Amgen (AMGN) Q3 2026 earnings review
Amgen raises its outlook as newer drugs outrun copycat losses
Amgen's newer medicines are growing fast enough to cover steep copycat losses on its older bone drugs. Revenue rose 8% to $10.4 billion—or nearly 12% by our math after stripping out last year's one-off rebate and government-order boosts—and profit per share excluding one-offs climbed 14%. Chief executive Robert A. Bradway raised the full-year outlook for a third time, though by our math the plan points to revenue growth slowing to 4% in the fourth quarter.
| Underlying revenue growth (by our math) | ~12% reported revenue $10.4B, +8% from a year ago |
|---|---|
| Profit per share, excluding one-offs | $6.45 +14% from a year ago |
| Prolia and XGEVA bone drug sales | $920M −45% combined from a year ago |
| Full-year revenue outlook | Raised $500M middle of the range: 6.9% growth |
⚖️ Verdict: 🟢 Bullish
The story got better because top-selling cholesterol drug Repatha, rare-disease drug UPLIZNA and lung-cancer drug IMDELLTRA accelerated while two late-stage autoimmune trials succeeded. Those gains absorbed a 45% drop in bone drugs Prolia and XGEVA and still lifted the annual plan. One caution: psoriasis drug Otezla fell 18% on weaker volume before 2027 Medicare price cuts even begin, and TAVNEOS sales dropped 30% from last quarter during an FDA withdrawal dispute.
The question now is whether Amgen's rising share of young drugs can keep total growth in the high single digits in 2027 when Otezla Medicare price cuts join the bone-drug decline. Either the 17 drugs growing double digits today carry the portfolio higher, or widening price and copycat cuts pull overall growth down. Management's first 2027 outlook next quarter will settle it.
🐂 Bull Case
Newer Drugs Outrun the Bone-Drug Patent Cliff
Amgen is replacing aging blockbusters with a broad group of newer medicines. Total revenue rose 8.5% from a year ago to $10.4 billion, and product sales grew 8.2% on higher prescription volume. Last year's third quarter included about $250 million in one-off rebate adjustments and a larger government order for Nplate, its blood-platelet medicine. Strip those out, and underlying revenue grew nearly 12% by our math.
Seventeen drugs grew at least 10% and 17 now sell at a pace above $1 billion a year, Amgen said. That breadth absorbed a $758 million combined drop in bone drugs Prolia and XGEVA. Because the growing portfolio is now much larger than the shrinking older drugs, volume gains easily covered copycat competition and induced a third raise to the full-year outlook.
What to watch: the combined growth rate of Amgen's six main growth pillars on the conference call. A reading above 20% against last year's high comparison base will show the portfolio transition is holding its pace.
Repatha Passes $1 Billion as Rare Disease Triples
Three key medicines gained commercial and regulatory ground this quarter. Repatha, Amgen's cholesterol injection, grew 37% from a year ago to $1.09 billion. In August, the company presented trial analysis showing Repatha cut deaths from any cause by 20% and heart-related deaths by 21% in high-risk patients who had never suffered a heart attack or stroke.
In rare diseases, UPLIZNA—an antibody for autoimmune nerve and organ conditions—nearly tripled to $451 million after winning approval for generalized myasthenia gravis, a muscle-weakening disorder. In cancer, small-cell lung cancer drug IMDELLTRA more than doubled to $406 million. The U.S. regulator cut required patient monitoring on the first two IMDELLTRA doses from 24 hours to between 6 and 8 hours, making hospital adoption easier.
What to watch: U.S. new-to-brand prescription growth for Repatha when management speaks on the call. Holding growth near 30% will confirm primary-care doctors are adopting the drug before rival oral pills arrive.
Late-Stage Trials Hit Goals in Sjögren's and Esophagitis
Amgen delivered two late-stage trial wins that were due in the second half of 2026. Dazodalibep, an experimental protein for Sjögren's disease—an autoimmune disorder causing severe dryness and organ inflammation—achieved "statistically significant and clinically meaningful improvements of systemic disease activity at Week 48" in its first Phase 3 study, Amgen said. A second Phase 3 study in patients with milder organ involvement will finish in the fourth quarter.
Meanwhile, severe-asthma drug TEZSPIRE "achieved histologic remission at Week 24 in 64.8% and 68.9% of EoE patients" in a Phase 3 study for eosinophilic esophagitis, an allergic swallowing disorder, compared with 3.5% on placebo. Amgen also started a head-to-head Phase 3 diabetes trial of obesity candidate MariTide against semaglutide, whose design "supports starting with monthly dosing, and staying on MariTide with as few as four or six doses per year".
What to watch: completion of the second Sjögren's trial, OASIZ 303, in the fourth quarter of 2026. Positive results there will allow Amgen to file dazodalibep for approval across the full patient population.
🐻 Bear Case
Biosimilar and Price Cuts Deepen Across Older Blockbusters
"The strength of our commercial portfolio, combined with important clinical advances and a promising late-stage pipeline, reinforces our confidence in Amgen’s ability to deliver durable growth well into the next decade," chief executive Robert A. Bradway said. Yet revenue losses across Amgen's older drugs widened sharply this quarter as copycat launches and U.S. government price rules took a deeper bite.
- Prolia (osteoporosis): down 45% to $632 million on 23% lower volume and lower prices
- XGEVA (bone cancer complications): down 47% to $288 million on 32% lower volume
- Otezla (psoriasis pill): down 18% to $481 million, led by a 13% volume drop
- Enbrel (arthritis): net selling price fell 14% under Medicare Part D price setting
Prolia and XGEVA fell 32% and 34% last quarter, so their erosion worsened "as multiple biosimilars have launched globally", Amgen said. More troubling is Otezla, where volume shrank 13% even before U.S. Medicare price setting starts for the drug in January 2027.
What to watch: initial 2027 revenue outlook in the fourth-quarter release. It will show whether newer drugs can keep outrunning a full year of denosumab copycats plus Otezla's upcoming Medicare price cut.
TAVNEOS Sales Drop 30% From Last Quarter Under FDA Cloud
Regulatory disputes are hurting one rare-disease medicine and delaying a key cancer trial. TAVNEOS, a pill for an autoimmune blood-vessel inflammation called ANCA-associated vasculitis, remains under a cloud after the U.S. Food and Drug Administration's drug center made a "request to voluntarily withdraw TAVNEOS from the U.S. market" over trial-data and liver-safety questions. Amgen requested a formal hearing in June and submitted supporting documents in July.
While the dispute drags on, TAVNEOS sales fell 30% from last quarter to $105 million, and slipped 2% from a year ago as prescription volume dropped 9%. A forced withdrawal would eliminate over $400 million in yearly sales and threaten a $2.4 billion balance-sheet asset. Separately, two trials testing an under-the-skin version of leukemia drug BLINCYTO remain on partial clinical hold by the FDA.
What to watch: the quarterly 10-Q filing's intangible-asset footnote for TAVNEOS. A write-down or warning of falling new-patient starts would signal that doctors are pulling back before the FDA rules.
Risks this quarter didn't answer
Five standing risks from prior quarters received no new data in the third-quarter earnings release and await the conference call or quarterly 10-Q filing.
- IRS tax dispute: a U.S. Tax Court ruling on $8.7 billion in back taxes plus interest for 2010–2015 is due no earlier than late 2026; the 10-Q tax footnote will update audit status.
- MariTide tolerability: Phase 3 obesity trials are running, but no Phase 3 vomiting or dropout rates have arrived to test how the monthly shot compares with weekly rivals.
- Oral PCSK9 competition: the release gives no prescription-share data showing whether Merck's approved cholesterol pill is slowing Repatha's new patient starts.
- Olpasiran readout date: the Phase 3 heart trial for lipoprotein(a) drug olpasiran is still listed as ongoing with no target completion date after slower cardiac event rates.
- Pharmaceutical tariffs: the three-year U.S. tariff relief granted in late 2025 remains in place, with no new policy changes reported this quarter.
👓 Other Themes
Overhead Cuts Offset Higher Research Costs
Amgen held its operating margin steady, excluding one-offs, at 47.3% of product sales—up 0.2 percentage points from a year ago and above the 43.1% to 45.2% second-half rate implied by its prior full-year plan by our math. Cost of sales rose 1.1 points to 19.3% on partner profit-sharing, and research rose 0.6 points to 21.3% on early pipeline deals, but selling and administrative costs fell 1.6 points to 17.0%.
💲 Other KPIs
Free cash flow—operating cash left after capital spending—fell 14.0% from a year ago, down from $4.25 billion in the third quarter of 2025. Amgen said last year's quarter benefited from the timing of customer collections and rebate payments, while capital spending for new factories rose 34.6% to $587 million (5.7% of revenue).
Total debt minus cash dropped by $4.66 billion over the first nine months of 2026 by our math. Amgen trimmed total debt by $597 million to $54.01 billion and built cash by $4.06 billion to $13.19 billion. The biotech group bought back zero shares for a third straight quarter despite an up-to-$3.0 billion buyback plan.
Reported net profit rose 20.1% from a year ago, lifting GAAP profit per share by 19.4% to $7.08. The bottom line included $1.47 billion in pre-tax paper gains on equity investments and $59 million in asset write-downs, compared with $1.96 billion in equity gains and a $400 million Otezla write-down a year ago.
🔮 Guidance
Raised. Amgen lifted the middle of its full-year sales plan by $500 million, pointing to 6.9% growth for the year by our math. That leaves about $10.26 billion for the fourth quarter, or 4.0% growth from a year ago against last year's heavy inventory buildup. It is the third raise this year: +$100 million in Q1, +$1.0 billion in Q2, and +$500 million now.
Raised. The middle of the profit-per-share target moved up $0.40 to $23.30, or 6.7% growth for the full year by our math. After $17.88 in the first nine months, the plan leaves $5.42 for the fourth quarter—up 2.5% from a year ago as late-year research spending rises. It is the third raise in three quarters: +$0.10, +$0.50, and +$0.40.
Raised. Management lifted the middle of the reported profit-per-share outlook by $2.37 to $18.81, representing 32.2% growth over 2025 by our math. The large increase reflects third-quarter paper gains on equity investments and lower acquisition write-offs, which cut the gap between GAAP and non-GAAP profit.
Unchanged. The full-year tax rate plan stays at a middle point of 15.75%, right in line with the 15.9% rate recorded in the third quarter and 15.2% across the first nine months.
Unchanged. The reported tax rate target remains at a middle point of 15.25%, matching the 15.5% rate through the first nine months of 2026.
Unchanged. The factory-building budget stays at $2.6 billion, up 39.9% from $1.86 billion in 2025 as the drugmaker builds manufacturing lines for MariTide and commercial volume growth. With $1.81 billion spent in the first nine months, the plan leaves about $788 million for the fourth quarter by our math.
Unchanged. The buyback cap stays at $3.0 billion, though Amgen has spent $0 on buybacks through the first nine months while accumulating $13.19 billion in cash.
❓ Key Questions
How fast did the six growth pillars grow together?
Last quarter management said its six main growth areas made up nearly 70% of product sales and grew 26%. The release omits that combined figure and Repatha's new-prescription rate; investors need both on the call to verify the portfolio shift.
Why is Amgen holding $13.2 billion cash without buybacks?
The company authorized up to $3.0 billion in 2026 share buybacks but has executed none through September while cash rose by $4.1 billion. Is management conserving cash for a potential U.S. Tax Court payment or pipeline acquisitions?
What caused TAVNEOS sales to drop 30% from Q2?
TAVNEOS revenue fell from $150 million in the second quarter to $105 million in the third, with volume down 9% from a year ago. How much are new patient starts slowing while the FDA withdrawal hearing request is pending?
Why did Otezla volume fall 13% before 2027 price cuts?
Management said last quarter that Otezla volume was holding up well, yet third-quarter volume dropped 13% from a year ago. What drove the sudden prescription drop ahead of January 2027 Medicare price setting?
When will the Olpasiran heart trial reach its readout?
The Phase 3 OCEAN(a)-Outcomes study has lacked a target completion date for four quarters because patients suffered fewer cardiac events than modeled. When does management now expect to unblind the primary data?