761,079
Royalties 21,281 42,104 71,766 165,373
Total Revenues 280,458 245,336 1,043,360 926,452
COST AND EXPENSES
Cost of revenues 35,704 32,753 136,510 125,198
Research and development 83,773 73,635 314,556 302,840
Selling, general and
administrative 68,017 46,209 232,096 170,058
Total Cost and Expenses 187,494 152,597 683,162 598,096
Income from Operations 92,964 92,739 360,198 328,356
Other income (expense), net (8,844) 9,784 29,299 158,749
INCOME BEFORE INCOME TAXES 84,120 102,523 389,497 487,105
Income Taxes 25,235 30,753 116,814 153,528
NET INCOME $58,885 $71,770 $272,683 $333,577
BASIC EARNINGS PER SHARE $0.40 $0.49 $1.84 $2.24
DILUTED EARNINGS PER SHARE $0.39 $0.47 $1.78 $2.16
SHARES USED IN CALCULATING:
BASIC EARNINGS PER SHARE 148,218 147,894 148,355 148,743
DILUTED EARNINGS PER SHARE 152,198 152,846 152,916 154,602
Condensed Consolidated Balance Sheets
(in thousands)
Dec. 31, 2001 Dec. 31, 2000
ASSETS
Current Assets
Cash and marketable securities $798,107 $682,412
Accounts receivable, net 177,582 143,178
Other current assets 122,038 102,681
Total current assets 1,097,727 928,271
Property and equipment, net 555,998 400,429
Other assets 67,321 103,156
$1,721,046 $1,431,856
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $294,942 $221,021
Long term debt & liabilities 77,272 104,433
Shareholders' equity 1,348,832 1,106,402
$1,721,046 $1,431,856
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, Director, Investor Relations, +1-617-679-2822, both of Biogen, Inc.
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