Amgen delivered a strong operational performance in 2025, achieving double-digit growth in both revenues and earnings per share, driven by a robust portfolio where 14 products achieved blockbuster status (>$1B sales) and 13 delivered double-digit growth. Key growth drivers included Repatha (+36% to $3B), Evenity (+34% to $2.1B), and the Rare Disease portfolio (+14% to $5.2B). The company continues to invest heavily in innovation, with R&D spending increasing 22% to a record $7.2B, primarily focused on the late-stage pipeline, particularly the obesity asset MariTide. For 2026, Amgen provided guidance for total revenues between $37.0B and $38.4B and non-GAAP EPS between $21.60 and $23.00, positioning the year as a 'springboard' for future growth despite anticipated headwinds from biosimilar competition for established products like Prolia and Otezla.
| Metric | Value | Change |
|---|---|---|
| 2025 Total Revenue Growth | 10% | Year-over-year growth |
| Repatha Sales | $3.0 billion | +36% year-over-year |
| Evenity Sales | $2.1 billion | +34% year-over-year |
| Rare Disease Portfolio Sales | $5.2 billion | +14% year-over-year |
| Oncology Portfolio Sales | $8.7 billion | +11% year-over-year |
| Biosimilars Sales | $3.0 billion | +37% year-over-year |
| Non-GAAP Operating Margin | 46% | Full year 2025 |
| Free Cash Flow | $8.1 billion | Full year 2025 |
| R&D Spending | $7.2 billion | +22% year-over-year |
Amgen is positioning MariTide as a paradigm-shifting therapy in the obesity market, distinct from current weekly injections. Management emphasized that MariTide is the only late-stage therapy offering monthly, bi-monthly, or quarterly dosing. This strategic focus on convenience and tolerability aims to address patient dissatisfaction with current weekly GLP-1 therapies. The Phase III program is fully enrolled, and management expressed high confidence that the dosing schedule will drive adherence and market share, potentially allowing patients to switch from other therapies to a more convenient maintenance regimen.
The Repatha franchise is undergoing a strategic expansion driven by new cardiovascular outcomes data (Vesalius CV). Management highlighted a 25% relative risk reduction in first cardiovascular events, which they believe will drive uptake in primary prevention—a significantly larger market than the secondary prevention population where it is currently established. This data supports a push to update clinical guidelines, positioning Repatha as the most evidence-backed PCSK9 inhibitor and defending it against incoming oral competitors.
Amgen is leveraging its rare disease portfolio, led by Uplizna, to drive growth through new indications. Following approvals in IgG4-related disease and generalized myasthenia gravis (gMG) in 2025, management is initiating pivotal studies for autoimmune hepatitis and CIDP. This strategy of expanding into adjacent autoimmune indications using a B-cell depletion mechanism allows them to capture high-value niche markets and extend the lifecycle of their biologic assets.
The company is doubling down on its biosimilars business as a core growth engine, generating $3B in sales in 2025 (+37%). Management highlighted the success of Pavlu (Eylea biosimilar), which reached $700M in sales, and noted the upcoming launch of biosimilars for Opdivo and Keytruda. This signals a strategic shift where biosimilars are not just a cash cow but a primary driver of top-line expansion and market share gain against entrenched biologics.
A significant regulatory setback occurred with Tavneos (avacopan), as the FDA requested a voluntary withdrawal due to concerns over data readjudication from the original ChemoCentryx trial. Management expressed surprise at the request, noting that the primary endpoint was not inferior even after readjudication. This creates uncertainty around the product's future and raises questions about the integrity of acquired assets and regulatory oversight.
Amgen faced pipeline attrition with the decision not to pursue regulatory approval for bimirtuzumab in gastric cancer due to underwhelming efficacy and the termination of the rocotinlimab partnership with Kowa Kirin. While management framed these as 'portfolio decisions' to focus resources, they represent sunk costs and a narrowing of the late-stage pipeline, increasing the pressure on MariTide to succeed.
The Olpasiran Phase III outcome study is experiencing delays due to lower-than-predicted endpoint accrual rates. Management noted that the aggregate endpoint accrual remains lower than initial predictions, pushing the timeline for the primary analysis further out. This delays a potential key catalyst in the cardiometabolic portfolio and extends the R&D burn rate without near-term revenue visibility.
Management guided for 'lower mid-single-digit year-over-year growth' in Q1 2026, citing seasonality, biosimilar competition for Prolia, and inventory dynamics. This cautious near-term outlook contrasts with the full-year optimism and suggests that the transition from legacy products to new growth drivers may create revenue volatility or air pockets in the early part of the year.
Overall: Management exhibited a high level of confidence and discipline throughout the call, emphasizing 'momentum' and 'execution' across the business. Bob Bradway was steady and assured, while Jay Bradner displayed scientific enthusiasm regarding the pipeline, particularly MariTide. The tone shifted to transparency and surprise when addressing the FDA's request to withdraw Tavneos, but quickly returned to optimism when discussing the company's broad growth drivers and 2026 outlook.
Confidence: HIGH - Management used definitive language regarding their growth drivers ('clear opportunity,' 'standard of care') and expressed strong conviction in their pipeline ('confidence continues to build'). They provided detailed guidance and strategic priorities, indicating a clear strategic path forward despite external challenges.
Management expects total revenues in the range of $37.0 billion to $38.4 billion. This range reflects continuing strong performance from six key growth drivers (Repatha, Evenity, Tezspire, Rare Disease, Oncology, Biosimilars) which are expected to more than offset anticipated declines from increased denosumab biosimilar competition and price declines.
Management guided for non-GAAP earnings per share between $21.60 and $23.00 for the full year 2026.
The company projects the full-year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. This guidance excludes potential business development transactions.
For the first quarter, management expects lower mid-single-digit year-over-year growth, citing seasonal headwinds, insurance reverifications, and the impact of denosumab biosimilar competition.
Hedging & Uncertainty: Management generally used direct and confident language ('We expect,' 'We remain on track'), but employed hedging when discussing specific timelines and uncertain regulatory outcomes. For example, regarding Olpasiran, they used 'as the study matures, we will update,' and regarding Tavneos, 'We're in discussions.' However, they aggressively rejected hedging around MariTide's efficacy, with Bradner stating, 'I reject part of the premise of your question,' regarding potential trade-offs. This mix suggests high confidence in commercial execution but caution regarding regulatory dependencies.
Meritide stands alone as the only therapy in late-stage development to offer the paradigm-changing prospect of strong efficacy and favorable tolerability at monthly, every other month, or even quarterly dosing. - Robert A. Bradway, Chairman and CEO
We were surprised by this [FDA request for Tavneos withdrawal]... There were concerns raised about a process followed by ChemoCentryx to readjudicate primary endpoint results. - James E. Bradner, Executive Vice President
I reject part of the premise of your question, this idea of less frequent dosing being an absolute tradeoff for efficacy we're not certain that we will see that. - James E. Bradner, Executive Vice President
We expect 2026 to bring another year of strong execution disciplined data generation, and new scientific advances as we continue to progress our robust pipeline. - James E. Bradner, Executive Vice President
We see further opportunity ahead as we scale these therapies... Uplizna exemplifies this growth opportunity with approvals in IgG4-related disease and generalized myasthenia gravis in 2025. - Robert A. Bradway, Chairman and CEO
Analyst Sentiment: Analysts were highly focused on the obesity landscape, specifically probing the dosing and efficacy profile of MariTide compared to competitors. There was also significant skepticism and detailed questioning regarding the FDA's request to withdraw Tavneos, with analysts like Umer Raffat pressing for clarity on the regulatory misstep. Questions regarding Repatha's competitive positioning against oral PCSK9 inhibitors were also prevalent.
Management Responses: Management was generally transparent and direct, particularly Jay Bradner who pushed back firmly against the premise that less frequent dosing would reduce efficacy for MariTide. Regarding Tavneos, Bradner admitted surprise but stuck to the facts of the ongoing dialogue. Murdo Gordon displayed confidence in Repatha's commercial strategy, emphasizing the superiority of their outcomes data over oral competitors.
MariTide Dosing & Efficacy: Analysts sought to understand if the convenience of monthly/quarterly dosing would come at the cost of weight loss efficacy compared to weekly therapies. Management rejected the trade-off premise, citing data showing weight maintenance on low doses.
Tavneos Regulatory Status: Analysts asked for details on the FDA's request for voluntary withdrawal and the specific data issues (readjudication of 9 patients). Management explained the issue but expressed limited ability to comment further due to ongoing discussions.
Repatha vs. Oral Competition: Analysts inquired about the threat of Merck's oral PCSK9 inhibitor. Management emphasized Repatha's unique outcomes data in primary prevention (Vesalius CV) as a competitive moat that orals lack.
Rare Disease Expansion: Analysts asked about the market opportunity for Uplizna in new indications like CIDP and Autoimmune Hepatitis. Management highlighted the high unmet need and steroid-sparing potential of the mechanism.
Amgen is successfully executing a pivot from legacy reliance to a diversified growth engine driven by cardiology, rare disease, and oncology. The 2025 results demonstrated resilience and double-digit growth despite well-telegraphed patent cliffs. The investment thesis rests heavily on the potential of MariTide; management's confidence in its differentiated monthly/quarterly dosing profile addresses a major gap in the current obesity market (persistence/tolerability) and could justify a premium valuation if Phase III data confirms the 'paradigm-shifting' potential. Furthermore, the Repatha franchise is revitalized by the Vesalius CV outcomes data, opening a massive primary prevention market that competitors cannot yet claim. Key risks include the regulatory overhang on Tavneos and the aggressive R&D spend impacting margins, but the 2026 guidance for double-digit EPS growth suggests strong operating leverage. With a 46% operating margin and $8.1B in free cash flow, the company has the financial firepower to weather these storms and invest in the pipeline. We recommend buying on strength as the company positions 2026 as a springboard for the next decade of growth led by MariTide and the expanded rare disease portfolio.
Management highlighted a significant shift in patient and prescriber preferences towards convenience and tolerability in chronic disease management. The rapid uptake of oral semaglutide and the enthusiasm for MariTide's monthly dosing indicate that the market is moving away from purely efficacy-driven decisions to 'total experience' considerations (dosing frequency, side effects). This suggests that future market leaders in obesity and diabetes will need to offer differentiated delivery mechanisms (e.g., monthly, oral) to capture share from weekly injectables.
The Vesalius CV trial results for Repatha signal a broader macro shift in cardiovascular care towards earlier, more aggressive intervention in primary prevention. Management's expectation that these results will drive updates to clinical guidelines and quality measures implies a systemic lowering of LDL-C treatment thresholds. This expands the addressable market for PCSK9 inhibitors significantly, moving them from secondary prevention niche to primary prevention standard of care.