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1
PART I
Item 1. BUSINESS
Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is committed to
unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the
complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions
that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer, Amgen has grown to be one of
the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a
pipeline of medicines with breakaway potential.
Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987. Amgen operates in one business
segment: human therapeutics.
Significant Developments
Following is a summary of significant developments affecting our business that have occurred since the filing of our Annual
Report on Form 10-K for the year ended December 31, 2014, and in early 2016.
Products/Pipeline
Cardiovascular
Corlanor® (ivabradine)
• In April 2015, we announced that the U.S. Food and Drug Administration (FDA) granted approval of Corlanor® to reduce
the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left
ventricular ejection fraction percent, who are in sinus rhythm with resting heart rate beats per minute and either
are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.
Repatha® (evolocumab)
• In July 2015, we announced that the European Commission (EC) granted marketing authorization for Repatha® for the
treatment of high cholesterol, as an adjunct to diet:
In combination with statins or other lipid-lowering therapies in patients unable to control their low-density
lipoprotein cholesterol (LDL-C) with maximum tolerated statin doses, or
Alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a
statin is contraindicated.
Repatha® is also approved in the European Union (EU) in combination with other lipid-lowering agents in patients with
homozygous familial hypercholesterolemia (age 12 and over). The effect of Repatha® on cardiovascular morbidity and
mortality has not been determined.
• In August 2015, we announced that the FDA granted approval of Repatha® as an adjunct to diet and maximally tolerated
statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic
cardiovascular disease, who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering
therapies for the treatment of patients with homozygous familial hypercholesterolemia, who require additional lowering
of LDL-C. The effect of Repatha® on cardiovascular morbidity and mortality has not been determined.
• In September 2015, we announced that we submitted an application to the FDA for a single-dosing option for the monthly
administration of Repatha®. The FDA has set a July 10, 2016, Prescription Drug User Fee Act (PDUFA) target action
date as a goal for the completion of their review of our application.
• In January 2016, we, together with our joint venture partner Astellas Pharma, Inc., announced that the Japanese Ministry
of Health, Labour and Welfare approved Repatha® for the treatment of patients with familial hypercholesterolemia or
hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase
inhibitors (statins).
• In February 2016, we announced that the phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody
in Statin Intolerant Subjects-3) trial evaluating Repatha® in patients with high cholesterol who cannot tolerate statins,
met its co-primary endpoints.