AMGN · Q4 2025 Earnings

Cautious

Amgen

Reported February 3, 2026

30-second summary

Revenue grew 8.6% YoY to $9.9B in Q4 with non-GAAP EPS of $5.29 and full-year revenue of $36.8B (+10%) landing above the high end of the raised guide. But the FY2026 guide is the story: $37.0–38.4B revenue (midpoint +2.4% YoY) and $21.60–23.00 non-GAAP EPS (midpoint +2.1% YoY) mark a stark deceleration from FY2025's +10% revenue growth, with Prolia/XGEVA biosimilar erosion and Repatha price compression cited as the proximate causes. Management offset the soft guide with a 6x step-up in share repurchase authorization to $3B and reinstated the operating margin anchor at 45–46% — but the underlying message is that 2026 is a transition year where the late-stage pipeline must carry the franchise.

Headline numbers

EPS

Q4 FY2025

$5.29

Revenue

Q4 FY2025

$9.90B

+8.6% YoY

Free cash flow

Q4 FY2025

$1.00B

Operating margin

Q4 FY2025

29.0%

Key financials

Q4 FY2025

Metric	Q4 FY2025	YoY	Q3 FY2025	QoQ
Revenue	$9.90B	+8.6%	$9.56B	+3.6%
EPS	$5.29	—	$5.64	-6.2%
Operating margin	29.0%	—	27.6%	+140bps
Free cash flow	$1.00B	—	$4.20B	-76.2%

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
Revenue	FY2025	$35.8 billion to $36.6 billion	$36.8 billion	+$0.2 billion above guide high end	Beat
Non-GAAP EPS	FY2025	$20.60 to $21.40	$21.84	+$0.44 above guide high end	Beat
GAAP EPS	FY2025	$13.76 to $14.60	$14.57	in-line with high end	Beat

New guidance

Metric	Period	Guide	YoY
Revenue	FY2026	$37.0 billion to $38.4 billion	—
Non-GAAP EPS	FY2026	$21.60 to $23.00	—
GAAP EPS	FY2026	$15.45 to $16.94	—
Non-GAAP Tax Rate	FY2026	16.0% to 17.5%	—
GAAP Tax Rate	FY2026	15.5% to 17.0%	—
Other Revenue	FY2026	$1.6 to $1.8 billion	—
Non-GAAP Operating Margin	FY2026	roughly 45 to 46 percent (as % of product sales)	—
Non-GAAP Other Income and Expense	FY2026	about $2.3 to $2.4 billion	—

Changes to prior guidance

Metric	Period	Prior guide	New guide	Δ	Result
Capital Expenditures	FY2026	$2.2 billion to $2.3 billion (FY2025)	approximately $2.6 billion (FY2026)	+$0.3 billion at midpoint	Raised
Share Repurchases	FY2026	not to exceed $500 million (FY2025)	not to exceed $3 billion (FY2026)	+$2.5 billion	Raised

Segment KPIs

Q4 FY2025

Segment	Q4 FY2025	YoY
Repatha	$0.87B	+44.0%
EVENITY	$0.599B	+39.0%
Prolia	$1.054B	-10.0%
TEZSPIRE	$0.474B	+60.0%

Other KPIs

Q4 FY2025

Segment	Q4 FY2025
Product Sales Growth (YoY)	7%
Volume Growth	10%
Net Selling Price Change	-4%
Products with Record Sales (FY2025)	18 products
Products Exceeding $1B Annual Sales	14 products
Products with Double-Digit Sales Growth (FY2025)	13 products
Non-GAAP Operating Margin	42.8%
Debt Leverage Ratio	3.2x EBITDA

Management tone

Narrative arc: Q1 platform-build → Q2 R&D-accelerate → Q3 outcome-data-validates → Q4 pipeline-carries-the-franchise.

Repatha's framing escalated again — from "outcomes-validated primary prevention option" in Q3 to "guideline-changing standard with the data to demand it" in Q4. The Q3 call positioned Vesalius CV as the catalyst; Q4 positions it as the catalyst that has now landed. From the call: "Given these results and our leadership in this category, we believe there's now a clear opportunity to update clinical guidelines and quality measures." This is management asserting that lipid guidelines should change because of their data — a step beyond Q3's framing that guidelines might change. Q4 Repatha at $870M (+44%) and EVENITY at $599M (+39%) suggest the commercial inflection started before guidelines even moved.

Maritide widened from multi-indication platform to category-defining paradigm. Q2 framed Maritide as four Phase III studies; Q3 added CV and HF to reach six; Q4's framing isolated it competitively: "Maritide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing." The "stands alone" language is notably more aggressive than the Q3 "well-positioned" framing — and arrives just as competitors disclose combination therapies. Adding T2D Phase 3 initiation in 2026 deepens the indication footprint.

IMDELLTRA's trajectory completed: from "launch in flight" (Q2) to "candidate standard of care" (Q3) to "standard of care with unprecedented survival benefits." From the call: "Imdeltra has rapidly become the standard of care in patients with second line or later small cell lung cancer, supported by unprecedented survival benefits." With 1,600+ US sites administering and majority of doses in community settings, the durability case is now made — but the next leg is first-line, which remains the 2026 catalyst.

R&D posture inverted sharply. Q2 stepped R&D growth to >20%, Q3 to mid-20s; Q4 guides FY2026 R&D growth at "low single digits" (ex-BD). The investment-cycle peak is now explicitly past, which is consistent with the reinstated 45–46% margin frame. This is the cleanest evidence that 2026 is a margin-recovery year being engineered into the guide.

Portfolio discipline turned visible. Two late-stage programs were terminated this quarter: rocatinlimab and bimerituzumab. Management framed this as resource reallocation: "With significant breadth and depth across all four therapeutic areas, we took a portfolio decision to focus resources on other late-stage programs." The willingness to kill late-stage assets — rather than push them to approval and disappoint commercially — is a tone shift from the "we're investing heavily in innovation" framing of Q2.

Recurring themes management leaned on this quarter:

Multi-indication pipeline expansion and lifecycle extensionOutcomes data strengthening competitive positioning and guideline influenceRare disease portfolio as sustained growth engine with early-lifecycle productsBispecific T-cell engager platform becoming standard of care across oncologyDisciplined capital allocation with selective portfolio pruningCardiometabolic franchise consolidation (Repatha, Opaziran, Maritide)

Risks management surfaced:

Denosumab biosimilar competition driving accelerated sales erosion in 2026Otesla price declines and generic launches particularly in E.U.FDA ongoing dialogue regarding TABNEOS for ANCA-associated vasculitisOlpaceran OCEAN-A outcome study event accrual rate lower than initial predictionsFirst quarter 2026 seasonal headwinds from insurance re-verification and 340B program utilization

Q&A highlights

Michael Yee · UBS Financial

Seeking clarity on Amgen's obesity portfolio strategy beyond Maritide, given competitors are disclosing combination therapies and monthly/bimonthly dosing options.

Management outlined a comprehensive obesity pipeline including clinical-stage asset AMG513 (mechanism not yet disclosed, Phase 1), preclinical programs in both GLP-1-based and non-GLP-1-based mechanisms, and both injectable and oral formulations. Emphasized Amgen's historical leadership in obesity and openness to external innovation.

AMG513 in Phase 1 clinical investigationPreclinical portfolio includes GLP-1-based and non-GLP-1-based programsBoth injectable and oral medicine candidates in developmentAmgen's obesity history dating back to leptin programs

Selby Richter · Goldman Sachs

Two-part question: (1) Confidence drivers for advancing Plisna/aplizumab into Phase 3 CIDP, and (2) Commercial strategy for Repatha in context of Merck's oral PCSK9 competitor launch.

For Plisna/CIDP: Highlighted CD19 B-cell depletion mechanism targeting autoantibody-mediated disease; noted 5-10% of CIDP patients have autoantibodies to perinodal proteins. For Repatha: Emphasized unique label with both secondary and primary prevention data (Vesalius trial), strong access/formulary preference, and focus on primary prevention segment where 40% of prescriptions currently originate.

CIDP prevalent population ~35,000 in U.S., 7,000-10,000 incident cases annuallyCD19-targeting mechanism addresses autoantibody-driven conditionsRepatha is only PCSK9 with both secondary and primary prevention data40% of Repatha prescriptions from primary prevention patients pre-Vesalius launch

Jeroen Werber · TD Cowan

Timing expectations for tezodolibep Phase 3 Sjögren's syndrome trial data completion in 2024; Phase 2-to-Phase 3 reliability assessment given disease challenges.

Management confirmed both Phase 3 studies in Sjögren's syndrome fully enrolled and completion expected second half of 2024. Noted tezodolibep targets CD40 ligand pathway; one study in moderate-to-severe symptomatic patients, second in high symptom burden with low systemic disease activity. Highlighted Phase 2 performance on SDI score (first medicine to improve this endpoint) as confidence driver for Phase 3.

Both Phase 3 Sjögren's trials fully enrolledCompletion expected second half of 2024Tezodolibep is CD40 ligand targeting biotherapeuticTwo study populations: moderate-to-severe symptomatic activity and high symptom burden with low systemic disease

David Amsellum · Piper Sandler

Two-part: (1) Whether true IgG4-related disease population exceeds historical literature estimates and market opportunity implications; (2) Early Plisna/Iptacopan utilization patterns in GMG and competitive positioning.

Management acknowledged disease prevalence is a 'moving object' with improved awareness/diagnosis expected as effective therapies become available; current diagnosed population estimated at ~35,000. On Plisna GMG: strong early uptake with ~50% bio-naive patients and ~50% switching from other therapies; prescribing breadth across multiple specialties; patients attracted to mechanism and dosing convenience.

Diagnosed IgG4-related disease population estimated at ~35,000ICD-10 coding only ~3 years in marketPlisna GMG: ~50% bio-naive, ~50% switches from other therapiesPrescribing breadth across multiple specialties

Terrence Flynn · Morgan Stanley

Specific design question on Maritide Phase 3 Type 2 diabetes CVOT trial control arm strategy, particularly given competitive data from other GLP-1 programs.

Management deferred specific Phase 3 design details (control arm, patient recruitment) to future engagement. Highlighted Phase 2 ongoing trial generating experience with low-BMI patients and A1C across dose range; positioned Maritide as potential paradigm shift with quarterly maintenance dosing option following monthly or bimonthly induction.

Phase 2 Type 2 Diabetes trial ongoing with additional parts enrollingPhase 2 data included low-BMI patient experienceA1C efficacy observed across dose rangeQuarterly maintenance dosing being explored post-monthly induction

Answers to last quarter's watch list

MariTide Phase 2 Part 2 maintenance readout — Resolved positively. Part 2 of the Phase 2 chronic weight management study is complete, with the large majority of participants maintaining their Part 1 weight loss for an additional 52 weeks on lower monthly or quarterly dosing. Tolerability was excellent (low nausea/vomiting, no new safety signals) and cardiometabolic improvements were sustained for the full second year. This is direct support for the "monthly, every other month, or even quarterly dosing" paradigm framing.

Resolved positively

Repatha post-Vesalius commercial inflection — Resolved with conviction. Q4 Repatha hit $870M (+44% YoY). Management explicitly called for clinical guideline updates citing the 25% relative risk reduction from Vesalius CV. This is the cleanest positive resolution on the print.

Resolved positively

Whether the withdrawn ~45% non-GAAP operating margin frame returns in FY2026 guidance — The anchor returned at 45–46% of product sales. Q3's withdrawal turned out to be a one-quarter disclosure gap rather than a permanent regression.

Resolved positively

Q4 non-GAAP operating margin landing — Q4 came in at 42.8%, compressing 430bps from Q3's 47.1% as R&D loaded in. FY non-GAAP EPS landed at $21.84, above the $21.00 midpoint, suggesting Q4 margin was actually slightly better than the implied path. Q1 2026 is guided to "roughly the same" as Q4 2025 at 42.8%, confirming the trough is in place. Status: Resolved (in line with watch framing)

IMDELLTRA first-line data progression — Management positioned IMDELLTRA as "standard of care" in 2L with unprecedented survival, with 1,600+ US sites administering and majority of doses in community settings. No specific 1L regulatory timing was disclosed on this print. The 2L narrative is now firmly established but 1L remains the open catalyst.

Continue monitoring

Tariff guidance update — Tariff exposure was not quantified in the FY2026 guide, despite management's repeated $3B+ US manufacturing investment framing this year. The guide language structure remained consistent with prior quarters.

Not resolved

What to watch into next quarter

Q1 2026 prints against the "lower mid-single-digit" growth guide — with Q1 op margin guided at the Q4'25 trough of ~42.8% and Prolia/XGEVA biosimilar erosion accelerating, watch whether Q1 revenue lands above or below ~$9.5B and whether the implied $27.5B 9-month residual to hit FY guide midpoint looks feasible

Prolia/XGEVA erosion rate — Q4 Prolia at $1,054M was -10% YoY; management explicitly guides "accelerated" 2026 erosion. Watch whether the Q1 decline steepens beyond -15% YoY, which would imply the FY revenue guide low end of $37B is at risk

Repatha pricing trajectory — management guided "roughly mid-single-digit" net selling price decline for Repatha in 2026 alongside continued strong volume. Watch whether Repatha can sustain >$800M quarterly run-rate as Merck's oral PCSK9 enters the market

Maritide Phase 3 T2D CVOT control-arm design — management deferred specifics on the control arm when pressed by Morgan Stanley, calling it "a subject for a future engagement." Watch whether Q1 commentary clarifies the comparator (placebo vs. active control vs. SoC standard of care) given competitor CVOT readouts will shape the regulatory bar

R&D spending discipline — guide of "low single digits" growth ex-BD is a sharp inversion from FY2025 mid-20s. Watch whether Q1 R&D run-rate materially undershoots Q4's loaded base or whether management uses BD transactions to selectively maintain spend

Tariff and pricing actions quantification — third consecutive quarter the guide excludes unimplemented tariffs and pricing-related actions. Watch whether Q1 commentary quantifies any exposure, particularly given the $2.6B FY26 capex run-rate is anchored on the US manufacturing buildout

Sources

Amgen Q4 2025 earnings press release (SEC filing, dated 2026-02-03): https://www.sec.gov/Archives/edgar/data/318154/000031815426000003/amgn-20251231earningsrelea.htm
Amgen Q4 2025 earnings call prepared remarks and Q&A (referenced via extracted transcript content)
Amgen Q3 2025 and Q2 2025 Tapebrief briefs (internal, for cross-quarter comparison)

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