Dosing Completed in Phase III trials of AMEVIVE™ (alefacept) in Chronic Plaque Psoriasis
/PRNewswire/ — Biogen, Inc. (Nasdaq: BGEN)
today announced that net income for the year ended December 31, 2000 increased
to $334 million or $2.16 per share, which includes $0.41 per share of net one-
time events. This resulted in full year 2000 operating earnings per share of
$1.75. On an operating basis, earnings per share increased 20 percent over
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Total revenues in 2000 were $926 million compared to $794 million in 1999.
Total AVONEX(R) (Interferon beta-1a) sales in 2000 were $761 million versus
$621 million in 1999, an increase of 23 percent.
For the three months ending December 31, 2000, the Company reported
earnings per share of $0.47 and revenues of $245 million, compared to earnings
per share of $0.44 and revenues of $225 million for the same quarter last
year. For the fourth quarter, sales of AVONEX were a record $203 million,
driven by an 8 percent increase versus Q3 sales in the US.
James C. Mullen, Biogen’s President and Chief Executive Officer, said,
“During the quarter, we reinvigorated sales of AVONEX, our flagship product
for treatment of relapsing forms of multiple sclerosis (MS). At the end of
2000, more than 97,000 patients throughout the world were on AVONEX therapy.
This represents more patients currently on AVONEX than on all other MS drugs
“Everything we have learned about AVONEX continues to reinforce its proven
results and usefulness in the treatment of MS. In particular, we recently
reported the CHAMPS study, which was published in September 2000 in the New
England Journal of Medicine. This study evaluated the effects of AVONEX in
reducing the rate at which individuals at high risk develop clinically
definite MS and achieved its primary endpoint.
“Biogen is now poised to take the next major steps toward becoming a
global, multi-product organization. We have completed dosing all patients in
our Phase III trials of AMEVIVE(TM) (alefacept) in chronic plaque psoriasis
and expect to have data from these trials by mid-year. Pending successful
conclusion of the trials, we anticipate product registration and launch in the
second half of 2002. We also expect to report Phase II results from studies
of ANTEGREN(R) (natalizumab) in MS and Crohn’s disease during the first
quarter of this year in conjunction with our partner, Elan Pharmaceuticals.
“In addition, we expect to double our clinical pipeline this year with the
introduction of three new drugs into the clinic. They are Adenosine A1 small
molecule antagonist for congestive heart failure, soluble lymphotoxin beta
receptor for autoimmune disease and interferon beta gene therapy for glioma.
In addition, we currently have 20 programs in our research pipeline.
“Biogen is a world leader in biology, and we are bringing this expertise
to our research programs. In particular, we are applying our knowledge of
biology to identifying drug targets and pathways that have come out of the
genomics revolution — a “biomining” approach that differs from the
“datamining” approach some other companies are applying. During the past
year, we refocused our research priorities into four key areas in which we
have a competitive research advantage and where there are significant clinical
and commercial opportunities — autoimmune disease, neurological disease,
cancer and fibrosis.”
For 2001, the Company expects AVONEX sales growth rate to be in the mid-
teens and earnings per share will be in a range of $1.90 – $1.98.
In addition to historical information, this press release contains
forward-looking statements within the meaning of the “safe harbor” provisions
of the Private Securities Litigation Reform Act of 1995. Reference is made in
particular to statements regarding review of data related to the study with
regulatory authorities. These statements are based on the Company’s current
beliefs and expectations as to such future outcomes. Factors which could cause
actual results to differ materially from the Company’s current expectations
include the risk that obstacles may arise 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 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.
The most common side effects associated with AVONEX treatment are flu-like
symptoms, muscle ache, fever and chills. Other common side effects seen, but
not statistically different between AVONEX and control groups, were headache,
pain and asthenia (weakness). These side effects usually go away within a day
after the injection and occur less often as the treatment continues.
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(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 ( Prescribing Information ).
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
NOTE: The Company’s conference call to discuss the data will be broadcast
via the internet at 5:00pm EST on Wednesday, January 17, 2001, and will be
accessible through the investor relations section of Biogen’s homepage,
Financial Results For The Fourth Quarter of 2000 Condensed Consolidated Statements Of Income (in thousands, except per share amounts) Three Months Ended Twelve Months Ended December 31, December 31, 2000 1999 2000 1999 REVENUES Product $203,232 $180,016 $761,079 $620,636 Royalties 42,104 45,339 165,373 173,799 Total Revenues 245,336 225,355 926,452 794,435 COST AND EXPENSES Cost of revenues 32,753 30,676 125,198 111,005 Research and development 73,635 60,267 302,840 221,153 Selling, general and administrative 46,209 38,682 170,058 146,026 Total Cost and Expenses 152,597 129,625 598,096 478,184 Income from Operations 92,739 95,730 328,356 316,251 Other income (expense), net 9,784 7,759 158,749 12,765 INCOME BEFORE INCOME TAXES 102,523 103,489 487,105 329,016 Income Taxes 30,753 34,140 153,528 108,566 NET INCOME $71,770 $69,349 $333,577 $220,450 BASIC EARNINGS PER SHARE $0.49 $0.46 $2.24 $1.47 DILUTED EARNINGS PER SHARE $0.47 $0.44 $2.16 $1.40 SHARES USED IN CALCULATING: BASIC EARNINGS PER SHARE 147,894 150,130 148,743 149,921 DILUTED EARNINGS PER SHARE 152,846 157,848 154,602 157,788 Condensed Consolidated Balance Sheets (in thousands) Dec. 31, 2000 Dec. 31, 1999 ASSETS Current Assets Cash and marketable securities $682,412 $654,539 Accounts receivable, net 143,178 137,363 Other current assets 102,681 118,324 Total current assets 928,271 910,226 Property and equipment, net 400,429 239,777 Other assets 103,156 127,970 $1,431,856 $1,277,973 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $221,021 $190,270 Long term debt & liabilities 104,433 108,173 Shareholders' equity 1,106,402 979,530 $1,431,856 $1,277,973