Welcome back to the deep dive where we take complex
source material on corporate giants and groundbreaking
science and give you the comprehensive shortcut
to understanding what really matters. And today
we are really cracking open the vault on a true
biotech behemoth. We really are a company whose
entire history is basically synonymous with the
rise of modern medicine itself. Amgen Inc. And
when we call it foundational, I mean, we are
talking about a company that has been there since
the very, very first waves of biotechnology.
Amgen's work is just. It's woven into the fabric
of treatments for chronic kidney disease, severe
anemia, supportive care for cancer. Yeah. They
aren't just a major player. Yeah. In a lot of
ways, they define the game in several of these
therapeutic areas. Absolutely. The company started
way back in 1980 with a name that, well. It perfectly
captured its audacious goal. It was founded as
Applied Molecular Genetics. AMGen. AMGen, exactly.
It's the perfect portmanteau for a company built
entirely on translating the promise of recombinant
DNA technology into actual, reliable pharmaceutical
products. And that combination of basic science,
the molecular genetics part, and the commercial
focus, the applied part, that really defined
their trajectory from day one. Right. It signaled
an intent to rapidly move forward. discovery
out of the lab and into the clinic exactly so
our mission today is driven by the sources you've
shared with us we're going to give you a comprehensive
shortcut to understanding Amgen's full story
Their staggering modern scale, the history of
their first blockbuster drugs, their core therapeutic
focus, which now generates tens of billions a
year, and the operational complexity of a company
this big. Which includes both stunning innovation
in their pipeline and some high -stakes legal
challenges in the courtroom. For sure. And to
set the scene, this isn't just a large company.
This is a component of the financial and scientific
infrastructure of the world. Amgen is ranked
as the 18th largest biomedical company by revenue.
Its economic standing is immense. It's a component
of the NASDAQ 100, the S &P 100, the S &P 500,
and, critically, the Dow Jones Industrial Average.
When you understand Amgen, you really understand
how foundational biotechnology operates on a
global scale. Okay, let's unpack this. Starting
immediately with the sheer undeniable scale of
this company, just using the 2024 data to truly
grasp the weight they carry in the economy. So
looking at the 2024 financial snapshot, the numbers
are, I mean, they're simply staggering. It really
validates its place on all those indices you
just mentioned. The total revenue figure sits
at U .S. $33 .4 billion. That's the kind of revenue
that dictates research directions for like entire
sectors. For the whole industry. And it's not
just the sales volume, the profitability demonstrated.
some serious operational maturity. We see operating
income at, what, $7 .26 billion and net income
at $4 .09 billion. Right. In an industry that
is just defined by massive R &D failure rates
and patent cliffs, maintaining consistent multi
-billion dollar profits, it shows they've truly
mastered that transition from discovery to efficient
mass production. They also have this colossal
physical footprint and a huge balance sheet with
total assets reported at US $91 .8 billion. Right.
That scale of assets, you know, the specialized
bioreactors, the clean rooms, the complex supply
chain infrastructure and all that extensive intellectual
property, it acts as a massive barrier to entry
for any smaller competitors. And that specialized
infrastructure, it requires specialized talent.
Their employee count worldwide sits at 28 ,000
people. 28 ,000. And these aren't just staff.
These are highly trained scientists, quality
control experts, logistics professionals. all
necessary to manufacture and distribute these
complex biologic drugs all over the world. Speaking
of their blueprint, let's just ground ourselves
geographically and historically for a second.
The company officially launched on April 8, 1980,
and its headquarters is still in Thousand Oaks,
California. Which is a crucial hub for the American
biotech industry. Absolutely. And the leadership
maintains a certain stability and a clear direction.
Robert A. Bradway is the chairman, president,
and CEO, while Howard Y. Chang is the chief scientific
officer. The experience they've accumulated over
four decades, particularly in managing the unique
challenges of biologic drug development, that
gives them a real operational edge. Now, here's
a corporate detail that is just absolutely critical
for understanding Amgen's operational risk and
their commercial strategy. And that's the extreme
supply chain concentration in the U .S. distribution
system. Ah, yes. We learned that Amgen receives
approximately 80 percent of its total revenues
from sales to just three large U .S. drug wholesalers.
80 percent. That is a massive centralization
of sales power. It creates a fascinating strategic
tension. Those three essential companies are
McKesson Corporation, Sincora, which used to
be AmerisourceBergen, and Cardinal Health. Right.
These wholesalers, they control the last mile
distribution network across the whole country.
They move drugs from the manufacturing plant
to nearly every pharmacy, clinic, and hospital.
So the implication of having 80 % of your revenue
concentrated with just three partners has to
be double -edged, right? On one hand, it drastically
simplifies commercial negotiations. You have
three massive contracts that determine most of
your yearly cash flow. But on the other hand,
it creates a massive dependency. Does that concentration
mean they're trading reliability for massive
market leverage against them? Well, it creates
leverage, yes, but for the wholesalers, not necessarily
for Amgen. Amgen must employ highly sophisticated
strategic countermeasures to manage this risk.
I'll bet. I mean, they are likely engaged in
these extraordinarily complex volume based contracts
that include guarantees, specific payment terms,
inventory sharing arrangements. Their logistics
teams are probably dedicated solely to optimizing
flows with just those three partners. It also
tells you something really profound about the
power structure of the American health care ecosystem.
Amgen can spend billions on R &D to create a
groundbreaking drug. But if just one of those
three wholesalers changes its terms or, you know,
faces. is a major logistical challenge. Amgen's
revenue stream is immediately at risk. They have
to prioritize the health of those three relationships
above almost everything else in their commercial
operations. Wow. Precisely. It's a structural
feature of the U .S. market, but that 80 % figure,
it's a loud warning signal. about the intensity
of that commercial dependency. Yeah. It really
underscores why Amgen is constantly investing
in supply chain resiliency and expanding its
own global manufacturing footprint, sort of hedging
against potential disruption in that core U .S.
distribution channel. And just to reiterate the
global context of the scale, Amgen's economic
power places it 134th on the Fortune 500 list
and 22nd on the Forbes Global 2000. It's a company
that has moved far, far beyond the initial ambitious
science. project it started as in 1980. No kidding.
They are a top -tier enterprise, but to understand
how they actually achieved this status, we have
to look back at those first crucial scientific
and commercial leaps they made. Which brings
us perfectly to how they did it, those foundational
scientific breakthroughs of the 1980s and 90s.
So the launch of applied molecular genetics in
April 1980 was... It was less a sure bet and
more a testament to scientific optimism, really.
It was backed by venture capitalists who were
betting big on this nascent, relatively unproven
field of recombinant DNA technology. And their
initial focus wasn't even the eventual blockbusters.
They were apparently interested in recombinant
human insulin first. And that focus shows you
exactly where the scientific momentum was at
the time, solving the problem of reliable, mass
-produced human proteins. This required immense
scientific... faith in investment, bringing together
a really heavy hitting initial scientific advisory
board featuring giants like Leroy Hood. Right.
They were essentially creating the playbook for
the modern biotech company as they went along.
And that early faith was pretty quickly rewarded
with capital. By June 17th, 1983, Amgen executed
a successful initial public offering. They raised
nearly $40 million by selling 2 million common
shares. And $40 million in 1983 for a company
that had Virtually no commercial products yet.
That was a huge declaration of market confidence
in the science itself. For sure. That successful
IPO provided the essential war chest to bridge
that chasm between pure lab research and the
lengthy, expensive clinical trials and manufacturing
scale -up that would follow. That money was the
fuel for their next massive discovery. Speaking
of massive discovery, let's turn to the Erythropoietin
revolution, the birth of Epogen. I mean, this
is truly the scientific achievement that cemented
Amgen's future. This was happening right around
the time of the IPO. In 1983, a research team
led by Fu Kun Lin achieved this seminal feat.
They successfully cloned the erythropoietin gene.
Can you break down the biology quickly for the
listener? What is erythropoietin or EPO and what
problem did its scarcity create for patients?
Sure. So erythropoietin is a hormone that's primarily
produced in the kidneys. It serves one vital
function. It signals the bone marrow to produce
red blood cells. So patients with chronic kidney
failure, especially those on dialysis, they suffer
from severe anemia because they're damaged kidneys
can't produce enough natural EPO. So before Amgen,
what did they do? Well, before Amgen's breakthrough,
these patients often had to rely on really difficult
blood transfusions, which were far from ideal
and carried a lot of risks. So by cloning the
gene, they could use these specialized cell lines
to act as tiny factories, basically, producing
safe, reliable, and massive quantities of human
EPO protein. Exactly. This recombinant process
led directly to epigen, or epoetin alpha, which
received FDA approval in 1989. And this wasn't
just a new drug. It created a whole new standard
of care. Right. It essentially solved the anemia
crisis for millions of dialysis and kidney disease
patients worldwide and immediately established
Amgen as a leading therapeutic company. The timeline
is so impressive. Founded in 1980, they clone
the gene in 83 and then have FDA approval by
1989. And they were thinking globally right away.
In 1984, they formed a joint venture with Kirin.
Yes. granting Karen the rights to Epogen in Japan,
securing a strategic foothold in a massive Asian
market really early on. That deal must have been
critical. Oh, it was. It not only secured capital,
but also demonstrated an understanding that these
breakthroughs needed global commercialization,
not just a U .S. market focus. But the breakthroughs
didn't stop there. Their second major development
tackled a different but an equally critical aspect
of blood disorders, neutropenia treatment with
Neupogen. Just a year after the Kiran deal, in
1985, another key Amgen team, this one led by
Larry Souza, cloned Granulocyte Colony Stimulating
Factor, or GCSF. And GCSF is sort of the white
blood cell equivalent of EPO, correct? Precisely.
GCSF stimulates the production of granulocytes,
which are white blood cells that are essential
for fighting off bacterial infections. And the
immediate target population was chemotherapy
patients. Right. Chemotherapy is, well, it's
a blunt instrument. It kills cancer cells, but
it also... destroys rapidly dividing immune cells.
This leads to a severely suppressed immune system,
a condition called neutropenia. Which leaves
patients highly vulnerable to life -threatening
infections. Exactly. And Neupogen, or filgrastim,
provided the essential support. So how did it
do that? Well, it was approved by the FDA in
1991, and Neupogen allowed patients to continue
their chemotherapy regimens with much greater
safety. Where Epigen addressed red blood cell
deficiency, Neupogen addressed white blood cell
deficiencies. And both from the same core tech.
These two drugs, both arrived from the same foundational
recombinant DNA technology, established Amgen
as an absolute powerhouse in supportive care
for two major chronic diseases, kidney failure
and cancer. And the company was scaling its operations
to match that scientific output. We see Gordon
Binder succeeding George Rathman as CEO in late
1988, which was right before the Ipigen launch.
Yeah. And operationally, they made huge investments.
In March 1993, they opened their facility in
Puerto Rico, which rapidly became their flagship
manufacturing site. You can't produce complex,
high -volume biologics like these without massive,
dedicated, specialized infrastructure. And the
quality of their work was recognized at the highest
level. In 1994, Amgen was only the fifth company
ever to receive the National Medal of Technology
and Innovation. Which is incredible. Yeah, specifically
for improving the quality of life for kidney
and cancer patients through these revolutionary
medicines. That is a phenomenal historical marker.
It just confirms the transformative societal
impact of their initial products. Yet the innovation
didn't stop once they had the drug. They immediately
began optimizing the drug delivery itself. Which
brings us to RNFs, or Darbopoietin Alpha. Developed
by Steve Elliott's team in the mid -1990s. Right.
And this is a beautiful example of chemical ingenuity
applied to a blockbuster molecule. Elliott's
team figured out how to use N -glycosylation,
which is essentially attaching more sugar molecules
to the original erythropoietin structure. Why
do that? I mean, it sounds like a subtle change,
but it had massive implications for patients.
It absolutely did. In biological terms, adding
those sugar molecules dramatically increased
the half -life of the protein in the bloodstream.
The original epigen required pretty frequent
injections, which is a real burden for chronic
patients. So, Aranesp. ARNS, by lasting significantly
longer, meant patients needed injections much
less often, maybe weekly or even biweekly instead
of multiple times a week. That's a massive improvement
in patient convenience and compliance. It takes
a successful, life -saving drug and makes it
dramatically more manageable for the user. It
ensures compliance stays high and maximizes its
commercial lifespan. It illustrates that continuous
optimization and formulation science is just
as vital as the initial discovery. Aranesp, as
we'll see, is still a major revenue driver two
decades later because of that early optimization
effort. Okay, that gives us the historical bedrock,
that moment they established their identity through
recombinant DNA. Now, let's fast forward and
examine what the modern Amgen portfolio looks
like, especially the drugs driving over $20 billion
in annual revenue today. Here's where it gets
really interesting, looking at the therapeutic
areas that are generating those massive 2024
revenue figures. I mean, while Epigen and Neupogen
built the house, today's financial engine is
focused heavily on bone health, inflammation,
and sophisticated targeted oncology. Let's begin
with their sheer dominance in bone health. Their
paired products, Prolia and Extiva, which both
use the molecule dinosumab, are absolutely essential
to the company's financials. Essential is the
word. Their combined 2024 revenues hit $6 .7
billion. That's a powerful concentration of revenue
stemming from a single versatile mechanism. Prolia
specifically targets osteoporosis, and the clinical
data supporting its use is just stellar. Trials
showed it reduced the rate of vertebral fractures
by 61 % and the risk of hip fractures by 40%.
That was for postmenopausal women. It was approved
back in... 2010. Right. And that reduction in
hip fracture risk is a defining characteristic.
A hip fracture is a massive morbidity and mortality
driver in the elderly population. It really is.
But what sets Dinosumab apart from the older
treatments, like bisphosphonates, which really
dominated the market before it? That's a crucial
point. Dinosumab operates differently. It's a
monoclonal antibody that specifically blocks
something called the rank ligand, or ang -ankale.
Okay. By stopping rancale from Activating osteoclasts,
those are the cells that break down bone. It
prevents bone loss and increases bone density.
Older bisphosphonates work by inducing osteoclast
suicide, which is a much less targeted mechanism.
Dinosumab offers a more precise, high -efficacy
solution. Which justifies its market dominance.
Exactly. And the commercial brilliance is the
dual application. Xgeva, approved the same year,
uses the exact same mechanism, dinosumab, but
it's targeted at cancer patients. Right, to prevent
skeletal -related events in patients whose solid
tumors have metastasized to the bone. Same science,
different patient population. Prolia helps prevent
general age -related bone loss, and Xgeva helps
cancer patients avoid pathological fractures,
spinal compression, or the need for radiation
to the bone. That strategic versatility just
maximizes the return on the dinosumab discovery.
And they really cemented this market leadership
with Evinity or Romasozumab. It's another osteoporosis
treatment approved in 2019. It generated $1 .5
billion in 2024. So they're not resting. No.
This shows they are constantly innovating within
their strongest therapeutic areas. Moving into
the autoimmune and inflammation portfolio, we
find another massive historic blockbuster, Enbrel
or Etanercept. This drug is a legacy product
from their 2002 Immunix acquisition. And despite
its age and all the competition, it still generated
$3 .3 billion in 2024 for various forms of arthritis
and chronic inflammatory diseases. Wow. And Brill
remains a flagship biologic for rheumatoid arthritis.
Its longevity really underscores the clinical
value of targeting TNF -alpha, a key inflammatory
molecule. But maintaining that revenue has to
be challenging. Oh, incredibly. They face constant
pressure from biosimilars. These are lower -cost
approved versions of the original biologic, which
necessitates aggressive commercial defenses and
specialized patient support programs. That's
the definition of a mature market fighter. Then
we have Otezla, or Apremilast, generating $2
.1 billion in 2024 revenues. Otezla is used primarily
for psoriasis and psoriatic arthritis, and it's
a key oral treatment, which contrasts with all
the injectable biologics. oral dosing form gives
it a major advantage. A huge advantage for patients
hesitant to start injectable biologics. It often
serves as a highly effective earlier line treatment.
And critically, Amgen has continuously expanded
its addressable market. They secured approval
in 2021 for adults with plaque psoriasis of any
severity level. Which massively increased the
pool of potential users. Absolutely. And we must
not overlook tepetza or tepertumumab. This was
acquired via the Horizon Deal, and it's a highly
specialized drug used for Graves' ophthalmopathy,
a debilitating condition affecting the eyes.
And it contributed $1 .8 billion in 2024 revenues.
This showcases their move toward ultra -specialty,
high -price, low -volume drugs, a strategic theme
we'll definitely return to. That move feels very
deliberate. Oh, it is. High -value rear - disease
treatments often have more predictable revenue
streams and are less susceptible to the intense
price pressure faced by the high volume drugs.
Let's pivot to cardiovascular and metabolism,
a growing and highly competitive sector. Their
major play here is Repatha or Evolucumab. Repatha
is a treatment for hyperlipidemia or high cholesterol
approved back in 2015. It brought in $2 .3 billion
in 2024. It belongs to the PCSK9 inhibitor class,
which works by dramatically lowering LDL or bad
cholesterol. Which significantly reduces cardiovascular
risk. But that $2 .3 billion market position
is intensely contested, isn't it? Oh, fiercely.
They're fighting rivals like Regeneron's Proluin
and increasingly innovative RNA -based drugs
like Novartis' Lecio. The competition in the
PCSK9 space is just brutal, making Repatha's
revenue stability a significant achievement.
And that market tension is so high that it spills
directly into the courtroom, a point that, as
you mentioned, is crucial to understanding the
company's operational risks later in our discussion.
Absolutely. Finally, let's look at their core
oncology and blood disorders portfolio, which
builds directly on that epogen -nupogen heritage.
Keprolis, a treatment for multiple myeloma, generated
$1 .5 billion in 2024. Keprolis, or carfilzomib,
is a proteasome inhibitor, a really key drug
in that specific cancer treatment pathway. And
Enplate, or Romiplastim, regulates platelet production,
generating $1 .4 billion. Which relates directly
back to their legacy in stimulating blood cell
growth, just focusing on different components
of the blood system. Exactly. And Aranesp, the
second -generation EPO drug, is still a significant
earner at $1 .3 billion in 2024, demonstrating
the extreme longevity of a well -engineered biologic.
This is amazing. And to compete across the entire
market, Amgen employs this smart dual strategy,
developing original blockbusters and manufacturing
biosimilars. Their biosimilars, like Mivasi,
Congenti, and Ryabni, they allow them to capture
market share from other biologics whose patents
have expired, providing lower -cost options and
ensuring they have products spanning all price
points. So in summary, Amgen's current financial
engine is fueled by established high -value chronic
disease management with Prolia and Enbrel, a
strong presence in complex blood and cancer treatments,
and a shrewd pivot toward high -growth, high
-value, rare disease markets. It's a portfolio
that demands continuous, aggressive, strategic
maneuvers to maintain that size and profitability.
The focus now is less on discovering the next
EPO and more on strategically buying and building
the next generation of specialized revenue streams.
Which is the perfect transition into how they
fuel that growth engine. Strategic acquisitions
and infrastructure build out. Amgen's history
confirms that internal R &D is really only half
the story. Strategic acquisition has always been
a core growth engine for them, allowing them
to rapidly gain market access and bolster their
pipeline. Historically, their moves were transformative.
The 2002 acquisition of Immunix Corporation was
just. It was epoch -making. It instantly brought
them the blockbuster embryo and cemented their
role in the inflammation market. And later, the
Onyx Pharmaceuticals deal. Right. The 2013 acquisition
of Onyx secured major oncology assets. But if
we look at their recent activity. There's a distinct
high -stakes shift. How so? The strategy is hyper
-focused on securing specialized assets, often
for rare or highly complex diseases. This helps
diversify their risk and, crucially, provides
some insulation from payer and pharmacy benefit
manager or PBM pressure that often targets those
high -volume chronic drugs. And the recent deals
are just massive. They're very telling of this
strategic pivot. Take Chemocentrics in 2022,
acquired for $3 .7 billion cash. This was purely
focused on rare diseases, adding Tavneos or Evacopin.
It's a drug to treat antineutrophil cytoplasmic
autoantibody -associated vasculitis. A mouthful,
I know, but a very serious, specific autoimmune
condition. Paying $3 .7 billion for a drug that
treats such a specific, rare disease really demonstrates
the economic calculus at play, doesn't it? Absolutely.
These treatments, while having fewer patients,
command extremely high prices, leading to more
predictable revenues that are less threatened
by generics or broad PBM exclusion lists. And
then the absolute monster of a deal. Horizon
Therapeutics acquired in 2023 for $27 .8 billion.
Yeah. Horizon specializes entirely in rare diseases,
bringing into PETSA, that Graves' ophthalmopathy
drug, and several other specialty treatments.
And it's crucial to pause on Horizon's corporate
structure here. as noted in the sources horizon
was originally incorporated in ireland back in
2014 through a tax inversion so by acquiring
a company structured that way amgen is willing
to navigate some pretty complex international
corporate and tax frameworks to secure these
highly valuable rare disease assets the 27 .8
billion dollar price tag confirms that specialized
market access is now their highest priority growth
factor we also saw the acquisition of five prime
therapeutics in 2021 for 1 .9 billion dollars
right and this was a very targeted acquisition
specifically aimed at enhancing their Asia -Pacific
oncology market share. It added the lead candidate,
B. marituzumab. So it shows a simultaneous focus
on rare disease consolidation in the West and
targeted pipeline expansion in high growth international
regions. The acquisition strategy is layered.
Domestic rare disease consolidation, massive
international rare disease expansion, and targeted
geographic pipeline boosts. But growth isn't
just about buying. Amgen actively builds. They
are continuously expanding their high -tech manufacturing
and R &D facilities all over the globe. Which
shows a deep commitment to controlling the complex
production process for biologics end -to -end.
Their global footprint is robust. They completed
a next -generation biomanufacturing facility
in Singapore in 2014. and expanded infrastructure
in West Greenwich, Rhode Island, starting in
2018. More recently, we see this massive commitment
to domestic manufacturing and security and supply
chain resiliency, particularly post -COVID. They
broke ground on a new high -tech facility in
Holly Springs, North Carolina, in 2022. And the
future investment figures are telling. In April
2025, they announced a $900 million expansion
of their facility in New Albany, Ohio. Which
is expected to nearly double job creation there.
And they aren't neglecting their roots. In September
2025, plans were announced for a $600 million
research center in Thousand Oaks, California.
And why spend $1 .5 billion combined on Ohio
manufacturing and California research? Because
manufacturing biologics is intensely complex
and specialized. This spending ensures they have
redundant, specialized capacity for new product
launches. It secures their supply chain against
global geopolitical instability, and it reinvests
in the pure discovery engine right at headquarters.
That kind of internal spending really underscores
that acquisitions are necessary, but they still
view controlling, cutting edge manufacturing
and internal discovery as non -negotiable strategic
pillars. And their global commercial commitment
is cemented by affiliate expansion in key markets.
They opened their China affiliate in 2013 and
established Amgen. KK as a wholly owned affiliate
in Japan in April 2020. Taking full control of
their Japanese presence. Exactly. Asia is clearly
baked in to their long -term growth forecast.
So this whole strategic growth section paints
a picture of a dynamic, aggressive, and highly
capitalized company that uses both its checkbook
and its construction crews to secure its future
position. They buy the best assets, and they
ensure they have the physical specialized capacity
worldwide to produce and distribute them efficiently.
Now let's turn our attention to the cutting edge.
What are they betting on for the next generation
of blockbusters? And what new science are they
chasing? When we talk about future bets, we first
need to just grasp the sheer scope of their current
research pipeline. They currently have 17 clinical
programs in phase three. Eight in phase two and
19 in phase one. That volume 44 active programs
across all phases, that's the cost of doing business
in biopharma. It provides the necessary diversification
to hedge against the high attrition rate that's
just inherent in clinical development. They're
casting a wide multi -billion dollar net. Let's
zoom in on a few specific programs, starting
with a breakthrough that defined Imgen the capacity
to solve historically undruggable problems. The
KRAS -G12C breakthrough with Lumacras or So Torsib?
This development is arguably one of those exciting
recent milestones in targeted oncology. The KRAS
protein is mutated in a massive percentage of
human cancers. And for the last 40 years, it
was considered a holy grail. It was untouchable
by traditional small molecules. Why was it considered
impossible to drug? Well, it was a technical
hurdle. KRAS is structurally very smooth. It
lacks a suitable deep binding pocket where a
traditional small molecule drug could latch on
and interfere with its function. It's like trying
to grab a billiard ball. Exactly. It's like trying
to stop a billiard ball with a tiny key. You
need a very specific, unique mechanism. Amgen
Sotorizib found a temporary transient pocket
specific to the G12C mutation, and that effectively
drugged the undruggable. And Sotorizib broke
that barrier. It was granted fast -track designation
in 2019 and received accelerated FD... approval
in May 2021 for NSCLC patients with that specific
KRAS mutation. Which was the first approved targeted
therapy for any KRAS mutation. That first -in
-class status is a major scientific validation.
And the clinical outcomes followed. A September
2022 late -stage study showed that Lumacra has
actually beat standard chemotherapy in trials,
which is the gold standard proof of efficacy
in cancer treatment. It provides a superior,
more targeted option for a patient population
that previously had very few choices. And reflecting
that complexity and innovation, the list price
was noted at $17 ,900 per month upon approval.
Yeah, which underscores the high investment required
to solve problems that decades of research just
couldn't crack. Okay, moving on, let's look at
their collaboration with AstraZeneca on Tespire,
or tezopilumab, which is focused on severe asthma
and sinusitis. TestBio received FDA approval
in December 2021 for severe asthma. It's a mechanism
that targets the TSLP pathway, which sits upstream
of many other inflammation pathways. Which means
it potentially addresses a wider range of the
underlying causes of severe asthma than existing
biologics. Exactly. And its market potential
is expanding rapidly beyond asthma. Positive
data from March 2025 showed best -in -class results
for treating chronic rhinosinusitis with nasal
polyps. So it could establish a best -in -disease
profile across multiple inflammatory diseases
of the airway. Potentially turning it into a
multi -indication platform drug. That versatility
is crucial for fueling billion -dollar growth.
But if we're talking about market potential and
headlines, we have to talk about Meritide, the
high -stakes anti -obesity candidate. The race
in the cardiometabolic and anti -obesity market
is the single biggest narrative in biopharma
right now. And Amgen is fielding a highly differentiated
contender with Meritide. Their focus is on differentiating
on convenience and efficacy. And the key differentiator
for Meritide is the dosing schedule, right? It's
administered once per month. by injection. Which
is a massive convenience advantage compared to
the current market leaders that require weekly
injections. Late -stage trials began in March
2025, putting Amgen in a strong competitive position.
However, this therapeutic area is notorious for
side effects, and Amgen hit that wall early.
Yes, the dosage challenge. In June 2025, they
announced they had to reduce the dosage of the
drug in ongoing trials to limit gastrointestinal
side effects, predominantly vomiting. Which is
the primary hurdle for patient retention in the
whole GLP -1 class. But here's a critical data
point that keeps the market incredibly excited.
Despite requiring a dosage reduction, patients
who continued taking the drug still lost approximately
20 % of their body weight. Which puts Meritide
squarely in that highly competitive 15 % to 22
% weight loss range achieved by the current injectable
market leaders. So if Amgen can finalize a monthly
dose that manages the side effects while retaining
that 20 % efficacy... The convenience factor
alone. could make Meritide a dominant force and
easily a multi -billion dollar product. That
potential is absolutely transformative. Finally,
let's look at their innovative R &D collaborations.
These show they are actively pursuing the next
three major waves of drug discovery outside of
their traditional recombinant platform. The integration
of artificial intelligence is key. The November
2023 partnership with Amazon Web Services, AWS,
is important because they're using generative
AI and machine learning, not just for discovering
new drug candidates. But also critically for
optimizing their highly specialized biologic
manufacturing process. And that manufacturing
optimization is often overlooked. AI can help
predict yields, reduce batch failures, and optimize
complex purification steps, leading to significant
cost savings and improved supply reliability
for these $33 billion in revenue products. Beyond
AI, they are deeply invested in next -generation
therapeutics. They have a massive collaboration
with Generate Biomedicines, potentially worth
up to $1 .9 billion. Focused on multispecific
drugs. What are those? Multispecifics are molecules,
often large proteins, designed to simultaneously...
bind to and influence two or more biological
targets. Instead of a drug hitting target A,
you have one drug hitting target A and target
B. Potentially creating a much more powerful
synergistic effect and reducing the likelihood
of resistance. Exactly. And they are exploring
other novel targeting methods. Collaborations
with Arrakis Therapeutics for novel targeted
RNA degrader therapeutics and Plexium for targeted
protein degradation therapies. These are the
bleeding edge of science. Oh, absolutely. RNA
degraders aim to destroy the messenger RNA, the
mRNA that carries the instructions for making
a harmful protein. It's like preventing the factory
from ever receiving the blueprint. And targeted
protein degradation. That uses the cell's own
internal waste disposal machinery to label and
destroy disease -causing proteins that have already
been made. So Amgen is not resting on its history
of cloning DNA. They are actively pursuing AI
-driven design, multi -target drugs, and sophisticated
internal destruction pathways, the technologies
that will define biopharma for the next few decades.
That robust pipeline strategy confirms they intend
to remain a cutting -edge scientific leader.
Now let's shift gears and look at the company's
broader corporate responsibilities, including
their significant philanthropic work and the
inevitable and costly legal scrutiny that comes
with operating at this staggering scale. A company
of Amgen's stature has a huge societal impact
that extends far beyond drug sales, particularly
through the Amgen Foundation, which has a very
targeted focus on science education. That focus
makes perfect sense given their history as a
science -first company. They see investing in
the next generation of scientists as a core part
of their mission. Right. They pledged $3 million
in 2017 and another $3 million in 2020 to Khan
Academy specifically to support the development
of free online biology lessons, promoting educational
equity globally. That's a direct investment in
global scientific literacy. They also partnered
with Harvard University in January 2020 to debut
LabExchange. A free online science education
platform offering virtual labs and complex simulations.
These programs are crucial because they democratize
access to high quality science education, which
is otherwise often restricted by geography or
cost. And the foundation also demonstrated rapid
responsiveness during the COVID -19 pandemic.
Committing up to $12 .5 million for relief efforts
in March 2020. And in terms of patient advocacy,
they provided a $2 million grant to the CDC Foundation
in 2021 to launch the Empowered Health Program.
Which focuses on promoting patient engagement
in cancer. treatment decision -making. That demonstrates
a recognition of the importance of informed consent
and patient autonomy in these complex care pathways.
Beyond the foundation, they engage in typical
corporate branding efforts, like securing the
title sponsorship of the Irish Open in golf,
rebranding it the Amgen Irish Open in late 2023.
Maintaining global visibility across different
demographics. Now let's address their political
engagement. Lobbying is, I mean, it's an absolute
necessity for any company operating in a highly
regulated, high -stakes sector like biopharma.
Our sources indicate that Amgen spends approximately
$10 million per year on lobbying in the United
States. That figure reflects the intense and
continuous nature of legislative and regulatory
battles, particularly concerning drug pricing,
reimbursement, and of course, patent protection.
And maintaining strict impartiality here, we
just note that their political contributions
have been mostly directed toward individuals
and organizations associated with the Democratic
Party. This is simply a reporting of the data
available on their political activities. It demonstrates
their necessity to engage across the political
landscape to manage regulatory risk. For sure.
But the complexity of their operation is never
clearer than when we juxtapose their scientific
achievements with their corporate. It's jarring,
isn't it? To see a company spending nearly $28
billion to acquire assets and investing hundreds
of millions in groundbreaking research while
simultaneously paying huge fines for illegal
marketing tactics. How do we reconcile that complexity?
It's the tension between the scientific mission
and the commercial imperative, and the legal
system often steps in when the latter overrides
the former. And we have two significant legal
issues we must detail. Let's start with the older
but very serious case involving Aronisp, that
second -generation EPO drug. In December 2012,
Amgen pleaded guilty and agreed to a massive
settlement for improper marketing. The settlement
was staggering, $762 million. It was broken down
into a $150 million criminal penalty and a $612
million civil resolution. But what's crucial
here is how the improper marketing occurred and
why it was so problematic. The source material
indicates that the case resolved 11 related whistleblower
complaints. According to the Department of Justice,
Amgen was promoting and selling the drug for
off -label uses, so uses not approved by the
FDA, at dosages that the FDA had explicitly rejected
or never approved. And that detail is the critical
lesson in corporate governance. When a company
promotes dosages that regulatory bodies have
deemed unsafe or ineffective, or attempts to
expand indications outside of what has been clinical,
proven, they cross a major ethical and legal
line. And the whistleblowers brought it to light.
Right, who were often company insiders. They
brought this serious misconduct to light, which
led to that massive financial accountability.
That's a stark reminder that even the most scientifically
advanced companies are subject to, well, human
greed and ethical failures in the pursuit of
revenue maximization. And the legal challenges
continue in the modern era, shifting from marketing
practices to intense antitrust issues. This brings
us right back to Repatha, their $2 .3 billion
cholesterol drug. This issue is very recent.
In May 2025, a jury ruled that Amgen owes Regeneron
$406 million. Why? For engaging in anti -competitive
practices to increase sales of Repatha at the
expense of Regeneron's competing drug, Proliment.
And this antitrust ruling is highly instructive
about market conduct. It is. The issue centered
on whether Amgen used its dominant position,
likely through exclusionary contracts or rebates
with the major U .S. distribution channels, perhaps
even those three wholesalers we discussed earlier,
to essentially block Perluent from competing
effectively in the market. So the argument is
that Amgen's commercial tactics went beyond normal
competition and actively stifled the market,
resulting in a huge financial penalty. It demonstrates
that maintaining market dominance requires constant
vigilance against monopolistic behavior charges.
The narrative of Amgen is therefore defined by
high achievement and high accountability. They're
solving undruggable cancers and funding vast
educational resources, but you're also paying
hundreds of millions in penalties for both marketing
misuse and anti -competitive market tactics.
highly lucrative arenas. That complexity, the
high highs and the low lows, is the enduring
reality of being a modern biotech giant. If we
synthesize this journey, we have traveled from
Amgen, starting as the small venture -backed
startup in 1980, dedicated to cloning the DNA
of complex human proteins, to a global multi
-trillion dollar market participant defined by
scale and strategic aggression. They define the
entire early life cycle of biotechnology with
foundational blockbusters like Apigen and Neupogen,
built massive market dominance in chronic care
with products like Prolia and Embrel, and are
now pivoting strategically into the rare disease.
market with acquisitions like that $27 .8 billion
purchase of Horizon Therapeutics. And they are
betting massive sums on the future, too, with
candidates like Maritide in the high -stakes
anti -obesity markets and pioneering the integration
of generative AI into both drug discovery and
manufacturing optimization. Amgen's operational
identity is ultimately defined by a dynamic balance.
unmatched scientific achievement, aggressive
commercial growth, and this continuous navigation
of high -stakes legal and ethical environments,
illustrated so vividly by both the Ernest Marketing
Settlement and the recent Repatha antitrust ruling.
Their history is synonymous with the entire evolution
of the biotech industry. So what does this all
mean for you, the listener? We've seen Amgen
achieve its first and most enduring successes
through the revolutionary science of recombinant
DNA, the genetic cloning of EPO and GCSF. They
are now investing heavily in AI integration and
new modalities like targeted protein degradation
and RNA degraders. Which raises an important
and I think a provocative question for you to
mull over. Given that Amgen defined its first
era on DNA and is now chasing the future with
AI and degradation technology, what technological
foundation will it be AI -driven design, the
specificity of targeted degradation, or maybe
even just the monthly convenience of a drug like
Maritide? What will be responsible for defining
the next $10 billion blockbuster drug in the
biopharma industry? Something to think about
long after we sign off. Thank you for joining
us for this deep dive into Amgen, Inc. We hope
you feel thoroughly informed. Until next time.