Key Takeaways The EC approved Gileads lenacapavir, branded Yeytuo, as twice-yearly HIV prevention for at-risk groups.Approval followed accelerated EMA review, CHMP backing, and PURPOSE 1 and 2 trial data.Lenacapavir strengthens Gileads HIV portfolio as Truvada faces generic competition in prevention.Gilead Sciences, Inc. ((GILD) announced that the European Commission (“EC”) has granted marketing authorization to HIV prevention drug lenacapavir, under the brand name Yeytuo.The EC approved lenacapavir, GILD’s ...

Key Takeaways Gilead shares fell 2.2% after CVS chose not to cover its new HIV prevention drug Yeztugo.Yeztugo, FDA-approved in June, is the first and only twice-yearly PrEP option in the U.S.Gilead's Kite will acquire Interius BioTherapeutics for $350M, impacting EPS by $0.23-$0.25.Shares of Gilead Sciences, Inc. ((GILD) tumbled 2.2% on Aug. 21, after pharmacy benefit manager CVS Health ((CVS) decided not to add the former’s new HIV prevention drug, Yeztugo (lenacapavir), to its commercial plans for now.As ...

Core Insights - Gilead Sciences, Inc. reported better-than-expected Q2 2025 results, with adjusted EPS of $2.01 surpassing the Zacks Consensus Estimate of $1.95 and remaining flat year over year [1] - Total revenues reached $7.1 billion, exceeding the Zacks Consensus Estimate of $6.9 billion, marking a 2% year-over-year increase driven by higher sales in HIV, Livdelzi, and Trodelvy [1] Financial Performance - Product sales increased 2% year over year to $7.1 billion; excluding Veklury, product sales rose 4% to $6.9 billion [5] - HIV product sales grew 7% year over year to $5.1 billion, driven by increased demand and higher average realized prices, beating estimates [5][6] - Biktarvy sales increased 9% year over year to $3.5 billion, holding over 51% market share in the U.S. treatment market [6] - Descovy sales surged 35% year over year to $653 million, maintaining over 40% market share in pre-exposure prophylaxis (PrEP) [7] - Liver Disease portfolio sales decreased 4% to $795 million, primarily due to lower chronic HCV sales impacted by Medicare Part D redesign [9] - Veklury sales plummeted 44% to $121 million due to reduced COVID-19-related hospitalizations [9] - Cell Therapy product sales fell 7% to $485 million, missing estimates due to competitive pressures [10] - Trodelvy sales increased 14% year over year to $364 million, driven by higher demand [11] Cost and Guidance - Adjusted product gross margin improved to 86.9% from 86% year over year [12] - R&D expenses rose to $1.5 billion from $1.3 billion due to increased clinical manufacturing activities [12] - Gilead raised its 2025 product sales guidance to between $28.3 billion and $28.7 billion, with adjusted EPS now anticipated in the range of $7.95-$8.25 [14][15] Pipeline Developments - Gilead received FDA approval for lenacapavir (Yeztugo), a twice-yearly injectable HIV-1 capsid inhibitor for prevention, marking a significant addition to its HIV portfolio [16][20] - The company entered a partnership with Kymera Therapeutics to develop a novel molecular glue degrader program targeting CDK2, with potential payments up to $750 million [18] Market Position - Gilead's strong performance in the HIV segment is expected to continue, with projected growth of approximately 3% in 2025, driven by Biktarvy and Descovy [19] - The approval of Yeztugo addresses barriers to PrEP adoption, providing a competitive advantage over daily oral medications [21] - Gilead's breast cancer drug Trodelvy is gaining market share, while cell therapies face competitive challenges [22][23]

Core Insights - The FDA approved Gilead Sciences' Yeztugo (lenacapavir) as the first and only twice-yearly PrEP option in the U.S. for HIV prevention, showing ≥99.9% efficacy in trials [1][2][5] - The European Medicines Agency's CHMP has recommended lenacapavir for PrEP, with a final decision from the European Commission expected later this year [2][3] - Positive trial results indicate lenacapavir's superiority over daily oral Truvada in preventing HIV infections [4][5] Company Developments - Gilead's Yeztugo could significantly contribute to revenue, with projections of $4.1 billion in sales by 2030 and $6.4 billion by 2035, driven by its ease of use compared to current treatments [6][7] - Needham upgraded Gilead's stock rating from Hold to Buy, forecasting a price of $133 based on positive physician feedback and market potential [6] Market Outlook - The HIV prevention market is expected to grow by approximately 49% by 2030, with Yeztugo anticipated to capture about 38% of this growth [7] - Gilead's revenue heavily relies on its HIV drugs, with around 70% coming from this segment, making Yeztugo a crucial growth driver [7]

Core Insights - Merck has initiated two late-stage clinical studies for MK-8527, a once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP) [1][8] - The studies aim to enroll nearly 9,000 participants and will compare MK-8527 with Gilead's daily oral PrEP pill, Truvada [2][8] - The initiation of these studies is backed by positive Phase II results showing similar adverse event rates between treatment and placebo [3] Company Developments - Merck is expanding its HIV portfolio, focusing on both prevention and treatment, with MK-8527 being a key component [6][10] - The FDA has accepted a regulatory filing for Merck's once-daily, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for treating HIV-1, with a decision expected by April 28, 2026 [7] - Merck is also collaborating with Gilead on a once-weekly, two-drug, single-tablet regimen of islatravir/lenacapavir (ISL/LEN) [9][10] Competitive Landscape - Merck's growing HIV portfolio positions it to compete with Gilead, which currently leads the market with its PrEP medications, Truvada and Descovy [11] - If approved, MK-8527 could challenge Gilead's dominance in the PrEP market [11] - Gilead's recent approval of lenacapavir, a twice-yearly injectable for HIV prevention, adds to the competitive pressure in the HIV therapeutic space [13] Market Context - GSK is another significant player in the HIV market, with strong sales driven by products like Cabenuva, Apretude, and Dovato [14] - The competitive dynamics in the HIV space are intensifying as companies innovate and expand their product offerings [11][14]

Core Insights - Gilead Sciences, Inc. (GILD) received FDA approval for lenacapavir, branded as Yeztugo, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg [1][7][10] - Yeztugo is the first and only twice-yearly PrEP option available in the United States, representing a significant advancement in HIV prevention [1][10] - The approval was based on late-stage studies, PURPOSE 1 and PURPOSE 2, which demonstrated that ≥99.9% of participants who received Yeztugo remained HIV-negative [2][8] Company Performance - Year to date, GILD shares have increased by 18.6%, contrasting with a 4% decline in the industry [4] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as its other prevention drug, Truvada, faces generic competition [12] Competitive Landscape - Yeztugo's long-acting dosing aims to improve PrEP uptake by addressing adherence challenges and stigma associated with daily oral medications [7][10] - Gilead's flagship drug, Biktarvy, holds over 51% of the treatment market share in the United States, indicating strong market positioning [11] - The approval of Yeztugo is expected to catalyze uptake among historically underserved populations, providing a competitive advantage over daily oral pills [11][10] Regulatory and Market Developments - Yeztugo was granted Breakthrough Therapy Designation and has also received validation from the European Medicines Agency for marketing authorization [9] - The approval of long-acting injectable forms of PrEP, such as Yeztugo and ViiV Healthcare's Apretude, indicates a growing trend in HIV prevention strategies [13][14]

Core Insights - The report maintains a positive outlook on the HIV sector, highlighting Gilead's long-acting therapy, Lenacapavir, as a potential game-changer in HIV treatment and prevention [1][3]. Group 1: HIV Mechanism and Treatment - HIV is a retrovirus that selectively targets CD4+ cells, integrating its genetic material into the host's genome, leading to viral replication [5][7]. - The primary treatment for AIDS is the "cocktail therapy," which combines multiple antiviral drugs to minimize resistance and maximize viral suppression [5][7]. Group 2: Lenacapavir's Impact - Lenacapavir is Gilead's first long-acting HIV capsid inhibitor, showing promising results in clinical trials for treating multi-drug resistant HIV in adults [9][11]. - In the CAPELLA study, 83% of participants using Lenacapavir achieved a viral load of less than 50 copies/mL after 52 weeks, compared to only 11% in the placebo group [13][14]. - Lenacapavir has significant potential in post-exposure prophylaxis (PrEP), with studies indicating a 100% reduction in HIV infection risk among participants receiving biannual injections [20][21]. Group 3: Market Potential and Future Developments - The global HIV infection rate in 2023 was approximately 39.9 million, with a significant portion of the population being women [15][18]. - Lenacapavir's approval for PrEP is anticipated to set a new standard in HIV prevention, potentially generating substantial revenue for Gilead [23]. - Other recent advancements in HIV treatments include Merck's dual-drug therapy achieving positive results in Phase III trials and ViiV Healthcare's long-acting antibody therapy showing good efficacy [24][26].