AVONEX(R) (Interferon beta-1a) Worldwide Sales Up 21% Over First Quarter 2001
CDP 571 (TNF alpha inhibitor), A Late Phase 3 Product Partnership
With Celltech, Bolsters Pipeline With Strategic Fit
in Crohn's Disease and Psoriasis.
FDA Schedules May 23 Advisory Committee Meeting for AMEVIVE(R) (alefacept),
Now Eight Months Into Review in U.S. and Europe
2002 Guidance Adjusted to $1.70 - $1.78,
Reflects Costs for the CDP 571 Collaboration With Celltech
And Added Sales & Marketing Spend for AVONEX
CAMBRIDGE, Mass., April 24 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced financial results for the first
quarter of 2002. For the three months ended March 31, 2002:
-- Worldwide product sales were $266 million, an increase of 21 percent
over first quarter, 2001. U.S. sales of $197 million increased 22
percent year over year. International sales of $69 million increased
18 percent year over year; in local currency, sales grew 26 percent.
-- Reported net income was $72 million, or $0.47 per share. Similarly, in
the first quarter of 2001, reported net income was $72 million, or
$0.47 per share.
-- Excluding a $2.2 million non-operating charge for the write-down of
equity securities, operating earnings per share was $0.48 in the first
quarter of 2002 versus $0.46 in operating earnings per share for the
first quarter of 2001.
"AVONEX continues its strong global growth, proof that the medical
community continues to value its long-term efficacy, safety, and convenience,"
said James C. Mullen, Biogen President and CEO. "Biogen also made substantial
progress in its pipeline last quarter: Our clinical trials are proceeding on
plan; the AMEVIVE Advisory Panel is right on schedule; and the addition of CDP
571 presents the prospect of another product launch in about 18 months."
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
FINANCIAL GUIDANCE
For the second quarter in 2002, the Company believes earnings per share
will be within the $0.37 - $0.41 range.
For the full year 2002, the Company's revised guidance is as follows:
For revenues in 2002, the Company expects:
-- Product revenues will increase to $1.1 billion.
-- Royalties will be within the range of $75 - $85 million.
-- Leading to total revenue growth in the mid-teens.
For Operating expenses in 2002, the Company expects:
-- R&D will increase as a percent of sales to 30-32 percent, driven by an
expanding pipeline, Phase 3 activity with ANTEGREN(R) (natalizumab),
and technology transfer costs related to CDP 571.
-- SG&A also will increase to 26-28 percent of sales to support AVONEX as
well as launch preparation for AMEVIVE.
Operating earnings per share in 2002 is expected to be $1.70 - $ 1.78.
Included in this guidance is the cost of the CDP 571 collaboration, which will
reduce operating earnings per share an estimated $0.10 - $0.14 in 2002.
"Biogen now is positioned to have four products on the market in 2005, by
which time we expect to reach our goal of $2 billion in annual revenues,"
Mullen said. "We will continue to look for strategic collaborations that
leverage our manufacturing capabilities."
2002 INVESTOR CALENDAR
-- Second quarter results July 18, 8:30 a.m. EST
-- Third quarter results October 17, 8:30 a.m. EST
CONFERENCE CALL AND WEBCAST
The Company's earnings conference call for the first quarter will be
broadcast via the Internet at 8:30 a.m. EST on April 24, 2002, and will be
accessible through the investor relations section of Biogen's homepage,
http://www.biogen.com.
FORWARD LOOKING STATEMENTS/ SAFE HARBOR
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 anticipated revenues, revenue growth,
operating expenses and ranges of revenues, earnings per share and operating
expenses, the Company's expectations regarding clinical trials for the
Company's pipeline products, and the Company's expectations regarding product
launches and products on the market.
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, including competition from 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 unexpected
delays in the review or marketing approval of AMEVIVE, any unexpected delays
or results in the clinical trials and/or the review or marketing approvals of
CDP 571 or ANTEGREN, any unanticipated increase in expenses including in the
areas of research and development and sales and marketing, 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,
product launches and products on the market 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. Only a small number of research and development programs
result in the commercialization of a product. Success in early stage clinical
trials does not ensure that later stage or larger scale clinical trials will
be successful. Even if later stage clinical trials are successful, the risk
exists that unexpected concerns may arise from analysis of data or from
additional data or that obstacles may arise or issues be identified in
connection with review of clinical data with regulatory authorities or that
regulatory authorities may disagree with the Company's view of the data or
require additional data or information or additional studies.
ABOUT BIOGEN
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biotechnology 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 worldwide sales of AVONEX(R)
(Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis,
and from the sales by licensees of a number of products, including alpha
interferon and hepatitis B vaccines and diagnostic products. Biogen's
research and development activities are focused on novel products for multiple
sclerosis, inflammatory, respiratory, kidney and cardiovascular diseases and
in developmental biology 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.
Financial Results For The First Quarter of 2002
Condensed Consolidated Statements Of Income
(in thousands, except per share amounts)
Three Months Ended
March 31,
2002 2001
REVENUES
Product $265,985 $219,997
Royalties 22,358 17,050
Total Revenues 288,343 237,047
COST AND EXPENSES
Cost of revenues 39,318 29,146
Research and development 82,467 72,770
Selling, general and administrative 73,390 48,560
Total Cost and Expenses 195,175 150,476
Income from Operations 93,168 86,571
Other income, net 7,028 16,463
INCOME BEFORE INCOME TAXES 100,196 103,034
Income Taxes 28,055 30,911
NET INCOME $72,141 $72,123
BASIC EARNINGS PER SHARE $0.49 $0.49
DILUTED EARNINGS PER SHARE $0.47 $0.47
SHARES USED IN CALCULATING:
BASIC EARNINGS PER SHARE 148,660 148,188
DILUTED EARNINGS PER SHARE 152,202 153,491
Condensed Consolidated Balance Sheets
(in thousands)
Mar. 31, 2002 Dec. 31, 2001
ASSETS
Current Assets
Cash and marketable securities $807,555 $798,107
Accounts receivable, net 172,936 177,582
Other current assets 135,578 122,038
Total current assets 1,116,069 1,097,727
Property and equipment, net 594,043 555,998
Other assets 65,593 67,321
$1,775,705 $1,721,046
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $277,015 $294,942
Long term debt & liabilities 73,367 77,272
Shareholders' equity 1,425,323 1,348,832
$1,775,705 $1,721,046
Media Contact:
Gregory Peterson
Vice President, Public Affairs
Biogen, Inc.
Tel: (617) 679-3763
Investment Community Contact:
Elizabeth Woo
Director, Investor Relations
Biogen, Inc.
Tel: (617) 679-2822
SOURCE Biogen, Inc.
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Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Related links:
http://www.biogen.com
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
CONTACT:
Gregory Peterson, Vice President, Public
Affairs, +1-617-679-3763, or Elizabeth Woo Director, Investor
Relations, +1-617-679-2822, both of Biogen
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