AVONEX® (Interferon beta-1a) Worldwide Sales Up 21% Over First Quarter 2001
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CDP 571 (TNFα inhibitor), A Late Phase 3 Product Partnership With Celltech,
Bolsters Pipeline With Strategic Fit in Crohn’s Disease and Psoriasis
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FDA Schedules May 23 Advisory Committee Meeting for AMEVIVE® (alefacept),
Now Eight Months Into Review in U.S. and Europe
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2002 Guidance Adjusted to $1.70 – $1.78,
Reflects Costs for the CDP 571 Collaboration With Celltech
And Added Sales & Marketing Spend for AVONEX
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.”
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® (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 product 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 resultsOctober 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.
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® (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