Collaborations Bolster the Company’s Pipeline Development Efforts
Biogen, Inc. (Nasdaq: BGEN)
today reported financial results for the third quarter of 2000. For the three
months ended September 30, 2000, the Company reported net income of
$68,381,000, an increase of 10 percent compared to the same period in 1999,
resulting in $0.44 per share. Revenues for the quarter were $233,754,000, up
12 percent over the third quarter of last year.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
James C. Mullen, Biogen’s President and Chief Executive Officer, said,
“With its proven results and broad-based efficacy, AVONEX(R) remains the
worldwide drug of choice among people with multiple sclerosis (MS) and their
physicians. This quarter, we saw global product revenue growth of 18 percent
year-over-year.
“More than 93,000 patients worldwide now use AVONEX. It is the only MS
treatment that has demonstrated proven results across a broad range of
meaningful clinical measures. As we learn more about AVONEX, the unique
benefits it brings to people with MS expand. At the end of September, our
landmark CHAMPS trial was published in the New England Journal of Medicine,
showing that early treatment with AVONEX significantly reduced the rate at
which individuals at high-risk for MS develop clinically definite multiple
sclerosis (CDMS). Treatment with AVONEX in this group of patients reduced the
rate of development of CDMS by 44 percent versus treatment with placebo and
reconfirmed the significant effect on brain inflammation, with a 91 percent
reduction in the volume of MRI lesions. We are now in the process of a global
registration for this additional indication.
“In addition, the positive results seen in primary progressive MS, a very
aggressive form of the disease, are very encouraging. These results, combined
with the effects previously seen with AVONEX in slowing the decline in
physical and cognitive abilities, reducing relapse rate, and slowing the
atrophy of brain tissue, clearly distinguish AVONEX from other therapies
available for this debilitating disease.
“We continue with aggressive development of our pipeline products. We
completed accrual for the Phase III trial of AMEVIVE(TM) months ahead of
schedule, and if all goes well we are on track to file for regulatory filing
in the second half of 2001. These Phase II data show that AMEVIVE is the
first disease-modifying agent for the treatment of psoriasis that has a long
duration of effect and is well tolerated. Phase III studies are ongoing to
further demonstrate the efficacy and safety of AMEVIVE in this population. We
also expect to bring three new programs into the clinic next year: ADENTRI(TM)
for acute and chronic congestive heart failure, LT beta-receptor for
autoimmune diseases, and interferon beta gene therapy for glioma. In
addition, we expect to begin Phase III trials of ANTEGREN(R) in MS and Crohn’s
disease in the second half of next year, pending successful completion of the
Phase II trials.
“During the past quarter, we intensified our investment in the important
new platform technology of genomics and expanded our long-term pipeline
capabilities and basic research programs with several collaborative
agreements. These include the Elan collaboration, a multi-year research and
development collaboration with Eos Biotechnology in the area of breast cancer,
and a multi-product gene-therapy development and commercialization
collaboration with Targeted Genetics.”
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 plans for future regulatory filings and
commencement of clinical trials. These statements are based on the Company’s
current beliefs and expectations as to such future outcomes. Drug development
involves a high degree of risk. Success in early stage clinical trials does
not ensure that later stage or larger scale clinical trials will be
successful. Factors which could cause actual results to differ materially
from the Company’s current expectations include the risk that a particular
product may not show therapeutic effect or an acceptable safety profile in
subsequent trials or may not meet applicable regulatory standards, or that
problems or delays may arise in preparation for or during clinical trials or
in the course of the development, testing or manufacturing of the product.
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 ( 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
http://www.biogen.com.
AVONEX(R) (Interferon beta-1a) is a registered trademark of Biogen, Inc.
AMEVIVE(TM) (alefacept) and ADENTRI(R) (adenosine A1 antagonist inhibitor) is
a trademark of Biogen, Inc. ANTEGREN(R) (natalizumab) is a registered
trademark of Elan Corporation. AVONEX(R) is approved in the U.S. and in most
other countries around the world for the treatment of relapsing forms of
multiple sclerosis.
NOTE: The Company’s earnings conference call for the third quarter will
be broadcast via the Internet at 5:00 p.m. EST on Tuesday, October 10, 2000,
and will be accessible through the investor relations section of Biogen’s
homepage, http://www.biogen.com.
Financial Results For The Third Quarter of 2000 Condensed Consolidated Statements Of Income (in thousands, except per share amounts) Three Months Ended Nine Months Ended September 30, September 30, 2000 1999 2000 1999 REVENUES Product $193,242 $163,448 $557,847 $440,620 Royalties 40,512 44,983 123,269 128,460 Total Revenues 233,754 208,431 681,116 569,080 COST AND EXPENSES Cost of revenues 33,027 28,498 92,445 80,329 Research and development 94,498 58,958 229,205 160,886 Selling, general and administrative 41,745 36,484 123,849 107,344 Total Cost and Expenses 169,270 123,940 445,499 348,559 Income from Operations 64,484 84,491 235,617 220,521 Other income (expense), net 33,204 8,092 148,965 5,006 INCOME BEFORE INCOME TAXES 97,688 92,583 384,582 225,527 Income Taxes 29,307 30,554 122,775 74,426 NET INCOME $68,381 $62,029 $261,807 $151,101 BASIC EARNINGS PER SHARE $0.46 $0.41 $1.76 $1.01 DILUTED EARNINGS PER SHARE $0.44 $0.39 $1.69 $0.96 SHARES USED IN CALCULATING: BASIC EARNINGS PER SHARE 148,074 150,108 149,026 149,851 DILUTED EARNINGS PER SHARE 153,702 158,198 155,188 157,768 Condensed Consolidated Balance Sheets (in thousands) Sept. 30, 2000 Dec. 31, 1999 ASSETS Current Assets Cash and marketable securities $659,034 $654,539 Accounts receivable, net 145,690 137,363 Other current assets 124,516 118,324 Total current assets 929,240 910,226 Property and equipment, net 350,704 239,777 Other assets 123,112 127,970 $1,403,056 $1,277,973 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $236,559 $190,270 Long term debt & liabilities 105,291 108,173 Shareholders' equity 1,061,206 979,530 $1,403,056 $1,277,973