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Core Viewpoint - Gilead Sciences, Inc. announced positive data from its phase I study of lenacapavir, a once-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP) [1][2][4] Group 1: Study Results - The phase I study evaluated the pharmacokinetics, safety, and tolerability of two intramuscular single-dose 5000mg lenacapavir formulations, involving 40 healthy adults aged 18 to 55 [3][6] - The study demonstrated that both formulations achieved and maintained plasma concentrations exceeding those associated with HIV prevention efficacy observed in late-stage studies [4][5] - The most commonly reported adverse event was injection site pain, which was alleviated by pretreatment with an ice pack, with medication-emergent adverse events being mostly mild to moderate [6] Group 2: Market Position and Future Plans - Gilead's shares have increased by 56.8% over the past year, contrasting with an 8.6% decline in the industry [2] - The company plans to initiate a phase III study for once-yearly lenacapavir in the second half of 2025 [4] - Lenacapavir is already approved in multiple countries for treating adults with multi-drug resistant HIV, and its potential approval for PrEP could further solidify Gilead's position in the HIV market [8][10] Group 3: Competitive Landscape - Gilead's Biktarvy remains the top prescribed regimen for both treatment-naïve and switch patients, maintaining a strong market share [8][10] - The approval of lenacapavir would enhance Gilead's competitive edge, as it requires administration only twice yearly compared to daily oral medications [10] - The HIV treatment landscape is becoming increasingly competitive, with GSK reporting a 13% growth in HIV sales in 2024, driven by demand for long-acting injectable medicines [12][13]

Core Insights - Gilead Sciences is preparing for the commercialization of its BCMA CAR T therapy, anito-cel, in partnership with Arcellx, with a launch anticipated next year [5]. Efficacy and Safety Data - The BCMA CAR T therapy has demonstrated a compelling 62% complete response rate and a 97% overall response rate, indicating strong efficacy in both high-risk and general populations with myeloma [6]. - Safety data shows that 86% of patients experienced grade one or no cytokine release syndrome (CRS) events, with the majority only experiencing mild symptoms such as fever [6]. - Long-term neurotoxicities associated with the therapy are also showing differentiation, suggesting a favorable safety profile [6].

Group 1 - Gilead Sciences (GILD) is outperforming the Medical sector with a year-to-date return of 27.1%, compared to the sector average gain of 6.8% [4] - Gilead Sciences holds a Zacks Rank of 2 (Buy), indicating strong analyst sentiment and an improving earnings outlook, with a 6.7% increase in the consensus earnings estimate for the full year [3] - The Medical - Biomedical and Genetics industry, which includes Gilead Sciences, has an average gain of 8% year-to-date, further highlighting GILD's strong performance [6] Group 2 - ANIXA BIOSCIENCES INC (ANIX) is another Medical stock that has outperformed the sector, with a year-to-date increase of 22.4% [4] - ANIXA BIOSCIENCES INC also holds a Zacks Rank of 2 (Buy), with a 10.9% increase in the consensus EPS estimate over the past three months [5] - Both Gilead Sciences and ANIXA BIOSCIENCES INC are expected to maintain their solid performance in the Medical sector [7]

Core Insights - Gilead Sciences has reached new 52-week highs, joining other healthcare stocks amid broader market pullbacks [1][2] - The stock has increased nearly 30% year-to-date, while the broader market indexes are in negative territory [2] Gilead's Industry Leadership - Gilead is a leader in developing drugs for HIV treatment and has a diverse portfolio for liver diseases, inflammation, respiratory diseases, and hematology/oncology [3] - Expected revenue for 2024 is $28.75 billion, with a projected dip of 1% this year but a rebound to $29.7 billion in fiscal 2026 [3] Gilead's EPS Growth - Annual earnings are projected to increase by 70% in FY25 to $7.87 per share, up from $4.62 last year, with a further 5% increase expected in FY26 [4] Gilead's P/E Valuation - Gilead trades at a forward earnings multiple of 14.6X, below Johnson & Johnson's 15.6X and the industry average of 19.1X [8] Gilead's Dividend - Gilead offers a 2.65% annual dividend yield, surpassing the S&P 500 average of 1.27% and the industry average of 1.49% [10] Bottom Line - Gilead Sciences holds a Zacks Rank 2 (Buy), indicating potential for further upside as EPS estimates for FY25 and FY26 have trended higher [12]

Company Performance - Gilead Sciences (GILD) shares have increased by 17.1% over the past month, reaching a new 52-week high of $117.39 [1] - The stock has gained 24.2% since the beginning of the year, outperforming the Zacks Medical sector and the Zacks Medical - Biomedical and Genetics industry, both of which have seen a 6% return [1] Earnings and Revenue Expectations - Gilead has a strong record of positive earnings surprises, having met or exceeded earnings consensus estimates in the last four quarters [2] - For the current fiscal year, Gilead is expected to report earnings of $7.86 per share on revenues of $28.55 billion, reflecting a 70.13% change in EPS and a -0.7% change in revenues [3] - For the next fiscal year, earnings are projected to be $8.17 per share on revenues of $29.7 billion, indicating a year-over-year change of 3.9% in EPS and 4.01% in revenues [3] Valuation Metrics - Gilead's current valuation metrics show it trades at 14.6X current fiscal year EPS estimates, below the peer industry average of 19.3X [7] - On a trailing cash flow basis, Gilead trades at 16.7X compared to the peer group's average of 15.4X, with a PEG ratio of 0.75 [7] Zacks Rank and Style Scores - Gilead holds a Zacks Rank of 2 (Buy) due to rising earnings estimates, making it a suitable choice for investors [8] - The company has a Value Score of B, Growth Score of B, and Momentum Score of B, resulting in a combined VGM Score of A [6] Industry Comparison - The Medical - Biomedical and Genetics industry is performing well, ranking in the top 30% of all industries, providing favorable conditions for Gilead and its peers [11] - Jazz Pharmaceuticals PLC (JAZZ), a competitor, has a Zacks Rank of 1 (Strong Buy) and has shown strong earnings performance, with a projected EPS of $23.12 on revenues of $4.3 billion for the current fiscal year [9][10]

Group 1 - Gilead Sciences, Inc. is experiencing strong performance in a challenging biotech market, with its stock significantly outperforming peers [1] - The company reported an 8% year-on-year growth in 2024, driven by demand-led volume growth in key products such as BIKTARVY, DESCOVY, and its oncology and liver portfolios [4] - For 2025, Gilead's guidance indicates a flat year-over-year product sales growth of approximately -0.5%, excluding BIKTARVY, with expectations for continued growth in the coming years [4]

Core Viewpoint - The health care sector is leading the market in 2025, contrary to expectations regarding the new administration's impact on pharmaceutical stocks [1] Sector Performance - The S&P 500 Health Care sector has shown a year-to-date performance of 8.45%, outperforming other sectors such as Consumer Staples (8.23%) and Financials (6.83%) [2] - Despite the overall S&P 500 Index being down 0.54% for the year, 9 out of 11 sectors remain in positive territory [2] Market Dynamics - There has been significant sector rotation, with investors moving away from growth and technology stocks towards more defensive sectors like health care and utilities [3] - The Zacks Medical – Biomedical and Genetics industry is currently ranked in the top 29% of approximately 250 Zacks Ranked Industries, indicating strong relative strength [8] Stock Analysis - Gilead Sciences (GILD) is highlighted as a leading stock within the biomedical industry, with a diversified product pipeline and expected FDA approval for its Lenacapavir solution for HIV prevention [10] - Gilead Sciences has a Zacks Rank of 2 (Buy) and has exceeded earnings expectations in the last four quarters, averaging a positive EPS surprise of 19.5% [11] - The stock has appreciated over 65% in the past year and is making new 52-week highs [11] Investment Strategy - The Zacks Rank System is designed to help identify winning stocks and outperform the market by focusing on industries and stocks with positive earnings estimate revisions [6] - The emphasis is on investing in leading stocks to maximize potential returns, particularly in the current market environment characterized by volatility [5][13]

Company Overview - Gilead Sciences operates in over 35 countries and focuses on innovative medicines for life-threatening diseases, including HIV, COVID-19, and cancer[16]. - The company has a diverse product portfolio, including treatments for HIV, COVID-19, and various cancers, with ongoing advancements in their therapeutic areas[18][20][22]. - Gilead's innovative medicines include first-in-class therapies that improve efficacy and reduce side effects, addressing unmet medical needs in virology and oncology[17]. Financial Performance - Total revenues increased by 6% to $28.8 billion in 2024, compared to $27.1 billion in 2023, driven by higher sales in HIV, Oncology, and Liver Disease[197]. - Net income attributable to Gilead decreased by 92% to $480 million in 2024, down from $5.7 billion in 2023, primarily due to increased expenses and impairment charges[198]. - Diluted earnings per share attributable to Gilead fell to $0.38 in 2024, compared to $4.50 in 2023[198]. Sales and Market Dynamics - In 2024, approximately 91% of U.S. product sales and 65% of total worldwide revenues were generated from three large wholesalers: Cardinal Health, Cencora, and McKesson[29]. - HIV product sales increased 8% to $19.6 billion in 2024, driven by higher demand and average realized price[204]. - Biktarvy sales rose 13% to $13.4 billion, primarily due to increased demand from patients switching from Genvoya and other Gilead products[203]. - Liver Disease product sales grew 9% to $3.0 billion, attributed to higher demand for chronic hepatitis treatments and the launch of Livdelzi[206]. - Veklury sales decreased 18% to $1.8 billion, mainly due to reduced COVID-19-related hospitalizations[207]. - Cell Therapy product sales increased 6% to $2.0 billion, driven by higher demand for Yescarta and Tecartus outside the U.S.[208]. - Trodelvy sales surged 24% to $1.3 billion, reflecting increased demand across all regions[209]. - A substantial portion of the company's sales is subject to discounts from list prices, including rebates to Medicaid agencies, which may limit the effect of price increases on net product sales[77]. Research and Development - The company has filed a New Drug Application for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis[34]. - Bulevirtide, for chronic hepatitis delta virus infection, has a Biologics License Application pending with the FDA, having received Orphan Drug and Breakthrough Therapy designations[34]. - Gilead's R&D efforts are focused on viral diseases, cancer, and inflammatory diseases, with significant resources allocated to both internal and external development[31]. - The company has committed to advancing its R&D pipeline, with several product candidates in Phase 3 clinical trials or pending marketing authorization reviews[33]. - Gilead plans to continue investing in its R&D pipeline, which includes over 100 pre-clinical and clinical-stage programs across core therapeutic areas[200]. Regulatory and Compliance - The company is subject to extensive regulations governing manufacturing processes, including compliance with current Good Manufacturing Practices (cGMP) as defined by FDA and EMA, which can lead to significant delays if new suppliers need qualification[75]. - The company must comply with the Risk Evaluation and Mitigation Strategy program mandated by the FDA, which includes educating medical personnel about potential side effects of therapies[76]. - The company is subject to extensive regulations by the FDA and EMA, and failure to comply could delay or halt commercialization of its products[118]. - The company has implemented training programs to ensure compliance with various healthcare fraud and abuse laws, which could lead to significant penalties if violated[81]. Competition and Market Challenges - Gilead faces significant competition from large pharmaceutical companies and pricing pressures from insurers and government payers, impacting market share and pricing strategies[30]. - The company’s HIV product sales may be adversely impacted by market share gains by competitive products or changes in treatment paradigms, necessitating careful management of operations and R&D spending[89]. - Legislative actions, such as the Inflation Reduction Act of 2022, may increase payment obligations and limit prices for the company's products, negatively impacting profitability[99]. - The company faces significant competition from global pharmaceutical and biotechnology companies, which may affect pricing and market share[96]. Strategic Initiatives - Gilead's strategic business development focuses on transformative science and building a sustainable portfolio for long-term growth[37]. - The company completed the acquisition of CymaBay Therapeutics for $4.3 billion, enhancing its Liver Disease portfolio with investigational candidate seladelpar[201]. - Gilead's equity compensation plans include 34.7 million common shares available for issuance, with a weighted-average exercise price of $69.85[179]. Employee and Corporate Culture - As of December 31, 2024, Gilead had approximately 17,600 employees[54]. - In 2023, approximately 1,700 people leaders began their development journey, with an additional 3,500 expected in 2024[60]. - Gilead's Total Rewards portfolio includes competitive base salary, incentive compensation, stock awards, and health and wellbeing benefits[61]. - The company is committed to pay equity, conducting annual pay equity reviews to ensure compensation practices are gender- and race-neutral[57]. - The company is focused on creating a culture of inclusion and belonging, supported by its inclusion council and employee resource groups[53]. Risks and Challenges - The company faces challenges in accurately forecasting sales due to difficulties in predicting demand and fluctuations in purchasing patterns, which can lead to product shortages or excess inventory[93]. - The company relies on third-party contract research organizations for clinical trials, outsourcing most of the clinical study activities[31]. - The company faces risks related to reliance on third-party contract research organizations (CROs) for clinical trials, which may lead to delays and increased costs if disputes arise[114]. - Ongoing shortages of certain cancer drugs, such as carboplatin and cisplatin, could impact the company's clinical trials and product manufacturing[115]. - The company is exposed to reimbursement pressures from government agencies and other third parties, which can affect the pricing and sales of its products[78]. Environmental and Social Responsibility - Gilead's corporate responsibility programs reflect its commitment to advancing global health and are overseen by the Corporate Responsibility Committee[62]. - The company is subject to environmental regulations that may increase operating costs, although it does not currently anticipate a material effect on capital expenditures or earnings[83]. - The company's corporate responsibility goals expose it to reputational risks and may impact stock price if not achieved[141]. Cybersecurity and Technology - Cybersecurity incidents are increasing in frequency and sophistication, posing risks to data confidentiality and operational integrity[151]. - The Board of Directors oversees cybersecurity risks, with the Audit Committee receiving quarterly updates from the Chief Information Security Officer (CISO)[168]. - The company engages third-party advisors to enhance its cybersecurity program and manage risks associated with third-party service providers[163]. - The effectiveness of internal controls over financial reporting could be negatively impacted if the ERP system is not implemented successfully[149].

Investors often turn to recommendations made by Wall Street analysts before making a Buy, Sell, or Hold decision about a stock. While media reports about rating changes by these brokerage-firm employed (or sell-side) analysts often affect a stock's price, do they really matter?Let's take a look at what these Wall Street heavyweights have to say about Gilead Sciences (GILD) before we discuss the reliability of brokerage recommendations and how to use them to your advantage.Gilead currently has an average bro ...