MANAGEMENT CONFIDENT IN FIRST CALL 2001 CONSENSUS OF $1.90
THIRD QUARTER 2001 EARNINGS PER SHARE
INCREASED TO $0.46 FROM $0.44 IN 2000
MANAGEMENT CONFIDENT IN FIRST CALL 2001 CONSENSUS OF $1.90
AVONEX® (Interferon beta-1a) sales up 29% over third quarter 2000.
– – –
AMEVIVE® (alefacept) regulatory filings officially accepted
for review by U.S. and European regulators.
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Promising Phase II ANTEGREN® (natalizumab) data presented in multiple sclerosis;
Phase III trials in Crohn’s Disease and MS planned for fourth quarter start.
– – –
Biogen and ICOS begin clinical co-development
of oral LFA-1 antagonists for immuno-inflammatory conditions.
For Immediate Release
Cambridge, MA (October 16, 2001) — Biogen, Inc. (NASDAQ: BGEN) today reported earnings per share increased to $0.46 for the third quarter of 2001, compared with $0.44 for the same period last year. Net income increased to $70 million from $68 million in the third quarter of 2000. Including royalties, total revenues for the quarter were $265 million, a 13% increase over the same period in 2000.
Included in Biogen’s Q3 reported financials was an $8 million upfront fee paid upon initiation of the ICOS collaboration. Excluding this one-time charge, Q3 EPS was $.49, an 11% increase over operating results for the same period last year. Based on these results, the Company expressed confidence in the First Call consensus for projected full-year operating earnings of $1.90 diluted earnings per share for the full year.
Product revenues for the quarter were $249 million. “Biogen’s revenue growth represents a robust 29% increase in AVONEX sales over the third quarter of last year,” said Biogen President and CEO Jim Mullen. “Our overall Q3 international sales were strong; however, there are some markets – especially in Germany – where we clearly have work to do. Biogen sees opportunities for improved performance in these markets, and we are making additional investments in sales and marketing support to capitalize on those situations.”
During the third quarter, both the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) accepted Biogen’s simultaneously filed submissions for AMEVIVE in moderate-to-severe chronic plaque psoriasis. “Biogen completed these international registration documents less than 100 days after the Phase III AMEVIVE trials completed – an impressive demonstration of this dedicated team’s capability and commitment. We anticipate receiving FDA and EMEA approval for AMEVIVE at the end of 2002 or the first quarter of 2003,” Mullen said.
Other events highlighted by the Company include:
- In September, Biogen and Elan Corporation, plc (NYSE: ELN) presented promising Phase II data for ANTEGREN at the ECTRIMS Conference in Dublin. The companies are on schedule to initiate Phase III ANTEGREN trials (in two indications: Crohn’s Disease and multiple sclerosis) during the fourth quarter.
- In July, Biogen and ICOS Corporation (NASDAQ: ICOS) finalized their agreement to collaborate worldwide on the development and commercialization of orally active, small molecule LFA-1 antagonists (including IC747, currently in a Phase 1 clinical trial) as oral therapeutics for the treatment of inflammatory conditions.
“With AMEVIVE in registration, ANTEGREN entering Phase III trials in two indications, and several programs about to enter Phase II…the breadth and depth of Biogen’s pipeline is rapidly emerging to be one of the industry’s best,” Mullen added.
Forward Looking Statements
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 the anticipated revenues and range of earnings per share for the, the Company’s expectations regarding the commencement of Phase III trials of ANTEGREN and commencement of earlier stage clinical trials of its other development-stage products and the Companies expectations regarding AMEVIVE approval.
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, any change in market acceptance for AVONEX in key markets worldwide, any unexpected negative results related to AVONEX, any unanticipated increase in expenses including in the areas of research and development, the impact of litigation and 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 to differ from the Company’s current expectations include 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. Success in early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful.
Factors which could cause actual results related to AMEVIVE approval to differ materially from the Company’s current expectations include the risk that unexpected concerns may arise from additional data analysis or from additional data or that obstacles may arise or issues be identified 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. In addition, the Company’s expectations with respect to AMEVIVE may be affected by other risks inherent in the biotechnology industry, including other actions by the Food and Drug Administration on regulatory matters, actions by the U.S. Patent and Trademark Office, and uncertainties regarding the status of biotechnology patents and litigation. If AMEVIVE is approved by the FDA, other risks include reimbursement and pricing decisions and the introduction of competitive products, 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.
About Biogen
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 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. (Please see full prescribing information at http://www.avonex.com ) 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. 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® (Interferon beta-1a) is a registered trademark of Biogen, Inc. AMEVIVE® (alefacept) is a registered trademark of Biogen, Inc. ANTEGREN® (natalizumab) is a registered trademark of Elan Corporation.
NOTE: The Company’s earnings conference call for the third quarter will be broadcast via the Internet at 8:30 a.m. EST on Tuesday, October 16, 2001, and will be accessible through the investor relations section of Biogen’s homepage, http://www.biogen.com .
| Financial Results For The Third Quarter of 2001 |