Core Insights - Gilead Sciences, Inc. (GILD) has demonstrated strong performance in 2025, with shares rising 26.5% year to date, significantly outperforming the industry growth of 6% [1][9] - The FDA approval of lenacapavir, branded as Yeztugo, for HIV prevention has been a pivotal event, marking it as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option in the U.S. [3][7] Gilead's HIV Portfolio - Gilead holds a leading position in the HIV treatment market, with its flagship drug Biktarvy commanding over 51% market share in the U.S. [4] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue, driven by strong performances from Biktarvy and Descovy [5] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as Truvada faces generic competition [6] Oncology and Cell Therapy - Gilead's oncology portfolio includes Trodelvy, which has shown strong performance in treating metastatic triple-negative breast cancer, with plans for further approvals [11] - However, the Cell Therapy franchise, including Yescarta and Tecartus, is facing competitive pressures in the U.S. and Europe [12] - Gilead's subsidiary Kite has acquired Interius BioTherapeutics for $350 million, enhancing its capabilities in CAR T-cell therapies [13] Liver Disease Portfolio - The FDA approval of seladelpar, branded as Livdelzi, for primary biliary cholangitis (PBC) has strengthened Gilead's liver disease portfolio [14][15] Financial Performance and Estimates - Gilead's shares are currently trading at a price/earnings ratio of 13.62x forward earnings, lower than the large-cap pharma industry's average of 14.83x [16] - Earnings estimates for 2025 have increased to $8.10 from $8.02, while the estimate for 2026 has slightly decreased to $8.50 from $8.53 [17] Strategic Collaborations - Gilead has partnered with the U.S. State Department to deliver lenacapavir, indicating a commitment to expanding its HIV prevention efforts [10] - The company is also collaborating with Merck to evaluate a combination treatment for HIV, with updates expected in 2026 [20] Dividend and Cash Position - Gilead has maintained a strong cash position, with $7.1 billion in cash and equivalents as of June 30, 2025, supporting its sustainable dividend yield of 2.76% [22] - In Q2 2025, Gilead paid out $994 million in dividends and repurchased $527 million of common stock, reflecting its commitment to returning value to shareholders [21]

Core Viewpoint - Gilead Sciences experienced a significant stock price increase of 8.28% following the release of its Q2 2025 financial results, driven by strong financial performance, the successful launch of the breakthrough HIV prevention drug Yeztugo, and ongoing diversification of its pipeline [1][3]. Financial Performance - Total revenue reached $7.08 billion, reflecting a 2% year-over-year growth, slightly below market expectations. Product sales amounted to $7.05 billion, also up 2%, with a 4% increase to $6.93 billion when excluding Veklury [4][7]. - GAAP earnings per share (EPS) were $1.56, a 21% increase from $1.29 in Q2 2024. Non-GAAP EPS remained stable at $2.01, primarily impacted by increased R&D expenses [4][6]. Business Segments Performance HIV Business - HIV product sales totaled $5.09 billion, a 7% increase year-over-year, accounting for 72% of total revenue. Biktarvy sales reached $3.5 billion, while Descovy saw a 35% increase to $653 million due to price hikes and increased demand [8][10]. - Yeztugo, the first long-acting HIV prevention drug, received FDA approval and is expected to launch in the second half of 2025, with plans to provide 2 million doses to low-income countries [9][18]. Liver Disease Business - Liver disease product sales were $795 million, down 4% year-over-year, primarily due to declining HCV revenues amid market shrinkage and generic competition. Livdelzi showed significant growth, although specific figures were not disclosed [12][13]. Oncology Business - Oncology product sales reached $849 million, a 1% increase. Trodelvy sales grew by 14% to $364 million, driven by increased demand. However, CAR-T therapies faced challenges, with overall sales declining by 7% [14][15]. Other Products - Veklury sales plummeted by 44% to $121 million due to decreased COVID-19 hospitalization rates. Other products generated $202 million, down 28% [16][17]. Guidance and Future Outlook - Gilead raised its full-year guidance, projecting product sales between $28.3 billion and $28.7 billion, up from previous estimates. GAAP EPS is now expected to be between $5.85 and $6.15 [5][24]. - The company remains optimistic about Yeztugo's market acceptance and the potential for growth in its HIV product line, while also acknowledging policy risks and market competition [25][26]. Key R&D Milestones - Yeztugo's FDA approval and WHO guideline recommendation mark significant advancements in the HIV field. However, some candidates faced clinical holds, impacting development timelines [18][19]. - Livdelzi's long-term safety data supports its potential in liver disease, while Trodelvy's positive trial results may expand its market [20][21]. Cost Control and Operational Efficiency - Non-GAAP gross margin improved to 86.9%, benefiting from product mix optimization. R&D expenses increased by 9% to $1.5 billion, driven by clinical manufacturing and research activities [21][22].

Core Insights - The FDA has accepted Gilead Sciences' New Drug Application for lenacapavir, an injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis, with a target action date of June 19, 2025 [1] - Gilead's lenacapavir showed 100% efficacy in preventing HIV in cisgender women during the Phase 3 PURPOSE 1 trial, leading to a recommendation to offer the drug to all trial participants [2] - Gilead's stock has increased by approximately 74% since June of the previous year and around 21% year-to-date [3] Company Performance - Gilead is experiencing a turnaround in its stock performance, currently trading at 13.3 times forward earnings, which is below the pharmaceutical industry average of 14 [4] - Concerns exist regarding Gilead's past performance, where a previous stock surge due to hepatitis C treatment success was followed by a decline as demand waned [5] - The company aims to increase U.S. PrEP users to over one million by 2030 to achieve $4 billion in annual sales, with over 400,000 Americans currently using PrEP [6] Market Position - Gilead's HIV drug Biktarvy is protected from generic competition until 2033, positioning the company favorably compared to others facing patent expirations [6] - HIV product sales increased by 6% year-over-year to $4.59 billion in Q1 2025, indicating strong market performance [7] - Potential reductions in federal funding for HIV prevention programs could impact market dynamics, as noted by industry experts [8]