AMGN 3/30/2023 Shareholder/Stockholder Letter Transcript:
2022 Letter to Shareholders | Amgen
LETTER TO
SHAREHOLDERS
Robert A. Bradway, Chairman and
Chief Executive Officer, Amgen Inc.
TO MY FELLOW SHAREHOLDERS:
Amgen performed very effectively in
2022, reaching roughly 10 million patients
around the world with our approved
medicines, advancing many promising
new medicines, delivering strong financial
performance, and keeping the Company
on track to achieve attractive growth
through the end of the decade.
Total revenues in 2022 were up 1% from the
prior year to a record $26.3 billion. We also
achieved record non-GAAP earnings per
share of $17.69, up 27% from the prior year,
and free cash flow of $8.8 billion.1
In a challenging year for the stock
market as a whole, Amgen delivered
total shareholder return in 2022 of 20%,
ahead of the S&P 500 and the NASDAQ
Biotechnology
indices, both
On the Cover: Yolaigna Ortiz works
of which
at Amgen s manufacturing complex in
Juncos, Puerto Rico. Since 1992, Amgen
has invested $4 billion to expand in Puerto
Rico, where we now have more than 2,400
employees and operate 24 hours a day, seven
days a week in our efforts to serve every patient,
every time.
1.
2
Non-GAAP financial measures. See reconciliations to U.S. generally
accepted accounting principles (GAAP) accompanying this letter.
declined last year. We returned
approximately $10.5 billion to shareholders
in 2022 through share repurchases and
dividends, with our dividend increasing for
the eleventh consecutive year, up 10% per
share over 2021.
Our portfolio now includes 27 approved
medicines, 16 of which generated record
2022 sales and nine of which generated
2022 sales in excess of $1 billion. Looking
across our portfolio as a whole, we
achieved healthy volume growth of 9% in
2022, partially offset by a 5% decline in net
selling price.
A number of our innovative medicines
performed particularly well last year,
including our cholesterol treatment
Repatha (sales +16% versus the prior
year), our osteoporosis medicines EVENITY
(+48%) and Prolia (+12%), and several of
our oncology and hematology therapies,
such as Nplate (+27%), BLINCYTO (+24%),
and KYPROLIS (+13%). Two of our newest
innovations LUMAKRAS /LUMYKRAS to
treat a type of non-small cell lung cancer
and TEZSPIRE to treat severe asthma
collectively contributed more than $450
million in 2022 sales, and we are pursuing
additional indications for both.
2022 Letter to Shareholders | Amgen
$26.3B $17.69 $4.4B
2022 Total Revenue
Non-GAAP
Earnings Per Share1
We also offer a number of high-quality
biosimilars that have been prescribed
to patients globally, with the potential to
deliver savings to healthcare systems
that can be reallocated toward innovative
medicines. In 2022, we generated positive
phase 3 clinical trial data for our biosimilar
GAAP Research and
Development Investment
51.5%
Non-GAAP
Operating Margin1,4
Product sales outside the U.S. exceeded $7
billion in 2022, with strong growth coming
from the Asia-Pacific region.
You can find more information about our
products at www.amgen.com/products.3
ADVANCING OUR PIPELINE
We invested $4.4 billion in research
and development in 2022, with three-
As a leader in the fight against cardiovascular disease, Amgen is
partnering with the Family Heart Foundation to highlight the urgent
need for the U.S. healthcare system to prioritize control of LDL (or
"bad") cholesterol, the leading modifiable risk factor for heart
attacks and strokes. "Our real-world analysis of 38 million high-risk
Americans found that less than 30% ever reach their recommended
LDL levels, and many are on no therapy at all," said Katherine
Wilemon (shown at left), the founder and CEO of the Family Heart
Foundation, which conducted the study. "Additionally, only 2% of
high-risk patients are treated with more than one lipid-lowering
therapy even though many patients can't get their LDL to goal with a
single medicine."
candidates to EYLEA , SOLIRIS , and
STELARA ,2 positioning us to be in the first
wave of these launches in the coming
years, which we know is critical to success.
2.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.,
SOLIRIS is a registered trademark of Alexion Pharmaceuticals, and
STELARA is a registered trademark of Janssen Biotech, Inc.
quarters of the molecules in our pipeline
representing potential first-in-class
medicines for serious diseases where
new treatments are very much needed.
I ll highlight three of these medicines that
3.
Reference to our website is not intended to function as a hyperlink,
and the information contained on our website is not intended to be a
part of this letter.
4.
Non-GAAP operating margin is calculated as a percentage of
product sales.
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2022 Letter to Shareholders | Amgen
we are advancing rapidly through clinical
development.
Olpasiran is being studied in patients
with high levels of lipoprotein(a), a type
of "bad" cholesterol that is genetically
determined and cannot be modified by
diet or exercise. Phase 2 data released
in 2022 showed remarkable reductions
in lipoprotein(a) levels of as much
as 95% in patients with established
cardiovascular disease. We are currently
enrolling several thousand patients in a
phase 3 cardiovascular outcomes trial.
In parallel, we are conducting a study
in the U.S. focused on Black Americans,
who are twice as likely to have elevated
lipoprotein(a) levels as non-Hispanic
whites. We are collaborating with the
Morehouse School of Medicine and the
Association of Black Cardiologists on this
study, recognizing that minorities are often
underrepresented in clinical trials despite
being more susceptible to many diseases
than the general population.
Tarlatamab is being studied as a
treatment for relapsed/refractory smallcell lung cancer (SCLC), a very aggressive
disease where the five-year survival rate
is a mere 3%. We released phase 1 data
In a drive to transform how medicines are discovered,
last year showing that tarlatamab
developed, and used, Amgen and its subsidiary deCODE
delivered significant antitumor
Genetics are mining human data at a scale that was once
activity and very encouraging
unimaginable. When Amgen acquired deCODE in 2012, for
overall survival rates and
example, deCODE had accumulated detailed genetic and health
response durability in heavily
information on approximately 100,000 people, all from deCODE s
pretreated SCLC patients.
home country of Iceland. Today, we have that information on 2.5
We are now enrolling
million volunteers from around the world. Our industry-leading human
patients in a potentially
data capabilities allow us to rapidly generate insights into disease
registrational trial of
and human health that inform our first-in-class clinical programs, said
tarlatamab.
David Reese, executive vice president, Amgen R&D. We have an unrivaled
opportunity to move personalized medicine forward.
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2022 Letter to Shareholders | Amgen
AMG 133 is a potential new medicine to
treat obesity, one of the most pressing
public health issues of our time. Once
thought to be a matter of lifestyle
solvable through willpower, obesity is
now understood to be a complex, serious
disease that affects approximately 750
million people worldwide and one which
can lead to a myriad of health problems.
Last year, we announced results from a
phase 1 trial showing that a once-monthly
dose of AMG 133 produced weight loss
that was notable for its degree, rate, and
durability. We have initiated a phase 2 trial
of AMG 133 and are studying additional,
earlier-stage molecules to treat obesity, all
with different mechanisms of action.
ACCESSING EXTERNAL INNOVATION
The three molecules described above are
all multispecific medicines, which we
believe represent the next wave of drug
discovery. Multispecifics are medicines
that have more than one target and can
work in a variety of ways. For example, as
is the case with olpasiran and tarlatamab,
they can act as "molecular matchmakers,"
linking a disease-causing target to a
potent natural effector in our bodies
that acts upon that target. They also can
bind to multiple targets, acting on each
one in a highly specific manner, as is the
case with AMG 133. Multispecifics give us
the potential to tackle the approximately
85% of disease-causing targets in the
body that have long been considered
"undruggable."
In December, we announced an
agreement to acquire Horizon
Therapeutics plc (Horizon) for $27.8 billion.
The acquisition is expected to close in the
first half of this year and will add a number
of first-in-class biologic medicines to our
portfolio that treat serious inflammatory
diseases. Horizon s best-selling product,
TEPEZZA , for example, is the first and
only medicine approved in the U.S. for
the treatment of active thyroid eye
disease, a progressive and potentially
vision-threatening disease that can cause
symptoms such as eye bulging and
double vision.
You can find more information about our
pipeline at www.amgenpipeline.com.5
5.
Reference to our website is not intended to function as a hyperlink,
and the information contained on our website is not intended to be a
part of this letter.
Even as we continue to invest heavily in our
own pipeline, we also recognize that there
is great innovation happening outside our
Company.
In October of last year, we acquired
ChemoCentryx, Inc. (ChemoCentryx)
for approximately $3.8 billion, net of
cash acquired, adding to our portfolio
TAVNEOS , a first-in-class medicine to treat
antineutrophil cytoplasmic autoantibody
(ANCA)-associated vasculitis, an
autoimmune disease that leads to
inflammation and eventual destruction of
small blood vessels in vital organs such as
the kidneys.
The strategic rationale behind both our
acquisition of ChemoCentryx and our
announced Horizon acquisition is the
same. We believe that our decades
of leadership in inflammation and
nephrology, combined with our global
presence and world-class biologic
capabilities, will enable us to reach many
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3/30/2023 Letter Continued (Full PDF)