PART I [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) This section presents Amgen's unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025, covering income, balance sheets, equity, and cash flows with detailed notes [Condensed Consolidated Statements of Income](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME) For the six months ended June 30, 2025, Amgen reported total revenues of $17.33 billion, a 9% increase year-over-year, with net income rising to $3.16 billion and diluted EPS to $5.84 Condensed Consolidated Statements of Income (Six Months Ended June 30) | Financial Metric | 2025 (in millions) | 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | Total revenues | $17,328 | $15,835 | +9.4% | | Operating income | $3,834 | $2,900 | +32.2% | | Net income | $3,162 | $633 | +399.5% | | Diluted EPS | $5.84 | $1.17 | +399.1% | [Condensed Consolidated Statements of Comprehensive Income](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20INCOME) For the six months ended June 30, 2025, comprehensive income was $2.68 billion, a significant increase from $767 million in the prior year, driven by higher net income despite other comprehensive losses Condensed Consolidated Statements of Comprehensive Income (Six Months Ended June 30) | Metric | 2025 (in millions) | 2024 (in millions) | | :--- | :--- | :--- | | Net Income | $3,162 | $633 | | Other comprehensive (loss) income | $(478) | $134 | | **Comprehensive Income** | **$2,684** | **$767** | [Condensed Consolidated Balance Sheets](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, Amgen's total assets decreased to $87.9 billion, primarily due to reduced cash, while total liabilities decreased to $80.5 billion from lower long-term debt, and stockholders' equity increased to $7.4 billion Condensed Consolidated Balance Sheet Highlights | Account | June 30, 2025 (in millions) | Dec 31, 2024 (in millions) | | :--- | :--- | :--- | | Cash and cash equivalents | $8,028 | $11,973 | | Total assets | $87,897 | $91,839 | | Long-term debt | $53,760 | $56,549 | | Total liabilities | $80,469 | $85,962 | | Total stockholders' equity | $7,428 | $5,877 | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20STOCKHOLDERS%27%20EQUITY) For the six months ended June 30, 2025, total stockholders' equity increased from $5.88 billion to $7.43 billion, driven by net income, partially offset by dividends and other comprehensive loss - Key drivers for the change in stockholders' equity in the first six months of 2025 were net income of **$3.16 billion**, offset by **$1.28 billion** in dividends and a **$478 million** other comprehensive loss[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2025, net cash from operating activities was $3.67 billion, while investing activities used $836 million and financing activities used $6.78 billion, resulting in a $3.95 billion decrease in cash Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 (in millions) | 2024 (in millions) | | :--- | :--- | :--- | | Net cash provided by operating activities | $3,671 | $3,148 | | Net cash used in investing activities | $(836) | $(434) | | Net cash used in financing activities | $(6,780) | $(4,357) | | **Decrease in cash and cash equivalents** | **$(3,945)** | **$(1,643)** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) These notes detail Amgen's accounting policies and financial results, covering operating segments, revenue breakdowns, tax disputes, fair value measurements, hedging, and legal proceedings - The company operates in a **single segment: human therapeutics** The Chief Executive Officer is the chief operating decision maker (CODM) and allocates resources on a consolidated basis[37](index=37&type=chunk)[38](index=38&type=chunk) - In January 2025, **Otezla** was selected for Medicare price negotiation under the IRA, leading to an **$800 million impairment charge** on its developed-product-technology rights intangible asset[74](index=74&type=chunk) - Amgen is in a **significant tax dispute** with the IRS for the 2010-2012 and 2013-2015 periods, involving proposed additional federal taxes of approximately **$3.6 billion** and **$5.1 billion**, respectively, plus interest and penalties[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=36&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on Amgen's financial performance, highlighting 9% revenue growth to **$17.3 billion**, 32% operating income increase, key product sales drivers, and capital allocation strategies including debt reduction and dividends Financial Highlights (Six Months Ended June 30, 2025) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Total Product Sales | $16,644M | $15,159M | +10% | | Total Revenues | $17,328M | $15,835M | +9% | | Operating Income | $3,834M | $2,900M | +32% | | Diluted EPS | $5.84 | $1.17 | +399% | - Product sales growth for the first six months of 2025 was driven by a **14% increase in volume**, partially offset by a **4% decline in net selling price**[160](index=160&type=chunk) - Operating expenses for the first half of 2025 increased by **4%**, primarily due to an **$800 million impairment charge** for the **Otezla** intangible asset and higher R&D expenses related to later-stage clinical programs like **MariTide**[164](index=164&type=chunk)[201](index=201&type=chunk)[204](index=204&type=chunk) - The company's capital allocation strategy focuses on investing in the business, **reducing debt**, and returning capital to shareholders via **dividends** and **stock repurchases** In the first half of 2025, Amgen repaid **$4.1 billion in debt** and paid **$2.6 billion in dividends**[222](index=222&type=chunk)[232](index=232&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This section reports no material changes to the company's market risk disclosures during the six months ended June 30, 2025, referencing the prior annual report - There were **no material changes** to the company's market risk profile during the first six months of 2025[235](index=235&type=chunk) [Item 4. Controls and Procedures](index=51&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that Amgen's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were **effective** as of June 30, 2025[236](index=236&type=chunk) - **No material changes** to internal control over financial reporting were identified during the quarter ended June 30, 2025[237](index=237&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=52&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) This section refers to Note 13 of the financial statements for recent developments in the company's legal proceedings, including contingencies and commitments - For updates on legal proceedings, the report directs readers to **Note 13, "Contingencies and commitments,"** in Part I of this 10-Q[240](index=240&type=chunk) [Item 1A. Risk Factors](index=52&type=section&id=Item%201A.%20RISK%20FACTORS) This section updates Amgen's risk factors, including pricing pressures from government initiatives, significant potential tax liabilities, geopolitical risks in international operations, complex manufacturing challenges, and global economic conditions - **Significant pricing pressure** continues from government and commercial payers The **Inflation Reduction Act (IRA)** has led to Medicare price setting for **ENBREL** (effective 2026) and **Otezla** (effective 2027) The **Most-Favored-Nations (MFN) Executive Order** and state-level **Prescription Drug Affordability Boards (PDABs)** pose additional risks[243](index=243&type=chunk)[245](index=245&type=chunk)[249](index=249&type=chunk) - The company faces **substantial potential tax liabilities** from its ongoing **U.S. Tax Court dispute** with the IRS over profit allocation for the 2010-2015 tax years and risks from the **OECD's global minimum tax agreement**[257](index=257&type=chunk)[259](index=259&type=chunk)[260](index=260&type=chunk) - International operations face risks from **geopolitical tensions** and new regulations The proposed **BIOSECURE Act** could restrict collaborations with certain **Chinese biotech companies**, and newly imposed **tariffs** are increasing production costs[268](index=268&type=chunk)[269](index=269&type=chunk)[282](index=282&type=chunk) - Manufacturing is complex and subject to disruptions Risks include **regulatory compliance**, reliance on **third-party manufacturers**, and potential impacts from new regulations on chemicals like **PFAS** in manufacturing and packaging[272](index=272&type=chunk)[279](index=279&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=63&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section details the company's stock repurchase activity, noting no repurchases during Q2 2025 and **$6.8 billion** remaining authorized for future repurchases - **No shares were repurchased** during the three months ended June 30, 2025[284](index=284&type=chunk) - As of June 30, 2025, **$6.8 billion** remained available for future stock repurchases under the authorized program[285](index=285&type=chunk) [Item 5. Other Information](index=63&type=section&id=Item%205.%20OTHER%20INFORMATION) This section discloses that no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025 - **No directors or officers adopted or terminated** a Rule 10b5-1 trading plan during the second quarter of 2025[286](index=286&type=chunk) [Item 6. Exhibits](index=63&type=section&id=Item%206.%20EXHIBITS) This section references the Index to Exhibits, listing all documents filed as part of this quarterly report, including agreements, governance, and data files - This section contains the **index listing all exhibits** filed with the Form 10-Q[287](index=287&type=chunk)[288](index=288&type=chunk)

Core Insights - Amgen reported $9.18 billion in revenue for the quarter ended June 2025, a year-over-year increase of 9.4%, with an EPS of $6.02 compared to $4.97 a year ago, exceeding both revenue and EPS consensus estimates [1] Financial Performance - Revenue from product sales reached $8.77 billion, surpassing the average estimate of $8.5 billion, reflecting a 9.1% increase year-over-year [4] - Other revenues amounted to $408 million, exceeding the average estimate of $345.97 million, representing a year-over-year increase of 17.6% [4] - The EPS surprise was +14.45% compared to the consensus estimate of $5.26 [1] Product Sales Breakdown - Neulasta (ROW) sales were $19 million, below the estimate of $23.31 million, showing a year-over-year decline of 36.7% [4] - Neulasta (U.S.) sales were $63 million, compared to the estimate of $70.64 million, reflecting a 16% year-over-year decrease [4] - Otezla (ROW) sales were $106 million, slightly below the estimate of $112.78 million, with a year-over-year decline of 5.4% [4] - Nplate (U.S.) sales were $228 million, slightly above the estimate of $227.77 million, showing a year-over-year increase of 6.5% [4] - Vectibix sales totaled $305 million, exceeding the estimate of $277.53 million, with a year-over-year increase of 13% [4] - BLINCYTO sales were $384 million, slightly below the estimate of $385.77 million, but represented a significant year-over-year increase of 45.5% [4] - Enbrel sales were $604 million, significantly below the estimate of $804.22 million, reflecting a year-over-year decline of 33.6% [4] - LUMAKRAS/LUMYKRAS sales were $90 million, in line with the estimate of $90.65 million, showing a year-over-year increase of 5.9% [4] Stock Performance - Amgen's shares returned +3.1% over the past month, outperforming the Zacks S&P 500 composite's +1% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - Revenues grew by 9% year over year, with volume increasing by 13% [4][10] - Non-GAAP operating expenses rose by 8%, with non-GAAP R&D growth of 18% year over year [33] - Free cash flow generated in the second quarter was $1.9 billion, reflecting operational momentum [33] Business Line Data and Key Metrics Changes - General Medicine sales increased, with Repatha delivering $696 million, up 31% year over year [10][11] - EVENITY sales increased by 32% year over year to $518 million, with significant growth in the U.S. and Japan [11][12] - Rare disease portfolio grew by 19% year over year, delivering nearly $1.4 billion in sales [14] - Oncology portfolio generated $2.2 billion in sales, growing 14% year over year [18] - Biosimilars portfolio sales grew by 40% year over year to $661 million [20] Market Data and Key Metrics Changes - The U.S. market saw continued demand growth across cardiology and primary care [11] - Inflammation treatments showed strong adoption, with TestBio sales up 46% year over year [17] - The biosimilars market is evolving, with Amgen's portfolio generating nearly $12 billion in sales since 2018 [20][86] Company Strategy and Development Direction - The company is focused on innovation and expanding its pipeline, particularly in obesity, rare diseases, and oncology [6][8] - AI is seen as a key driver for enhancing innovation across the company [7][34] - The company aims to improve patient access and affordability while maintaining a commitment to innovation [5][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver innovation and growth in the long term [9][36] - The company anticipates total revenues for 2025 to be in the range of $35 billion to $36 billion [35] - Management acknowledged the need for reform in the U.S. healthcare system to improve medicine affordability [45][46] Other Important Information - The company is investing heavily in its late-stage pipeline, with a focus on Meritide and other key programs [34][36] - Capital expenditures for 2025 are expected to be $2.3 billion to expand network capacity [34] Q&A Session Summary Question: Granularity on Meritide data in Q4 - Management indicated that more data will be shared in due course regarding the phase two type two diabetes study and chronic weight management studies [41][42] Question: Thoughts on drug pricing reforms - Management emphasized the need for reform in the U.S. healthcare system and expressed a willingness to work with the administration to achieve objectives [44][46] Question: Appetite for M&A in rare diseases - Management remains interested in growing the rare disease business both organically and through potential acquisitions [49][50] Question: Design considerations for Meritide CVOT study - Management acknowledged the interest in the recent data from competitors and indicated that they are closely monitoring the situation [65][66] Question: Timeline for filing approval for bimetuzumab - Management has not disclosed the regulatory strategy yet but is excited about the positive results and their implications for patient treatment [70][71] Question: Confidence in the TestBiR COPD program - Management expressed strong confidence in the mechanism and the responder population for the TestBiR program [106][107] Question: Future of obesity treatments - Management is exploring opportunities to augment their offerings in obesity, including the potential for oral small molecules [111]

Financial Data and Key Metrics Changes - In Q2 2025, revenues grew by 9% year over year, reaching $9.2 billion, with volume growth at an impressive 13% [4][10][31] - Non-GAAP operating expenses rose by 8%, with R&D expenses increasing by 18% year over year [32][33] - Free cash flow generated in the second quarter was $1.9 billion, reflecting operational momentum [32] Business Line Data and Key Metrics Changes - General Medicine saw Repatha sales increase by 31% year over year to $696 million, while EVENITY sales grew by 32% to $518 million [10][11][12] - Rare Disease portfolio sales grew by 19% year over year, totaling nearly $1.4 billion, with TEPEZZA growing by 5% [14][15] - Oncology portfolio sales increased by 14% year over year, generating $2.2 billion, driven by the BiTE platform [18][19] Market Data and Key Metrics Changes - The U.S. market showed continued demand growth across cardiology and primary care, with a significant increase in prescriber engagement [11][12] - Biosimilars portfolio sales grew by 40% year over year to $661 million, contributing significantly to top-line growth [20][21] Company Strategy and Development Direction - The company is focused on advancing a world-class pipeline, with significant investments in innovation and AI to enhance productivity [5][33] - There is a strong emphasis on expanding the rare disease portfolio and exploring M&A opportunities in this area [50] - The company aims to maintain rigorous financial discipline while driving innovation in high unmet medical needs [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential, highlighting the importance of innovation and patient access [5][36] - The company anticipates total revenues for 2025 to be in the range of $35 billion to $36 billion, with non-GAAP earnings per share between $20.2 and $21.3 [34] Other Important Information - The company is actively engaged in discussions with government officials regarding pricing and tariffs, emphasizing the need for more innovation [5][44] - The company plans to return capital to shareholders through competitive dividend payments, which increased by 6% compared to 2024 [33] Q&A Session Summary Question: Granularity of data on Meritide maintenance - Management indicated that more data will be shared in due course regarding the phase two type two diabetes study and chronic weight management studies [40][41] Question: Thoughts on drug pricing reforms - Management acknowledged the need for reform in the U.S. healthcare system and expressed a willingness to work with the administration to achieve objectives [43][45] Question: Appetite for M&A in rare diseases - Management reiterated interest in growing the rare disease business both organically and through potential licensing or acquisition opportunities [48][50] Question: Design considerations for Meritide CVOT study - Management noted that they are closely following the field and will share plans for pivotal studies in diabetes and cardiovascular outcomes in due course [65][66] Question: Confidence in Testspire COPD program - Management expressed strong confidence in the mechanism and profile of Testspire, emphasizing the distinct pathways involved [106][108]

Financial Performance - Amjen's adjusted EPS exceeded expectations at $62 per share, compared to the street's estimate of $529 [1] - Revenue surpassed estimates, reaching $918 billion, against an expected $894 billion [1] - The company is slightly increasing full-year revenue estimates to $35-36 billion, while the street expected $3537 billion [2] - Full-year adjusted EPS guidance is also increasing, but the midpoint is slightly lower than analysts' expectations [3] Product Performance & Market Dynamics - Osteoporosis drug Prolia's revenues met expectations, but it now faces biosimilar competition in the US [1] - Rare disease and cancer drugs showed some strength [2] - There was weakness in inflammation, excluding the drug Otesla [2] Future Outlook - The guidance includes the estimated impact of implemented tariffs but does not anticipate future pharma-specific tariffs or price adjustments [3] - Data from part two of the phase 2 obesity trial is expected in the fourth quarter [3][4]

Financial Performance - Revenues increased by 9% YoY in Q2 2025, reaching $9.179 billion, with product sales contributing $8.771 billion[9, 105] - Non-GAAP EPS grew by 21% YoY in Q2 2025, reaching $6.02[9, 105] - The company invested $1.7 billion in research and development in Q2 2025, an increase of 18% YoY[9] - Free cash flow was $1.9 billion in Q2 2025, compared to $2.2 billion in Q2 2024[107] Product Sales Highlights - Fifteen products achieved double-digit sales growth, including Repatha, EVENITY, IMDELLTRA, BLINCYTO, TEZSPIRE, UPLIZNA, and TAVNEOS[9, 17] - Repatha sales increased by 31% YoY to $696 million, driven by a 36% increase in volume[12, 23] - EVENITY sales increased by 32% YoY to $518 million, primarily driven by volume growth[12, 23] - UPLIZNA sales increased by 91% YoY to $176 million, driven by 79% volume growth[12, 27] - TEZSPIRE sales increased by 46% YoY to $342 million, driven by volume growth[12, 32] - IMDELLTRA generated $134 million in sales, with a 65% quarter-over-quarter increase[12, 37] Pipeline Development - MariTide: Phase 3 studies are enrolling for obesity and overweight, with or without Type 2 diabetes mellitus, and for adults living with heart failure with preserved or mildly reduced ejection fraction and obesity[42] - UPLIZNA: FDA review of Phase 3 data in generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025[46] - TEZSPIRE: FDA review of Phase 3 data in chronic rhinosinusitis with nasal polyps is ongoing, with a PDUFA date of October 19, 2025[59] - IMDELLTRA: Reduced the risk of death by 40% and significantly extended median OS by more than five months compared to SOC chemotherapy in patients with SCLC who progressed on or after one line of platinum-based chemotherapy[71]

Amgen boosted its 2025 guidance after quarterly results beat Wall Street’s estimates on the back of strong sales from older medicines https://t.co/ZKgYw1wi8R ...

Exhibit 99.1 News Release One Amgen Center Drive Thousand Oaks, CA 91320-1799 Telephone 805-447-1000 www.amgen.com AMGEN REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS THOUSAND OAKS, Calif. (Aug. 5, 2025) - Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2025. "We're delivering strong performance and reaching more patients with innovative medicines and biosimilars that address serious diseases. We continue to invest in science that enables longer, healthier lives and supports ...

Industry Overview - The second-quarter earnings season for the drug and biotech sector is in full swing, with major companies like Pfizer, Eli Lilly, Amgen, Gilead Sciences, and Novo Nordisk set to announce results [1] - The earnings season began mid-July with Johnson & Johnson reporting strong results, exceeding estimates for both earnings and sales [1] Company Performance Pfizer (PFE) - Pfizer has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 43.49% [6] - The Zacks Consensus Estimate for second-quarter sales and earnings is $13.78 billion and 58 cents per share, respectively [6] - Higher sales from products like Vyndaqel and Padcev are expected to offset weaker sales from Prevnar and Ibrance [8] Eli Lilly (LLY) - Eli Lilly's performance has been mixed, exceeding earnings expectations in two of the last four quarters, with an average earnings surprise of 6.69% [11] - The Zacks Consensus Estimate for second-quarter sales and earnings stands at $14.75 billion and $5.61 per share, respectively [11] - Strong demand for Mounjaro and Zepbound is anticipated to drive top-line growth [12] Amgen (AMGN) - Amgen has shown strong performance, beating earnings estimates in each of the last four quarters, with an average earnings surprise of 8.34% [14] - The Zacks Consensus Estimate for second-quarter sales and earnings is $8.86 billion and $5.26 per share, respectively [14] - Sales growth is expected to be driven by products like Evenity and Repatha, despite price declines due to higher rebates [15] Gilead Sciences (GILD) - Gilead's performance has been mixed, with earnings beating estimates in three of the last four quarters, averaging a surprise of 16.48% [17] - The Zacks Consensus Estimate for second-quarter sales and earnings is $6.95 billion and $1.95 per share, respectively [17] - Increased demand for HIV therapies like Biktarvy is expected to boost sales [18] Novo Nordisk (NVO) - Novo Nordisk's performance has been mixed, with earnings beating estimates in one of the last four quarters, delivering an average surprise of 0.02% [20] - The Zacks Consensus Estimate for second-quarter sales and earnings is $11.79 billion and 93 cents per share, respectively [20] - The company lowered its 2025 sales and operating profit growth outlook due to weaker momentum in key markets for its semaglutide-based drugs [21]

Core Insights - Amgen is scheduled to release its earnings on August 5, 2025, with historical trends indicating a tendency for negative one-day returns post-announcement [2][3] - Analysts project earnings of $5.28 per share and revenue of $8.91 billion, compared to $4.97 per share and $8.39 billion in the same quarter last year [3] - The company has a market capitalization of $160 billion and reported $34 billion in revenue over the past twelve months, resulting in $7.4 billion in operating profits and a net income of $5.9 billion [4] Historical Performance - Over the past five years, Amgen's stock has declined 58% of the time following earnings announcements, with a median drop of -2.8% and a maximum one-day negative return of -7.2% [2][7] - Positive one-day returns occurred approximately 42% of the time, with the percentage increasing to 45% when considering the last three years [7] - The median of the eight positive returns was 3.6%, while the median of the eleven negative returns was -2.8% [7] Trading Strategies - Event-driven traders can utilize historical trends to inform their positioning ahead of earnings releases [6] - A strategy involves assessing the correlation between immediate and medium-term returns post-earnings to guide trading decisions [6][8] - The correlation between one-day and five-day returns can indicate potential trading positions, particularly if the one-day return is positive [8]