AMGEN (AMGN) Company Report

UPLIZNA to enter Phase III trials in autoimmune hepatitis and CIDP in 2026; CIDP prevalence in the U.S. is ≈35,000 with 7,000–10,000 new cases annually; AIH population considered larger though less defined.
Daxdilimab (ILT-7 targeting) achieved Phase II success in discoid lupus, meeting primary and key secondary endpoints, supporting advancement to Phase III in cutaneous lupus.
Dazodalibep, a CD40 ligand inhibitor, is in two Phase III trials for Sjögren’s syndrome—one in moderate–severe systemic disease and one in high symptomatic burden—after Phase II efficacy across both patient subsets.
TEZSPIRE approved for chronic rhinosinusitis with nasal polyps showed significant reductions in polyp severity, surgery needs, and steroid use; pipeline expands to COPD and eosinophilic esophagitis (Phase III readouts H2 2026) and an inhaled TSLP fragment (AMG 104) completing Phase II.

7 days ago

Transcript

Amgen expands immunology pipeline with new trials and label expansions

AMGN

UPLIZNA (anti-CD19) to enter Phase III studies in autoimmune hepatitis (AIH) and chronic inflammatory demyelinating polyneuropathy (CIDP) later in 2026; U.S. CIDP prevalence is estimated at 35,000 with 7,000–10,000 new annual cases, while AIH’s pool is larger but not precisely quantified.
Daxdilimab (anti-ILT-7) met its primary and key secondary endpoints in a Phase II study for discoid lupus, and Amgen is evaluating Phase III design and broader cutaneous lupus indications.
Dazodalibep, a CD40-ligand inhibitor, has completed enrollment in two Phase III trials targeting moderate-to-severe systemic and high-symptomatic/low-systemic Sjögren’s syndrome following positive Phase II results.
TEZSPIRE (anti-TSLP) gained approval in chronic rhinosinusitis with nasal polyps after the Phase III Waypoint trial showed significant polyp reduction, near-elimination of surgery need, and reduced steroid use versus placebo—leveraging an upstream mechanism versus IL-4/5/13 inhibitors.
Amgen anticipates Phase III readouts for TEZSPIRE in eosinophilic esophagitis (prevalence ~1 in 700 in the U.S.) and COPD in H2 2026, and is developing AMG 104, an inhaled TSLP antibody fragment, as a potential alternative to injectable biologics.

7 days ago

Transcript

Amgen outlines immunology pipeline at Piper Sandler symposium

AMGN

UPLIZNA (anti-CD19) will enter Phase III trials in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy, with an estimated U.S. CIDP population of 35,000 prevalent and 7,000–10,000 incident patients annually.
Daxdilimab (anti-ILT-7) met its primary and key secondary endpoints in a Phase II discoid lupus study, prompting planning for a pivotal Phase III trial in cutaneous lupus manifestations.
Dazodalibep (CD40L inhibitor) is in two Phase III trials for Sjögren’s syndrome, targeting systemic disease activity and high symptomatic burden subgroups, with readouts expected in H2 2026.
TEZSPIRE (anti-TSLP) was approved for chronic rhinosinusitis with nasal polyps, demonstrating reduced polyp severity, surgery need and steroid use, and is being evaluated in COPD and eosinophilic esophagitis, with EoE data due H2 2026.
The inhaled TSLP antagonist AMG 104 completed Phase I and is in Phase II for severe asthma, aiming to deliver an upstream biologic directly to the lungs, with trial completion expected H1 2026.

7 days ago

Transcript

Amgen reports Q4 2025 results

AMGN

Earnings

Guidance Update

New Projects/Investments

Amgen delivered double-digit revenue and EPS growth in 2025, driven by 14 blockbuster products (>$1 B sales), 13 with double-digit growth, and 18 achieving record sales.
Key growth drivers in 2025 included Repatha (+36% to >$3 B), Evenity (+34% to $2.1 B), Tezspire (>30%), a $5.2 B rare disease portfolio, and $3 B in biosimilars sales.
For 2026, Amgen expects total revenues of $37.0–38.4 B and non-GAAP EPS of $21.60–23.00, noting a Q1 headwind from U.S. insurance cycles and biosimilar competition.
R&D momentum includes six global phase III MariTide trials, the VESALIUS-CV trial showing a 25% relative risk reduction with Repatha, and full FDA approval of Imdelltra for small cell lung cancer.

Feb 3, 2026, 9:30 PM

Transcript

Amgen posts Q4 2025 results

AMGN

Earnings

Guidance Update

Strong full-year performance: Amgen delivered double-digit revenue and EPS growth in 2025, with 14 blockbuster products, 13 achieving double-digit sales growth, and 18 setting record results.
Franchise drivers: Key portfolio highlights include Repatha (+36% to >$3 billion) , Evenity (+34% to $2.1 billion) , Tezspire (+52% to $1.5 billion) , rare disease (+14% to ~$5.2 billion) , innovative oncology (+11% to $8.7 billion) , and biosimilars ($3 billion).
Financial metrics: Non-GAAP operating margin of 46%, 22% increase in R&D to $7.2 billion, $8.1 billion free cash flow, $2.2 billion capex, $6 billion of debt retired, and $2.38 quarterly dividend (+6%).
2026 outlook: Projected revenues of $37.0 billion–$38.4 billion and non-GAAP EPS of $21.60–$23.00, with up to $3 billion in share repurchases and $2.6 billion capex; anticipates Q1 headwinds from benefit-plan changes, biosimilar competition, and inventory adjustments.

Feb 3, 2026, 9:30 PM

Transcript

Amgen reports Q4 2025 results and provides 2026 guidance

AMGN

Earnings

Guidance Update

Q4 ’25 revenue of $9.87 B, up 9% YoY; product sales of $9.37 B, up 7%; Non-GAAP EPS of $5.29 (flat YoY).
FY 2025 revenue of $36.75 B (+10%) and Non-GAAP EPS of $21.84 (+10%).
2026 guidance: revenue of $37.0 B–$38.4 B; Non-GAAP EPS of $21.60–$23.00.
Invested $7 B in R&D (+22% YoY) while maintaining a 46% Non-GAAP operating margin; advanced pipeline with five FDA approvals and key Phase 3 milestones.

Feb 3, 2026, 9:30 PM

Presentation

Amgen reports Q4 2025 results and 2026 outlook

AMGN

Earnings

Guidance Update

Amgen delivered 10% full-year sales growth in 2025 with double-digit revenue and EPS gains; 14 products reached blockbuster status, 13 posted double-digit sales growth, and 18 hit record sales.
Key 2025 growth drivers included: Repatha up 36% to >$3 B, Evenity up 34% to $2.1 B, Tezspire up 52% to $1.5 B, rare disease portfolio up 14% to $5.2 B, innovative oncology up 11% to $8.7 B, and $3 B in biosimilars sales.
Full-year non-GAAP R&D spending rose 22% to $7.2 B, funding late-stage programs such as MariTide and Olpasiran; generated $8.1 B in free cash flow and retired $6 B of debt.
2026 guidance forecasts revenues of $37.0 B–$38.4 B, non-GAAP EPS of $21.60–$23.00, and a non-GAAP operating margin near 45%–46%.

Feb 3, 2026, 9:30 PM

Transcript

Amgen reports Q4 and full year 2025 financial results

AMGN

Earnings

Guidance Update

Dividends

Amgen delivered Q4 2025 total revenues of $9.9 billion (+9% YoY) and full year revenues of $36.8 billion (+10% YoY); GAAP EPS rose to $2.45 in Q4 (+111% YoY) and $14.23 for FY 2025 (+88% YoY).
Fourth-quarter GAAP operating margin increased 2.5 percentage points to 29.0%, and full-year margin rose 3.1 points to 25.8%.
Declared a Q4 dividend of $2.38 per share, a 6% increase versus Q4 2024.
Issued 2026 guidance: total revenues of $37.0 billion–$38.4 billion, GAAP EPS of $15.45–$16.94, and non-GAAP EPS of $21.60–$23.00.

Feb 3, 2026, 9:03 PM

8-K

Amgen reports fourth quarter and full year 2025 results

AMGN

Earnings

Dividends

Guidance Update

Q4 revenues were $9.9 B (up 9% YoY) and full-year revenues were $36.8 B (up 10% YoY).
GAAP EPS rose to $2.45 in Q4 (+111%) and $14.23 for the year (+88%); non-GAAP EPS was $5.29 in Q4 (flat) and $21.84 for the year (+10%).
Full-year free cash flow was $8.1 B versus $10.4 B in 2024; Q4 free cash flow was $1.0 B versus $4.4 B in Q4 2024.
The company declared a Q4 dividend of $2.38 per share (up 6%), and ended 2025 with $9.1 B in cash and $54.6 B of debt (3.2× leverage).
2026 guidance: revenues of $37.0–38.4 B, GAAP EPS of $15.45–16.94, and non-GAAP EPS of $21.60–23.00.

Feb 3, 2026, 9:01 PM

Press Release

Amgen regains global rights to atopic dermatitis candidate rocatinlimab

AMGN

New Projects/Investments

Amgen terminated its development and commercialization agreement with Kyowa Kirin, regaining global control of the rocatinlimab program outside Japan.
Rocatinlimab, an anti-OX40 monoclonal antibody for atopic dermatitis, achieved rIGA 0/1 response at Week 16 in Phase 3 ROCKET-IGNITE and ROCKET-HORIZON trials, with consistent safety and no new signals.
The pediatric ROCKET-ASCEND trial is ongoing, with interim data confirming a favorable safety and tolerability profile in children.
Amgen reaffirmed its strong commitment to addressing the high unmet medical need in atopic dermatitis.

Jan 31, 2026, 3:28 PM

Press Release

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Earnings Transcripts

Quarterly earnings call transcripts for AMGEN.

Q4 2025

Feb 3, 2026

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Q3 2025

Nov 4, 2025

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Q2 2025

Aug 5, 2025

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AMGEN (AMGN)

Analyst Earnings Quarterly Reports

Q3 2025

Q2 2025

Q1 2025

Q4 2024

Q4 2025

Executives

Robert A. Bradway

David M. Reese

James E. Bradner

Murdo Gordon

Peter H. Griffith

Board Members

Amy E. Miles

Brian J. Druker

Charles M. Holley, Jr.

Ellen J. Kullman

Greg C. Garland

Mary E. Klotman

Michael V. Drake

Robert A. Eckert

S. Omar Ishrak

Tyler Jacks

Wanda M. Austin

Analyst Coverage

Salveen Richter

Terence Flynn

Yaron Werber

David Amsellem

Christopher Schott

Jay Olson

Courtney Breen

Evan Seigerman

Matthew Phipps

Umer Raffat

David Risinger

Michael Yee

Mohit Bansal

Alexandria Hammond

Gregory Renza

Alex Hammond

Carter L. Gould

Chris Schott

Louise Chen

Christopher Raymond

Conor MacKay

Geoff Meacham

James Shin

Luca Issi

Michael DiFiore

Michael Gee

Mike DiFiore

Olivia Brayer

Sadia Rahman

Timothy Anderson

Trung Huynh

Latest news

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Amgen's MariTide Delivers on Maintenance Promise: 'Large Majority' Keep Weight Off With Monthly or Quarterly Dosing

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Q4 2025

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