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 Avonex, a popular drug for the treatment of relapsing multiple sclerosis (MS); Tysabri, a drug treatment for MS and Crohn's disease; Rituxan, a monoclonal antibody developed jointly with Genentech that treats non-Hodgkin's lymphoma and rheumatoid arthritis; and Fumaderm, a psoriasis drug marketed in Germany. Other products include Plegridy for MS and Alprolix for hemophilia B. Founded in 1978, Biogen serves customers in more than 90 countries.
Among Biogen's top selling drugs, Avonex is sold in markets around the globe and accounts for 30% of annual revenues. The firm's Avonex pen is a single-use autoinjector version of the drug for once-weekly dosing.
Tecfidera (which accounts for another 30% of revenue) 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).
Another top-selling global drug is Tysabri, bringing in about 20% of revenues. Tysabri was co-marketed with Elan until 2013 when Biogen purchased full rights. 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 the Genentech partnership account for another 20% 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.
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, BIIB037 and (in collaboration with Eisai) BAN2401 for Alzheimer's disease, and STX-100 for idiopathic pulmonary fibrosis. The company is partnering with AbbVie Biotherapeutics to develop and commercialize Zinbryta, another MS treatment; it also has a collaboration agreement with Acorda to develop and market MS treatment products containing fampridine outside the US. In addition, Biogen has three separate agreements with Isis 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 accounted for about 70% 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 account for more than 10% of the firm's total revenues. 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).
Biogen's revenues and profits have steadily risen over the years as sales of its products have increased, including a 40% increase in revenues to some $9.7 billion in 2014 due to significant growth in Tecfidera sales. Revenues related to Tysabri sales also grew that year, primarily due to price increases.
Net income spiked 58%, from $1.8 billion to $2.9 billion, due to revenue growth and the absence of collaboration expenses after Biogen bought Tysabri from Elan (now owned by Perrigo) and launched Tecfidera. Cash from operations has also shown steady growth over the last five years including in 2014 when the company reported a 25% increase to $2.9 billion due to higher profits and a decline in cash used in inventory.
The company pursues growth through a combination of internal R&D efforts and through partnerships, alliances, and acquisitions. R&D expenses totaled $1.9 billion in 2014, up from $1.4 billion in 2013 and $1.3 billion in 2012.
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), Isis Pharmaceuticals (spinal muscular atrophy) and other drugmakers, and it continuously looks to expand its pipeline through acquisitions and partnerships.
The company's newest treatments include those for hemophilia (Eloctate and Alprolix) and MS (Tecfidera).
Biogen continues to initiate agreements with other firms to develop new products. In 2014, it 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.
Although Biogen's annual revenues were up for 2014, sales of Tecfidera slowed down during 2015, the same year that Tysabri failed in a late-stage clinical trial for secondary progressive MS. The company responded to these setbacks 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, Biogen announced plans to spin off its growing hemophilia operations into a separate, publicly traded company. 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 2013 Biogen purchased full rights to Tysabri from partner Elan for some $3.3 billion. Following the transaction, the companies no longer split profits from the sales of the drug.
In 2015 the company agreed to buy UK-based Convergence Pharmaceuticals, a clinical-stage biopharmaceutical, to gain access to that firm's CNV1014802 candidate for the treatment of trigeminal neuralgia and sciatica.