07.11.16
Headquarters: Cambridge, MA
twitter.com/biogenidec
www.biogenidec.com
Headcount: 7,350
Year Established: 2003
Revenues: $10,764 (+11%)
Net Income: $3,547 (+21%)
R&D: $2,013 (+6%)
Top Selling Drugs
Coming off another great year, Biogen continued its growth in 1Q16 with revenues up 7% to $2.7 billion and earnings of $971 million, up 18%. Growth was driven by Tecfidera, up 15% to $946 million, Eloctate sales of $108 million, and Alprolix sales of $75 million. While revenues were partially offset by a 19% drop in Avonex sales, Tysabri brought in $477 million, up 3%.
Among recent pipeline advances, Biogen and AbbVie won FDA approval for Zinbryta (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS). Zinbryta significantly reduced the annualized relapse rate, the primary endpoint of studies, by 45% compared to Avonex and by 54% compared to placebo.
EU approval for Zinbryta is on the horizon as well and some analysts expect the drug to reach peak sales of around $500 million. While Zinbryta offers greater convenience, Biogen already markets its every-two-weeks MS treatment Plegridy, approved in 2014, and both drugs will compete with Avonex.
Biogen’s MS franchise is not without its challenges. Tecfidera, despite impressive sales, has seen a slowing growth rate, and earlier this year Europe revoked one of its key patents. Biogen is appealing the decision but stands to lose as much as $1 billion in annual sales if it fails.
On the biosimilar front, Biogen won key approvals in the EU for Flixabi, an infliximab biosimilar referencing Remicade, developed by the joint venture Samsung Bioepis, and Benepali, the first Etanercept biosimilar referencing Enbrel.
Among Biogen’s late-stage assets, Aducanumab, its investigational drug for early Alzheimer’s disease was accepted into the EMA PRIority MEdicines (PRIME) program, and is currently being evaluated in two global Phase III studies for safety and efficacy in slowing cognitive impairment and disease progression.
Finally, Biogen recently unveiled plans to spin off its hemophilia business as part of an effort to focus on neurology therapies. In January, Biogen and development partner Sobi received EU approval for ELOCTA for the treatment of haemophilia A, and in May, Alprolix, an extended half-life therapy for haemophilia B was approved. The two drugs, previously approved in the U.S., had combined revenues of $640 million during the twelve-month period ended March 31, 2016. Biogen says the spin-off will result in two lean, profitable companies.
twitter.com/biogenidec
www.biogenidec.com
Headcount: 7,350
Year Established: 2003
Revenues: $10,764 (+11%)
Net Income: $3,547 (+21%)
R&D: $2,013 (+6%)
Top Selling Drugs
Drug | Indication | 2015 Sales | (+/-%) |
Avonex | multiple sclerosis | $2,630 | -13% |
Tecfidera | multiple sclerosis | $3,638 | 25% |
Tysabri | multiple sclerosis | $1,886 | -4% |
Plegridy | multiple sclerosis | $339 | n/a |
Coming off another great year, Biogen continued its growth in 1Q16 with revenues up 7% to $2.7 billion and earnings of $971 million, up 18%. Growth was driven by Tecfidera, up 15% to $946 million, Eloctate sales of $108 million, and Alprolix sales of $75 million. While revenues were partially offset by a 19% drop in Avonex sales, Tysabri brought in $477 million, up 3%.
Among recent pipeline advances, Biogen and AbbVie won FDA approval for Zinbryta (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS). Zinbryta significantly reduced the annualized relapse rate, the primary endpoint of studies, by 45% compared to Avonex and by 54% compared to placebo.
EU approval for Zinbryta is on the horizon as well and some analysts expect the drug to reach peak sales of around $500 million. While Zinbryta offers greater convenience, Biogen already markets its every-two-weeks MS treatment Plegridy, approved in 2014, and both drugs will compete with Avonex.
Biogen’s MS franchise is not without its challenges. Tecfidera, despite impressive sales, has seen a slowing growth rate, and earlier this year Europe revoked one of its key patents. Biogen is appealing the decision but stands to lose as much as $1 billion in annual sales if it fails.
On the biosimilar front, Biogen won key approvals in the EU for Flixabi, an infliximab biosimilar referencing Remicade, developed by the joint venture Samsung Bioepis, and Benepali, the first Etanercept biosimilar referencing Enbrel.
Among Biogen’s late-stage assets, Aducanumab, its investigational drug for early Alzheimer’s disease was accepted into the EMA PRIority MEdicines (PRIME) program, and is currently being evaluated in two global Phase III studies for safety and efficacy in slowing cognitive impairment and disease progression.
Finally, Biogen recently unveiled plans to spin off its hemophilia business as part of an effort to focus on neurology therapies. In January, Biogen and development partner Sobi received EU approval for ELOCTA for the treatment of haemophilia A, and in May, Alprolix, an extended half-life therapy for haemophilia B was approved. The two drugs, previously approved in the U.S., had combined revenues of $640 million during the twelve-month period ended March 31, 2016. Biogen says the spin-off will result in two lean, profitable companies.