Key Takeaways Amgen shares have climbed 13.5% YTD, outperforming the industry, sector and S&P 500.Strong sales from Repatha, Evenity, Blincyto and new biosimilars offset legacy product declines.Pipeline focus on MariTide and new biosimilars aims to counter Prolia and Xgeva's patent expiries.Amgen’s (AMGN) stock has risen 13.5% so far this year compared with an increase of 1.6% for the industry. The stock has also outperformed the sector and S&P 500 Index, as seen in the chart below.AMGN Stock Outperforms In ...

Core Insights - Royalty Pharma has acquired a royalty interest in Amgen's Imdelltra for $885 million upfront, with an option for BeOne Medicines to sell additional royalties for up to $65 million within the next 12 months [1][2][3] - Imdelltra is a first-in-class bispecific T-cell engager targeting DLL3, aimed at treating extensive-stage small cell lung cancer (ES-SCLC), a disease with limited treatment options [2][6] - The transaction aligns with Royalty Pharma's strategy of acquiring royalties on transformative life sciences products, enhancing its long-term growth and portfolio diversification [2][3] Financial Details - Royalty Pharma will pay $885 million upfront for approximately 7% royalty on worldwide net sales of Imdelltra, with potential total payments up to $950 million [3] - BeOne retains the option to sell an additional portion of its royalty for up to $65 million within the next year [3] - Imdelltra sales reached $215 million in the first half of 2025, with projections to exceed $2.8 billion by 2035 based on analyst consensus [2] Market Context - Small cell lung cancer affects approximately 360,000 patients globally each year, with a poor prognosis and a five-year survival rate of only 7% for invasive disease [2] - Imdelltra received accelerated approval from the U.S. FDA in May 2024 for patients who have progressed after platinum-based chemotherapy [2]

整理 | GLP1减重宝典内容团队 Viking Therapeutics 股价周二暴跌，此前公司公布的肥胖症口服药 中国国家药监局药品审评中心（CDE）官网近日公示，安进申报的1类新药AMG获得临床试验默示许可，拟用于 射血分数保留的或轻度降低 的心力衰竭合并肥胖。 | 44 | JXSL2500096 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 | 1 | | --- | --- | --- | --- | --- | --- | | | | | | 胖 | | | 45 | JXSL2500095 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 | 1 | | | | | | 胖 | | | 46 | JXSL2500094 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 胖 | 1 | | 47 | JXSL2500093 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 胖 | 1 | | 48 | JXSL2500 ...

Group 1 - The core viewpoint is that U.S. President Trump's pharmaceutical tariffs may be implemented based on Section 232, as stated by White House advisor Navarro [1] - Following this announcement, Pfizer's stock dropped over 0.7%, while UnitedHealth fell more than 0.4%. Conversely, Amgen's stock increased by 0.6%, Johnson & Johnson rose by 0.1%, and AstraZeneca's ADR gained 0.4% [1]

Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending August 1, 2025, was reported at **+2.8%**, an increase from **+1.7%** the previous week and **+2.6%** over the past 12 weeks [1][6]. - For the week ended August 1, the **US total market weekly TRx YoY change** was **+2.8%**, compared to **+0.9%** a year ago. The **rolling 4-week TRx YoY** was **+2.9%** and the **rolling 12-week TRx YoY** was **+2.6%** [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: - The drug **Cobenfy** was approved for schizophrenia on September 26, 2024. The current scripts are approximately **2,010** for the week, up from **1,950** the previous week. To meet 2025 consensus expectations, Cobenfy's TRx needs to track at **~2-3x** the volumes from recent schizophrenia launches [3]. - The consensus estimate for Cobenfy has decreased from **$196 million** to **$171 million**, implying that approximately **129K TRx** are required to meet these estimates [3]. - **Vertex Pharmaceuticals (VRTX)**: - The drug **Journavx** was approved for acute pain on January 30, 2025, with current scripts at approximately **6,800**, up from **6,430** the previous week. It is noted that hospital scripts, which account for about **35%** of total scripts, are not captured by IQVIA [4]. - To achieve a sales target of **$78 million**, approximately **345K total scripts** are needed, assuming a **$225 net price per script** [4]. - **Gilead Sciences (GILD)**: - The launch comparison for **Yeztugo** (lenacapavir) shows current TRx at approximately **210**, down from **300** the previous week. The injectable formulation accounts for **50%** of total TRx [5]. Additional Insights - The **extended unit (EUTRx)** weekly YoY growth was reported at **+1.9%**, which is below the TRx YoY growth [2]. - The **sequential weekly TRx growth** was **-0.1%**, an improvement from **-1.2%** the week before [2]. - The **biopharma industry view** is categorized as **attractive**, while the major pharmaceuticals industry view is **in-line** [7]. Notable Trends - The **momentum of top outpatient drugs** indicates varying performance across different companies, with notable declines in some established drugs like **Humira** (AbbVie) showing a **-40%** YoY change, while newer drugs like **Mounjaro** (Eli Lilly) and **Zepbound** (Eli Lilly) show significant growth rates of **69%** and **257%** respectively [24]. Conclusion - The conference call highlights a positive trend in the US drug market with specific growth in total prescriptions. However, individual company performance varies significantly, with newer drugs showing strong growth potential while established drugs face declines. The insights provided can guide investment decisions in the biopharma sector.

Core Insights - Amgen (AMGN) reported strong quarterly performance with second-quarter 2025 earnings and sales exceeding estimates, showcasing consistent top-line growth [1][3] - Total revenues increased by 9% year over year to $9.2 billion, with product revenues also rising by 9% to $8.77 billion, driven primarily by volume growth despite declining drug prices [1][6] Revenue Performance - Amgen's total revenues rose 9% year over year to $9.2 billion, with product revenues increasing to $8.77 billion [1][6] - Fifteen of Amgen's products, including Repatha, Blincyto, Tezspire, Uplizna, Tavneos, and Evenity, achieved double-digit volume growth [2] - Rare disease drugs contributed significantly, with sales rising 19% year over year to nearly $1.4 billion, now annualizing at over $5 billion [8] Key Drug Performance - Repatha generated revenues of $696 million, up 31% year over year, driven by a 36% increase in volume [5] - Evenity recorded sales of $518 million, up 32% year over year, benefiting from solid volume growth [6] - Prolia revenues decreased by 4% year over year to $1.12 billion due to lower pricing [7] - Blincyto sales rose 45% year over year to $384 million, driven by broad prescribing [12] Oncology and Biosimilars - Amgen's oncology portfolio grew 14% year over year, generating over $2.2 billion in sales [12] - Biosimilar sales surged 40% year over year to $661 million, with new launches contributing to growth [15][16] Established Products and Inflammation Drugs - Sales of established products decreased by 5% year over year to $533 million [22] - Otezla sales increased by 14% to $618 million, driven by volume growth [19] Future Outlook - Amgen raised its revenue and earnings outlook for 2025, expecting total revenues in the range of $35 billion to $36 billion [23] - Key drugs like Repatha, Evenity, Tezspire, and oncology drugs are expected to drive growth, although pricing pressures may offset some gains [24][25]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: Biopharma in North America - **Market Analysis**: The latest weekly Total Prescription (TRx) year-over-year (YoY) growth for the week ending July 25, 2025, was +1.7%, a decrease from +3.0% the previous week and +2.6% over the past 12 weeks [1][2][6] Core Company Insights Bristol Myers Squibb (BMY) - **Cobenfy Launch**: Approved for schizophrenia on September 26, 2024. Weekly scripts were approximately 1,950, down from 2,060 the previous week. To meet 2025 consensus expectations, Cobenfy TRx needs to track at 2-3 times the volumes of recent schizophrenia launches, requiring about 129K TRx at an estimated net price of $1,200 [3][14][16] Vertex Pharmaceuticals (VRTX) - **Journavx Launch**: Approved for acute pain on January 30, 2025. Weekly scripts were around 6,430, up from 6,240 the previous week. Hospital scripts, which are not captured by IQVIA, account for approximately 28% of total scripts. To achieve estimated sales of $65 million, about 289K total scripts are needed [4][19] Gilead Sciences (GILD) - **Yeztugo Launch**: Approved on June 18, 2025, with weekly TRx of approximately 300, an increase from 240 the previous week. The injectable formulation accounted for 45% of total TRx, while the oral formulation made up 55% [5][22] Eli Lilly (LLY) - **Mounjaro and Zepbound**: The launch of Mounjaro is showing strong growth, with a 69% increase in TRx YoY. Zepbound has seen a remarkable 268% increase in TRx YoY [9][26] Additional Insights - **Market Trends**: The extended unit (EUTRx) weekly YoY growth was +0.9%, indicating a more positive trend compared to TRx YoY growth. This suggests that physicians are increasingly writing longer-duration prescriptions [2][35] - **Key Product Performance**: The performance of major pharmaceutical products shows significant variations, with some experiencing substantial declines (e.g., Humira -41% YoY) while others like Sotyktu and Mounjaro are seeing strong growth [26][48] Important Metrics - **TRx Growth**: The overall TRx growth for the biopharma sector is showing signs of slowing down, with the latest figures indicating a need for companies to adapt their strategies to maintain growth [1][31] - **Sales Estimates**: Consensus estimates for various drugs have been adjusted, reflecting the dynamic nature of the market and the competitive landscape [3][4][5] Conclusion The biopharma industry in North America is currently experiencing mixed performance across different companies and products. While some new launches are showing promising growth, overall market trends indicate a slowdown in prescription growth, necessitating strategic adjustments by companies to meet evolving market demands.

Company Mission & Core Values - Amgen's mission is to fight the world's toughest diseases by integrating biology and technology [2] - Amgen maintains the highest standards for reliability, scientific accuracy, and decision quality [2] GPT-5 Impact & Assessment - GPT-5 excels in ambiguous situations where context is crucial [3] - GPT-5 demonstrates superior performance on objective quality measures [3] - GPT-5 represents a potential breakthrough moment for Amgen [3] AI & Biotechnology - Advancements in AI, such as GPT-5, have the potential to fundamentally transform biotechnology [4] - GPT-5 helps accelerate Amgen's mission of serving patients [4]

Core Insights - Amgen reported Q2 earnings with a revenue increase of 9% year-over-year to $9.179 billion, exceeding market expectations of $8.94 billion [1] - Net profit surged 92% year-over-year to $1.432 billion, translating to earnings per share (EPS) of $2.65; adjusted EPS was $6.02, surpassing the market forecast of $5.29 [1] - Product sales rose by 9%, driven primarily by volume growth, although partially offset by a 3% decrease in net selling prices [1] Financial Performance - Revenue for the quarter was $9.179 billion, higher than the anticipated $8.94 billion [1] - Net profit reached $1.432 billion, a significant increase from the previous year [1] - Adjusted EPS was reported at $6.02, exceeding market expectations [1] Product Sales - Sales growth was primarily driven by volume increases, with 15 products achieving at least double-digit sales growth, including Repatha, Evenity, and Imdeltra [1] - The overall product sales increase was partially mitigated by a 3% decline in net selling prices [1] Outlook - Amgen raised its full-year revenue guidance to a range of $35 billion to $36 billion, up from the previous estimate of $34.3 billion to $35.7 billion, with market expectations at $35.4 billion [1] - Adjusted EPS guidance was also increased to a range of $20.2 to $21.3, compared to the prior forecast of $20 to $21.2, with market expectations at $20.91 [1]

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)