Finvest
AMGN Biotechnology · Large cap · Biotech · Dividend payer · Thesis updated June 11, 2026

Growth drugs race a patent cliff

01 Running thesis

New drugs must outrun Prolia

Amgen is in a handoff year. Older bone drugs Prolia and XGEVA are losing protection, and biosimilars, which are copycat versions of complex biologic drugs, are now taking share. In Q1 2026, that franchise dropped 32% year over year to $1.1 billion.

The good news is that the rest of the portfolio is doing real work. Amgen said its 6 key growth drivers made up 70% of sales in Q1 2026 and grew 24% in aggregate. That helped management raise full-year 2026 revenue guidance to $37.1 billion to $38.5 billion and non-GAAP EPS guidance to $21.70 to $23.10.

The stock still has a balanced setup. Repatha, EVENITY, TEZSPIRE, rare disease drugs, oncology drugs, and biosimilars can keep the company growing. But the company must prove that Prolia and XGEVA erosion will not eat too much of that growth.

MariTide could change the story if it works. Amgen is testing whether people can switch from weekly obesity injections to MariTide given every 8 or 12 weeks. That convenience could matter, but the study still has to show the drug can compete on weight loss, safety, and staying power.

May 2026The Q1 2026 Form 10-Q confirmed the main story from earnings. Growth products are offsetting pressure for now, while Prolia and XGEVA erosion and Tavneos risk remain live.
Apr 2026Q1 results were strong enough for higher 2026 guidance, with the 6 key growth drivers at 70% of sales and up 24% in aggregate. The same update added a larger IRS risk because the 2016 to 2018 tax years are now under audit.
Feb 2026The 2025 Form 10-K set a clearer timing window for the IRS case, with a Tax Court decision expected no earlier than the second half of 2026. It also confirmed Amgen is contesting the FDA request to withdraw Tavneos.
Feb 2026Management warned that Prolia would face accelerated erosion in 2026 as multiple biosimilars launched globally. MariTide remained the main pipeline upside, but the Tavneos withdrawal request added regulatory risk.
Nov 2025The Q3 2025 filing supported the Repatha bull case after positive VESALIUS-CV data. It also confirmed that Prolia and XGEVA sales erosion from biosimilars had begun.
Nov 2025Q3 2025 results beat expectations and management raised full-year guidance. Repatha data improved the growth case, while Prolia biosimilar pressure stayed the main offset.
Aug 2025The Q2 2025 filing showed strong volume growth, but also sharper pricing pressure on mature products. ENBREL weakness and new policy risks made the setup more mixed.
Aug 2025Q2 2025 earnings showed that portfolio growth was still more than offsetting the first Prolia biosimilar impact. Management raised 2025 revenue and EPS guidance.
02 Business model

Patents, factories, and drug sales

Amgen makes money by selling prescription medicines to wholesalers, distributors, and health systems. Most products are biologics, which are drugs made from living cells. They are hard to copy, but once patents expire, biosimilars can pressure both volume and price.

The moat comes from research skill, patents, clinical data, and large-scale biologic manufacturing. A drug company also needs payer access, which means insurance plans and government programs must agree to cover the medicine at a usable price.

The model can break in three main ways. A major drug can lose exclusivity faster than expected. A pipeline drug can fail in trials. Or payers and governments can force lower net prices, which is already a risk for Otezla under Medicare price setting beginning in 2027.

Amgen is also trying a more direct model in the U.S. AmgenNow started with Repatha at a monthly price of $239, aiming to make access simpler and more affordable for patients.

03 Product portfolio

What sells, what could grow

Growth engine

Repatha

Repatha is a cholesterol-lowering drug and one of Amgen's strongest growth drivers. It had $876 million in Q1 2026 sales, up 34% year over year.

Growth engine

EVENITY

EVENITY treats osteoporosis and is helping offset the Prolia decline. It had $562 million in Q1 2026 sales, up 27% year over year.

Growth engine

UPLIZNA

UPLIZNA is part of Amgen's rare disease push. It had $262 million in Q1 2026 sales, up 188% year over year.

Growth engine

TEPEZZA

TEPEZZA treats thyroid eye disease and came with the Horizon deal. It had $490 million in Q1 2026 sales, up 29% year over year.

Cash cow

Prolia and XGEVA

These denosumab bone drugs are still large, but they are now the main headwind. Combined sales were $1.1 billion in Q1 2026, down 32% year over year.

Steady

Biosimilars

Amgen also sells biosimilars, which are lower-cost versions of complex biologic drugs. This business helps diversify sales as some of Amgen's own older drugs face biosimilar competition.

Option

MariTide

MariTide is Amgen's late-stage obesity drug candidate. New Phase 3 studies will test switching from weekly obesity drugs to an every 8-week or 12-week schedule.

04 Business segments

One reported segment, many drug lines

6 key growth drivers70%growing fast
Other human therapeutics30%declining

Amgen reports as one human therapeutics segment. The mix below uses Q1 2026 product sales color from management: 6 key growth drivers at about 70% of sales and the rest of the portfolio at about 30%.

05 Risk factors

What could break the thesis

Prolia and XGEVA erosion

High impact · High odds

The denosumab franchise is already shrinking after loss of exclusivity. Prolia and XGEVA sales fell 32% year over year in Q1 2026, and management expects faster erosion through the rest of 2026 as multiple biosimilars launch globally.

We watchQuarterly Prolia and XGEVA sales, plus management comments on biosimilar share and price pressure.

Bigger IRS tax dispute

High impact · Medium odds

Amgen is waiting for a U.S. Tax Court decision on its 2010 to 2015 IRS dispute, expected no earlier than the second half of 2026. The risk grew in April 2026 when the IRS also issued a draft notice for the 2016 to 2018 tax years with similar profit allocation claims.

We watchThe U.S. Tax Court decision and any company estimate of possible liability for the 2016 to 2018 audit.

MariTide disappoints

High impact · Medium odds

MariTide is the largest pipeline swing because obesity is a huge market and current leaders dose weekly. A less frequent schedule could help, but only if the drug shows strong weight loss, clean safety, and good patient persistence.

We watchPhase 3 enrollment updates, switching study design details, and any weight loss or safety readouts.

Tavneos regulatory overhang

Medium impact · Medium odds

The FDA requested a voluntary withdrawal of TAVNEOS in January 2026, and Amgen contested the request. That creates uncertainty for a drug acquired through ChemoCentryx and adds noise to the rare disease story.

We watchFDA hearing steps, final withdrawal decisions, and any change in U.S. TAVNEOS sales.

Drug pricing pressure

Medium impact · High odds

Government and commercial payers keep pushing for lower net prices. Otezla was selected for Medicare price setting beginning in 2027, which Amgen expects to cause further net selling price declines.

We watchOtezla net selling price trends, Medicare price setting updates, and broader U.S. pricing policy changes.
06 Quick answers

In one breath

What is Amgen known for?

Amgen is known for biologic medicines used in bone disease, cancer, heart disease, rare disease, inflammation, and other serious illnesses. Its major current growth products include Repatha, EVENITY, UPLIZNA, TEPEZZA, TEZSPIRE, oncology drugs, and biosimilars.

Why are Prolia and XGEVA a problem for Amgen?

Prolia and XGEVA lost key protection and now face biosimilar competition. Their combined Q1 2026 sales fell 32% year over year to $1.1 billion, and management expects faster erosion during the rest of 2026.

What is MariTide?

MariTide is Amgen's late-stage obesity drug candidate. Amgen is studying whether patients can switch from weekly obesity injections to MariTide on an every 8-week or 12-week schedule.

What is the biggest legal risk for Amgen?

The biggest legal risk is the IRS tax dispute over profit allocation between the United States and Puerto Rico. The 2010 to 2015 case is waiting for a U.S. Tax Court decision, and the IRS is now also auditing the 2016 to 2018 tax years.