Company Performance - Gilead Sciences (GILD) has gained approximately 21% year-to-date, significantly outperforming the average return of -4.7% for the Medical sector [4] - Gilead Sciences holds a Zacks Rank of 2 (Buy), indicating a positive earnings outlook and strong analyst sentiment [3][4] - Alignment Healthcare (ALHC) has also outperformed the sector with a return of 16.8% year-to-date and holds a Zacks Rank of 2 (Buy) [5] Industry Comparison - Gilead Sciences is part of the Medical - Biomedical and Genetics industry, which has seen an average loss of 2.9% this year, indicating GILD's superior performance within this specific industry [6] - Alignment Healthcare belongs to the Medical Services industry, currently ranked 56, which has experienced a decline of 2.8% year-to-date [6] Sector Overview - The Medical sector includes 987 individual stocks and currently holds a Zacks Sector Rank of 5, reflecting its relative performance compared to other sectors [2] - The Zacks Rank system focuses on earnings estimates and revisions, which have historically been successful in identifying stocks likely to outperform the market in the near term [3]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Gilead Sciences, Inc. and its officers or directors [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 in trial participants [3] - Following the announcement of the clinical hold, Gilead's stock price decreased by $2.91, or 2.58%, closing at $110.09 per share on the same day [3] 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 Insights - Gilead Sciences is highlighted as a company with potential investment opportunities in the current market landscape [1] Company Overview - The analysis focuses on Gilead Sciences, providing insights into its market trends and investment potential [1] Market Trends - The video discusses broader market trends that may impact Gilead Sciences and its performance [1]

Strategic Transformation & Growth - Gilead is making meaningful progress on strategic transformation with a strong 2023 execution, leading to a catalyst-rich 2024[5, 11, 28, 65] - The company's pipeline has grown by 88% since 2019, positioning it to deliver 10+ new transformative therapies by the end of 2030[18, 19] - Gilead's base business has returned to consistent growth, with an expected 7-8% year-over-year growth in 2023 driven by HIV and Oncology[21, 22] Oncology - Gilead is accelerating its oncology business, aiming for >$3 billion/year[7, 13, 30, 67] - Oncology revenue has grown significantly, reaching ~$3 billion in FY23, representing ~12% of total revenue compared to 2% in FY19[36] - Trodelvy programs reinforce pan-tumor potential, with >30 active or planned trials and >30,000 patients treated[40, 41] - In 1L mNSCLC, Trodelvy plus pembrolizumab demonstrated a strong 69% ORR in PD-L1 TPS>50% and 44% ORR in PD-L1 TPS<50% in the Phase 2 EVOKE-02 trial[48] - Yescarta is the 1 cell therapy in 2L+ LBCL with long-term, 5-year OS of 43% in 3L LBCL and delivered >6,000 cell therapies to patients in 2023[54] HIV - Gilead has a leading HIV portfolio poised for durable growth[9, 15, 32, 69] - Biktarvy is a global leader in HIV treatment, with >47% U S market share in Q3 2023 and projected U S and EU LOE in 2033[72, 73] - The company has an industry-leading HIV development portfolio with 10 clinical programs with lenacapavir[75, 76] - Gilead anticipates 5 potential new HIV product launches by 2030 in treatment & PrEP[17, 71, 78]

Commercial Execution & Market Opportunity - Kite has a broad global ATC footprint with unrivaled patient reach across 420+ ATCs in 25+ countries[14, 34] - The cell therapy market has significant untapped potential, with opportunities to drive market growth in Europe, where 2L+ class share is approximately 20%[38, 41] - Kite's global commercial strategy aims to grow class share by bringing treatment closer to patients and breaking down referral barriers[43] - The company is advancing its portfolio into $40 billion+ markets, including lymphoma & leukemia ($10B-$12B), multiple myeloma ($15B-$20B), and autoimmune diseases ($15B-$20B)[20, 21] Manufacturing Excellence - Kite boasts an industry-leading 14-day turnaround time in the U S for Yescarta and a 96% manufacturing success rate[14, 10] - The company has >24,000 manufacturing capacity by 2026 and >1 million square feet of manufacturing and R&D space[103, 104] - Kite is targeting a biologics product gross margin of approximately 80% in the U S by 2030 through operational excellence and cost improvements[136] - Plans are rapidly advancing for anito-cel manufacturing, leveraging Kite's existing capabilities to achieve similar turnaround times and success rates to Yescarta[137, 140] Clinical Development & Pipeline - Yescarta demonstrates statistically significant overall survival (OS) vs Salvage ± HDCT + ASCT in 2L LBCL, with 43% of patients alive at 5 years in 3L+ LBCL[47] - In ZUMA-7, Yescarta showed a 27% reduction in the risk of death (OS HR 0 726, p=0 0168) and a >4x median EFS in 2L LBCL[197] - The company is developing KITE-753, a CD19/CD20 dual-targeting CAR T with a rapid manufacturing process (3 days) to preserve T cell stemness[228, 231]

HIV Prevention Breakthrough - A new injectable medicine, Tuggo, represents a potential milestone in HIV prevention [1] - Tuggo is a first-of-its-kind medicine for preventing HIV, administered only twice a year [2] - Clinical trials showed almost 100% protection against HIV with the injectable [2] - The injectable is the result of 20 years of work by Gilead scientists [2] Compliance and Efficacy - Pill-based HIV prevention faces compliance challenges, with only about 50% of people taking pills being compliant [3] - CDC data indicates only about one-third of the population defined by CDC are compliant with pill-based medicine [3] - Non-compliance with pills can lead to breakthrough cases of HIV [4] - The twice-a-year injectable aims to improve prevention by meeting people where they are in terms of adherence [4]

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]

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