Amgen 2015 Annual Report Download - page 48

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• We continue to innovate with patient- and provider-friendly delivery systems to differentiate our products. The Neulasta®
Onpro™ kit was approved by the FDA at the end of 2014 and now represents approximately one fourth of our U.S.
Neulasta® business. We also submitted applications to regulators, including the FDA and EMA, for a single-dosing option
for the monthly administration of Repatha®.
• In 2015, we continued to execute the transformation and process improvement efforts announced in 2014. As part of
these efforts, we committed to a more focused operating model. Our transformation and process improvement efforts
across the Company have enabled us to reallocate resources to fund many of our innovative pipeline and growth
opportunities to deliver value to patients and shareholders.
• Finally, we continued returning capital to shareholders in 2015 through the payment of dividends and stock repurchases.
We paid dividends of $0.79 per share of common stock in each of the four quarters of 2015, representing a 30% increase
over the quarterly dividend paid in each of the four quarters of 2014. In December 2015, we declared a dividend of $1.00
per share of common stock for the first quarter of 2016, payable in March 2016, representing a 27% increase over the
quarterly dividends paid in 2015. We also repurchased 12 million shares of our common stock throughout 2015 at an
aggregate cost of $1.9 billion. As of December 31, 2015, $4.9 billion remained available under the Board of Directors-
approved stock repurchase program.
We believe that we are uniquely positioned for the opportunities arising in biology and to deliver our strategy focusing on
the areas of oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience. We have
near- and long-term opportunities ahead, including: (i) successfully executing on new product launches, (ii) advancing our robust
pipeline with new innovative biologics and new delivery systems, (iii) the development, approval and launch of our biosimilars
and (iv) advancing the next-generation manufacturing of high quality biologics. We expect our legacy products to continue to
generate significant cash flows. In addition, we continue to focus on collaborating with innovators and value-creating business
development activities to expand our approach to deliver significant impact for patients and advance programs where there remains
high unmet medical need. Finally, we continue to expand into new geographic growth markets, enabling us to be present in over
100 countries.
Our business will continue to face various challenges. Certain of our products will face increasing competitive pressure as
a result of competitive product launches, including from biosimilars. 2016 is the first full year we are competing without patent
protection on several of our principal products in the United States. For additional information, including information on the
expiration of patents for various products, see Part I, Item 1. Business-Marketing, Distribution and Selected Marketed Products-
Patents and see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition.
Current global economic conditions also pose challenges to our business, including continued pressure to reduce healthcare
expenditures. Efforts to reduce healthcare costs are being made by third-party payers including governments and private payers.
In the United States, various actions have been taken aimed at reducing healthcare spending. The continuing prominence of U.S.
budget deficits increases the risk that taxes, fees, rebates, or other federal measures that would further reduce our revenues or
increase our expenses may be enacted. As a result of global economic conditions, as well as public and private health care provider
focus, the industry continues to experience significant pricing pressures and other cost containment measures.
Our long-term success depends to a great extent on our ability to continue to discover, develop and commercialize innovative
products and acquire or collaborate on therapies currently in development by other companies. The discovery and development
of safe and effective new products, as well as the development of additional indications for existing products, are necessary for
the continued strength of our business. We must develop new products over time in order to offset revenue losses when products
lose their exclusivity or competing products are launched, as well as in order to provide for revenue and earnings growth. We
devote considerable resources to R&D activities. However, successful product development in the biotechnology industry is highly
uncertain. We are also confronted by increasing regulatory scrutiny of safety and efficacy both before and after products launch.
Finally, our product sales can be affected by wholesaler and end-user buying patterns. These effects can cause fluctuations
in quarterly product sales and have generally not been significant when comparing full-year product performance to the prior year.
See Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products and Part I, Item 1A. Risk Factors for
further discussion of certain of the factors that could impact our future product sales.