Amgen announced positive interim Phase 2 study results for MariTide in June 2025, demonstrating significant weight loss (up to 20%) and improvements in cardiometabolic parameters. Additionally, interim Phase 3 data for IMDELLTRA/IMDYLLTRA in SCLC showed a 40% reduction in the risk of death, and Bemarituzumab met its primary endpoint of overall survival in gastric cancer, signaling strong potential for future growth drivers.

The European Commission granted marketing authorization approval for TEPEZZA in June 2025, expanding its market reach. Furthermore, the FDA approval of UPLIZNA for IgG4-RD in Q2 2025 led to the reclassification of its intangible asset from IPR&D to developed-product-technology rights with a gross carrying value of $350 million, indicating successful pipeline progression to commercialization.

Total product sales increased by 9% for the three months and 10% for the six months ended June 30, 2025, primarily driven by robust volume growth of 13% and 14% respectively. Notable contributors to this growth include Repatha (31% Q2 YoY), EVENITY (32% Q2 YoY), BLINCYTO (45% Q2 YoY), and TEZSPIRE (46% Q2 YoY), highlighting strong market adoption for these products.

Management successfully reduced Cost of Sales by 7% for both the three and six months ended June 30, 2025, primarily due to lower amortization expense from the Horizon inventory step-up and reduced manufacturing costs. Selling, General and Administrative (SG&A) expenses also decreased by 5% and 6% for the respective periods, reflecting a focus on operational efficiency and integration of acquired assets.

Research and Development (R&D) expense increased by 21% to $1,744 million for the three months and 16% to $3,230 million for the six months ended June 30, 2025. This increase is attributed to strategic investments in Later-Stage Clinical Programs, including MariTide, demonstrating management's commitment to advancing its pipeline and securing future growth.

Amgen demonstrated proactive financial management by repaying $3.5 billion and extinguishing $602 million of debt during the six months ended June 30, 2025, resulting in a $228 million gain on extinguishment. This reduction in debt contributed to a decrease in net interest expense and improved the company's capital structure, signaling prudent liquidity management.

The Inflation Reduction Act (IRA) and the Most-Favored-Nations (MFN) Prescription Drug Pricing Executive Order continue to negatively impact Amgen's business, with ENBREL and Otezla selected for Medicare price setting in 2026 and 2027 respectively. The OBBBA, enacted July 4, 2025, also introduces various provisions effective 2026 and beyond, which are expected to materially affect sales and profitability due to lower reimbursement rates and increased penalties.

Patents for key products Prolia and XGEVA expired in February 2025 in the U.S. and will expire in November 2025 in Europe, leading to expected sales erosion from biosimilar competition in the second half of 2025. This is evidenced by a 4% decline in Prolia sales and a 5% decline in XGEVA sales for the three months ended June 30, 2025, highlighting a significant competitive threat.

Amgen faces substantial potential tax liabilities from ongoing IRS disputes for 2010-2012 ($3.6 billion additional federal tax plus interest) and 2013-2015 ($5.1 billion additional federal tax plus interest, $2.0 billion penalties), with a decision expected no earlier than H2 2026. Furthermore, global minimum tax agreements (15% rate) enacted in key foreign jurisdictions and new U.S. legislation (OBBBA) introduce complexity and potential for increased tax burdens.

Despite a 3-4% decline in net selling prices for total product sales, Amgen achieved 13% and 14% volume growth for the three and six months ended June 30, 2025, respectively. This indicates strong demand and competitive positioning for products like Repatha (+31% Q2 YoY), EVENITY (+32% Q2 YoY), and BLINCYTO (+45% Q2 YoY), allowing the company to gain market share through increased adoption.

ENBREL sales declined by 34% for the three months and 25% for the six months ended June 30, 2025, primarily due to lower net selling prices resulting from increased 340B Program mix and Medicare Part D redesign. Otezla also faces future pricing pressure as it was selected by CMS for Medicare price setting beginning 2027, leading to an $800 million impairment charge in Q1 2025, underscoring the impact of regulatory actions on key products.

The expiration of patents for Prolia and XGEVA in the U.S. in February 2025 has led to the launch of biosimilar competition, contributing to a 4% decline in Prolia sales and a 5% decline in XGEVA sales for the three months ended June 30, 2025. This trend is expected to continue and will likely impact sales erosion in the second half of 2025, challenging Amgen's competitive position in these segments.

Cost of sales decreased by 7% for both the three and six months ended June 30, 2025, reaching 32.8% and 34.5% of total revenues respectively. This improvement was driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by higher profit share expense and changes in sales mix.

Selling, General and Administrative (SG&A) expenses decreased by 5% for the three months and 6% for the six months ended June 30, 2025. This reduction was primarily due to lower commercial product-related expenses and decreased Horizon acquisition-related expenses, indicating successful integration and optimization efforts by management.

Amgen noted that recent tariffs on imported equipment, construction materials, and key inputs have increased costs in H1 2025, and future tariffs could further increase costs and disrupt supply chains. The ongoing reliance on a single or small number of vendors and suppliers for manufacturing expansion also presents a risk, potentially leading to delays and increased expenses for capital projects.

Research and Development (R&D) expense increased by 21% to $1,744 million for the three months and 16% to $3,230 million for the six months ended June 30, 2025. This significant increase was primarily driven by intensified investments in Later-Stage Clinical Programs, including the promising MariTide asset, signaling a strategic focus on advancing late-stage pipeline candidates.

Amgen reported encouraging Phase 2 data for MariTide, showing substantial weight loss and cardiometabolic improvements, and positive interim Phase 3 results for IMDELLTRA/IMDYLLTRA, demonstrating a 40% reduction in mortality risk for SCLC patients. These results underscore the company's ability to develop innovative human therapeutics and strengthen its future product portfolio.

The expiration of patents for key products like Prolia and XGEVA in the U.S. in February 2025, and upcoming expirations in Europe, exposes Amgen to increased biosimilar competition. Ongoing patent litigation related to Repatha and newly filed lawsuits concerning biosimilar versions of Prolia/XGEVA and PAVBLU highlight the continuous challenges in protecting intellectual property in the biopharmaceutical industry.

Amgen reduced its total long-term debt from $56,549 million as of December 31, 2024, to $53,760 million as of June 30, 2025. During the six months ended June 30, 2025, the company repaid $3.5 billion and opportunistically repurchased $602 million in principal amount of debt for an aggregate cost of $228 million, resulting in a $228 million gain on extinguishment. This reflects a strategic focus on optimizing the capital structure.

The Board of Directors declared quarterly cash dividends of $2.38 per share in March and August 2025, representing a 6% increase over the quarterly cash dividends paid in 2024. This consistent increase in shareholder returns, despite no share repurchases during the period, demonstrates management's confidence in the company's sustained profitability and strong financial position.

Cash used in investing activities increased to $836 million for the six months ended June 30, 2025, up from $434 million in the prior year, primarily due to higher capital expenditures of $780 million. The company estimates full-year 2025 investments in capital projects to be approximately $2.3 billion, indicating a significant commitment to expanding manufacturing capacity to support future product demand.

The provided 10-Q filing primarily focuses on financial performance, operational results, and risk factors. While Amgen's business mission includes discovering and delivering innovative human therapeutics to fight diseases and reduce the social and economic burden of disease, the filing does not contain specific, quantitative details or dedicated sections on environmental, social, or governance initiatives beyond standard corporate disclosures.

Amgen acknowledges that uncertain macroeconomic conditions, including inflation, fluctuating interest rates, and instability in the financial system, continue to pose challenges. These factors, alongside rising healthcare costs and geopolitical conflicts, contribute to a dynamic and challenging operating environment, potentially impacting demand and increasing operational expenses.

The enactment of the OBBBA on July 4, 2025, and the Administration's Most-Favored-Nations (MFN) Executive Order, along with state-level Prescription Drug Affordability Boards (PDABs), are creating significant pricing and reimbursement pressures. These initiatives, including the selection of ENBREL and Otezla for Medicare price setting, are expected to lead to net price declines and impact future product sales.

New tariffs, such as the universal 10% tariff on imported goods and the potential Section 232 pharmaceutical tariff, are noted as increasing manufacturing and operating costs. Retaliatory tariffs from other countries and the BIOSECURE Act, which could restrict collaborations with certain biotechnology companies in China, add to the uncertainty and potential disruption of global supply chains and market access.