AMGN · Q3 2025 Earnings

Bullish

Amgen

Reported November 4, 2025

30-second summary

Revenue grew 12.4% YoY to $9.56B in Q3 with non-GAAP EPS of $5.64 and 14% volume growth offsetting -4% net selling price, driven by Repatha (+40% to $794M), TEZSPIRE (+40% to $377M), and EVENITY (+36% to $541M). Management raised FY revenue guide by $800M at the low end to $35.8–36.6B and non-GAAP EPS to $20.60–21.40, while simultaneously stepping R&D growth from "over 20%" to "mid-20s" — a reinvestment posture made credible by the Vesalius CV outcome win for Repatha in primary prevention. The Vesalius readout is the quarter's defining event; it converts Repatha from a secondary-prevention franchise into a candidate primary-prevention standard, with management positioning roughly 100 million globally as the new addressable pool.

Headline numbers

EPS

Q3 FY2025

$5.64

Revenue

Q3 FY2025

$9.56B

+12.4% YoY

Gross margin

Q3 FY2025

66.3%

Free cash flow

Q3 FY2025

$4.20B

Operating margin

Q3 FY2025

27.6%

Key financials

Q3 FY2025

Metric	Q3 FY2025	YoY	Q2 FY2025	QoQ
Revenue	$9.56B	+12.4%	$9.18B	+4.1%
EPS	$5.64	—	$6.02	-6.3%
Gross margin	66.3%	—	65.7%	+60bps
Operating margin	27.6%	—	30.3%	-270bps
Free cash flow	$4.20B	—	$1.91B	+119.8%

Guidance

Guidance is issued for the full year only, refreshed each quarter. Prior and new below are the same FY updated this quarter.

Actuals vs prior guidance

Metric	Period	Prior guide	Actual	Δ	Result
Non-GAAP EPS	Q3 FY2025	—	$5.64	in-line	Met
GAAP EPS	Q3 FY2025	—	$5.93	in-line	Met
Revenue	Q3 FY2025	—	$9.557 billion	in-line	Met

Changes to prior guidance

Metric	Period	Prior guide	New guide	Δ	Result
Revenue	FY2025	$35.0 billion to $36.0 billion	$35.8 billion to $36.6 billion	+$0.8B low end, +$0.6B high end	Raised
Non-GAAP EPS	FY2025	$20.20 to $21.30	$20.60 to $21.40	+$0.40 low end, +$0.10 high end	Raised
GAAP EPS	FY2025	$10.97 to $12.11	$13.76 to $14.60	+$2.79 low end, +$2.49 high end	Raised
Non-GAAP Tax Rate	FY2025	14.5% to 16.0%	15.0% to 16.5%	+50bps low end, +50bps high end	Raised
Capital Expenditures	FY2025	approximately $2.3 billion	$2.2 billion to $2.3 billion	-$0.1B at low end	Lowered
Non-GAAP OINE	FY2025	approximately $2.2 billion	$2.1 billion to $2.2 billion	-$0.1B at low end	Lowered
Non-GAAP R&D Expense Growth	FY2025	over 20%	mid-20s percentage rate year-over-year	Raised from >20% to mid-20s range	Raised
Non-GAAP Operating Margin	FY2025	roughly 45%	Withdrawn — no replacement	—	Withdrawn

Reaffirmed unchanged this quarter: Share Repurchases (not to exceed $500 million)

Segment KPIs

Q3 FY2025

Segment	Q3 FY2025	YoY
Repatha	$0.794B	+40.0%
TEZSPIRE	$0.377B	+40.0%
EVENITY	$0.541B	+36.0%

Other KPIs

Q3 FY2025

Segment	Q3 FY2025
Product Sales Growth	12%
Volume Growth	14%
Net Selling Price Change	-4%
Double-Digit Growth Products	16 products
Non-GAAP Operating Margin	47.1%
GAAP Operating Margin	27.6%
Free Cash Flow	$4.2 billion
R&D Expense as % of Product Sales	20.8%

Management tone

Narrative arc: Q1 platform-build → Q2 R&D-accelerate → Q3 outcome-data-validates.

Repatha shifted from "primary-prevention optionality" to "primary-prevention standard with the data in hand." Last quarter management noted 40% of Repatha new-to-brand was already primary prevention but framed LES-CVOT as the catalyst; this quarter Vesalius CV delivered, and the framing escalated. From the call: "The Visalia CB results demonstrate that Repatha provides additive benefit above and beyond statins, delivering even more reduction in cardiovascular events in primary prevention patients at higher risk." The shift is significant — this is the first PCSK9 to prevent first cardiovascular events in a 12,000+ patient trial, and management is positioning it as the AHA-presentation centerpiece that breaks payer prior-authorization friction.

R&D spend posture escalated again, in a measured way the market should respect. Q2 moved R&D from high-teens to "over 20%"; Q3 moves it to "mid-20s." Notably this happened alongside an EPS raise — meaning revenue strength and tax benefits absorbed the incremental spend without breaking the bottom line. The non-GAAP operating margin "~45%" anchor was simultaneously withdrawn, which reads as management wanting flexibility to keep investing without being held to the percentage frame.

IMDELLTRA's framing moved from "second-line standard of care" to "first-line maintenance and induction." From the call: "Imdeltra demonstrated a promising overall survival of 25.3 months, approximately doubling survival observed in other studies featuring the existing standard of care... 12-month overall survival of 81%, with median overall survival not yet reached." The Q2 emphasis was community-setting adoption in 2L; the Q3 emphasis is line-of-therapy expansion. That is a material widening of the IMDELLTRA TAM.

Meritide widened from obesity-only to multi-indication platform. Q2 described Maritide as four Phase III studies in obesity/diabetes/OSA. Q3 added Maritide CV and Maritide HF Phase III studies for atherosclerotic CV disease and heart failure respectively — six global Phase III studies now underway. This is the same playbook applied to Repatha (single indication → outcomes platform → multi-indication) being executed on the obesity franchise pre-launch.

Manufacturing-as-moat became an explicit talking point for the first time in the coverage period. Management cited "more than $3 billion in planned investments in the U.S. this year alone" on top of >$40B since 2017. The framing is defensive (tariff context) but also competitive — Amgen wants this contrasted against peers with more offshore exposure.

Recurring themes management leaned on this quarter:

Multi-indication platform expansion (Repatha in primary prevention, TESPIRE in CRSwNP, Meritide in CV/HF)Volume-driven growth outpacing price declines across industryBispecific T-cell engager (BITE) platform delivering transformative oncology outcomesSignificant unmet need and treatment penetration runway across therapeutic areasU.S.-based manufacturing as strategic advantage and investment priorityEarly lifecycle rare disease and GLP-1 portfolio positioning for sustained growth

Risks management surfaced:

Event rate accrual lower than initial predictions for Olpaceran Ocean A Phase III studyThree biosimilars launched to Prolia with expected competitive dynamics and sales impactFortitude 102 gastric cancer trial stopped for inadequate efficacyTariff impacts on guidance (estimated impacts included; additional tariffs not yet implemented excluded)Regulatory timing dependencies for multiple late-stage programs (PDUFA dates December 2025-2026)

Q&A highlights

Jay Olson · Oppenheimer

Inquired about Vesalius CV results for Repatha, expected market impact, what to look for at AHA presentation, and lessons learned applicable to Olpassaran

Management expressed strong enthusiasm for Vesalius CV results. Highlighted that this is the first and only PCSK9 inhibitor to demonstrate prevention of first cardiovascular events (75% of MIs are first events). Emphasized the study included 12,000+ patients globally and hit both dual primary endpoints. Positioned results as a 'landmark' trial that will drive physician awareness and patient access through affordable pricing via Amgen partnership

First PCSK9 inhibitor to demonstrate prevention of first heart attacks/strokes75% of MIs are first events12,000+ patients enrolled globallyBoth dual primary endpoints achieved

Terrence Flynn · Morgan Stanley

Requested overview of 2026 business drivers and P&L considerations; also asked about gastrointestinal ulcerations in Rocatinlamab ASTRO trial

Management outlined key growth drivers: PATHA, Avenity, Tespire, Innovative Oncology, Rare Disease annualizing >$5B; Biosimilar annualizing ~$3B. Operating margin at ~47% in 2024. Indicated R&D expense step-change completed; no incremental step-change expected. Completed multiple Phase III studies in 2025 (Repath, Acellius confirmatory, rocatinlamab, bemerituzumab). Non-GAAP operating margin guidance 45% for 2025 includes $200M business development in Q3. On ASTRO: 52-week rocatinlamab study in adolescents with atopic dermatitis showed GI side effects mostly mild, not excessive

14% volume growth for PATHA, Avenity, Tespire, Innovative Oncology, Rare DiseaseRare Disease annualizing >$5 billionBiosimilar annualizing ~$3 billionOperating margin ~47% in 2024

Chris Schott · J.P. Morgan

Asked about Amgen's view on obesity market dynamics given recent competitive updates (Metsera), Medicare pricing discussions, and Amgen's role with Meritide and broader pipeline

Management expressed strong enthusiasm for obesity opportunity, emphasizing Meritide's differentiation versus existing weekly injectable GLP-1s. Highlighted obesity as major public health crisis affecting ~40% of U.S. adults, costing $170B+ annually to healthcare. Stressed underpenetrated market requiring differentiated assets, not 'just another weekly injectable peptide' with 55% failure-to-continue rates. Noted 20+ years of discovery research in obesity/metabolic medicine. Mentioned additional pipeline: Phase 1 asset AMG513 and preclinical programs in incretin and non-incretin pathways (oral and injectable). Positioned Meritide as potentially monthly or less frequent with well-defined profile

~40% of U.S. adults have BMI >30; ~20% of children$170+ billion annual U.S. healthcare cost for obesity55% failure-to-continue rate for weekly injectable GLP-1sEstimated 20,000 U.S. patients in addressable market (but actual market potentially larger)

David Amselem · Piper Sandler

Asked about strong Duplizumab performance in IgG4-related disease label expansion, pent-up demand, sales opportunity refresh, and competitive dynamics in GMG with rapid label expansion

Management stated early IgG4 launch with ~300 unique prescribers. Cautioned against characterizing as 'pent-up demand' given IgG4 only received its own ICD-10 code in 2023, resulting in diagnosis awareness/education as catalyst for growth. Estimated ~20,000 U.S. patients but noted actual market could be much larger due to new diagnostic codes. Highlighted overwhelming efficacy (87% flare reduction) and substantial steroid sparing. For GMG: expects strong presence given convenient dosing (twice yearly after loading dose), durable effect, and differentiation targeting CD19 B-cell compartment (immature and mature cells). Noted GMG as dissatisfied market despite multiple entrants due to frequent treatment switching (median 1-1.5 years per therapy, patients see 2-3 medications)

~300 unique prescribers for Duplizumab in IgG4 at early stageIgG4 received ICD-10 code in 2023Estimated 20,000 U.S. IgG4 patients; actual market potentially larger87% flare reduction achieved in trials

Yaron Werber · TD Cowan

Asked about Meritide Phase 2 part two readout expected by year-end, design specifics regarding dosing (quarterly full-dose, monthly low-dose, placebo, Q12 weeks), presentation venue, and expectations

Management clarified part two is a maintenance study (not powered to demonstrate weight loss differences between arms). Tests quarterly full-dose, monthly low-dose, and placebo against continued treatment. Enrollment required >15% weight loss in part one. While part two lacks strong statistical power for comparison purposes, it will provide first maintenance experience and guidance for Phase 3 design. Study will inform maintenance strategy. Management indicated more detail on disclosure approach to follow

Part 2 is maintenance study, not powered for significant weight loss comparisonsEnrollment criterion: >15% weight loss in part oneTests quarterly full-dose, monthly low-dose, placebo, continued target doseWill inform Phase 3

Answers to last quarter's watch list

Maritide Phase 2 Part 2 readout in Q4 2025 — Management confirmed the readout is on track but recast expectations: Part 2 is a maintenance study not powered for between-arm weight-loss differences. It will inform Phase 3 design, not deliver a headline efficacy comparison.

Continue monitoring

LES-CVOT (Vesalius CV) readout — Resolved decisively. The trial met both dual primary MACE endpoints in 12,000+ primary-prevention patients at elevated CV risk, with management calling it "landmark." Full data at AHA. This is the single most positive event in the quarter and likely removes a meaningful chunk of payer prior-authorization friction on Repatha.

Resolved positively

Non-GAAP operating margin trajectory in 2H — Q3 non-GAAP operating margin landed at 47.1%, well above the prior "~45%" FY frame, and the ~45% anchor was then withdrawn entirely. R&D guidance was simultaneously stepped up from ">20%" to mid-20s YoY. The print suggests Q4 will see further sequential compression as R&D loads in. Status: Not resolved (disclosure framework changed)

IMDELLTRA community-setting adoption — Management did not re-disclose a specific community-setting share figure this quarter; the IMDELLTRA narrative pivoted to first-line maintenance/induction with 25.3-month OS and 81% 12-month OS in DELPHI-303. The line-of-therapy expansion thesis was reinforced even though the community-mix update was not.

Continue monitoring

Inflammation segment — TEZSPIRE +40% to $377M plus the new CRSwNP approval suggests the franchise's growth driver is functioning. Segment-level Q3 disclosure was thinner than Q2 but the product-level evidence supports a flip back toward growth.

Continue monitoring

Biosimilar growth durability — Management cited biosimilars annualizing ~$3B in the 2026 framing on the call, suggesting sustained scale despite three Prolia biosimilars now competing against Amgen's own franchise. No specific Q3 biosimilar growth rate was disclosed in the extracted data.

Continue monitoring

What to watch into next quarter

Meritide Phase 2 Part 2 maintenance readout — now reframed by management as Phase 3 design input rather than a headline efficacy event; watch the durability of weight loss in the quarterly-full-dose and monthly-low-dose arms vs continued-target-dose, and the GI tolerability profile during taper

Repatha post-Vesalius commercial inflection — track sequential Repatha growth against Q3's $794M / +40% YoY base; the question is how quickly AHA data plus updated lipid guidelines translate into reduced prior-authorization friction and new-prescriber growth

Whether the withdrawn ~45% non-GAAP operating margin frame returns in FY2026 guidance — its removal this quarter gave management flexibility, but its absence is the single biggest disclosure regression in the quarter; watch for a replacement profitability anchor on the FY2026 guide call

Q4 non-GAAP operating margin landing — with R&D now growing mid-20s YoY and Q3 at 47.1%, Q4 should compress meaningfully sequentially; watch whether the FY non-GAAP EPS midpoint of $21.00 implies a Q4 margin near or below 43%

IMDELLTRA first-line data progression — the 81% 12-month OS in DELPHI-303 first-line induction with median OS not yet reached is the key 2026 catalyst; watch for updated DELPHI-303 maturity disclosures and any timing signal on a 1L regulatory filing

Tariff guidance update — current FY guide excludes unimplemented tariffs and post-announcement pricing actions; watch whether Q4 guidance refresh quantifies tariff exposure for the first time, especially given management's $3B US manufacturing investment framing

Sources

Amgen Q3 2025 earnings press release (SEC filing, dated 2025-11-04): https://www.sec.gov/Archives/edgar/data/318154/000031815425000070/amgn-20250930earningsrelea.htm
Amgen Q3 2025 earnings call prepared remarks and Q&A (referenced via extracted transcript content)
Amgen Q2 2025 brief (Tapebrief internal, for cross-quarter comparison)

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