Summary of Amgen Conference Call - February 12, 2026 Company Overview - **Company**: Amgen (NasdaqGS:AMGN) - **Focus**: Development of innovative therapies for autoimmune diseases and other conditions Key Products and Developments UPLIZNA - **Indications**: Plans to initiate Phase III studies for autoimmune hepatitis (AIH) and chronic inflammatory demyelinating polyneuropathy (CIDP) later in 2026 - **Mechanism**: B-cell depleter targeting CD19, effective in conditions driven by pathogenic B-cells - **Market Potential**: - CIDP prevalent pool in the U.S. estimated at 35,000 patients, with 7,000-10,000 new cases annually - AIH likely has a larger patient population, though exact numbers are difficult to ascertain - **Rationale**: Proven effectiveness in similar conditions like IgG4-related disease and generalized myasthenia gravis supports the potential for UPLIZNA in AIH and CIDP [1][2][3][4][6] Daxdilimab - **Indications**: Positive Phase II results in discoid lupus; previously failed in systemic lupus erythematosus (SLE) - **Mechanism**: Targets immunoglobulin-like transcript seven protein (ILT-7), depleting plasmacytoid dendritic cells involved in interferon production - **Clinical Results**: - Discoid lupus study met primary endpoint of reduced disease severity at week 24 - Secondary endpoint also showed clinical benefit - **Future Plans**: Considering Phase III study for discoid lupus, with potential for broader indications in autoimmune diseases driven by plasmacytoid dendritic cells [9][10][11][13][16] Dazodalibep - **Indications**: Targeting Sjögren's syndrome with two ongoing Phase III studies - **Mechanism**: Inhibits CD40 ligand, disrupting B-cell activation and downstream inflammatory cascades - **Clinical Management**: Current management is symptomatic; no definitive treatments exist - **Phase II Results**: Showed improvement in disease activity index and patient-reported outcomes, providing confidence for Phase III studies [18][26][29][32] TEZSPIRE - **Indications**: Recently expanded label for chronic rhinosinusitis with nasal polyps - **Mechanism**: Targets TSLP, addressing upstream drivers of inflammation, differentiating it from therapies targeting downstream cytokines (IL-4, IL-5, IL-13) - **Clinical Results**: Phase 3 Waypoint study showed significant reduction in nasal polyp severity and decreased need for surgery - **Market Potential**: High overlap between chronic rhinosinusitis and asthma (approximately 20% of asthma patients also have nasal polyps), enhancing TEZSPIRE's market reach [35][36][37][42][45] Eosinophilic Esophagitis (EoE) - **Unmet Need**: Current treatments are limited, primarily involving proton pump inhibitors and corticosteroids - **Prevalence**: Estimated at 1 in 700 people in the U.S. - **Phase III Study**: Expected data in the second half of 2026, with potential for TEZSPIRE to address this unmet need [47][49][51] Competitive Landscape - **Dazodalibep vs. Nipocalimab**: Dazodalibep is the first therapy to demonstrate efficacy in both subgroups of Sjögren's syndrome in Phase II, with ongoing Phase III studies to confirm its effectiveness [32][34] Future Outlook - **Execution Focus**: Amgen aims to build penetration in existing indications before exploring new ones for TSLP-targeted therapies - **Inhaled TSLP Therapy**: AMG 104, an inhaled TSLP antibody fragment, is in Phase II trials, with potential to provide an alternative to injected biologics for asthma management [65][66][70][74] Conclusion - Amgen is positioned to leverage its innovative therapies across multiple autoimmune conditions, with significant clinical data supporting the efficacy of its products. The company is focused on executing its current strategies while preparing for future opportunities in the evolving therapeutic landscape.

Core Insights - Amgen reported revenue of $9.56 billion for the quarter ended September 2025, reflecting a 12.4% increase year-over-year and a 6.87% surprise over the Zacks Consensus Estimate of $8.94 billion [1] - The earnings per share (EPS) for the quarter was $5.64, which is an increase from $5.58 in the same quarter last year, resulting in a 12.8% surprise over the consensus EPS estimate of $5.00 [1] Financial Performance Metrics - Product sales for Neulasta in the ROW were $20 million, slightly above the estimated $19.55 million, but down 23.1% year-over-year [4] - Neulasta sales in the U.S. reached $72 million, exceeding the estimate of $60.9 million, but down 14.3% from the previous year [4] - XGEVA sales in the ROW were $182 million, surpassing the average estimate of $144.77 million, marking an 8.3% year-over-year increase [4] - Enbrel sales in the ROW were $6 million, below the estimated $7.36 million, reflecting a 25% decline year-over-year [4] - Other revenues amounted to $420 million, exceeding the average estimate of $373.34 million, with a year-over-year increase of 19.3% [4] - Total product sales were $9.14 billion, surpassing the estimated $8.55 billion, representing a 12.1% increase year-over-year [4] - BLINCYTO total sales were $392 million, slightly below the estimate of $412.7 million, but showing a 19.9% increase year-over-year [4] - Otezla total sales reached $585 million, slightly above the estimate of $582.08 million, with a year-over-year increase of 3.7% [4] - Total sales for Neulasta were $92 million, exceeding the estimate of $79.77 million, but down 16.4% year-over-year [4] - Enbrel total sales were $580 million, below the estimate of $645.48 million, reflecting a 29.7% decline year-over-year [4] - LUMAKRAS/LUMYKRAS total sales were $96 million, slightly below the estimate of $100.05 million, down 2% year-over-year [4] - TEZSPIRE total sales were $377 million, exceeding the estimate of $364.18 million, with a significant year-over-year increase of 40.2% [4] Stock Performance - Amgen's shares returned +0.7% over the past month, compared to the Zacks S&P 500 composite's +2.1% change, indicating a performance in line with the broader market [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the market in the near term [3]

Core Insights - Amgen reported strong financial results for Q3 2025, with total revenues increasing by 12% to $9.6 billion compared to Q3 2024, driven by a 14% volume growth in product sales, despite a 4% decrease in net selling prices [6][16][17] Financial Performance - Total revenues for Q3 2025 reached $9.6 billion, a 12% increase from Q3 2024 [6] - Product sales grew by 12%, with 14% volume growth offset by a 4% decline in net selling prices [6] - GAAP EPS rose 14% from $5.22 to $5.93, while non-GAAP EPS increased by 1% from $5.58 to $5.64 [6][11] - Free cash flow for Q3 2025 was $4.2 billion, up from $3.3 billion in Q3 2024 [13][16] Product Sales Highlights - Sixteen products achieved double-digit sales growth, including Repatha (40% increase), EVENITY (36% increase), and TEZSPIRE (40% increase) [6][8] - Enbrel sales decreased by 30% year-over-year, primarily due to a 38% drop in net selling price [6][8] - Ultra-Rare products generated $200 million in sales, a 6% increase year-over-year [8] Operating Expenses and Margins - Total operating expenses increased by 9% year-over-year, with R&D expenses rising by 31% due to higher spending on late-stage clinical programs [11][12] - GAAP operating income increased from $2.0 billion to $2.5 billion, with an operating margin of 27.6%, up 2.5 percentage points [11][12] - Non-GAAP operating margin decreased by 2.5 percentage points to 47.1% [11][12] Cash Flow and Balance Sheet - Operating cash flow for Q3 2025 was $4.7 billion, compared to $3.6 billion in Q3 2024 [13] - Cash and cash equivalents totaled $9.4 billion, while debt outstanding was $54.6 billion as of September 30, 2025 [13][16] Guidance for 2025 - The company expects total revenues for 2025 to be in the range of $35.8 billion to $36.6 billion, with GAAP EPS projected between $13.76 and $14.60 [17]

Core Insights - Amgen reported a strong Q2 2025 with a 9% increase in GAAP revenue to $9.18 billion and a non-GAAP EPS of $6.02, exceeding analyst expectations [1][2][5] - The company emphasized pipeline advancements and product launches as key drivers of growth, despite a decline in free cash flow [1][4][5] Financial Performance - Non-GAAP EPS reached $6.02, a 21% increase from $4.97 in Q2 2024, surpassing the consensus estimate of $5.28 [2][5] - GAAP revenue was $9.18 billion, up 9% year-over-year, compared to $8.4 billion in Q2 2024 [2][5] - Non-GAAP operating margin improved to 48.9%, a 0.7 percentage point increase from the previous year [2][6] - Free cash flow decreased to $1.9 billion from $2.2 billion in Q2 2024, attributed to higher capital spending and tax payment timing [2][5][15] Product Performance - Sales growth varied across product lines, with Repatha and EVENITY increasing over 30%, while Prolia saw a 4% decline [7][8] - Rare disease products UPLIZNA and TAVNEOS experienced significant revenue increases of 91% and 55%, respectively [7][11] - Inflammation products showed mixed results, with TEZSPIRE growing 46% and Enbrel declining 34% [8] - Oncology products like IMDELLTRA reported strong growth, while older drugs faced competitive pressures [12][13] Pipeline and Innovation - Amgen's pipeline includes promising candidates like MariTide for obesity, which showed strong phase 2 data [10][12] - UPLIZNA is under FDA review for generalized myasthenia gravis, with a decision expected by December 14, 2025 [11] - The company is focusing on expanding its biosimilars portfolio, although pricing pressures are increasing [13][16] Strategic Focus - Amgen is committed to expanding its product pipeline and international market presence while investing in advanced manufacturing [4][16] - The company plans to maintain a capital spending target of $2.3 billion and has set a revenue target of $35.0–$36.0 billion for FY2025 [17][18] - Management highlighted the importance of new drug approvals and the impact of biosimilar competition on established products as key areas to monitor [19]