FDA Advisory Committee Recommendation and Complete Response Letter
Advance AMEVIVE(R) (alefacept) Towards Approval
AFFIRM, the First Phase 3 Trial for ANTEGREN(R) (natalizumab) in Multiple
Sclerosis (MS), Fully Accrued; Other Trials Progressing On Schedule
James C. Mullen Elected Chairman of Biogen following James L. Vincent's
Retirement
Management Reaffirms 2005 Goal of $2 Billion in Revenues
CAMBRIDGE, Mass., July 18 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced financial results for the second
quarter of 2002. For the three months ended June 30, 2002:
-- Worldwide product sales were $251 million, an increase of three percent
over second quarter 2001.
-- U.S. sales of $176 million increased two percent year over year.
The lower growth was primarily due to an inventory reduction by some
wholesalers of approximately one week, an impact of roughly $14-16
million.
-- International sales were $75 million, an increase of seven percent
year over year; in local currency, sales grew 11 percent year over
year.
-- Reported net income was $43 million, or $0.29 per share. This compares
to reported net income of $72 million, or $0.47 per share in the second
quarter of 2001.
-- Operating net income was $48 million, or $0.31 per share. Operating net
income excludes a charge for severance and other benefits of $5.8
million related to Mr. Vincent's retirement which are included in
selling, general and administrative expenses.
James C. Mullen, Biogen's Chairman and CEO, said, "Based on prescription
data and wholesaler shipments, AVONEX(R) (Interferon beta-1a) demand has
remained constant. However, reported sales were soft due, in large part, to
inventory reductions in the wholesaler channels. This trend ended in mid-June
and we expect that at approximately 1.5 weeks of inventory in the system,
there will be no further corrections.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
"More importantly, Biogen continued progress on its key late-stage
programs, staying on course for our goal of $2 billion in revenue and 3 to 4
commercial products by 2005. With AMEVIVE, we have successfully worked with
the FDA to keep the approval process on track. We look forward to making this
new treatment for psoriasis available to patients in the near future."
LATE-STAGE PIPELINE UPDATE
AMEVIVE
On May 23rd, the Dermatologic & Ophthalmic Advisory Committee convened by
U.S. Food and Drug Administration (FDA) voted to recommend AMEVIVE for market
approval.
In June, Biogen received a Complete Response Letter from the FDA on its
application for approval to market AMEVIVE in the U.S. as a treatment for
moderate-to-severe chronic plaque psoriasis. No new clinical trials were
requested prior to approval. The Agency proposed post-marketing clinical
studies to further profile the safety and effectiveness of AMEVIVE. The
Company is working closely with FDA to address the questions raised and move
forward rapidly in the approval process.
Biogen has responded to all questions regarding AMEVIVE from the European
regulatory agency. The Company continues to expect that the commercial launch
of AMEVIVE is on track for late 2002 / early 2003 in both the U.S. and Europe.
CDP 571
In April, Biogen and Celltech announced a collaboration for the research,
development, manufacturing and commercialization of CDP-571, Celltech's
humanized anti-TNF alpha antibody product. CDP-571 is completing Phase 3
development as a treatment for Crohn's disease.
Phase 3 results are expected in the third quarter of 2002.
ANTEGREN
Biogen and Elan are collaborating on two Phase 3 trials for ANTEGREN in
the treatment of MS.
The AFFIRM study is a Phase 3 trial designed to determine whether ANTEGREN
is effective in slowing the rate of disability in MS and reducing the rate of
clinical relapses. AFFIRM completed accrual this quarter with over 900
patients.
The SENTINEL Phase 3 trial, which will be one of the largest trials
conducted in MS, is designed to determine whether the treatment of MS with
ANTEGREN in combination with AVONEX is more effective than AVONEX treatment
alone in slowing the rate of disability in MS and in reducing the rate of
clinical relapses.
Biogen and Elan are also conducting the largest Phase 3 trial in Crohn's
disease with approximately 850 patients.
The SENTINEL and Crohn's disease trials are progressing to complete
enrollment by year end.
2002 FINANCIAL GUIDANCE
For the full year 2002, Biogen reaffirmed guidance (originally announced
on June 7, 2002) as follows:
-- Total revenue growth of 6-10%
-- Operating earnings per share of $1.50 - $1.60
For the third quarter of 2002, operating earnings per share are expected
in the range of $0.32 - $0.38.
INVESTOR CALENDAR
-- Third quarter results Friday, October 18, 2002, 8:30 a.m. EST
-- Fourth quarter results Thursday, January 23, 2003, 8:30 a.m. EST
-- First quarter results Friday, April 18, 2003, 8:30 a.m. EST
CONFERENCE CALL AND WEBCAST
The Company's earnings conference call for the second quarter will be
broadcast via the Internet at 8:30 a.m. EST on July 18, 2002, and will be
accessible through the investor relations section of Biogen's homepage,
http://www.biogen.com.
FORWARD LOOKING STATEMENTS/ SAFE HARBOR
This press release contains forward-looking statements regarding expected
future financial results, anticipated regulatory approval and commercial
launch of AMEVIVE, goals for future commercial products and expected
milestones in the development of the Company's late-stage pipeline products.
These statements are based on the Company's current beliefs and
expectations. A number of risks and uncertainties could cause actual results
to differ materially. For example, financial results, including future
revenues, revenue growth and earnings per share, may be affected by the impact
of competitive products on AVONEX sales, any slowing of growth of the multiple
sclerosis market, any change in market acceptance of AVONEX in key markets
worldwide, 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 and in-licensing and product opportunities. Approval and
commercial launch of AMEVIVE is subject to the Company's ability to work with
FDA to adequately address questions and provide the clarification and
information requested in the Complete Response Letter. Approval of AMEVIVE and
the Company's expectations regarding its late stage pipeline and future
commercial products are also subject to the other risks inherent in drug
development, including the risk of unexpected new data or information,
unexpected technical or manufacturing issues and intellectual property
disputes. 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.
For more detailed information on the risks and uncertainties associated
with these forward looking statements and the Company's other activities see
the Outlook section in MD&A of the Company's Annual Report on Form 10-K and
quarterly reports on Form 10-Q filed with the Securities and Exchange
Commission. The Company does not undertake any obligation to publicly update
any forward-looking statements.
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 U.S. and European sales of
AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of multiple
sclerosis, (Please see full prescribing information at
http://www.avonex.com.), and from the worldwide 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 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.
Financial Results For The Second Quarter of 2002
Condensed Consolidated Statements Of Income
(in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2002 2001 2002 2001
REVENUES
Product $250,542 $243,140 $516,527 $463,137
Royalties 18,721 17,445 41,079 34,495
Total Revenues 269,263 260,585 557,606 497,632
COST AND EXPENSES
Cost of revenues 36,209 35,202 75,527 64,348
Research and development 89,348 79,118 171,815 151,888
Selling, general and
administrative 91,567 55,189 164,957 103,749
Total Cost and Expenses 217,124 169,509 412,299 319,985
Income from Operations 52,139 91,076 145,307 177,647
Other income, net 8,104 11,533 15,132 27,996
INCOME BEFORE INCOME TAXES 60,243 102,609 160,439 205,643
Income Taxes 16,868 30,757 44,923 61,668
NET INCOME $43,375 $71,852 $115,516 $143,975
BASIC EARNINGS PER SHARE $0.29 $0.48 $0.78 $0.97
DILUTED EARNINGS PER SHARE $0.29 $0.47 $0.76 $0.94
SHARES USED IN CALCULATING:
BASIC EARNINGS PER SHARE 149,231 148,602 148,945 148,395
DILUTED EARNINGS PER SHARE 152,033 153,337 152,118 153,414
Condensed Consolidated Balance Sheets
(in thousands)
Jun. 30, 2002 Dec. 31, 2001
ASSETS
Current Assets
Cash and marketable securities $793,465 $798,107
Accounts receivable, net 181,904 177,582
Other current assets 155,757 122,038
Total current assets 1,131,126 1,097,727
Property and equipment, net 652,833 555,998
Other assets 62,165 67,321
$1,846,124 $1,721,046
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $291,215 $294,942
Long term debt & liabilities 72,033 77,272
Shareholders' equity 1,482,876 1,348,832
$1,846,124 $1,721,046
SOURCE Biogen, Inc.
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CONTACT:
Media Contact: Tim Hunt, Director, Public
Affairs, +1-617-679-4996, or Investment Community Contact:
Elizabeth Woo, Director, Investor Relations, +1-617-679-2822,
both of Biogen, Inc.
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