Gilead(GILD)

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Gilead's HIV Prevention Treatment Lenacapavir Shows Potential
ZACKS· 2024-10-11 14:50
Gilead Sciences, Inc. (GILD) recently announced additional efficacy, safety and demographic data from its late-stage study on lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for the prevention of HIV. Data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention option. Additional Data From GILD's HIV Study The double-blind, multicenter, randomized study phase III study, PURPOSE 2, is evaluating the safety and efficacy of twice-yearly su ...
Gilead Sciences (GILD) Increases Yet Falls Behind Market: What Investors Need to Know
ZACKS· 2024-10-08 23:06
In the latest market close, Gilead Sciences (GILD) reached $85.21, with a +0.92% movement compared to the previous day. The stock's performance was behind the S&P 500's daily gain of 0.97%. Meanwhile, the Dow experienced a rise of 0.3%, and the technology-dominated Nasdaq saw an increase of 1.45%.Heading into today, shares of the HIV and hepatitis C drugmaker had gained 6.64% over the past month, outpacing the Medical sector's loss of 3.72% and the S&P 500's gain of 5.41% in that time.Analysts and investors ...
Consider Buying Gilead To Benefit From Its Strong Outlook, Favorable Valuation
Seeking Alpha· 2024-10-05 13:58
Core Viewpoint - Gilead's lenacapavir drug is expected to significantly enhance the company's revenue and profit margins by effectively preventing nearly all HIV transmission, positioning it as a potential blockbuster product for the firm [1] Group 1 - Gilead's lenacapavir drug has shown promising results in preventing HIV transmission [1] - The long-term financial outlook for Gilead is positive due to the anticipated success of lenacapavir [1]
GILD Grants Right for HIV PrEP Candidate to Six Generic Companies
ZACKS· 2024-10-03 17:10
Core Insights - Gilead Sciences has entered licensing agreements with six pharmaceutical companies to produce a low-cost version of lenacapavir for HIV prevention in 120 low-and lower-middle-income countries [1][3] - Lenacapavir has shown promising results in late-stage studies, achieving primary efficacy goals and demonstrating superior efficacy compared to Truvada [2] - Gilead aims to support access to lenacapavir through a royalty-free licensing program and will supply the drug at no profit until generic manufacturers can meet demand [3][5] Licensing Agreements - The selected companies for manufacturing lenacapavir include Dr. Reddy's Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan [1] - The agreements cover lenacapavir for both prevention and treatment of multi-drug-resistant HIV [3] - Gilead's choice of partners was based on their experience in producing high-quality generics and sterile injectable medicines [3] Market Strategy - Gilead plans to register lenacapavir in 18 countries that account for approximately 70% of the HIV burden in the licensed regions [5] - The countries targeted for registration include Botswana, Kenya, Nigeria, South Africa, and others [5] - Gilead has previously enabled access to affordable treatments for HIV and other diseases through partnerships, distributing over 30 million treatments in low-and middle-income countries [5] Clinical Development - Two pivotal studies, PURPOSE 1 and PURPOSE 2, have shown that lenacapavir, administered twice a year, is more effective than the daily oral dose of Truvada [2] - Gilead plans to submit global regulatory filings for lenacapavir by the end of 2024 [2] - Year-to-date, Gilead's shares have increased by 4.6%, outperforming the industry average decline of 1.5% [2]
Gilead Sciences (GILD) Stock Slides as Market Rises: Facts to Know Before You Trade
ZACKS· 2024-09-24 23:06
Company Performance - Gilead Sciences closed at $83.79, with a -0.24% change from the previous session, underperforming the S&P 500's gain of 0.25% [1] - The stock has increased by 9.13% over the past month, contrasting with the Medical sector's loss of 1.51% and the S&P 500's gain of 1.65% [1] - The upcoming earnings report is projected to show earnings per share (EPS) of $1.66, a decrease of 27.51% year-over-year, with expected quarterly revenue of $6.98 billion, down 0.98% from the previous year [1] Fiscal Year Estimates - For the entire fiscal year, earnings are projected at $3.78 per share, representing a -43.75% change from the prior year, while revenue is expected to be $27.63 billion, reflecting a +1.9% change [2] - Recent revisions to analyst forecasts are important as they indicate short-term business trends, with positive revisions seen as a favorable sign for the company's outlook [2] Valuation Metrics - Gilead Sciences has a Forward P/E ratio of 22.23, which is higher than the industry average of 21.46, suggesting it is trading at a premium [3] - The company has a PEG ratio of 2.91, compared to the industry average PEG ratio of 2.21, indicating a higher valuation relative to projected earnings growth [3] Industry Context - The Medical - Biomedical and Genetics industry, part of the Medical sector, holds a Zacks Industry Rank of 80, placing it in the top 32% of over 250 industries [4] - The Zacks Industry Rank measures the strength of industry groups, with the top 50% rated industries outperforming the bottom half by a factor of 2 to 1 [4]
Gilead Stock Rises as HIV Prevention Injection Meets Study Goals
ZACKS· 2024-09-13 17:56
Core Insights - Gilead Sciences, Inc. announced positive interim results from a late-stage study of lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, showing a 96% reduction in HIV infections compared to daily Truvada [1][3] - The study demonstrated that 99.9% of participants in the lenacapavir group did not acquire HIV, with only two infections among 2,180 participants [3] - Gilead's stock rose 2.74% following the announcement, reflecting investor confidence in the drug's potential [1] Study Details - The PURPOSE 2 study involved over 3,200 participants, including cisgender men, transgender individuals, and gender non-binary individuals aged 16 and older [3] - The study met its primary efficacy endpoint, confirming lenacapavir's superiority over both background HIV incidence and Truvada [4] - The independent Data Monitoring Committee recommended stopping the blinded phase of the trial and offering lenacapavir to all participants [4] Market Implications - The success of lenacapavir in the PURPOSE 2 study positions Gilead to initiate global regulatory filings by the end of 2024, with a potential launch in 2025 [6] - Lenacapavir's twice-yearly administration offers a competitive advantage over daily oral medications, addressing a broader population in need of HIV prevention options [7] - Gilead is a dominant player in the HIV market, having developed the first single-tablet regimen and the first long-acting injectable treatment [7] Competitive Landscape - GSK's Apretude, another long-acting injectable for HIV prevention, was approved by the FDA in 2021, representing a key competitor for Gilead [8] - GSK reported a 13% growth in HIV sales in the second quarter, driven by demand for its long-acting drugs [8]
Why Gilead Sciences Stock Thrashed the Market Today
The Motley Fool· 2024-09-12 22:11
Core Insights - Gilead Sciences experienced a nearly 3% increase in stock price following positive results from a late-stage clinical trial of its investigational HIV drug lenacapavir, which significantly outperformed the S&P 500 index's 0.8% increase on the same day [1]. Group 1: Clinical Trial Results - The second phase 3 trial of lenacapavir met key efficacy endpoints, demonstrating a 96% reduction in new HIV infections compared to background incidence [2]. - Lenacapavir, administered biannually, proved to be more effective than the daily medication Truvada, which has been a standard treatment for HIV [2]. - Gilead's CEO highlighted the potential of lenacapavir to transform HIV prevention and contribute to ending the epidemic [2]. Group 2: Regulatory Approval Process - Gilead plans to utilize data from both clinical trials for regulatory approval submissions, expected to begin by the end of this year [3]. - Specific details regarding the timing and locations of these submissions were not disclosed [3].
Gilead's twice-yearly shot cut HIV infections by 96% in trial
CNBC· 2024-09-12 13:29
Gilead's twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday.The positive phase three trial data on Lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention."Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, ...
Gilead Sciences, Inc. (GILD) Baird Global Healthcare Conference (Transcript)
2024-09-11 00:00
Gilead Sciences, Inc. (NASDAQ:GILD) Baird Global Healthcare Conference September 10, 2024 10:50 PM ET Company Participants Johanna Mercier - Chief Commercial Officer Conference Call Participants Brian Skorney - Baird Brian Skorney [Starts abruptly] biotech analysts here. [Technical Difficulty] to have presenting with us next, Gilead Sciences. Thanks for coming today. We really appreciate it. Maybe just to kick things off, I'll kind of ask the general question to give a broad overview of what Gilead does and ...
Gilead Sciences, Inc. (GILD) Baird Global Healthcare Conference (Transcript)
Seeking Alpha· 2024-09-11 00:00
Core Insights - Gilead Sciences is focusing on expanding its portfolio beyond virology, particularly in oncology and inflammation, while maintaining its leadership in HIV treatment [2][5][42] - The company has a strong market position in HIV treatment, with Biktarvy holding approximately 70% market share and an annual run-rate of about $13 billion [2][7][8] - Lenacapavir, a new molecule for HIV prevention, has shown 100% efficacy in trials, presenting a significant opportunity to transform the PrEP market [3][11][12] HIV Treatment - Gilead holds a 70% share in the HIV treatment market, with Biktarvy growing at approximately 3% year-on-year [2][7] - The company is developing a pipeline that includes weekly and monthly oral treatments, as well as long-acting injectables [2][8] - Lenacapavir is expected to enhance Gilead's position in the PrEP market, targeting a broader demographic beyond the current 400,000 users in the U.S. [11][12][13] Oncology - Gilead is expanding its oncology portfolio with Trodelvy, which is currently used in breast cancer treatment and is being explored for earlier lines of therapy [4][30] - The company is also investigating opportunities in lung cancer and endometrial cancer, with ongoing clinical trials [36][30] - ASCENT-03 and ASCENT-04 trials are expected to provide data that could support the use of Trodelvy in earlier treatment lines [32][30] Inflammation - Livdelzi, recently approved for primary biliary cholangitis (PBC), is positioned as a differentiated product with a focus on alleviating pruritus, a significant symptom for patients [21][22] - The PBC market in the U.S. consists of approximately 130,000 to 140,000 patients, with Livdelzi expected to capture a share of the second-line treatment market [22][24] - Gilead aims to leverage its established liver team to promote Livdelzi effectively among prescribers [21][22] Business Development - Gilead's strategy includes pursuing smaller, bolt-on acquisitions to enhance its oncology and inflammation portfolios, rather than large-scale deals [39][38] - The company is open to exploring opportunities in virology if they align with its strategic goals [39][38] - Gilead's focus remains on building a diversified pipeline while maintaining strong internal capabilities [39][38]