| GILD 吉利德科学 | | | | --- | --- | --- | | 110 280 0.000 +0.00% | | 收盘价 08/07 16:00 美东 | | 113.480 + 3.200 +2.90% | | 盘前价 08/08 04:35 美东 | | 三五四号 2 8 8 | | ● 快捷交易 | | 最高价 110.670 | 开盘价 110.580 | 成交量 919.03万 | | 最低价 108.535 | 昨收价 110.280 | 成交额 10.1亿 | | 平均价 109.859 | 市空室 M 23.17 | 总市值 1371.81亿(m) | | 振 幅 1.94% | 市盈率(静) 290.21 | 总股本 12.44亿 | | 换手率 0.74% | 市净率 7.159 | 流通值 1368.97亿 | | 52周最高 118.284 委 比 -- | | 流通股 12.41亿 | | 52周最低 70.167 | 量 比 1.36 | 每 手 1股 | | 历史最高 118.284 | 股息TIM 3.100 | | | 历史最低 0.396 | 股息率ITM ...

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.

Analyst's Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in GILD over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Hi there ...

Core Insights - Gilead Sciences reported quarterly earnings of $2.01 per share, exceeding the Zacks Consensus Estimate of $1.95 per share, with an earnings surprise of +3.08% [1] - The company generated revenues of $7.08 billion for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 1.95% and showing a year-over-year increase from $6.95 billion [2] - Gilead's stock has increased by approximately 19.4% year-to-date, outperforming the S&P 500's gain of 7.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $2.16, with expected revenues of $7.45 billion, and for the current fiscal year, the EPS estimate is $8.02 on revenues of $28.68 billion [7] - The estimate revisions trend for Gilead was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Gilead belongs, is currently ranked in the top 41% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - The company reported base business sales of $6.9 billion, growing 4% year over year, driven by strong performance in HIV products [6][41] - Total product sales reached $7.1 billion, reflecting a 2% year-over-year increase, partially offset by a 44% decline in Vecluri sales due to fewer COVID-19 related hospitalizations [6][41] - Non-GAAP diluted EPS for the quarter was $2.01, with a product gross margin of 87% [42][41] Business Line Data and Key Metrics Changes - HIV sales amounted to $5.1 billion, representing a 7% year-over-year growth, with Biktarvy and Descovy contributing significantly [14][41] - Biktarvy sales grew 9% year over year to $3.5 billion, while Descovy saw a remarkable 35% increase to $653 million [14][16] - Trodelvy sales reached $364 million, up 14% year over year, reflecting strong demand in metastatic breast cancer [24][41] Market Data and Key Metrics Changes - The U.S. PrEP market has expanded to over 5 million active users, growing in the mid-teens year over year [17][20] - Descovy's market share for PrEP grew to over 40% in the U.S., with unrestricted access covering 88% of total lives [17][66] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue [20][21] Company Strategy and Development Direction - The company is focused on expanding its HIV product portfolio, with plans for up to eight additional product launches by 2033 [32] - The recent FDA approval of lenacapavir (YES2Go) is seen as a transformative step in HIV prevention, with a strong commercial launch strategy in place [5][18] - The company aims to enhance its oncology pipeline, particularly with Trodelvy, which is expected to advance into first-line treatment settings [10][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the HIV portfolio and the potential of lenacapavir to significantly impact the HIV epidemic [8][20] - The company is closely monitoring the macroeconomic landscape and is prepared to adapt its strategies as needed [47] - Management highlighted the importance of maintaining operational discipline while pursuing growth opportunities [48] Other Important Information - The company returned $1.5 billion to shareholders in the second quarter, including $527 million in share repurchases [48] - A new $6 billion share repurchase program has been approved to support continued buybacks [48] Q&A Session Summary Question: Can you elaborate on the early uptake with YES2Go? - Management reported strong early uptake with over 25,000 customer calls executed, indicating high awareness and readiness for the launch [51][56] Question: How durable is the growth rate for Descovy? - Management noted that the PrEP market is growing at about 15% year over year, with Descovy's performance driven by favorable access and reduced co-pays [63][66] Question: What is the potential impact of the MFN proposal on Gilead's business? - Management acknowledged ongoing discussions regarding the MFN proposal and emphasized the importance of maintaining patient access to medications [71][72] Question: How would changes in the USPSTF guidelines affect commercialization? - Management expressed confidence that even if guidelines change, the company could still ensure access to HIV prevention through strong payer relationships [80][82] Question: What updates should be expected regarding the WONDERS program? - Management indicated that updates on the WONDERS program would be forthcoming, particularly following the resolution of the clinical hold [85]

Financial Data and Key Metrics Changes - The company reported base business sales of $6.9 billion, a 4% year-over-year increase, driven by growth in Biktarvy, Descovy, Libdelzi, and Trodelvy [6][42] - Total product sales reached $7.1 billion, reflecting a 2% year-over-year growth, with a notable decline in Vecluri sales by 44% due to fewer COVID-19 related hospitalizations [6][42] - Non-GAAP diluted EPS for the quarter was $2.01, with an operating margin of 46% [42][44] Business Line Data and Key Metrics Changes - HIV sales amounted to $5.1 billion, showing a strong 7% year-over-year growth, primarily driven by increased demand and higher average realized prices [14][42] - Biktarvy sales grew 9% year-over-year to $3.5 billion, while Descovy saw a remarkable 35% increase to $653 million, marking its strongest quarter ever [7][16] - Trodelvy sales increased by 14% year-over-year to $364 million, reflecting continued strength in metastatic breast cancer [24][42] Market Data and Key Metrics Changes - The U.S. PrEP market has expanded to over 5 million active users, growing in the mid-teens year-over-year, with Descovy capturing over 40% market share [17][21] - The company anticipates HIV sales to grow approximately 3% in 2025, up from a previous assumption of flat revenue year-over-year [21][44] - The company is experiencing strong demand for Libdelzi, with revenue almost doubling from $40 million in Q1 to $78 million in Q2 [22][42] Company Strategy and Development Direction - The company is focused on expanding its HIV product portfolio, targeting up to eight additional product launches by 2033, including five by 2030 [32] - The recent FDA approval of lenacapavir (YES2Go) for HIV prevention is seen as a transformative opportunity to address the epidemic [5][32] - The company is committed to facilitating access to lenacapavir globally, partnering with the Global Fund to reach approximately 2 million people in low-income countries over three years [20][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance in both HIV treatment and prevention, leading to an increase in full-year sales guidance [21][44] - The company remains cautious about potential impacts from the Medicare Part D redesign, which is expected to affect the HIV business by approximately $900 million in 2025 [21][44] - Management emphasized the importance of maintaining operational discipline and adapting to macroeconomic changes while driving forward with new product launches [44][49] Other Important Information - The company returned $1.5 billion to shareholders in Q2, including $527 million in share repurchases, and announced a new $6 billion repurchase program [48] - R&D expenses were up 9% year-over-year, reflecting investments in clinical manufacturing and study activities, with expectations for flat expenses for the full year [42][44] Q&A Session Summary Question: Early uptake of YES2Go and expected trends - Management reported over 25,000 customer calls executed in the field, with a target base of about 15,000, indicating strong early engagement [51][56] - The company anticipates achieving 75% access for YES2Go within six months of launch and 90% within twelve months [58][60] Question: Durability of Descovy's growth rate - Management noted that the PrEP market is growing at about 15% year-over-year, with Descovy's performance driven by favorable access and reduced co-pays [66][69] - There may be a slight decline in Descovy's growth as YES2Go gains traction, but overall market growth is expected to continue [66][70] Question: Impact of MFN proposal on Medicaid - Management acknowledged ongoing discussions regarding the MFN proposal and emphasized the importance of maintaining patient access to medications [74][76] - The company highlighted that HIV treatment has a strong safety net, ensuring coverage for patients even in changing legislative environments [78][79] Question: Changes in commercialization approach if PrEP is removed as a preventative medicine - Management expressed confidence in the current guidelines supporting prevention services and noted that the market has been growing robustly even before recent guidelines [82][84] Question: Confidence in the WONDERS program following clinical hold - Management expressed high confidence in the treatment pipeline, emphasizing a variety of approaches being explored [87]

PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Presents Gilead Sciences, Inc.'s unaudited interim financial statements as of June 30, 2025, detailing financial position, operations, and cash flows [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$55.7 billion** by June 30, 2025, driven by reduced cash, while liabilities and debt also declined Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,144 | $9,991 | | Total current assets | $14,718 | $19,173 | | Intangible assets, net | $18,566 | $19,948 | | Goodwill | $8,314 | $8,314 | | **Total assets** | **$55,721** | **$58,995** | | **Liabilities & Equity** | | | | Total current liabilities | $11,189 | $12,004 | | Long-term debt, net | $22,140 | $24,896 | | **Total liabilities** | **$36,131** | **$39,749** | | **Total stockholders' equity** | **$19,590** | **$19,246** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Gilead reported **$7.08 billion** in Q2 2025 revenues and a significant turnaround to **$3.28 billion** net income for the first six months of 2025 Q2 2025 vs Q2 2024 Statement of Operations (in millions, except EPS) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total revenues | $7,082 | $6,954 | | Operating income | $2,474 | $2,644 | | Net income attributable to Gilead | $1,960 | $1,614 | | Diluted EPS | $1.56 | $1.29 | Six Months 2025 vs 2024 Statement of Operations (in millions, except EPS) | Metric | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | | Total revenues | $13,749 | $13,640 | | Operating income (loss) | $4,711 | $(1,678) | | Net income (loss) attributable to Gilead | $3,275 | $(2,556) | | Diluted EPS (loss) | $2.61 | $(2.05) | - A significant driver of the improved six-month performance was the reduction in Acquired IPR&D expenses to **$315 million** in 2025 from **$4.17 billion** in 2024, and lower IPR&D impairments of **$190 million** compared to **$2.43 billion** in the prior year[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities decreased to **$2.6 billion** for the first six months of 2025, with significant cash used in financing activities Six Months Ended June 30 Cash Flow Summary (in millions) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $2,584 | $3,544 | | Net cash used in investing activities | $(2,531) | $(2,514) | | Net cash used in financing activities | $(4,993) | $(4,314) | | **Net change in cash and cash equivalents** | **$(4,848)** | **$(3,313)** | - Significant financing activities in the first six months of 2025 included **$1.3 billion** in stock repurchases, **$1.8 billion** in debt repayments, and **$2.0 billion** in dividend payments[26](index=26&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed disclosures on accounting policies, revenue breakdown, acquisitions, impairment charges, legal proceedings, and tax rates [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 and first-half 2025 financial results, highlighting revenue drivers, expense changes, and capital allocation priorities - Total revenues increased **2%** to **$7.1 billion** in Q2 2025, driven by higher HIV, Livdelzi, and Trodelvy sales, partially offset by lower HCV and Veklury sales[108](index=108&type=chunk) - Net income for the first six months of 2025 was **$3.3 billion**, a significant improvement from a **$2.6 billion** net loss in the same period of 2024, primarily due to the absence of large IPR&D expenses and impairment charges from 2024[109](index=109&type=chunk)[110](index=110&type=chunk) - Key business updates include FDA approval for Yeztugo (lenacapavir) for HIV PrEP, conditional EU marketing authorization for seladelpar for PBC, and positive topline results from the Phase 3 ASCENT-03 trial for Trodelvy[105](index=105&type=chunk)[106](index=106&type=chunk) [Results of Operations - Revenues](index=33&type=section&id=Results%20of%20Operations%20-%20Revenues) Total product sales for Q2 2025 were **$7.05 billion**, up **2%** year-over-year, driven by strong HIV franchise growth, offsetting declines in Veklury and Liver Disease sales Product Sales by Therapeutic Area (Q2 2025 vs Q2 2024, in millions) | Therapeutic Area | Q2 2025 Sales | Q2 2024 Sales | YoY Change | | :--- | :--- | :--- | :--- | | **Total HIV** | **$5,088** | **$4,745** | **+7%** | | Biktarvy | $3,530 | $3,232 | +9% | | Descovy | $653 | $485 | +35% | | **Total Liver Disease** | **$795** | **$832** | **-4%** | | **Veklury** | **$121** | **$214** | **-44%** | | **Total Oncology** | **$849** | **$841** | **+1%** | | Cell Therapy | $485 | $521 | -7% | | Trodelvy | $364 | $320 | +14% | - HIV product sales growth was driven by higher demand and higher average realized price, which includes the impact of the U.S. Medicare Part D program redesign[113](index=113&type=chunk) - Veklury sales continued to decline significantly, down **44%** in Q2 and **45%** in the first half of 2025, due to lower rates of COVID-19-related hospitalizations[117](index=117&type=chunk) [Results of Operations - Costs and Expenses](index=36&type=section&id=Results%20of%20Operations%20-%20Costs%20and%20Expenses) R&D expenses increased **10%** in Q2 2025, with a **$190 million** IPR&D impairment for bulevirtide, while Acquired IPR&D and impairments significantly decreased year-over-year for the first six months Costs and Expenses (Q2 2025 vs Q2 2024, in millions) | Expense Category | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Cost of goods sold | $1,501 | $1,544 | -3% | | Research and development (R&D) | $1,491 | $1,351 | +10% | | Acquired IPR&D | $61 | $38 | +61% | | IPR&D impairments | $190 | $0 | NM | | Selling, general & administrative (SG&A) | $1,365 | $1,377 | -1% | - A partial impairment charge of **$190 million** was recorded in Q2 2025 for the bulevirtide IPR&D asset, reflecting a more competitive market outlook[136](index=136&type=chunk) - For the first six months of 2024, the company recorded a **$2.4 billion** partial impairment charge for the Trodelvy NSCLC IPR&D asset after the Phase 3 EVOKE-01 study did not meet its primary endpoint[138](index=138&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) Gilead held **$5.1 billion** in cash as of June 30, 2025, with **$2.6 billion** in operating cash flow and **$5.0 billion** used in financing activities for dividends, debt, and repurchases Cash Flow Summary (Six Months Ended June 30, in millions) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $2,584 | $3,544 | | Net cash used in investing activities | $(2,531) | $(2,514) | | Net cash used in financing activities | $(4,993) | $(4,314) | - The company's capital priorities are: (i) investing in the business and R&D, (ii) partnerships and business development, (iii) growing the dividend, and (iv) repurchasing shares[152](index=152&type=chunk) - In August 2025, the Board of Directors declared a quarterly dividend of **$0.79 per share**[158](index=158&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk disclosures were reported since the 2024 Annual Report, except for updates in specific financial notes - There were no material changes to the company's market risk disclosures from the 2024 Annual Report, except for updates provided in Notes 3, 4, 5, and 9 of this 10-Q[163](index=163&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were effective as of June 30, 2025, while noting ongoing changes due to a new ERP system implementation - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[164](index=164&type=chunk) - The company is implementing a new enterprise resource planning (ERP) system in phases, which has required changes to its internal control over financial reporting[165](index=165&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 10 for detailed descriptions of significant pending legal proceedings, including generic challenges, antitrust lawsuits, and government investigations - For a detailed description of significant legal proceedings, the report refers to Note 10 in Part I, Item 1[167](index=167&type=chunk) - As of December 31, 2024, the company had accrued approximately **$242 million** for legal matters, including **$200 million** for a settlement with the U.S. Attorney's Office that was paid in Q2 2025[79](index=79&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section details material risks that could adversely affect Gilead's business, including product, development, regulatory, operational, and financial risks [Product and Commercialization Risks](index=43&type=section&id=Product%20and%20Commercialization%20Risks) Gilead faces risks from heavy reliance on HIV product revenues, complexities of cell therapy commercialization, intense competition, and significant pricing pressures - A substantial portion of revenue comes from HIV products, and the inability to sustain sales or introduce new competitive products could force a scale-back of operations[169](index=169&type=chunk) - The Inflation Reduction Act (IRA) is anticipated to increase payment obligations, limit prices, and increase rebates, thereby reducing profitability[184](index=184&type=chunk)[185](index=185&type=chunk) - The company faces significant competition, and successful commercialization depends on reimbursement from third-party payers who are increasingly attempting to limit or regulate drug prices[181](index=181&type=chunk)[182](index=182&type=chunk) - The company has identified and seized counterfeit versions of its medicines sold by unauthorized distributors, posing a risk to patient health and the company's reputation[196](index=196&type=chunk)[197](index=197&type=chunk) [Product Development and Supply Chain Risks](index=47&type=section&id=Product%20Development%20and%20Supply%20Chain%20Risks) The company faces significant risks in clinical trials, including unfavorable results and delays, and relies heavily on third-party CROs and limited suppliers for manufacturing - There are numerous risks in clinical trials, including unfavorable results; in June 2025, the FDA placed a clinical hold on HIV treatment trials of GS-1720 and GS-4182[200](index=200&type=chunk) - Gilead depends on third-party contract manufacturing organizations (CMOs) for the majority of its active pharmaceutical ingredients and drug products, and some materials are sourced from a single supplier[204](index=204&type=chunk) [Regulatory and Other Legal Risks](index=49&type=section&id=Regulatory%20and%20Other%20Legal%20Risks) Gilead's operations are subject to complex and evolving regulations, with risks from non-compliance, healthcare laws, intellectual property challenges, and ongoing litigation - The company is subject to complex FDA and international regulations, and failure to comply can result in significant penalties, product recalls, or suspension of approvals[207](index=207&type=chunk)[211](index=211&type=chunk) - Generic manufacturers are actively seeking to market generic versions of Gilead's products, leading to patent litigation that could result in an earlier-than-expected loss of exclusivity[220](index=220&type=chunk) - The company is involved in numerous litigation and government investigation matters, which require substantial resources and could result in significant monetary damages or penalties[223](index=223&type=chunk)[225](index=225&type=chunk) [Operational Risks](index=52&type=section&id=Operational%20Risks) Gilead's global operations are exposed to risks from public health emergencies, foreign currency fluctuations, climate change, ERP system implementation, and cybersecurity threats - Global operations are subject to risks including foreign currency exchange fluctuations, political instability, and changes in trade policies[227](index=227&type=chunk) - Climate change poses physical risks to facilities located in vulnerable regions (e.g., California) and transition risks from evolving environmental regulations[228](index=228&type=chunk)[229](index=229&type=chunk) - The company is currently implementing a new ERP system, which entails risks of business disruption, cost overruns, and potential negative impacts on internal controls[241](index=241&type=chunk) - Cybersecurity attacks are increasing in frequency and sophistication, posing a threat to sensitive data, intellectual property, and business operations[242](index=242&type=chunk)[243](index=243&type=chunk) [Strategic and Financial Risks](index=56&type=section&id=Strategic%20and%20Financial%20Risks) Gilead faces risks from unsuccessful acquisitions and collaborations, potential impairment charges, increased debt from financing transactions, and changes in effective tax rates - Acquisitions and collaborations may not be successful and can lead to significant impairment charges, such as those recorded for IPR&D assets in Q2 2025 and Q1 2024[246](index=246&type=chunk) - The company has incurred additional debt to finance strategic transactions, which could result in credit rating downgrades and reduced financial flexibility[247](index=247&type=chunk) - The company's effective tax rate is subject to change based on the mix of earnings across jurisdictions and evolving tax laws, which could adversely affect earnings[248](index=248&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2025, Gilead repurchased approximately **5.0 million** shares for **$528 million**, and a new **$6.0 billion** stock repurchase program was authorized in July 2025 Stock Repurchase Activity (Q2 2025) | Period | Total Shares Purchased (thousands) | Average Price Paid per Share | Shares Purchased as Part of Program (thousands) | | :--- | :--- | :--- | :--- | | April 2025 | 1,711 | $105.88 | 1,662 | | May 2025 | 1,936 | $103.00 | 1,888 | | June 2025 | 1,887 | $109.49 | 1,425 | | **Total** | **5,534** | **$106.10** | **4,975** | - In July 2025, the Board authorized a new **$6.0 billion** stock repurchase program with no fixed expiration, to begin after the current **$5.0 billion** program is completed[250](index=250&type=chunk) [Item 5. Other Information](index=57&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[253](index=253&type=chunk) [Item 6. Exhibits](index=57&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Form 10-Q, including various agreements, indentures, compensatory plans, and certifications - The Exhibit Index lists all documents filed with the report, such as merger agreements, indentures for senior notes, equity incentive plans, and officer certifications[256](index=256&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk)

Financial Performance - Gilead lifted its full-year outlook after strong HIV drug sales in the second quarter [1] - Revenue and earnings modestly beat analyst expectations [1]

Financial Performance - Total product sales excluding Veklury increased by 4% year-over-year (YoY) to $6.9 billion, driven by HIV, Livdelzi, and Trodelvy[8] - Total HIV product sales increased by 7% YoY to $5.1 billion[12] - Oncology product sales increased by 1% YoY to $849 million[12] - Veklury sales decreased by 44% YoY to $121 million[12] - Liver disease product sales decreased by 4% YoY to $795 million[12] - Cell Therapy product sales decreased by 7% YoY to $485 million[12] HIV Business - Biktarvy sales increased by 9% YoY[8] - Descovy sales increased by 35% YoY[8] - FY25 HIV revenue guidance updated to reflect year-to-date (YTD) strength, expecting >7% YoY growth[22] Oncology - Trodelvy sales increased by 14% YoY[8] - Cell Therapy saw a 7% YoY decrease due to evolving competitive landscape[8] Pipeline and Regulatory Updates - FDA approved Yeztugo (lenacapavir) as a twice-yearly injection for HIV prevention[8] - Phase 3 ASCENT-03 & -04 data for Trodelvy in 1L mTNBC showed clinically meaningful results, with FDA filings expected in ~2H 2025[8]

[Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Overall Performance](index=1&type=section&id=Overall%20Performance) Gilead's Q2 2025 total revenue increased 2% to $7.1 billion, with GAAP EPS rising to $1.56 and non-GAAP EPS flat at $2.01 Q2 2025 Key Financial Metrics | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenue | $7.1 billion | $7.0 billion | +2% | | Product Sales | $7.1 billion | $6.9 billion | +2% | | Product Sales (ex-Veklury) | $6.9 billion | $6.7 billion | +4% | | GAAP Diluted EPS | $1.56 | $1.29 | +21% | | Non-GAAP Diluted EPS | $2.01 | $2.01 | 0% | | Operating Cash Flow | $827 million | $1,325 million | -38% | - The increase in GAAP EPS was primarily driven by net unrealized gains on securities in Q2 2025 compared to net unrealized losses in Q2 2024, partially offset by a **$190 million** IPR&D impairment charge related to the MYR acquisition[6](index=6&type=chunk) - During the quarter, Gilead paid **$994 million** in dividends and repurchased **$527 million** of common stock[6](index=6&type=chunk) [Product Sales Performance](index=1&type=section&id=Product%20Sales%20Performance) Total product sales increased 2% to $7.1 billion, driven by HIV and Trodelvy, offset by declines in Veklury and Cell Therapy [HIV Franchise](index=1&type=section&id=HIV%20Franchise) HIV franchise sales grew **7%** to **$5.1 billion**, led by **Biktarvy** and **Descovy** Q2 2025 HIV Product Sales (YoY) | Product | Q2 2025 Sales | Change (YoY) | | :--- | :--- | :--- | | **Total HIV** | **$5.1 billion** | **+7%** | | Biktarvy | $3.5 billion | +9% | | Descovy | $653 million | +35% | [Liver Disease Franchise](index=2&type=section&id=Liver%20Disease%20Franchise) Liver Disease sales decreased **4%** to **$795 million** due to lower HCV sales, partially offset by other products - Liver Disease sales decreased **4%** to **$795 million**, mainly driven by lower HCV sales[8](index=8&type=chunk) - The decline in HCV was partly offset by sales growth from Livdelzi, Hepcludex, and HBV products[8](index=8&type=chunk) [Oncology Franchise](index=2&type=section&id=Oncology%20Franchise) Oncology sales showed mixed results, with **Trodelvy** up **14%** but Cell Therapy down **7%** due to competition Q2 2025 Oncology Product Sales (YoY) | Product/Category | Q2 2025 Sales | Change (YoY) | | :--- | :--- | :--- | | **Trodelvy** | **$364 million** | **+14%** | | **Cell Therapy** | **$485 million** | **-7%** | | Yescarta | $393 million | -5% | | Tecartus | $92 million | -14% | [Veklury (COVID-19)](index=2&type=section&id=Veklury%20(COVID-19)) Veklury sales significantly declined **44%** to **$121 million** due to lower COVID-19 hospitalization rates - Veklury sales decreased **44%** to **$121 million**, driven by lower COVID-19 hospitalization rates[8](index=8&type=chunk) [Operating Expenses and Profitability](index=2&type=section&id=Operating%20Expenses%20and%20Profitability) Gross margins improved, R&D expenses increased due to clinical activity, while SG&A remained flat, impacting profitability Q2 2025 Operating Metrics | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Product Gross Margin (GAAP) | 78.7% | 77.7% | | Product Gross Margin (Non-GAAP) | 86.9% | 86.0% | | R&D Expenses (GAAP) | $1.5 billion | $1.4 billion | | SG&A Expenses (GAAP) | $1.4 billion | $1.4 billion | | Effective Tax Rate (GAAP) | 19.3% | 21.4% | | Effective Tax Rate (Non-GAAP) | 18.8% | 17.8% | - The increase in R&D expenses was primarily due to increased clinical manufacturing and study expenses, as well as valuation adjustments to the MYR-related contingent consideration[13](index=13&type=chunk) [Guidance and Outlook](index=2&type=section&id=Guidance%20and%20Outlook) [Full-Year 2025 Guidance](index=2&type=section&id=Full-Year%202025%20Guidance) Gilead raised its full-year 2025 guidance for product sales (ex-Veklury) and EPS, while lowering Veklury sales forecast Updated Full-Year 2025 Guidance | Metric | New Guidance (Aug 7, 2025) | Prior Guidance | | :--- | :--- | :--- | | Product Sales | $28.3B - $28.7B | $28.2B - $28.6B | | Product Sales (ex-Veklury) | $27.3B - $27.7B | $26.8B - $27.2B | | Veklury Sales | ~$1.0B | ~$1.4B | | Diluted EPS (GAAP) | $5.85 - $6.15 | $5.65 - $6.05 | | Non-GAAP Diluted EPS | $7.95 - $8.25 | $7.70 - $8.10 | [Key Business and Pipeline Updates](index=3&type=section&id=Key%20Business%20and%20Pipeline%20Updates) [Virology](index=3&type=section&id=Virology) Virology highlights include FDA approval for **Yeztugo** HIV PrEP, a Global Fund partnership, and a clinical hold on HIV trials - Received U.S. FDA approval for **Yeztugo® (lenacapavir)** for pre-exposure prophylaxis (PrEP), making it the first twice-yearly HIV prevention option[17](index=17&type=chunk) - Announced a strategic partnership with the Global Fund to accelerate access to lenacapavir for HIV PrEP in low- and lower-middle-income countries[17](index=17&type=chunk) - The FDA placed a clinical hold on the HIV treatment trials of investigational candidates GS-1720 and/or GS-4182[17](index=17&type=chunk) [Oncology](index=3&type=section&id=Oncology) Oncology updates include positive **Trodelvy** Phase 3 results, **Yescarta** real-world data, and a new licensing deal with Kymera Therapeutics - Announced positive topline results from the Phase 3 ASCENT-03 trial evaluating **Trodelvy** in 1L metastatic triple-negative breast cancer (mTNBC)[17](index=17&type=chunk) - Presented new real-world data supporting the use of **Yescarta** in outpatient care settings for patients with relapsed or refractory large B-cell lymphoma[17](index=17&type=chunk) - Entered into an exclusive option and license agreement with Kymera Therapeutics to develop novel oral molecular glue CDK2 degraders for oncology[17](index=17&type=chunk) [Inflammation](index=4&type=section&id=Inflammation) New data on **Livdelzi** for primary biliary cholangitis was presented at EASL, including an interim long-term study analysis - Presented new data at EASL from multiple analyses evaluating **Livdelzi** for the treatment of primary biliary cholangitis[18](index=18&type=chunk) [Corporate Developments](index=4&type=section&id=Corporate%20Developments) Corporate developments include a **$0.79** dividend, a **$6.0 billion** stock repurchase program, and a DOJ settlement - The Board declared a Q3 2025 dividend of **$0.79 per share**[25](index=25&type=chunk) - A new **$6.0 billion** stock repurchase program was authorized by the Board[25](index=25&type=chunk) - Reached a final settlement agreement with the U.S. Department of Justice for a legacy compliance matter, which was previously accrued in 2024[25](index=25&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Unaudited income statements for Q2 and H1 2025 and 2024, detailing revenues, costs, operating income, and net income [Condensed Consolidated Balance Sheets](index=14&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Unaudited balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and equity Balance Sheet Summary | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable debt securities | $7,126 million | $9,991 million | | Total Assets | $55,721 million | $58,995 million | | Total Liabilities | $36,131 million | $39,748 million | | Stockholders' Equity | $19,590 million | $19,246 million | [Selected Cash Flow Information](index=15&type=section&id=Selected%20Cash%20Flow%20Information) Cash flow details for Q2 and H1 2025 and 2024, covering operating, investing, and financing activities, including non-GAAP free cash flow Cash Flow Summary (Three Months Ended June 30) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $827 million | $1,325 million | | Net cash used in investing activities | ($2,116) million | ($307) million | | Net cash used in financing activities | ($1,566) million | ($2,953) million | [Detailed Product Sales Summary](index=8&type=section&id=Detailed%20Product%20Sales%20Summary) Detailed product sales breakdown by therapeutic area, major product, and geographic region for Q2 and H1 2025 and 2024 [Reconciliation of GAAP to Non-GAAP Measures](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) Detailed reconciliation tables for GAAP to non-GAAP financial results for reported periods and full-year 2025 guidance