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ORION System Weekly Stock Recommendation: Amgen ($AMGN) – Verdora Excellence Alliance

Many people’s first impression of Amgen is:

“A long-established large biotechnology company.”

Unlike Moderna, it does not have an mRNA-focused growth story.

Unlike smaller biotechnology companies, where one Phase 3 result can dramatically change the company’s valuation.

But this is exactly where AMGN is often underestimated.

Amgen’s real strength is not:

Betting on a single drug.

Instead, the company combines:

Mature product cash flow + multiple fast-growing medicines + oncology pipeline + cardiovascular business + rare disease assets + next-generation obesity treatment opportunities.

Therefore, when analyzing AMGN on September 21, the most important question is not:

“Will the next drug succeed?”

The real question is:

Can Amgen use its already substantial cash flow to successfully transition from legacy products to the next generation of major growth medicines?


First Look at the Latest Results: Quarterly Revenue Surpasses $10 Billion

In Q2 2026, Amgen generated total revenue of:

$10.1 billion.

Up:

10% year over year.

Product sales increased:

9%.

Growth was mainly driven by:

Higher sales volume.

GAAP EPS increased from:

$2.65 in the same period last year

to:

$4.37.

A year-over-year increase of:

65%.

Non-GAAP EPS reached:

$6.29.

An increase of:

4%.

More importantly, Q2 free cash flow reached:

$3.5 billion.

Compared with:

$1.9 billion

in the same period last year.

This highlights one of the biggest differences between Amgen and many biotechnology companies still operating in the clinical development stage:

Amgen is not simply spending cash while waiting for future products.

The company already has strong current earnings power.

And it can use that cash flow to invest in the next generation of medicines.


However, $10.1 Billion in Revenue Is Not the Most Important Number

The more important development is:

Amgen is undergoing a transformation in its product portfolio.

In Q2, the company’s six key growth drivers increased by:

26% year over year.

These products already represented nearly:

70% of quarterly product sales.

At the same time:

22 products achieved double-digit growth.

Based on Q2 sales performance annualized:

17 products have already reached more than $1 billion in annual sales.

This is highly significant.

Because it shows Amgen is no longer:

A large biotechnology company supported by only one or two legacy products.

Its revenue base is becoming increasingly diversified.


Repatha Is Becoming One of Amgen’s Most Important Growth Drivers

Repatha is a PCSK9 inhibitor designed to reduce LDL cholesterol.

Q2 sales reached:

$953 million.

An increase of:

37% year over year.

Growth was mainly driven by:

Higher sales volume.

If Q2 performance is simply annualized, Repatha is approaching:

A $4 billion annualized product scale.

But the more important development came on:

August 31.


August 31: Repatha Released Significant New Data

Amgen announced a prespecified analysis from the Phase 3:

VESALIUS-CV study.

The study included more than:

12,000 patients

who had not previously experienced myocardial infarction or stroke but were considered at elevated cardiovascular risk.

The results showed that adding Repatha to standard lipid-lowering therapy achieved:

A 20% reduction in all-cause mortality risk.

The reduction in mortality risk began to emerge after approximately:

1.5 years of treatment

and continued through a median follow-up period of:

4.6 years.

Why is this announcement particularly important?

Because historically, Repatha has mainly been associated with:

“Lowering cholesterol after cardiovascular disease has already occurred.”

However, VESALIUS-CV is expanding the potential role of Repatha:

Intervening before a first heart attack or stroke occurs in high-risk patients.


This Could Expand Repatha’s Potential Patient Population

Treating patients who have already experienced a heart attack is known as:

Secondary Prevention.

Treating patients who have not yet experienced a heart attack but are already considered high risk is known as:

Primary Prevention.

These two patient groups represent completely different market opportunities.

If Repatha can eventually expand further into high-risk primary prevention patients, its commercial opportunity could continue to grow.

More importantly, Repatha is no longer a newly launched product waiting for market validation.

It was first approved in:

2015.

By 2026, it had already been used by approximately:

9 million patients worldwide.

Therefore, the logic is not:

“A new drug may succeed.”

Instead:

“An already successful medicine may continue expanding into additional patient populations.”


But Amgen’s Most Potentially Transformative Asset Is Not Repatha

It is:

MariTide

The full name of MariTide is:

maridebart cafraglutide.

This is Amgen’s obesity treatment currently under development.

The obesity market has already become clearly established.

Novo Nordisk has:

Wegovy.

Eli Lilly has:

Zepbound.

Therefore, Amgen is not entering an empty market.

But what MariTide is trying to solve is a different issue:

Treatment frequency.


Current Leading GLP-1 Weight Loss Medicines Usually Require Weekly Injections

That means approximately:

52 injections per year.

MariTide’s long-acting design aims to move from:

Once-monthly dosing

toward longer maintenance schedules of:

Once every eight weeks, or potentially once every quarter.

In other words, future treatment could potentially require only:

4–6 doses per year.

In its Q2 update, Amgen stated that MariTide’s design supports monthly dosing initially while exploring longer-term maintenance schedules requiring only four or six doses annually.

This is what makes MariTide particularly interesting.

It does not necessarily need to prove:

“I can achieve greater weight loss than every competing GLP-1 therapy.”

If it can ultimately deliver:

Competitive efficacy + significantly lower dosing frequency,

that alone could create meaningful differentiation.


More Importantly, MariTide Is No Longer an Early-Stage Experiment

As of August 4, Amgen had already advanced multiple Phase 3 MariTide programs.

Including:

MARITIME-1

Targeting adults with obesity or overweight conditions without type 2 diabetes.

MARITIME-2

Targeting patients with obesity or overweight conditions who also have type 2 diabetes.

Additional studies include:

MARITIME-CV

Studying cardiovascular outcomes.

MARITIME-HF

Studying patients with heart failure.

MARITIME-OSA-1 / OSA-2

Studying obesity-related obstructive sleep apnea.

And:

MARITIME-SWITCH

Specifically studying patients switching from weekly tirzepatide or semaglutide to MariTide, while evaluating:

Every-eight-week or quarterly dosing schedules.

This shows Amgen is not simply betting on:

“Whether an obesity drug can be developed.”

The company is already building a complete Phase 3 clinical program around MariTide.


If MariTide Succeeds, Amgen Would Enter a Completely Different Market Scale

Amgen already owns many billion-dollar products.

But the obesity market has a unique characteristic:

The potential patient population is extremely large, and treatment may require long-term use.

Therefore, the importance of MariTide is not simply:

“Adding another medicine.”

It could potentially:

Create a major new growth curve for an established biotechnology company.

This is why AMGN cannot be evaluated only by looking at today’s $10.1 billion quarterly revenue.

MariTide represents:

An asset with no meaningful current sales, but the potential to significantly reshape future revenue composition.


Another Fast-Growing Area Is Oncology

One of the most important assets in this category is:

IMDELLTRA.

In Q2, global IMDELLTRA sales reached:

$288 million.

Compared with:

$134 million

in the same period last year.

Growth:

115% year over year.

The increase was mainly driven by higher volume.

At first glance, $288 million may not appear large compared with Amgen’s biggest products.

But the key point is:

It is growing extremely quickly.

And in September, another important Phase 3 development emerged.


September 8: IMDELLTRA Took a Major Step Toward First-Line Treatment

Amgen announced results from the:

Phase 3 DeLLphi-305 study.

The study evaluated:

IMDELLTRA + AstraZeneca’s IMFINZI

as first-line maintenance treatment for patients with extensive-stage small cell lung cancer.

The study met its primary endpoint at the prespecified interim analysis.

Compared with IMFINZI alone, the combination treatment demonstrated:

A statistically significant and clinically meaningful improvement in Overall Survival.

At the same time:

PFS — Progression-Free Survival

and

ORR — Objective Response Rate

also achieved the relevant endpoints.

Why is this especially important?

Because IMDELLTRA initially entered the market mainly for:

Patients whose disease had progressed after previous treatments.

If it can move further into:

First-line treatment pathways,

the potential patient population and treatment duration could both expand.


Small Cell Lung Cancer Remains One of the Most Difficult Areas to Treat

One characteristic of this cancer type is:

Rapid progression and aggressive behavior.

Therefore, treatments that can truly improve:

Overall Survival

are particularly important.

IMDELLTRA belongs to a class of therapies known as:

DLL3-targeted BiTE bispecific T-cell engager therapies.

In simple terms:

One side binds to:

DLL3 on cancer cells.

The other side binds to:

T cells.

It then brings immune cells directly closer to tumor cells.

A simple way to understand it is:

Building a bridge between T cells and cancer cells.

The goal is to help the body’s own immune system attack tumors more precisely.


On September 14, IMDELLTRA Also Addressed a Practical Treatment Challenge

The FDA approved a shortened monitoring period following the first two IMDELLTRA doses.

This may not appear as significant as a successful Phase 3 trial.

However, from a commercialization perspective, it is highly important.

Because when oncology medicines enter real-world clinical use, treatment success depends not only on efficacy, but also on:

Patient convenience.

Hospital workflow complexity.

Required monitoring duration.

Healthcare resource utilization.

Reducing monitoring requirements could help lower practical barriers during treatment.

Therefore, successful commercialization of a medicine requires more than:

“Strong clinical data.”

It also requires:

Physicians being willing to prescribe it, hospitals being able to administer it efficiently, and patients being able to complete treatment.

As of September 21, this aspect had already begun improving.


Beyond Repatha and IMDELLTRA, Amgen Has a Broad Portfolio of Fast-Growing Products

In Q2:

EVENITY: $714 million, up 38% year over year.

TEPEZZA: $576 million, up 14% year over year.

KRYSTEXXA: $400 million, up 15% year over year.

UPLIZNA: $335 million, up 90% year over year.

TAVNEOS: $150 million, up 36% year over year.

TEZSPIRE: $486 million, up 42% year over year.

BLINCYTO: $472 million, up 23% year over year.

The most important takeaway from these figures is:

Growth is not coming from only one product.

Cardiovascular medicine.

Bone health.

Rare diseases.

Inflammation.

Oncology.

All contain products showing meaningful growth.

This is one of the biggest differences between a large biotechnology company and a smaller biotech company.


A Single Drug Failure Does Not Necessarily Determine Amgen’s Future

A smaller biotechnology company may only have:

One major product candidate.

If Phase 3 succeeds, company value may increase significantly.

If Phase 3 fails, the impact can be severe.

Amgen is very different.

The company has:

Dozens of commercialized products.

Therefore, the key question when analyzing AMGN is not:

“Will one specific drug succeed?”

Instead:

“Can the growth of new products exceed the decline of older products?”

That is the core mathematical question.


Because Amgen Also Faces Significant Pressure From Mature Products

For example:

Prolia.

Q2 sales:

$759 million.

Down:

32% year over year.

The decline was mainly caused by the launch of multiple biosimilar competitors globally.

XGEVA

generated:

$352 million in sales.

Down:

34% year over year.

It also faced biosimilar competition.

Otezla

declined:

21%.

Enbrel

declined:

4%.

This is the natural challenge faced by large pharmaceutical companies.

No medicine remains without competition forever.

Patent expiration.

Biosimilar entry.

Pricing pressure.

All eventually affect mature product revenue.


Therefore, Amgen’s Real Story Is a Product Transition Relay Race

The first stage may have been led by:

Enbrel, Prolia, and XGEVA.

These mature medicines generated substantial cash flow over many years.

Now they are increasingly facing competitive pressure.

The second stage is already being carried by:

Repatha, TEZSPIRE, EVENITY, UPLIZNA, and IMDELLTRA.

The third stage could potentially come from:

MariTide and other late-stage pipeline assets.

Therefore, Amgen’s ability to continue growing will ultimately depend on:

Whether the second and third stages can move fast enough to replace the decline of older products.

Q2 revenue growth of 10% suggests that, as of September 21, this transition was still moving forward.


Another Major Financial Advantage: Strong Cash Flow

Q2 free cash flow:

$3.5 billion.

Same period last year:

$1.9 billion.

Why is this particularly important for Amgen?

Because drug development requires significant investment.

Large Phase 3 trials.

Manufacturing facilities.

Commercial expansion.

Acquisitions.

All require substantial capital.

Amgen’s biggest advantage is:

Its mature products continue generating cash, allowing new drug development to be funded internally.

This creates a very different risk profile compared with smaller biotechnology companies that may rely heavily on external financing.


The Company Also Raised Its 2026 Full-Year Outlook

Following the Q2 earnings report, Amgen expects full-year 2026 revenue of:

$40.5 billion–$41.8 billion.

Non-GAAP EPS is expected to reach:

$22.30–$23.50.

Therefore, as of September 21, the company had not shown clear signs of operational slowdown.

Key growth products continued expanding.

Cash flow remained strong.

At the same time, multiple late-stage pipeline programs continued advancing.


One of Amgen’s Biggest Risks Is Whether MariTide Can Deliver on Its Potential

The obesity market is extremely large.

But competition is equally intense.

Eli Lilly and Novo Nordisk have already established strong positions.

Future competition may also come from:

Oral therapies.

Long-acting treatments.

Multi-target medicines.

Different therapeutic mechanisms.

Therefore, simply achieving:

“Weight loss.”

will not be enough for MariTide.

The company still needs to demonstrate:

Efficacy.

Safety.

Long-term weight maintenance after discontinuation.

Potential cardiovascular benefits.

And most importantly:

Whether lower dosing frequency can become a true competitive advantage.

Therefore, MariTide currently represents:

Significant potential + significant validation requirements.

The potential market opportunity should not be directly treated as future revenue.


The Second Risk Is the Speed of Decline in Mature Products

Prolia declined:

32%.

XGEVA declined:

34%.

These are no longer theoretical concerns.

They are already appearing directly in financial results.

Therefore, each quarter investors need to continue comparing:

How much revenue new products are adding.

Against:

How much revenue mature products are losing.

If new product growth cannot keep pace with mature product declines, overall growth could face pressure.


The Third Risk Is the Inherent Uncertainty of Drug Development

This is similar to Moderna.

Having more clinical programs does not mean every program will succeed.

Especially for major assets such as MariTide, which could influence Amgen’s growth structure for the next decade, disappointing late-stage results could significantly affect market expectations.

Therefore, while Amgen is much more diversified than smaller biotechnology companies, it still faces:

Clinical development risk.


One Future Event Must Also Be Clearly Separated

According to Amgen’s official news releases, the company announced:

Positive Phase 3 topline results for Dazodalibep in moderate-to-severe systemic Sjögren’s disease

on:

September 22.

However, the analysis time point is:

September 21.

Therefore, this information was not yet available at the time.

It cannot be used retroactively to justify:

“AMGN was worth watching on September 21 because Dazodalibep Phase 3 succeeded.”

That would be a typical example of using future information.

Therefore, the September 21 investment logic does not depend on this announcement.


So What Was Actually Known on September 21?

The available information was already sufficient:

Q2 revenue reached:

$10.1 billion, up 10% year over year.

Six key growth products increased:

26%.

Repatha sales increased:

37%.

IMDELLTRA increased:

115%.

TEZSPIRE increased:

42%.

UPLIZNA increased:

90%.

Free cash flow reached:

$3.5 billion.

At the same time:

Repatha had received new long-term cardiovascular data.

IMDELLTRA Phase 3 data had shown that the combination treatment could improve overall survival outcomes in extensive-stage small cell lung cancer.

MariTide had already entered multiple Phase 3 programs.

These were the fundamental factors available on September 21.


Therefore, AMGN on September 21 Should Not Be Viewed Simply as a “Defensive Healthcare Stock”

Amgen does have mature products.

It does have strong cash flow.

It is more stable than many smaller biotechnology companies.

However, focusing only on these characteristics would overlook the most interesting transformation currently taking place.

The company is simultaneously experiencing:

Pressure from patents and biosimilar competition on older products

↓

Rapid growth from a new generation of commercial products

↓

Late-stage assets such as MariTide preparing to become future growth drivers.

This represents a classic:

Large Biotechnology Product Cycle Transition.


Amgen’s Past Growth Was Driven by Successful Medicines

Historically, Amgen’s growth was built on:

Medicines that had already achieved commercial success.

Today, Amgen needs to rely on:

New medicines replacing older products.

Looking ahead, Amgen needs MariTide, IMDELLTRA, and other pipeline assets to prove that:

The company can not only protect its current $40 billion-plus revenue base, but also create the next phase of growth.

Therefore, as of:

September 21, 2026,

the key question for AMGN is not:

“What will next quarter’s EPS be?”

The more important question is:

“Can the growth rate of next-generation products consistently exceed the decline rate of older products?”

If Repatha continues expanding into broader cardiovascular markets, IMDELLTRA successfully moves into earlier treatment settings, and MariTide gains a meaningful position in the massive obesity market through lower dosing frequency, Amgen could complete a significant product transition.

This is also what separates AMGN from many biotechnology companies:

It is not placing the entire future on a single drug.

Instead, the company is:

Using today’s successful medicines to continuously buy time for tomorrow’s potential blockbuster therapies.