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Biogen Idec Delivers Double-Digit Top & Bottom-Line Growth In Second Quarter 2013

Stocks in this article: BIIB

AVONEX (interferon beta-1a)

AVONEX remains one of the most prescribed treatments for relapsing forms of MS worldwide and continued to gain market share during the second quarter within the injectable segment of the MS market.

Additional Pipeline Development Highlights

During the second quarter, Biogen Idec achieved a number of milestones toward the development of its research and late-stage pipeline:

  • In May 2013, Biogen Idec announced it submitted a BLA to the FDA for approval of PLEGRIDY™ (peginterferon beta-1a), the Company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis. In June 2013, Biogen Idec also submitted a Marketing Authorisation Application for PLEGRIDY to the EMA. Both filings have been accepted by the respective regulatory authorities and the Company anticipates approval and commercial launch in mid-2014.
  • In May 2013, Biogen Idec also announced that the FDA accepted the Company’s BLA for the marketing approval of ELOCTATE™ (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. ELOCTATE is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of providing long-lasting protection and reducing the burden of treatment for patients with this chronic condition. The Company anticipates a second quarter 2014 approval and commercial launch of ELOCTATE in the United States.
  • In June and July 2013, Biogen Idec showcased new data from a number of development and early-stage research programs at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress. Researchers presented 33 abstracts and 10 presentations on clinical and pre-clinical research in hemophilia, the breadth of which reflects the Company’s commitment to innovation and the scientific advancement of hemophilia treatment and care. Data presented included new analyses of the phase 3 A-LONG study of ELOCTATE and B-LONG study of ALPROLIX™, results of which add to the growing body of evidence supporting the potential efficacy and safety of these long-lasting clotting factor candidates for the treatment of hemophilia A and B. The ISTH Congress was held from June 29 through July 4 in Amsterdam, The Netherlands.

Conference Call and Webcast

The Company's earnings conference call for the second quarter will be broadcast via the internet at 8:00 a.m. EDT on July 25, 2013, and will be accessible through the Investors section of Biogen Idec's homepage, www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the conference call and will be subsequently available on the website for one month.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the Company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.

Safe Harbor

This press release contains forward-looking statements, including statements about 2013 financial guidance, potential product launches and timing thereof, regulatory actions, anticipated clinical trial data readouts, and the commercialization and impact of potential treatments. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements.

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