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01/09 22:26
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reflects a positive outlook with strong product development, strategic focus on biosimilars, and promising pipeline assets like VESALIUS-CV and MariTide. Despite some unclear management responses, the emphasis on growth drivers, disciplined capital allocation, and innovative strategies in obesity and cardiovascular markets suggest a positive sentiment. The Q&A reveals enthusiasm for future opportunities and robust R&D investments, supporting a positive stock price movement.
Revenue Revenues increased 12% year-over-year to $9.6 billion, driven by strong performance of six key growth drivers and discrete items like $250 million from favorable changes to U.S. estimated sales deductions and a $90 million government order for Nplate.
Volume Growth Volume grew 14% year-over-year, reflecting the strength of the portfolio and disciplined execution.
Non-GAAP Operating Margin Non-GAAP operating margin was 47%, reflecting significant investments across the business, including a 31% year-over-year growth in non-GAAP R&D spending.
Non-GAAP R&D Spending Non-GAAP R&D spending grew 31% year-over-year, driven by business development transactions and increased investment in the late-stage pipeline.
Free Cash Flow Generated $4.2 billion in free cash flow in the third quarter, reflecting operational momentum and rigorous management of working capital.
Debt Retirement $6.0 billion of debt retired in 2025, contributing to a return to pre-Horizon capital structure ahead of plan.
Tax Rate Non-GAAP tax rate increased 4.8 percentage points year-over-year to 18.2%, primarily due to the change in earnings mix.
Repatha Sales Repatha delivered $794 million in sales, up 40% year-over-year, driven by increased adoption and the launch of the AmgenNow direct-to-patient program.
EVENITY Sales EVENITY delivered $541 million in sales, up 36% year-over-year, driven by higher prescription volumes and increased market share in the bone builder segment.
Prolia Sales Prolia delivered $1.1 billion in sales, an increase of 9% year-over-year, though future sales are expected to be impacted by increased competition from biosimilars.
Rare Disease Portfolio Rare disease portfolio grew 13% year-over-year to $1.4 billion, driven by strong performance across products like UPLIZNA and TEPEZZA.
TEZSPIRE Sales TEZSPIRE sales increased 40% year-over-year to $377 million, driven by its differentiated profile and recent approval for additional indications.
Oncology Portfolio Innovative oncology portfolio grew 9% year-over-year to $2.3 billion, driven by products like IMDELLTRA and BLINCYTO.
Biosimilar Portfolio Biosimilar portfolio sales increased 52% year-over-year to $775 million, now annualizing at $3 billion, driven by new launches and strong adoption.
AmgenNow: A new direct-to-patient platform launched in the U.S. to provide access to Repatha at one of the lowest prices globally, enhancing affordability and access.
MariTide: Phase III studies for chronic weight management and cardiovascular conditions are fully enrolled, with additional studies in obstructive sleep apnea initiated.
Olpasiran: Event-driven Phase III cardiovascular outcome study is progressing, targeting Lp(a) to reduce cardiovascular events.
TEZSPIRE: Approved for chronic rhinosinusitis with nasal polyps and enrolling patients for COPD studies. Achieved over $1 billion in sales year-to-date, with strong growth in severe uncontrolled asthma and new indications.
IMDELLTRA: Established as standard of care in second-line small cell lung cancer with promising survival data in combination therapies.
BLINCYTO: Initiated a study for subcutaneous administration in relapsed/refractory B-ALL.
Xaluritamig: Advancing in Phase III studies for metastatic castrate-resistant prostate cancer.
Repatha: Sales increased 40% year-over-year, now annualizing at $3 billion. Significant opportunity exists with 100 million people needing LDL-C lowering.
EVENITY: Sales grew 36% year-over-year, with significant untapped potential in the U.S. and Japan.
Biosimilar Portfolio: Sales increased 52% year-over-year, annualizing at $3 billion, with new launches driving growth.
Manufacturing Investments: Over $3 billion planned investments in the U.S. in 2025, building on $40 billion since 2017.
AI and Technology: Accelerating molecule design, trial enrollment, and manufacturing optimization using AI.
Debt Management: $6 billion of debt retired in 2025, returning to pre-Horizon capital structure ahead of plan.
Policy Engagement: Engaging with policymakers to improve access, protect innovation, and strengthen the biomanufacturing ecosystem.
Pipeline Expansion: Focused on advancing late-stage programs like MariTide, Olpasiran, and Xaluritamig for long-term growth.
Declining Selling Prices: The company is experiencing declining selling prices across the industry, which could impact revenue growth despite volume increases.
Generic Competition: The introduction of a generic competitor for RAVICTI in the rare disease portfolio is expected to negatively impact sales.
Increased Competition for Prolia: Three biosimilars have launched in the U.S., and increased competition is expected to negatively impact Prolia sales in future quarters.
Regulatory and Tariff Risks: The guidance includes the estimated impact of implemented tariffs but does not account for tariffs or pricing actions announced but not yet implemented, creating uncertainty.
Supply Chain and Manufacturing Investments: Significant investments in manufacturing and R&D are required to meet growing global demand, which could strain resources and budgets.
Unmet Potential in Key Markets: Products like Repatha and EVENITY have significant untapped potential, but underutilization and low treatment rates pose challenges to realizing full market potential.
Clinical Trial Risks: The OCEAN(a) Phase III cardiovascular outcome study for Olpasiran is progressing slower than initial predictions, which could delay results and impact timelines.
Efficacy Concerns in Oncology: The FORTITUDE-102 study for bemarituzumab in gastric cancer was stopped due to inadequate efficacy, raising concerns about the success of certain oncology programs.
Economic and Financial Risks: The company has significant debt obligations, although progress has been made in retiring debt. Changes in tax rates and earnings mix also pose financial risks.
Revenue Guidance for 2025: Amgen has raised its 2025 revenue guidance to a range of $35.8 billion to $36.6 billion, reflecting strong portfolio performance and business momentum.
Non-GAAP Earnings Per Share (EPS) Guidance for 2025: The company expects non-GAAP EPS to be between $20.60 and $21.40 for 2025.
Capital Expenditures for 2025: Amgen anticipates capital expenditures of approximately $2.2 billion to $2.3 billion in 2025, aimed at expanding network capacity for its product portfolio and innovative pipeline.
Non-GAAP R&D Expenses for 2025: Non-GAAP R&D expenses are expected to grow at a mid-20s percentage rate year-over-year in 2025, driven by increased investment in late-stage programs and business development transactions.
Non-GAAP Tax Rate for 2025: The company projects a non-GAAP tax rate in the range of 15.0% to 16.5% for 2025.
Free Cash Flow: Amgen generated $4.2 billion in free cash flow in Q3 2025, reflecting operational momentum and rigorous management of working capital.
Pipeline and Product Development: Amgen is advancing late-stage programs, including MariTide, Olpasiran, Xaluritamig, and rare disease treatments, which are expected to drive sustainable long-term growth.
AI and Technology Investments: The company is accelerating investments in AI and technology across the value chain, including trial enrollment, manufacturing optimization, and customer engagement.
Biosimilar Portfolio: Amgen's biosimilar portfolio is annualizing at $3 billion in sales, with additional launches expected to provide meaningful top-line growth and durable cash flow.
TEZSPIRE Expansion: TEZSPIRE has been approved for additional indications, including chronic rhinosinusitis with nasal polyps, and is expected to help a broader patient population.
MariTide Phase III Studies: Amgen is conducting six global Phase III studies for MariTide, targeting obesity, cardiovascular disease, and obstructive sleep apnea, with robust enrollment and evidence generation.
Olpasiran Phase III Study: The OCEAN(a) Phase III cardiovascular outcome study for Olpasiran is fully enrolled, with updates on primary analysis timing to be provided as the study matures.
UPLIZNA Approvals and Indications: UPLIZNA is progressing toward approval for generalized myasthenia gravis and has shown potential across a spectrum of IgG4-related disease patients.
IMDELLTRA and BLINCYTO Oncology Advances: Amgen is advancing its bispecific T cell engager platform, with IMDELLTRA and BLINCYTO showing strong clinical results and expanding indications.
Dividend Payments: In addition to the increase of 31% in non-GAAP R&D described above, we continue to advance and accelerate technology and AI across the value chain from discovery to development to manufacturing and through to commercial execution. For 2025, we now expect capital expenditures of roughly $2.2 billion to $2.3 billion to expand network capacity for our products across the portfolio and our innovative pipeline, including MariTide. Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, California and Massachusetts. We expect our projects to continue to be on budget and on time. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share, representing a 6% increase compared to the third quarter of 2024.
Share Repurchase: We continue to strengthen our balance sheet with $4.5 billion of debt retired in 2024 and $6.0 billion of debt retired in 2025. 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.
The earnings call reflects a positive outlook with strong product development, strategic focus on biosimilars, and promising pipeline assets like VESALIUS-CV and MariTide. Despite some unclear management responses, the emphasis on growth drivers, disciplined capital allocation, and innovative strategies in obesity and cardiovascular markets suggest a positive sentiment. The Q&A reveals enthusiasm for future opportunities and robust R&D investments, supporting a positive stock price movement.
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