Drug Development & Efficacy - Gilead's new injectable is the first of its kind for HIV prevention, administered only twice a year [3] - Clinical trials showed almost 100% protection against HIV [3][19] - The injectable addresses compliance issues associated with daily pills, where only about 50% of people taking pills are compliant [5] Market & Public Health Impact - There are still 30,000 new HIV infections a year in the United States and 13 million worldwide [6] - Over 700 new cases occur weekly in the US, with about 100 HIV-related deaths [6] - Certain regions, like the Southern United States, and demographics, such as women, Black and Latino men in the South, are disproportionately affected [7] Pricing & Accessibility - The injectable is priced roughly in line with other branded PrEP medicines [9] - Preventing an HIV infection can save as much as $11 million in lifetime costs [9] - Over 90% of existing PrEP medicines are covered by insurance companies [10] - Gilead has programs for uninsured individuals and those needing co-pay support [10] - Licensing agreements with six generic manufacturers will provide medicines to over 120 low and middle-income countries [11] Patent & Generics - The injectable has standard patent protection for 12 to 15 years [8] - Generic versions will be available in other countries in about two years, but not in the US for 12 years [12]

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 - Zacks Premium provides various tools for investors to enhance their stock market engagement and confidence [1][2] Zacks Style Scores - Zacks Style Scores are indicators that assist investors in selecting stocks likely to outperform the market within 30 days, rated from A to F based on value, growth, and momentum characteristics [3][8] - The Value Score focuses on identifying undervalued stocks using financial ratios like P/E and Price/Sales [4] - The Growth Score emphasizes a company's financial health and future growth potential, analyzing projected and historical earnings and cash flow [5] - The Momentum Score helps investors capitalize on price trends, utilizing recent price changes and earnings estimate shifts [6] - The VGM Score combines all three Style Scores, providing a comprehensive assessment of stocks based on value, growth, and momentum [7] Zacks Rank and Performance - The Zacks Rank is a proprietary model that leverages earnings estimate revisions to guide investors in stock selection, with 1 (Strong Buy) stocks achieving an average annual return of +25.41% since 1988, significantly outperforming the S&P 500 [8][9] - Investors are encouraged to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal success [10][11] Company Spotlight: Gilead Sciences - Gilead Sciences specializes in developing treatments for HIV and other diseases, with total sales from its HIV franchise reaching $19.6 billion in 2024, reflecting an 8% year-over-year growth [12] - Gilead holds a 3 (Hold) Zacks Rank and a VGM Score of A, with a Momentum Style Score of B, indicating potential for upward movement [13][14] - Recent analyst revisions for Gilead's earnings estimates have been positive, with the Zacks Consensus Estimate for fiscal 2025 increasing to $7.92 per share and an average earnings surprise of 16.5% [13]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive has bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Group 2 - The company is focused on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4] - Automation and software tools, including generative AI, are used, but all content is edited and authored by humans [5]

Core Viewpoint - The FDA has approved Gilead's lenacapavir, a twice-yearly antiviral injection for HIV prevention, which could significantly impact global public health and help in the fight against the HIV epidemic [2][5]. Product Efficacy and Impact - Lenacapavir has shown the ability to virtually eliminate new HIV infections when administered every six months, outperforming existing daily pills and monthly injections [3][12]. - In clinical trials, the injection demonstrated a 99.9% efficacy rate, with only two infections among over 2,000 patients, proving to be 89% more effective than Gilead's daily pill Truvada [12][13]. Market Potential and Pricing - Analysts estimate lenacapavir could achieve peak sales of around $4 billion globally for both prevention and treatment [7]. - The current price for lenacapavir, under its treatment brand Sunlenca, exceeds $42,200 per year, but it could potentially be produced for as low as $26 to $40 annually [6]. Access and Distribution - Gilead plans to align the pricing of lenacapavir for HIV prevention with existing branded PrEP options, which are around $2,000 per month for daily pills [8]. - The company has licensed six generic manufacturers to produce lower-cost versions of the injection for 120 low- and lower-middle-income countries, and will supply doses for up to 2 million people at no profit before generics are available [9]. Challenges to Implementation - Proposed cuts to federal funding for HIV prevention, particularly affecting Medicaid, pose a significant threat to access for underserved populations [14][15]. - The potential reduction in funding could destabilize HIV prevention efforts and make it harder to distribute Gilead's injection effectively [16][17].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Gilead Sciences, Inc. and its officers or directors [1] Group 1: Company Developments - On June 10, 2025, Gilead announced that the U.S. FDA placed a clinical hold on its HIV treatment trials for GS-1720 and GS-4182 due to safety concerns related to decreases in CD4+ T-cell and absolute lymphocyte counts [3] - Following the FDA announcement, Gilead's stock price decreased by $2.91, or 2.58%, closing at $110.09 per share on the same day [3] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4]

Core Viewpoint - Gilead Sciences has shown strong performance in 2023 despite recent setbacks, with stock up 18% compared to the S&P 500's 2% gain, and is focused on resolving clinical trial issues while improving profitability [2][3]. Financial Performance - Gilead's stock valuation is around $110 per share, indicating potential for growth [3]. - Revenue growth has been marginal, with a 4.7% increase over the last 12 months from $27 billion to $29 billion, compared to the S&P 500's 5.5% growth [5]. - Quarterly revenues recently shrank by 0.3% to $6.7 billion year-over-year, while the S&P 500 improved by 4.8% [5]. - Gilead's operating income over the last four quarters was $11 billion, yielding a high operating margin of 37.4% [5]. - Net income for the last four quarters was $6.0 billion, resulting in a net income margin of 20.8% [6]. Valuation Metrics - Gilead's Price-to-Sales (P/S) ratio is 4.8, compared to the S&P 500's 3.1 [5]. - The Price-to-Earnings (P/E) ratio for Gilead is 23.2, while the S&P 500 stands at 26.9 [5]. - Gilead's Price-to-Free Cash Flow (P/FCF) ratio is 14.0, significantly lower than the S&P 500's 20.9 [5]. Financial Stability - Gilead's balance sheet is strong, with a Debt-to-Equity Ratio of 18.1% compared to the S&P 500's 19.4% [9]. - Cash and cash equivalents amount to $7.9 billion, representing a Cash-to-Assets Ratio of 14.0% [9]. Downturn Resilience - Gilead stock has historically shown greater resilience during market downturns, with a smaller peak-to-trough decline compared to the S&P 500 during various crises [7][9].

Core Viewpoint - Gilead Sciences, Inc. (GILD) is initiated with a Strong Buy rating and a price target of $181, focusing on its transformative therapies in HIV, viral hepatitis, oncology, and other unmet medical needs globally [1]. Group 1: Company Overview - Gilead is engaged in the discovery, development, and commercialization of therapies that address significant medical needs [1]. - The company operates in various therapeutic areas, including HIV, viral hepatitis, and oncology, indicating a diversified portfolio [1]. Group 2: Research Methodology - Moretus Research employs a structured, repeatable framework to identify companies with durable business models and mispriced cash flow potential [1]. - The research emphasizes rigorous fundamental analysis combined with a judgment-driven process, focusing on clarity and actionable insights [1]. - Valuation methods are based on sector-relevant multiples tailored to each company's business model, ensuring comparability and relevance [1]. Group 3: Investment Philosophy - Moretus Research targets underappreciated companies undergoing structural changes or temporary dislocations, where disciplined analysis can yield asymmetric returns [1]. - The research aims to elevate the standard for independent investment research by providing professional-grade insights and a strong filter for essential information in equity analysis [1].

Core Insights - Gilead Sciences, Inc. (GILD) has announced that the FDA has placed a clinical hold on studies for pipeline candidates GS-1720 and GS-4182 for HIV treatment due to safety concerns regarding CD4+ T-cell and lymphocyte counts [1][3][4] - Following the announcement, GILD shares fell by 2.6%, although the stock has gained 20% year-to-date, contrasting with a 0.5% decline in the industry [1] Gilead's HIV Treatment Pipeline - The clinical hold affects two phase II/III studies comparing the combination of GS-1720 and GS-4182 with Biktarvy in both virologically suppressed and treatment-naive HIV-1 patients, as well as three additional phase I studies [4][7] - Despite the setback, Gilead remains a market leader in HIV treatments, with Biktarvy accounting for over 51% of the U.S. treatment market [5][6] Market Performance and Future Prospects - Biktarvy continues to be the leading prescribed regimen for HIV-1 infection, while Descovy maintains over 40% market share in the PrEP market [6][7] - Gilead's late-stage studies for lenacapavir, which is under priority review for HIV prevention, could further solidify its position in the market [8] - However, Biktarvy sales may face pressure due to changes in Medicare Part D, impacting overall HIV growth [9] Competitive Landscape - Gilead faces competition from GSK plc, which is seeing strong demand for its HIV portfolio, including Cabenuva and Apretude [9][10]

Core Viewpoint - Gilead Sciences' stock experienced a decline of over 2% following negative news regarding its investigational HIV treatment program, contrasting with a 0.6% gain in the S&P 500 index [1][2]. Regulatory Action - The U.S. Food and Drug Administration (FDA) has ordered a halt to Gilead's clinical trials involving a two-drug combination aimed at treating HIV [2]. - The FDA's decision was prompted by findings of low CD4+ T-cell levels in some trial participants, although the cause of these deficiencies remains unclear [4]. Drug Information - The two drugs involved are GS-1720, a weekly administered treatment, and GS-4182, a pill version of lenacapavir (commercially known as Sunlenca) [5]. - Gilead is also testing these drugs against its existing HIV treatment, Biktarvy, in various stages of clinical trials [4]. Pipeline and Future Prospects - Despite the FDA's hold, Gilead has indicated that it is developing numerous other HIV combination treatments that are not impacted by this regulatory action [5]. - The company maintains a robust pipeline with 58 investigational programs, suggesting that the FDA's pause may not represent a significant setback for Gilead [6].