Amgen is among the biggest of the biotechs. The company uses cellular biology and medicinal chemistry to target cancers, kidney ailments, inflammatory disorders, and metabolic diseases. Its top protein-based therapeutic products include Neulasta and Neupogen (both used as anti-infectives in cancer patients), Aranesp and Epogen (used to fight anemia in chronic kidney disease and cancer patients), and Enbrel for rheumatoid arthritis. In addition, Amgen has extensive drug research and development programs. Its products are marketed in more than 100 countries to doctors, hospitals, pharmacies, and other health care providers.
Amgen's six therapeutic areas of focus are oncology and hematology, cardiovascular disease, inflammation, bone health, nephrology, and neuroscience.
In addition to Neulasta, Neupogen, Aranesp, Epogen, and Enbrel, some of the company's marketed drugs include XGEVA (for the prevention of skeletal-related events) and Sensipar/Mimpara (for the treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis). Amgen also markets Vectibix, Nplate, Kyprolis, BLINCYTO, Repatha, Corlanor, and IMLYGIC.
On the pipeline, Amgen has a few products in phase 3 testing: Its GAUSS-3 study is evaluating Repatha for lowering cholesterol in patients who can't tolerate statins; ARCADE is being studied as a treatment for anemic patients with myelodysplastic syndrome (MDS); and the ASPIRE study is comparing treatments for relapsed multiple myeloma.
Amgen has a 50-50 partnership with Japanese brewer and drugmaker Kirin through which it develops and out-licenses certain product rights. Additionally, it has a collaboration with AstraZeneca to develop and commercialize some of the monoclonal antibodies from its clinical inflammation portfolio. The company is also working with UCB to develop and commercialize romosozumab, which has shown positive results for the treatment of osteoporosis in postmenopausal women. Amgen is also working with Bayer HealthCare to develop and commercialize Nexavar around the world.
Amgen operates distribution centers in the US (primarily in California and Kentucky) and the Netherlands. Though its products are marketed in over 100 countries (primarily in North America and Europe), the US accounts for about 80% of revenue. In 2015, Amgen continued to expand into growth markets, adding new markets in Latin America, Asia, and the Middle East.
The company operates manufacturing facilities in Brazil, Ireland, the Netherlands, Puerto Rico, Singapore, and Turkey.
Sales and Marketing
Sales of the company's top offerings -- Neulasta, Enbrel, Aranesp, Epogen, and Sensipar/Mimpara -- together account for more than 70% of annual revenues. Most of these sales take place within the US market, where they are distributed through wholesalers including AmerisourceBergen, McKesson, and Cardinal Health. Amgen employs a direct sales force in the US, Canadian, and European markets to promote its products; it uses partners and independent representatives in other global markets. For instance, Kirin sells the Neupogen/Neulasta compunds in Asian markets, and Enbrel is marketed internationally by Pfizer.
Amgen also markets certain of its products directly to consumers using print, online, and television advertising. With partners, the company markets products to health care providers including physicians, hospitals, and pharmacies.
Sales to AmerisourceBergen, McKesson, and Cardinal Health each account for more than 10% of total revenue.
The company’s revenue has been trending up for several years and 2015 didn't buck the trend. Revenue rose 8% to $21.7 billio, as all products had increased sales except Epogen and Neupogen. Gains were largely due to an increase in average net sales prices and driven by higher demand. Epogen and Neupogen sales were down 9% each, due to decreased demand in the US.
Net income, which has also been rising, increased 35% to $6.9 billion in 2015 thanks to the higher revenue and lower research and development expenses. Cash flow from operations, like net income, has been climbing; it rose 6% to $9.1 billion in 2015.
To prepare for the future loss of patent protection on its top products in coming years, Amgen is launching new products it hopes will best its bestsellers, and expanding market share outside of the US. The company expects an increase in competition in future years due to US health care reform legislation that aims to allow for the approval of biosimilars (generic biotech drugs) in a shorter amount of time. Such rules already apply in the European Union, where the firm faces competition from generic biologics on products including Aranesp, Neupogen, and Neulasta. In fact, the company is itself now engaging in the world of biosimilars. It has nine biosimilars in development, and it established a partnership with Daiichi Sankyo in 2016 to commercialize nine biosimilars (including copies of adalimumab, bevacizumab, and trastuzumab) in Japan.
In 2014 it reacquired the rights to several medications in emerging markets and made good on its plan to be in 75 markets by 2016, two years ahead of schedule. It also received FDA approval to market its bispecific T-cell engager (BiTE) immunotherapy BLINCYTO to treat a certain form of acute lymphoblastic leukemia, and it gained European approval to market Repatha for the treatment of uncontrolled cholesterol.
Looking for other new products, Amgen's research and development activities are focused on identifying and validating targets through human genetics. Amgen boasts a bulging internal R&D pipeline of compounds target cancer, inflammation, kidney disease, and neurological, cardiovascular, and bone and blood disorders, mostly based on biotech (molecular and cellular biology) technologies. In addition to its proprietary efforts, the company expands its product line through periodic acquisitions and partnerships. For example, Amgen has co-development deals with drugmakers including Takeda Pharmaceutical; it has a neuroscience collaboration with Novartis encompassing Alzheimer's disease and migraine headache studies.
The company also relies on gaining additional approvals on its existing bestsellers to round out its revenue channels and extend their patent protection as long as possible. For example, in addition to being a key player in the rheumatoid arthritis market, Enbrel's sales have climbed as the FDA has approved the drug to be used for psoriasis and other related inflammatory conditions. Amgen also works to shift existing patients over to its newer, next-generation products as patents expire; for instance, as Neupogen begins to face competition from biosimilars in some markets, the company has worked to shift patients over to Neulasta, its newer patent-protected offering for neutropenia (a low white-blood cell condition found in chemotherapy patients). In 2015, the company launched the Neulasta Onpro kit, a new drug delivery option for chemotherapy patients.
As part of its global expansion strategy, in 2014 Amgen completed the construction of a new manufacturing plant in the Tuas Biomedical Park area of Singapore.
In addition, Amgen has been conducting cost-cutting efforts, including the streamlining of facilities and sales of some non-core assets. After selling a couple of non-core plants in previous years, in 2014 the company closed facilities in Washington and Colorado and laid off around 2,900 people, or about 15% of its workforce, to redirect money to upcoming product launches. Amgen aims to keep its operations nimble to minimize losses from patent expirations and other competitive and economic hazards that might impact its operations.
Mergers and Acquisitions
While the US market accounts for almost 80% of annual revenues, Amgen has also been working to extend its reach in international markets. In addition to extending its product offerings into high-growth regions such as Japan, China, Russia, and Africa, the firm has made select international acquisitions. In 2015 the company agreed to buy Netherlands-based Dezima Pharma, a biotechnology firm working on cardiovascular disease treatments. The $1.55 billion deal added Dezima's AMG 899 and Repatha (cholesterol inhibitors for patients with high lipids in the blood) to Amgen's portfolio.