Amgen raises 2025 revenue guidance to $35.8B–$36.6B with 14% volume growth, launches AmgenNow platform

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Amgen raises 2025 revenue guidance to $35.8B–$36.6B with 14% volume growth, launches AmgenNow platform
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Earnings Call Insights: Amgen Inc. (AMGN) Q3 2025

MANAGEMENT VIEW

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CEO Robert Bradway stated that "Amgen delivered another strong quarter, driven by rising demand for our medicines and meaningful progress across the pipeline. Volume growth once again paced our progress in an environment where selling prices are declining across the industry." He emphasized revenues were up 12% year-over-year and volume up 14%, with 16 products growing at double-digit rates. Bradway announced the launch of AmgenNow, a direct-to-patient platform in the U.S. for Repatha, noting this as "an important step forward in helping more people benefit from the kind of innovation as represented by Repatha." He highlighted expansion in all four therapeutic areas and pointed out that biosimilar revenues rose over 50% year-over-year, now annualizing at roughly $3 billion in sales.

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Bradway confirmed over $3 billion in planned U.S. manufacturing investments this year, building on $40 billion invested since 2017. He underscored strong momentum for upcoming products like MariTide and Olpasiran, and reaffirmed confidence in Amgen's ability to sustain long-term growth, stating, "We're encouraged by the momentum we're seeing in the business and confident in our ability to deliver innovation and growth well into the next decade."

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CFO Peter Griffith said, "In the third quarter, revenues increased 12% year-over-year to $9.6 billion, reflecting the continued strong performance of our six key growth drivers, Repatha, EVENITY, TEZSPIRE, and our innovative oncology, rare disease and biosimilar portfolios." Griffith highlighted $250 million from favorable U.S. sales deductions and a $90 million government order for Nplate. He noted non-GAAP operating margin was 47% and R&D investment grew 31% year-over-year, mentioning, "We are pleased to report that we have returned to our pre-Horizon capital structure ahead of plan, and we will achieve greater than $500 million in pretax cost synergies in 2025 in connection with the acquisition." Guidance for 2025 was raised to $35.8 billion to $36.6 billion in total revenue and non-GAAP EPS of $20.60 to $21.40.

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Executive Vice President Murdo Gordon reported that sales increased 12% year-over-year, driven by 14% volume growth, and emphasized Repatha's 40% sales growth and the launch of the AmgenNow program with a monthly price of $239. EVENITY sales rose 36% year-over-year, and TEZSPIRE sales grew 40% year-over-year. The rare disease portfolio grew 13% to $1.4 billion, and biosimilar sales rose 52% to $775 million.

OUTLOOK

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Amgen raised its 2025 revenue guidance to $35.8 billion to $36.6 billion and non-GAAP earnings per share to $20.60 to $21.40. Griffith stated, "This guidance includes the estimated impact of implemented tariffs. It does not account for tariffs or pricing actions announced or described, but not yet implemented."

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Increases in R&D investment are projected, with non-GAAP R&D expenses expected to grow at a mid-20s percentage rate year-over-year in 2025. Non-GAAP OI&E is expected to be in the range of $2.1 billion to $2.2 billion, and non-GAAP tax rate in the range of 15.0% to 16.5%. Capital expenditures for 2025 are projected at $2.2 billion to $2.3 billion.

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No sales are expected for WEZLANA in the fourth quarter. The company continues to expect its full-year non-GAAP operating margin to be roughly 45%.

FINANCIAL RESULTS

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Revenues rose 12% year-over-year to $9.6 billion, with non-GAAP operating margin at 47%. Free cash flow was $4.2 billion in the third quarter. The company reported $105 million in RAVICTI sales and noted a $250 million benefit from favorable U.S. sales deductions and a $90 million government order for Nplate. Dividend payments were $2.38 per share, up 6% from the prior year.

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Product highlights included Repatha with $794 million in quarterly sales, EVENITY at $541 million, Prolia at $1.1 billion, UPLIZNA at $155 million, TEPEZZA at $560 million, TAVNEOS at $107 million, TEZSPIRE at $377 million, and IMDELLTRA at $178 million. Biosimilar portfolio sales reached $775 million.

Q&A

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Salveen Richter, Goldman Sachs: Asked about confidence in Olpasiran and event rates in the OCEAN(a) outcome study. James Bradner replied, "Our conviction remains very strong... Olpasiran has true best-in-class properties. It's frequency of administration is better. The depth of Lp(a) suppression is better, has a very clean safety profile."

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Terence Flynn, Morgan Stanley: Questioned guidance for 2026 and R&D expense trajectory. Peter Griffith responded that Amgen is "focused on achieving industry-leading margins while continuing to invest in the very best innovation," and does not anticipate another step change in R&D expenses.

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Jay Olson, Oppenheimer: Asked about VESALIUS-CV and Repatha market impact. James Bradner said, "Cardiovascular disease is still the #1 killer... Repatha, so firmly established as accessible, affordable, efficacious in the prevention of recurrent CV events... this is the first -- the only PCSK9 to demonstrate such an effect." Murdo Gordon added, "We will make sure that immediately after the presentation of these data that our medical teams, our field sales teams, our patient support organizations are out there in full force."

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Other questions addressed biosimilar guidance, MariTide data updates, obesity market strategy, policy for biosimilars, and UPLIZNA uptake in new indications.

SENTIMENT ANALYSIS

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Analysts were focused, enthusiastic, and pressed for details on pipeline assets, market expansion, and R&D investment. The tone was largely positive, with probing on execution, market opportunity, and product differentiation.

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Management maintained a confident and constructive tone, especially in prepared remarks, with repeated emphasis on growth and innovation. During Q&A, management was measured, reiterating conviction in pipeline assets and financial discipline. Confidence was reinforced through phrases such as "we are confident" and "our conviction remains very strong."

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Compared to the previous quarter, management's tone showed even greater confidence, particularly as guidance was raised and access initiatives like AmgenNow were launched. Analysts' tone remained engaged and constructive, with continued focus on innovation and market expansion.

QUARTER-OVER-QUARTER COMPARISON

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Revenue guidance was raised from $35.0–$36.0 billion in Q2 to $35.8–$36.6 billion in Q3. Non-GAAP EPS guidance increased from $20.20–$21.30 to $20.60–$21.40.

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Volume growth accelerated from 13% in Q2 to 14% in Q3. Revenue growth increased from 9% to 12% year-over-year.

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AmgenNow was newly launched this quarter to expand direct patient access to Repatha at reduced pricing.

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R&D investment growth rate increased from 18% in Q2 to 31% in Q3, with further acceleration projected.

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Management's confidence in the pipeline and new products increased, as did focus on product launches and global market expansion.

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Analysts' focus continued to center on pipeline progress, market opportunities, and strategic initiatives, with heightened attention to the impact of new data releases and direct-to-patient programs.

RISKS AND CONCERNS

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Increased competition for Prolia from biosimilars is expected to negatively impact future sales.

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The rare disease product RAVICTI now faces a generic competitor as of October.

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The OCEAN(a) event-driven study for Olpasiran is proceeding slower than anticipated due to a lower event accrual rate.

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FORTITUDE-102 for bemarituzumab in gastric cancer was stopped for inadequate efficacy, which management acknowledged did not meet "our standard for an Amgen medicine."

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Management is monitoring evolving U.S. biosimilar policy and competition, and is prepared to adapt development and commercialization strategies as guidance changes.

FINAL TAKEAWAY

Amgen's third quarter 2025 results reflect strong momentum in product volume and revenue growth, driven by key growth drivers across all therapeutic areas and reinforced by the launch of the AmgenNow platform for direct patient access. The company raised its 2025 revenue and earnings guidance, signaled ongoing commitment to innovation and manufacturing investment, and highlighted accelerating R&D to support its expanding late-stage pipeline. Management expressed confidence in new product launches, robust pipeline progression, and its ability to sustain long-term growth while proactively addressing evolving market and policy dynamics.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/amgn/earnings/transcripts]

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