With its pipeline full of biotech drugs, Biogen (formerly Biogen Idec) aims to meet the unmet needs of patients around the world. The biotech giant is focused on developing treatments in the areas of immunology and neurology. Its product roster includes best-selling drugs Tecfidera and Avonex (interferon) for the treatment of relapsing multiple sclerosis (MS); Tysabri, a drug treatment for MS and Crohn's disease; Fampyra, which improves walking in adults with MS; and Eloctate, a treatment for hemophilia. Other products include Plegridy for MS and Alprolix for hemophilia B. Founded in 1978, Biogen serves customers in more than 90 countries.
Biogen's top selling drug, Tecfidera is sold in markets around the globe and accounted for 34% of annual revenues in 2015. It is an oral therapy marketed in the US for the treatment of patients with relapsing forms of MS. It is sold in Europe for patients with relapsing-remitting MS (RRMS).
The firm's next-best seller, Avonex (interferon), accounted for 27% of revenue in 2015. A treatment to improve walking in adults with MS, the Avonex pen is a single-use auto-injector version of the drug for once-weekly dosing.
Another top-selling global drug is Tysabri, bringing in 18% of revenue. Despite the drug's troubled regulatory history -- the drug can only be prescribed under a strict risk management plan due to the possible side effect of a rare brain condition -- the company continues to pursue additional uses for the drug.
Rituxan sales conducted through a partnership with Genentech account for another 12% of sales and are classified as "unconsolidated joint business" revenues. In addition to non-Hodgkin's lymphoma and rheumatoid arthritis, Rituxan is approved to treat leukemia, follicular lymphoma, and vasculitis.
Another drug, MS treatment Fampyra (also known as Ampyra), is sold in partnership with Acorda Therapeutics. The company is also co-marketing Zinbryta, another MS treatment, in the US with AbbVie.
In addition to gaining revenue from the development and sales of its products (both directly and through partnerships), Biogen receives royalties on some patents it has licensed to other companies. For instance, The Medicines Company pays royalties on sales of anticoagulant Angiomax.
Products in Biogen's pipeline include the anti-LINGO program for MS, BAN2401 (in collaboration with Eisai) for Alzheimer's disease, and STX-100 for idiopathic pulmonary fibrosis. In addition, Biogen has three separate agreements with Ionis to develop and commercialize antisense therapeutics for the treatment of myotonic dystrophy type 1.
Biogen has offices in the US, Australia, Canada, Japan, the US, and several European countries. It has direct sales operations in about 30 countries and operates through distribution partners in another 60 countries.
The US is Biogen's largest market, bringing in 61% of total revenue in 2015. Europe follows, with Germany alone representing 6% of revenue and the rest of Europe bringing in 14% of revenue.
Sales and Marketing
The company primarily distributes its products in the US through wholesale pharmaceutical distributors, mail-order specialty distributors, and shipping service providers. Two wholesale distributors, AmerisourceBergen and McKesson, each accounted for more than 10% of the firm's total revenue in 2015. Outside of the US, distribution varies, but includes wholesale pharmaceutical distributors and third-party distribution partners.
Avonex is marketed through Biogen's direct sales force to specialist physicians and hospitals in North America, Europe, and select other countries around the globe. The company also handles global marketing efforts for Tysabri. Genentech handles sales and marketing duties for Rituxan, while marketing duties for Fampyra are split with Acorda (Biogen sells the drug in Europe and Canada, while Acorda sells it in the US).
In 2015, Biogen spent $108.6 million on advertising, up from $92.9 million in 2014 and $72.7 million in 2013.
Biogen's revenues and profits have steadily risen over the years as sales of its products have increased. In 2015, net revenue rose 11% to $10.8 billion, largely due to sales of Tecfidera and Eloctate. Tecfidera sales rose 25% that year as sales in existing markets increased; the drug also continues to be launched in new markets, boosting sales even further. Eloctate sales skyrocketed in 2015, rising by nearly 450% to $319.7 million versus $58.4 million in 2014.
Net income has also been on the rise and, in 2015, it increased 21% to $3.6 billion due to the higher revenue and a decline in selling, general, and administrative expenses (including a drop in corporate giving). Cash flow from operations rose 26% to $3.7 billion that year.
The company pursues growth through a combination of internal R&D efforts and through partnerships, alliances, and acquisitions. R&D expenses totaled $2 billion in 2015, up from $1.9 billion in 2014 and $1.4 billion in 2013.
Biogen's pipeline of drug candidates is focused on treatments for central nervous system ailments including Alzheimer's, MS, amyotrophic lateral sclerosis (ALS), hemophilia, neuropathic pain, and lupus. In addition to proprietary candidates, the company has collaborative development candidates with Genentech, Portola Pharmaceuticals (lupus and rheumatoid arthritis), Ionis Pharmaceuticals (spinal muscular atrophy) and other drugmakers, and it continuously looks to expand its pipeline through acquisitions and partnerships.
In 2014, Biogen entered into an agreement with Eisai to jointly develop E2609 and BAN2401, two Eisai candidates for the treatment of Alzheimer's disease. It also entered into an R&D and commercialization agreement with Sangamo BioSciences, through which the partners will develop candidates for the treatment of sickle-cell disease and beta-thalassemia. The following year Biogen entered into a collaboration with Fondazione Telethon and Ospedale San Raffaele to develop gene therapies for the treatment of hemophilia A and B.
In 2015, Tysabri failed in a late-stage clinical trial for secondary progressive MS. The company responded to the setback by initiating certain restructuring efforts, including stopping tests for Tysabri's effectiveness against secondary progressive MS, as well as stopping test for pipeline drug anti-TWEAK's effectiveness against lupus nephritis. Biogen also cut some 880 employees (about 11% of its workforce) that year. In 2016, the company's anti-LINGO MS drug failed in mid-stage trials; Biogen is exploring additional studies for the treatment.
Also in 2016, Biogen announced plans to spin off its growing hemophilia operations into a separate, publicly traded company named Bioverativ. Its marketed products will include Eloctate and Alprolix; the new firm will also continue with discovery and development of hemophilia therapies utilizing XTEN technology.
Mergers and Acquisitions
Biogen has expanded its operations through purchases of drug development firms, as well as by purchasing commercialized and development-stage drugs. In 2015 the company acquired UK-based Convergence Pharmaceuticals, a clinical-stage biopharmaceutical, for $200.1 million. The deal added Convergence's CNV1014802 candidate (for the treatment of trigeminal neuralgia and sciatica) to Biogen's pipeline.