Company Overview - Amgen is one of the largest biotech companies globally, with a strong presence in oncology, cardiovascular disease, inflammation, bone health, and rare diseases markets [12] - The company has developed successful drugs such as Epogen and Neupogen, and launched next-generation products like Aranesp and Neulasta [12] - Amgen's acquisition of Immunex Corporation provided access to the blockbuster drug Enbrel, although older drugs are facing declining sales due to competition [12] Financial Performance - Amgen has a Zacks Rank of 3 (Hold) and a VGM Score of A, indicating a solid position in the market [13] - The company is forecasted to achieve year-over-year earnings growth of 4.6% for the current fiscal year [13] - Recent upward revisions in earnings estimates by 10 analysts have increased the Zacks Consensus Estimate by $0.13 to $20.76 per share [13] - Amgen has an average earnings surprise of 8.3%, suggesting a positive trend in financial performance [13] Investment Potential - With a solid Zacks Rank and top-tier Growth and VGM Style Scores, Amgen is recommended for investors' consideration [14]

Core Viewpoint - Amgen (AMGN) reported strong first-quarter earnings and sales for 2025, with total revenues increasing by 9% year over year and product revenues rising by 11% to $7.87 billion, driven by volume growth despite price declines [1][2][3] Revenue Performance - Total revenues rose 9% year over year, with product revenues increasing 11% to $7.87 billion, reflecting strong volume growth across all areas [1][2] - Sales of key products such as Prolia, Xgeva, Repatha, Blincyto, and Evenity exceeded estimates, with 14 products achieving double-digit volume growth [3][4] Key Drug Performance - Repatha generated $656 million in sales, up 27% year over year, with volume growth of 41% offset by a 9% price decline [4] - Evenity recorded sales of $442 million, a 29% increase year over year, driven by strong demand [5] - Prolia revenues reached $1.1 billion, up 10% from the previous year, as higher volumes mitigated lower pricing impacts [5] Rare Disease Drug Sales - Sales of rare disease drugs rose 3% year over year to $1 billion, with Tepezza and Krystexxa impacted by U.S. wholesaler inventory changes [8][9] - Tepezza sales declined 10% to $381 million, while Krystexxa remained flat at $236 million; Uplizna grew 14% to $91 million, and Tavneos saw a 76% increase to $90 million [9] Oncology Portfolio - Amgen's oncology portfolio grew 10% year over year, generating over $2 billion in sales, with Blincyto as a key driver at $370 million, up 52% [10][11] - Xgeva delivered revenues of $566 million, while Kyprolis saw a 14% decline to $324 million due to competitive pressures [11] Biosimilars Contribution - Biosimilar portfolio sales increased by 35% year over year to $735 million, with new products like Wezlana contributing significantly [12][13] - Wezlana generated $150 million in sales, while Pavblu brought in $99 million [13] Inflammation Drugs - Otezla sales were $437 million, up 11%, while Enbrel revenues declined 10% to $510 million, with both products beating estimates [15] Overall Conclusion - Amgen's key medicines, including Evenity, Repatha, and Blincyto, drove sales growth, offsetting declines from oncology biosimilars and established products like Enbrel [16] - Increased pricing pressures and competition are expected to impact sales of several products, with potential revenue headwinds from brands like Otezla and Lumakras [17]

Group 1 - The Q1 earnings season is performing well, with 72% of S&P 500 companies that have reported beating estimates [1] - The blended year-over-year earnings advance is currently at 12.8%, which is five percentage points above the previous level [1]

Core Viewpoint - Amgen reported strong first-quarter 2025 results, exceeding earnings and revenue estimates, driven by robust product sales despite rising operating costs [1][20][21]. Financial Performance - Adjusted earnings per share were $4.90, surpassing the Zacks Consensus Estimate of $4.16, marking a 24% year-over-year increase [1]. - Total revenues reached $8.1 billion, exceeding the Zacks Consensus Estimate of $7.95 billion, reflecting a 9% year-over-year growth [1]. Product Revenue Breakdown - Total product revenues increased by 11% year-over-year to $7.87 billion, with volume growth of 14% partially offset by price declines [2]. - Prolia generated $1.1 billion in revenue, up 10% year-over-year, beating estimates [3]. - Evenity sales rose 29% year-over-year to $442 million, exceeding expectations [4]. - Repatha revenues increased by 27% year-over-year to $656 million, driven by a 41% rise in volumes [5]. - Xgeva delivered revenues of $566 million, up 1% year-over-year, beating estimates despite currency headwinds [6]. - Kyprolis sales declined 14% year-over-year to $324 million due to competitive pressures [7]. - Otezla sales were $437 million, up 11% year-over-year, beating estimates [9]. - Enbrel revenues fell 10% year-over-year to $510 million due to lower prices [10]. - Tezspire recorded sales of $285 million, up 65% year-over-year, exceeding expectations [11]. - New biosimilars, Wezlana and Pavblu, generated $150 million and $99 million in sales, respectively [12]. Cost and Margin Analysis - Adjusted operating margin increased by 2.5 percentage points to 45.7% [15]. - Adjusted operating expenses rose by 4% to $4.55 billion, with R&D expenses increasing by 11% [15]. Guidance and Future Outlook - Amgen reaffirmed its 2025 guidance, expecting total revenues between $34.3 billion and $35.7 billion and adjusted earnings per share between $20.00 and $21.20 [16]. - The company is developing MariTide, a new obesity treatment, with ongoing phase III studies [17][18][19]. Market Performance - Amgen's stock has risen 9.4% year-to-date, outperforming the industry, which has seen a 1.2% decline [21].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37702 Amgen Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) One Amgen Center Drive Thousand Oaks California QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES E ...

Core Insights - Amgen reported $8.15 billion in revenue for Q1 2025, a year-over-year increase of 9.4% and an EPS of $4.90, up from $3.96 a year ago, exceeding both revenue and EPS consensus estimates [1] Financial Performance - Revenue of $8.15 billion surpassed the Zacks Consensus Estimate of $7.95 billion by 2.47% [1] - EPS of $4.90 exceeded the consensus estimate of $4.16 by 17.79% [1] - Total product sales reached $7.87 billion, compared to the average estimate of $7.59 billion, reflecting a year-over-year change of 10.6% [4] Product Sales Breakdown - Neulasta (ROW): $20 million, -35.5% YoY, below estimate of $26.10 million [4] - Neulasta (U.S.): $109 million, +25.3% YoY, above estimate of $67.86 million [4] - Otezla (ROW): $94 million, -6.9% YoY, below estimate of $103.34 million [4] - Otezla (U.S.): $343 million, +17.1% YoY, above estimate of $299.70 million [4] - BLINCYTO: $370 million, +51.6% YoY, above estimate of $337.78 million [4] - Repatha: $656 million, +26.9% YoY, above estimate of $615.59 million [4] - KYPROLIS: $324 million, -13.8% YoY, below estimate of $381.49 million [4] - Vectibix: $267 million, +8.1% YoY, above estimate of $250.50 million [4] - Enbrel: $510 million, -10.1% YoY, slightly above estimate of $502.53 million [4] - Other revenues: $276 million, -16.1% YoY, below estimate of $347.10 million [4] - Neulasta (Total): $129 million, +9.3% YoY, above estimate of $93.87 million [4] Stock Performance - Amgen shares returned -4.8% over the past month, compared to the Zacks S&P 500 composite's -0.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market [3]

Core Viewpoint - Amgen reported quarterly earnings of $4.90 per share, exceeding the Zacks Consensus Estimate of $4.16 per share, and showing an increase from $3.96 per share a year ago, representing an earnings surprise of 17.79% [1][2] Financial Performance - The company achieved revenues of $8.15 billion for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 2.47%, and up from $7.45 billion year-over-year [2] - Over the last four quarters, Amgen has exceeded consensus EPS estimates four times and topped revenue estimates three times [2] Stock Performance - Amgen shares have increased approximately 11.6% since the beginning of the year, contrasting with a decline of -5.3% in the S&P 500 [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $5.29 on revenues of $8.82 billion, and for the current fiscal year, it is $20.57 on revenues of $34.99 billion [7] - The outlook for the Medical - Biomedical and Genetics industry is favorable, ranking in the top 32% of over 250 Zacks industries, suggesting potential for outperformance [8]

Financial Data and Key Metrics Changes - Revenue grew 9% year over year, reaching $8.1 billion, with volume growth of 14% reflecting increased patient demand for innovative medicines [4][49] - Non-GAAP operating expenses rose 4%, with R&D expenses increasing by 12% year over year [50] - Non-GAAP operating margin was 45.7%, above previous guidance due to timing of R&D spending [50] Business Line Data and Key Metrics Changes - General Medicine saw Repatha sales increase by 27% year over year, generating $656 million in Q1 [18] - Rare Disease portfolio grew 3% year over year, delivering $1 billion in sales, with TEPEZZA and KRYSTEXXA impacted by U.S. wholesaler inventory changes [23] - Oncology portfolio generated over $2 billion in sales, growing 10% year over year, driven by the bispecific T cell engager platform [28] Market Data and Key Metrics Changes - U.S. product sales grew 14%, with 14 products delivering double-digit growth [17] - Repatha sales outside the U.S. increased by 29% year over year, reaching $442 million [21] - Evenity sales in the U.S. grew 36% year over year, with Prolia sales reaching nearly $1.1 billion [22][23] Company Strategy and Development Direction - The company is focused on addressing large underserved patient populations with multiple products, particularly in general medicine and rare diseases [5][6] - Continued investment in manufacturing and R&D, with nearly $5 billion invested in U.S. capital projects since 2017 [14][58] - The company aims to maintain leadership in biosimilars and innovative therapies while navigating potential tariff and tax changes [13][58] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing strong patient demand and ongoing product launches [16] - The company is well-positioned to deliver innovation and growth, despite operating in a volatile environment [16] - Management reaffirmed 2025 revenue guidance of $34.3 billion to $35.7 billion and non-GAAP EPS guidance of $20 to $21.2 [54] Other Important Information - The company generated $1 billion in free cash flow in Q1, reflecting operational momentum [51] - The FDA granted breakthrough therapy designation for blinatumomab for subcutaneous treatment of B-ALL [11][46] - The company is advancing multiple Phase 3 studies across various therapeutic areas, including obesity and rare diseases [36][42] Q&A Session Summary Question: What should be expected at ADA regarding Meritide? - Management highlighted strong efficacy and tolerability data from Phase II studies, with a focus on mechanistic insights and ongoing Phase III trials [62][64] Question: What is the commercial strategy for Aplisna in IgG4? - The company is excited about being the first approved therapy for IgG4, with a focus on engaging rheumatologists and leveraging its experience in autoimmune diseases [68][70] Question: How does the company view competition from oral obesity medications? - Management expressed confidence in Meritide's efficacy and tolerability, noting that while oral medications may enter the market, Meritide's unique dosing schedule provides a competitive advantage [80][84] Question: How is Repatha performing against competitors like Lecvio? - Management acknowledged competition but emphasized Repatha's strong profile and ongoing efforts to improve access and affordability for patients [88][90] Question: What is the expected uptake of Tableau following the Q code implementation? - The company reported positive reception of PABLUE among retina specialists and is working on contracting with larger groups [95] Question: How is the company addressing payer dynamics in the obesity market? - Management is focused on ensuring broad access to obesity medications and is monitoring recent changes in the payer environment [99]

Financial Data and Key Metrics Changes - The company reported revenues of $8.1 billion for Q1 2025, reflecting a 9% year-over-year increase, driven by 14% volume growth from key brands [48] - Non-GAAP operating expenses rose by 4%, with R&D expenses increasing by 12% year-over-year, indicating continued investment in the late-stage pipeline [49] - The non-GAAP operating margin was 45.7%, above previous guidance due to the timing of R&D spending [49] Business Line Data and Key Metrics Changes - Global product sales grew by 11% year-over-year, with the U.S. market showing a 14% increase [18] - Repatha sales increased by 27% year-over-year, reaching $656 million in Q1, driven by improved access and prescriber engagement [19] - The rare disease portfolio grew by 3% year-over-year, generating $1 billion in sales, although sales of TEPEZZA and KRYSTEXXA were impacted by changes in U.S. wholesaler inventory levels [23] Market Data and Key Metrics Changes - The biosimilars portfolio generated $735 million in sales, a 35% increase year-over-year, with PABLUE sales reaching $99 million [31] - Evenity sales grew by 36% in the U.S., highlighting the potential for further market penetration as fewer than 250,000 patients have been treated to date [22] - The oncology portfolio, including products like BLINCYTO and IMDELTRA, grew by 10% year-over-year, generating over $2 billion in sales [29] Company Strategy and Development Direction - The company is focused on addressing large underserved patient populations in general medicine, rare diseases, and oncology, with multiple product launches and positive clinical trial data [5][6] - There is a commitment to innovation, with significant investments in R&D and manufacturing capacity in the U.S. [14][56] - The company aims to adapt to potential changes in tariffs and taxes while maintaining long-term growth strategies [13][55] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing strong patient demand for innovative medicines and the successful execution of multiple Phase 3 studies [16] - The company reaffirmed its 2025 total revenue guidance in the range of $34.3 billion to $35.7 billion, along with non-GAAP earnings per share guidance between $20 and $21.2 [52] - Management acknowledged the competitive landscape but emphasized the unique value propositions of their products, particularly in the PCSK9 category [88] Other Important Information - The company has invested nearly $5 billion in U.S. capital projects since 2017 and announced an additional $2 billion in expansions in Ohio and North Carolina [14] - The integration of Horizon is progressing well, with expectations to achieve $500 million in pre-tax cost synergies by the end of the year [49] Q&A Session Summary Question: What should be expected at ADA regarding Meritide? - Management highlighted strong efficacy and tolerability data from Phase II studies, with a focus on new mechanistic data to be presented at ADA [60][62] Question: What is the commercial strategy for Uplenza in IgG4? - The company is excited about being the first approved therapy for IgG4, with a focus on engaging rheumatologists and leveraging its existing presence in inflammation and autoimmune diseases [68][70] Question: How does the company view competition from oral obesity medications? - Management acknowledged the competition but emphasized the unique dosing schedule and efficacy of Meritide, which they believe will maintain its competitive edge [82][84] Question: What is the outlook for Repatha amidst increasing competition? - The company recognizes competition but believes Repatha has the best profile in the PCSK9 category, with ongoing efforts to improve access and affordability for patients [88][90]

Q1 2025 Financial Performance - Total revenue increased by 9% year-over-year, reaching $8.149 billion[97] - Product sales increased by 11% year-over-year, totaling $7.873 billion[97] - Non-GAAP EPS increased by 24% year-over-year, reaching $4.90[97] - Research and development investment increased by 12% year-over-year, reaching $1.5 billion[9] - Free cash flow was $980 million in Q1 2025, compared to $459 million in Q1 2024[117] Product Performance Highlights - Repatha sales increased by 27% year-over-year, reaching $656 million, driven by 41% volume growth[12, 22] - EVENITY sales increased by 29% year-over-year, reaching $442 million, driven by volume growth[12, 22] - Prolia sales increased by 10% year-over-year, reaching $1.099 billion, driven by 13% volume growth[12, 22] - TEZSPIRE sales increased by 65% year-over-year, reaching $285 million, driven by volume growth[12, 32] - BLINCYTO sales increased by 52% year-over-year, reaching $370 million, primarily driven by volume growth[12, 37] - IMDELLTRA generated $81 million in sales in Q1 2025[12, 17, 37] Pipeline and Regulatory Updates - FDA approved UPLIZNA for the treatment of IgG4-RD in adult patients[9, 51] - Positive Phase 3 data from IMDELLTRA, UPLIZNA, and rocatinlimab[9] - Initiated multiple Phase 3 trials of MariTide and TEZSPIRE[9] - The company expects 2025 revenue to be in the range of $34.3 billion to $35.7 billion[101]