AMGEN INC (AMGN) Q3 2025 Earnings Summary

Executive Summary

• Amgen delivered a strong Q3 2025: total revenues rose 12% year over year to $9.6B, driven by 14% volume growth; non-GAAP EPS was $5.64 and GAAP EPS was $5.93 .
• Bold beats versus consensus: revenue beat by ~$0.59B and non-GAAP EPS beat by ~$0.63, aided by ~$250M favorable U.S. sales deductions and a $90M Nplate U.S. government order in the quarter .
• FY2025 guidance raised across revenue ($35.8–$36.6B), GAAP EPS ($13.76–$14.60), non-GAAP EPS ($20.60–$21.40), and tax rates, reflecting momentum and higher investment in late-stage programs .
• Key catalysts: landmark Repatha VESALIUS-CV primary-prevention data (presented Nov. 8) and pending IMDELLTRA U.S. confirmatory PDUFA on Dec. 18; management also launched AmgenNow to expand Repatha access at $239/month, potentially broadening adoption .

What Went Well and What Went Wrong

What Went Well

• Volume-led growth across the portfolio with 16 products delivering double-digit sales growth; CEO: “We delivered strong volume growth this quarter…” .
• Cardiovascular and bone health outperformance: Repatha sales +40% to $794M; EVENITY +36% to $541M; TEZSPIRE +40% to $377M, all primarily volume-driven .
• Free cash flow surged to $4.2B (vs. $3.3B last year), debt reduced by $6.0B YTD, and dividend paid increased 6% year over year; operating cash flow was $4.7B .

What Went Wrong

• Pricing headwinds and mix: Enbrel sales fell 30% YoY on lower net price tied to Medicare Part D redesign and higher 340B mix; non-GAAP operating margin dropped 2.5 pts to 47.1% .
• Biosimilar competition: management expects Prolia and XGEVA to erode with U.S. biosimilar launches; caution flagged for remainder of 2025 .
• Non-GAAP tax rate rose 4.8 pts to 18.2% and an Otezla intangible impairment of $400M weighed on GAAP optics; R&D up 31% on later-stage programs (e.g., MariTide) .

Financial Results

Revenue and EPS vs. Prior Periods and Estimates

Values retrieved from S&P Global.*

Margins and Tax Rates

KPIs

Selected Product Sales (Q3 2025 vs. Q3 2024)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• CEO Robert Bradway: “We delivered strong volume growth this quarter… With disciplined investment and a pipeline of first‑in‑class medicines, we’re focused on expanding access, advancing innovation, and sustaining long‑term growth” .
• CFO Peter Griffith: “We are raising our 2025 guidance ranges for both revenue and non-GAAP EPS… We continue to advance and accelerate technology and AI across the value chain” .
• R&D Head Jay Bradner: Repatha VESALIUS-CV “asked a clinically vital question… both primary MACE endpoints were met… no new safety signals” .
• Commercial Lead Murdo Gordon: Repatha direct-to-patient pricing through AmgenNow at $239/month “nearly 60% below the current U.S. list price,” aimed at improving access .

Q&A Highlights

• Olpasiran (Lp(a)) timeline: Event accrual running lower than initial predictions; conviction remains “best-in-class” profile; readout timing will be updated as it matures .
• Biosimilar policy dynamics: Management views U.S. biosimilar market as functioning well; wary of policies that might push it toward generic-market dynamics; confident in AMJEVITA’s long-term success .
• MariTide Phase 2 Part 2: Maintenance-focused design (quarterly full dose, monthly low dose vs placebo/continued target dose); informative for Phase 3 maintenance; not powered for large between-arm WL differences .
• UPLIZNA market build: Early IgG4-RD launch (≈300 unique prescribers); GMG could see strong uptake given durable efficacy, steroid sparing, q6-month dosing post-loading .

Estimates Context

• Revenue beat: Actual $9.56B vs consensus ~$8.97B; non-GAAP EPS beat: $5.64 vs $5.01. Discrete items ($250M favorable U.S. sales deductions and a $90M Nplate order) boosted Q3 sales, helping the beat; FY guidance was raised accordingly .
• Margins/tax: Non-GAAP operating margin declined 2.5 pts (47.1%) given higher R&D and mix; non-GAAP tax rate increased to 18.2%, implying sell-side models likely need higher tax rate assumptions for FY2025 .

Values retrieved from S&P Global for consensus estimates.*

Key Takeaways for Investors

• Strong quarter with broad-based volume strength and bold beats; FY guidance raised across revenue and EPS—supports near-term sentiment and estimate revisions higher .
• Cardiovascular narrative strengthening: VESALIUS-CV primary-prevention success plus AmgenNow pricing should expand Repatha’s reach; watch AHA full data readout .
• Oncology catalyst path: IMDELLTRA confirmatory PDUFA (Dec. 18) and growing Phase 3 footprint could drive further adoption and sentiment .
• Obesity optionality: MariTide advancing with six Phase 3 trials; Q4 2025 Phase 2 maintenance data will inform dosing and commercialization strategy .
• Mind the headwinds: Enbrel pricing/mix pressure and expected biosimilar-driven erosion in Prolia/XGEVA; non-GAAP margin compression from elevated R&D investment .
• Cash generation remains robust (FCF $4.2B), debt reduced meaningfully YTD; dividend intact—provides flexibility for pipeline and shareholder returns .
• Model updates: lift revenue/EPS for FY2025, adjust tax rate higher, consider discrete Q3 items when assessing core run-rate; monitor Q4 demand normalization post inventory/pricing tailwinds .