Amgen 2015 Annual Report Download - page 1

Dear Shareholders,
2015 was a momentous year for Amgen. It was a
year in which we delivered impressive financial
results and an unprecedented six innovative new
product offerings to the market, each of which
helped serve patients suffering from serious
illness. In doing so, we demonstrated clear
progress toward our 2018 commitments to
investors and solidly advanced our strategy for
long-term growth.
We achieved record results in revenues and
earnings in 2015. The strengths of our products
were reflected in eight percent revenue growth,
to a record $21.7 billion. Our 19 percent
adjusted earnings per share* growth reflects
tight control of our business and the benefits of
our ongoing transformation efforts—efforts that
were launched company-wide three years ago.
Beyond delivering record operating results for
2015, we made substantial progress along every
dimension of our strategy: advancing innovative
medicines and a portfolio of biosimilar medicines
to address serious illness; expanding our
geographic reach; transitioning to next-
generation manufacturing; improving our biologic
drug delivery systems; and allocating capital to
shareholders while investing substantially in our
business for long-term growth. My intent in this
letter is to briefly address the progress we have
made on each of these strategic elements.
A Clear, Long-Term Strategy for Growth and
Value Creation
Founded 35 years ago, Amgen’s mission is
clear: it is to serve patients. Our strategy is
also clear: it is to develop innovative medicines
that meet important unmet medical needs.
This focus guided us when we developed our
first medicine three decades ago for patients
suffering from kidney disease. The same
unwavering focus inspired us as we launched six
innovative products during the past year,
including our novel medicine for certain patients
at risk for heart disease, the most significant
unmet medical need facing society today.
Indeed, the common denominator for products
we develop in all six focused therapeutic
areas—oncology/hematology, cardiovascular
disease, inflammation, bone health, nephrology
and neuroscience—is the innovative contribution
they make to addressing serious illness.
There is much discussion about the cost of
innovation in healthcare today. Against this
backdrop, we recognize that new medicines
must help alleviate the social and economic
burden of disease. This calls for truly innovative
medicines that provide large beneficial effects,
not just marginal improvements over existing
therapies. This understanding guides our
investment in the business opportunities we
pursue.
We recognize that investing in developing
innovative medicines is risky. And we also
recognize that shareholders who support this
investment require an appropriate return on the
capital they commit to Amgen. We believe we
have a long track record of delivering these
returns, and it is one we aim to maintain.
As a leading provider of innovative medicines,
Amgen advocates for policies and practices that
make our medicines available to all patients for
whom these therapies are appropriate. In some
cases, that means providing direct assistance to
patients who cannot otherwise afford our
medicines.
A New Cycle of Innovative, Breakaway
Medicines Addressing Important
Unmet Needs
In 2015, we built a solid foundation for future
growth with an unprecedented four innovative
launches in oncology and two in cardiovascular
disease. All of these treatments are showing
positive initial reception by physicians, patients
and payers.
In oncology, for instance, one year after launch,
more than one in four of our Neulasta®
(pegfilgrastim) patients in the United States
are already using the recently launched
Neulasta® Onpro™ kit, a convenient, innovative
delivery option for certain patients who have just
completed chemotherapy. And Kyprolis®
(carfilzomib), our treatment for relapsed or
refractory multiple myeloma, a difficult-to-treat
blood cancer, has strengthened its profile as a
backbone of therapy for patients. The extremely
encouraging ASPIRE and ENDEAVOR study data
are now incorporated into Kyprolis®’ US
prescribing information, demonstrating proven
efficacy in three different treatment regimens.
In cardiovascular disease, Repatha®
(evolocumab), the first PCSK9 inhibitor
in the world approved for the treatment of
certain patients requiring additional LDL
cholesterol lowering, is off to a strong
competitive start in the United States and
Europe. We expect that data over the coming
year from our event-driven outcomes study, as
well as from our cardiovascular coronary imaging
study, will allow us to fully articulate the value of
Repatha® and drive further adoption by both
cardiovascular specialists and general
practitioners.
Following behind our six product launches are a
number of additional exciting innovative pipeline
opportunities progressing in focused therapeutic
areas. Building on our long-term investment in
treating kidney disease, for instance, our
nephrology product candidate Parsabiv™
(etelcalcetide) is under review by global
regulators as a potential novel-dose, highly
effective treatment for patients with secondary
hyperparathyroidism receiving hemodialysis.
Meanwhile, romosozumab, now in Phase 3
development, holds potential as a novel
bone-building therapy for patients with
osteoporosis. Two Phase 3 episodic migraine
studies are progressing rapidly for AMG 334,
an antibody uniquely directed at the receptor
for calcitonin gene-related peptide (CGRP).
Also of note in cardiovascular disease is
Letter to
Shareholders
*This is a non-GAAP financial measure. See reconciliation to US generally accepted accounting principles (GAAP) accompanying this letter.
Robert A. Bradway, Chairman and Chief Executive Officer, Amgen Inc.