AMGN Q2 2025: Biosimilars revenue rises 40% to near $12B
- Biosimilars portfolio strength: The Q&A highlighted Amgen’s robust biosimilars business—with nearly $12 billion in cumulative revenue and strong, 40% growth—demonstrating the company’s ability to generate steady cash flow and market share in an increasingly competitive segment.
- Robust pipeline and strong enrollment in high-impact programs: Positive feedback on Meritide, including strong Phase III enrollment and encouraging ADA presentation data, underpins confidence in its potential to capture significant market share in chronic obesity management.
- Commitment to expanding rare disease capabilities: The management emphasized an ongoing appetite for both organic growth and strategic acquisitions in the rare disease space, supporting long-term expansion in areas with substantial unmet medical needs.
- Uncertainty in long-term clinical outcomes for Meritide: Questions were raised regarding the granularity of maintenance data and optimal dosing schedules for Meritide, suggesting that the phase three design may face challenges in clearly demonstrating long‐term efficacy in obesity management, thereby increasing the risk that outcomes may not meet expectations.
- Regulatory and competitive challenges in the biosimilars market: Analysts queried the potential changes in regulatory standards (such as reliance on PK comparability versus full phase three trials) and noted evolving competitive dynamics, which could delay approvals or pressure margins in this business segment.
- Competitive pressure from emerging oral therapies and compounding issues: Queries about Amgen’s appetite for oral obesity treatments and concerns over unlawful compounding indicate potential market share erosion if competitors successfully capture a larger portion of the obesity market with more convenient oral formulations or if compounding products disrupt the value proposition of Amgen’s biologics.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Total Revenues ($USD Billions) | FY 2025 | $34.3B to $35.7B | $35B to $36B | raised |
Non-GAAP EPS ($USD) | FY 2025 | $20.00 to $21.20 | $20.2 to $21.3 | raised |
Non-GAAP Operating Margin (%) | FY 2025 | 46% | 45% | lowered |
Non-GAAP R&D Expense Growth (%) | FY 2025 | Approximately 20% | Over 20% | raised |
Non-GAAP Tax Rate (%) | FY 2025 | 14.5% to 16% | 14.5% to 16% | no change |
Capital Expenditures ($USD Billions) | FY 2025 | $2.3 billion | $2.3 billion | no change |
Share Repurchases ($USD Millions) | FY 2025 | Not expected to exceed $500 million | Not expected to exceed $500 million | no change |
Other Revenue ($USD Billions) | FY 2025 | $1.4 billion | $1.4 billion | no change |
Incremental R&D Expense ($USD Millions for Q3 2025) | Q3 2025 | no prior guidance | Approximately $200 million | no prior guidance |
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Rare Disease M&A
Q: Investment appetite in rare disease deals?
A: Management emphasized a strong focus on growing the rare disease portfolio both organically and through targeted acquisitions, noting robust late‐stage activity and an attractive pipeline. -
Repatha Outcomes
Q: What outcome bar will Repatha set?
A: Leaders noted that a positive primary prevention outcome would reinforce aggressive LDL lowering and drive broader market uptake, a key theme supporting future revenue. -
Drug Pricing
Q: Views on Medicaid MSN and DTC?
A: Executives stated it’s premature to detail proposals while reaffirming their commitment to affordability through innovation and improved patient access. -
Biosimilar Dynamics
Q: How will IV biosimilars compete?
A: Management remains confident in their biosimilar portfolio, highlighting extensive market experience and strong regulatory and clinical execution to sustain growth. -
Compounding/IP
Q: Concern over compounding impacting products?
A: The team stressed that, given their biologic nature, their molecules are not subject to compounding, ensuring robust IP protection and a reliable supply framework. -
INVELTRA Growth
Q: What’s driving INVELTRA’s volume?
A: Growth is attributed to increased uptake among small cell lung cancer patients, with compelling survival benefits and improved deployment in both academic and community settings. -
Biosimilar Regulatory
Q: Could regulatory changes ease biosimilar trials?
A: Management pointed out that while potential easing could favor biosimilar development, the technical challenges remain high, reinforcing confidence in their strong process development capabilities. -
Meritide CVOT Design
Q: How will Meritide’s CVOT design perform versus peers?
A: Leaders indicated that ongoing phase three studies will define the control arm using accumulated event data, leveraging robust clinical insights to compete effectively. -
CELIA CVOT Timeline
Q: Is the CELIA CVOT readout event-driven?
A: Management confirmed that the readout is fully tied to accumulated clinical events, ensuring an outcome-driven milestone in the trial. -
AMG 732 Differentiation
Q: How does AMG 732 differ from TEPEZZA?
A: Executives described AMG 732 as a next-generation, subcutaneously administered IGF-1R antibody that builds on TEPEZZA’s target validation to address thyroid eye disease. -
Meritide Maintenance Data
Q: Will second-year data detail maintenance dosing?
A: Management expects forthcoming phase two diabetes studies to provide granularity on maintenance dosing, which should clarify long-term efficacy in weight management. -
Miratide Dose Escalation
Q: Why adopt a three-step dose escalation?
A: The approach was chosen to ensure a smooth and well-tolerated dose increase with minimal GI risk, aligning patient safety with optimal efficacy. -
Obesity Oral Molecule
Q: Plans for an oral obesity option?
A: While injectable Meritide remains the flagship, management is open to exploring promising oral candidates via business development or new discovery efforts. -
Testfire COPD
Q: Confidence in Testfire despite competitor setbacks?
A: Leadership expressed strong belief in Testfire’s mechanism, noting that patient response appears linked to blood eosinophil levels, distinct from competitor pathways. -
Meritide Phase III Changes
Q: Any phase III modifications after ADA feedback?
A: Management confirmed that no changes were made post-ADA, citing robust enrollment and strong confidence from key opinion leaders in the current design. -
FORTITUDE Filing Timeline
Q: When will the FORTITUDE filing occur?
A: The team did not disclose a firm filing date, explaining that the regulatory strategy will integrate forthcoming triplet study data with results expected by late 2025 or early next year.
Research analysts covering AMGEN.