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AMGEN INC (AMGN)·Q1 2025 Earnings Summary
Executive Summary
- Amgen delivered solid Q1 2025 results: total revenue $8.15B (+9% YoY) and non-GAAP EPS $4.90 (+24% YoY), both above S&P Global consensus; GAAP EPS was $3.20 boosted by an unrealized BeiGene equity gain, partially offset by an $800M Otezla impairment . Estimates context below (S&P Global).
- Product sales grew 11% on 14% volume growth, led by Repatha ($656M, +27% YoY), BLINCYTO ($370M, +52%), TEZSPIRE ($285M, +65%), EVENITY ($442M, +29%), and strong biosimilar momentum (PAVBLU $99M; WEZLANA $150M) .
- FY25 guidance reaffirmed: revenue $34.3–$35.7B; non-GAAP EPS $20.00–$21.20; non-GAAP tax rate 14.5–16.0; capex ~$2.3B; buybacks ≤$500M; non-GAAP R&D raised to ~20% growth (from mid-teens), and OI&E lowered to ~$2.3B .
- Pipeline/catalysts: IMDELLTRA Phase 3 (DeLLphi-304) showed overall survival benefit in 2L SCLC (details at ASCO); UPLIZNA approved for IgG4-RD; TEZSPIRE CRSwNP PDUFA 10/19/25; MariTide Phase II full data to be presented at ADA and Phase III program underway—key stock catalysts .
- Manufacturing and U.S. policy positioning: significant U.S. manufacturing expansions in Ohio (+$900M) and North Carolina; management emphasized ability to adapt to tariffs/tax changes, a support to supply reliability and policy resilience .
What Went Well and What Went Wrong
What Went Well
- Broad-based volume-driven growth: “Volume grew 14%, reflecting growing patient demand…14 medicines delivered double-digit sales growth” (Bradway) .
- Oncology BiTE platform momentum: IMDELLTRA delivered OS benefit vs chemo in 2L SCLC; BLINCYTO granted Breakthrough Therapy Designation for subcutaneous administration in r/r B-ALL .
- Rare disease expansion: UPLIZNA won first and only FDA approval for IgG4-RD, with MITIGATE trial showing 87% flare risk reduction and corticosteroid sparing .
What Went Wrong
- Otezla impairment: $800M intangible asset impairment weighed on GAAP results; GAAP Other OpEx up sharply .
- Price/mix headwinds: net selling price decreased 6% overall; Enbrel down 10% YoY on 47% lower net price (340B mix, discounts), and continued biosimilar pressure expected on Prolia/XGEVA in 2H25 .
- TEPEZZA/KRYSTEXXA inventory effects: U.S. wholesaler inventory reductions impacted reported sales; management does not expect similar reductions for remainder of year—still a near-term headwind .
Financial Results
Values with * retrieved from S&P Global.
Selected Product Sales and YoY Growth (Q1 2025)
KPIs and Cash Flow
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “We’re off to a strong start in 2025…strong volume growth…important new product launches and positive Phase III data.” – Robert Bradway, CEO .
- “Our U.S. launch of IMDELLTRA…continues its strong momentum, generating $81 million in sales…recently announced…superior overall survival vs chemotherapy.” – Murdo Gordon, Commercial .
- “UPLIZNA…first and only treatment for IgG4-RD…delivering durable and sustained efficacy…with every 6-month dosing.” – James Bradner, R&D .
- “We are reaffirming our 2025 total revenue guidance…also reaffirming our non-GAAP EPS…we now expect non-GAAP R&D expense to grow ~20%…and non-GAAP OI&E to be ~$2.3 billion.” – Peter Griffith, CFO .
Q&A Highlights
- MariTide Phase II at ADA: management emphasized sustained efficacy without plateau through 52 weeks and the importance of dose escalation for tolerability; detailed mechanistic data to be presented; Phase III design informed by Phase II learnings .
- UPLIZNA commercialization: rheumatology-led strategy in IgG4-RD given new diagnostic code; expectation of broad access and steroid-sparing benefits; positioning for gMG with every-6-month dosing convenience .
- Biosimilars retina: PAVBLU adoption helped by permanent Q code and prefilled syringe; contracting with larger retina groups underway .
- Repatha competitive landscape: continued class underpenetration and improved access; primary prevention outcomes study (VESALIUS-CV) a key differentiator .
- TEPEZZA adoption: broadening prescriber base (ophthalmology/endocrinology), inventory normalization expected; subcutaneous route anticipated to ease site-of-care challenges .
Estimates Context
Values with * retrieved from S&P Global.
- Q1 2025: Revenue beat by ~$0.11B; non-GAAP EPS beat by ~$0.64; broad-based product strength and operating margin expansion supported the beat .
- Q4 2024: Revenue and EPS both ahead of consensus; momentum into 2025 maintained (S&P Global and company disclosures).
- Q1 2024: EPS beat and revenue essentially in line/slight miss vs consensus (S&P Global and company disclosures).
Key Takeaways for Investors
- Near-term trading: Strong Q1 beat on both revenue and EPS with reaffirmed FY guidance and raised R&D investment should be supportive; watch ASCO (IMDELLTRA), ADA (MariTide) as catalysts .
- Pipeline validations: IMDELLTRA OS benefit and UPLIZNA approval broaden high-conviction growth drivers in oncology and rare inflammatory diseases .
- Margin trajectory: Non-GAAP operating margin 45.7% (vs 43.2% LY, 49.6% Q4), indicating resilient profitability amid price/mix headwinds .
- Biosimilars execution: Early U.S. wins (WEZLANA, PAVBLU) demonstrate first-wave strategy; note cadence updates (WEZLANA Q2 pause after Q1 bolus) .
- Risk management: Anticipate denosumab (Prolia/XGEVA) biosimilar erosion in 2H25; inventory normalization for TEPEZZA/KRYSTEXXA; continued price pressure (e.g., Enbrel) .
- Policy/operations: Expanding U.S. manufacturing footprint strengthens supply reliability and mitigates policy risks (tariffs/taxes), supporting long-term execution .
- Estimates recalibration: Street likely to lift EPS/revenue estimates for FY25 post beat and catalysts; monitor updated OI&E (~$2.3B) and higher non-GAAP R&D growth (~20%) in models .
S&P Global disclaimer: All consensus estimate values marked with * were retrieved from S&P Global.