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Gilead Sciences Rallies 27.2% in Six Months: Buy or Sell the Stock?
ZACKS· 2025-07-08 14:56
Key Takeaways GILD stock has surged 27.2% in six months, outpacing its industry, sector, and the S&P 500 index. FDA approval of Yeztugo, the first twice-yearly PrEP, strengthens GILD's HIV portfolio and market edge. New liver drug Livdelzi and rising earnings estimates support GILD's growth and dividend sustainability.Shares of Gilead Sciences, Inc. (GILD) have gained 27.2% in the past six months against the industry’s decline of 2.2%. The stock has also outperformed the sector and the S&P 500 index in th ...
FDA Approves Gilead's Twice-Yearly Shot for HIV Prevention
ZACKS· 2025-06-19 18:31
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]
FDA Places Clinical Hold on Gilead's HIV Studies, Stock Down
ZACKS· 2025-06-11 14:50
Key Takeaways GILD's HIV studies on GS-1720 and GS-4182 were paused due to CD4 and lymphocyte count concerns. The clinical hold affects two phase II/III trials and three phase I studies of GILD's HIV candidates. Biktarvy and Descovy remain strong performers as GILD pushes forward with lenacapavir for HIV prevention.Gilead Sciences, Inc. (GILD) announced that the FDA has placed a clinical hold on studies on pipeline candidates, GS-1720 and/or GS-4182, for the treatment of HIV.GS-1720 is an investigational ...
Gilead Sciences (GILD) FY Conference Transcript
2025-06-10 16:20
Summary of Gilead's Conference Call Company Overview - **Company**: Gilead Sciences - **Industry**: Biotechnology Key Points and Arguments Growth Strategy - Gilead is focusing on three core franchises: virology (HIV), oncology, and inflammation, with a strong emphasis on diversifying beyond virology [3][4] - The company has a robust balance sheet and cash flows, allowing for effective management of operating expenses and investment in growth opportunities [4][5] HIV and Lenacapavir Launch - The launch of lenacapavir for HIV PrEP is imminent, with a PDUFA date set for June 19 [7] - Gilead has been advocating for funding core HIV services, and discussions with the government have been positive regarding support for these programs [8] - Lenacapavir is reported to be 100% effective in preventing HIV, with high community awareness expected to drive uptake [9][10] - The target population for PrEP in the U.S. is approximately 1.2 million, with current users around 400,000, primarily men who have sex with men [13][14] - Gilead aims to improve compliance among current users and expand access to underserved communities [15][16] Reimbursement and Coverage - Gilead expects high insurance coverage for lenacapavir, similar to existing PrEP medications, with an anticipated 70-75% coverage within six months post-launch [22][23] - The company has various support systems in place for individuals with HIV, ensuring access to treatment [24][25] Pipeline and Innovation - Gilead has multiple long-acting HIV programs in development, including a once-a-year injection expected to be available by 2028 [27][28] - The company is also working on alternatives to its leading HIV treatment, Biktarvy, with several programs in various stages of development [32][34] Oncology Developments - Gilead presented significant data at ASCO for Trodelvy in treating triple-negative breast cancer, which could become the new standard of care [36][40] - The oncology business is currently generating over $3 billion annually, with Trodelvy contributing over $1 billion [44] - Gilead is expanding its oncology pipeline with ongoing trials in various cancer types, including lung cancer and multiple myeloma [45][46] Business Development and Future Outlook - Gilead plans to continue investing in late-stage research and development, with a focus on mid-stage acquisitions to complement its portfolio [55][57] - The company is committed to returning value to shareholders through dividends and share buybacks [58] Regulatory Environment - Gilead is actively engaging with the administration regarding potential policy changes, including the MFN executive order, emphasizing the need for a balanced approach to drug pricing [59][60] - The company believes it is less vulnerable to tariffs due to its significant U.S. presence and IP holdings [64][66] Additional Important Content - Gilead's long-term strategy includes exploring novel inflammation targets to complement its existing therapeutic areas [53] - The company is focused on maintaining a competitive edge in the biotechnology sector through innovation and strategic partnerships [54][66]
Gilead Sciences Stock Gains 21% YTD: Buy, Sell or Hold?
ZACKS· 2025-05-30 16:10
Core Viewpoint - Gilead Sciences, Inc. has demonstrated strong performance in a volatile market, with shares up 21.1% year-to-date, significantly outperforming the industry and the S&P 500 Index, which declined by 4.7% [1][8]. Group 1: HIV Market Leadership - Gilead is a dominant player in the HIV market, with its flagship drug Biktarvy accounting for over 51% of the treatment market share in the U.S. [4] - The company’s Descovy for pre-exposure prophylaxis (PrEP) maintains over 40% market share in the U.S. [5] - The FDA has accepted new drug applications for lenacapavir for HIV prevention, with a target action date of June 19, 2025, which could enhance Gilead's HIV franchise [5][6]. Group 2: Liver Disease Portfolio - The FDA approval of seladelpar (Livdelzi) for primary biliary cholangitis (PBC) strengthens Gilead's liver disease portfolio and validates its CymaBay acquisition [7][9]. Group 3: Oncology Business Challenges - Gilead's oncology portfolio, including the Cell Therapy franchise and Trodelvy, faces competitive pressures, particularly in the U.S. and Europe, which are expected to continue into 2025 [10]. - Despite challenges, positive results from the phase III ASCENT-03 study on Trodelvy indicate potential for improvement in the oncology business [11]. Group 4: Financial Performance and Estimates - Gilead's shares trade at a price/earnings ratio of 13.70x forward earnings, lower than the large-cap pharma industry's average of 14.62x but higher than its historical mean of 10.53x [12]. - Earnings estimates for Gilead have increased, with the 2025 bottom-line estimate rising to $7.91 from $7.87, and the 2026 estimate improving to $8.39 from $8.31 [14]. Group 5: Strategic Positioning and Dividends - Gilead's strategic deals and acquisitions are aimed at diversifying its business, although Biktarvy sales may face pressure due to Medicare Part D redesign [17]. - The company has a strong cash position of $7.9 billion as of March 31, 2025, and has consistently increased dividends, declaring a quarterly dividend of $0.79 per share for Q2 2025, indicating a sustainable yield of 2.91% [18].
Gilead Sciences vs GSK: Which HIV Drugmaker is a Smarter Buy Now?
ZACKS· 2025-05-20 18:01
Gilead Sciences, Inc. (GILD) and GSK (GSK) are pioneers in the human immunodeficiency virus (HIV) treatment space.Gilead Sciences is a dominant player in the HIV market with market-leading treatments. HIV drug sales accounted for 69% of total product sales in the first quarter of 2025. GILD’s diverse portfolio also includes drugs for liver, hematology/oncology and inflammation/respiratory diseases.GSK, too, has a strong HIV portfolio in the industry. HIV drug sales accounted for 23% of total sales in the fi ...
2 High-Yield Dividend Stocks to Buy in May and Hold Forever
The Motley Fool· 2025-05-10 12:45
When investing in dividend stocks, paying attention to the right things is essential. A high yield can be attractive, but the most critical factor to consider is a company's underlying operations.Businesses that are solid enough to perform well over extended periods, while consistently raising their payouts, are precisely what income investors should gravitate toward. Here are two corporations which fit that description: AbbVie (ABBV -0.71%) and Gilead Sciences (GILD -1.33%).These two healthcare dividend pa ...
3 Biotech Giants Gaining From U.S. Sales and Policy Shifts
MarketBeat· 2025-05-02 11:02
Core Insights - The current global trade environment is marked by rising tariffs and tensions, prompting investors to seek stability in defensive sectors that are less impacted by economic fluctuations [1][2] - Large-cap biotech companies with a strong domestic focus, such as Gilead Sciences, Amgen, and AbbVie, are gaining attention as potential defensive investments due to their reliance on the U.S. market [2][3] Biotech Companies Overview - Gilead Sciences derives approximately 70.0% of its Q1 2025 product revenue from the U.S., Amgen generates about 74.7% of its Q4 2024 product sales domestically, and AbbVie obtains roughly 74.8% of its Q1 2025 net revenue from the United States [3][4] - The significant concentration of domestic sales provides a buffer against retaliatory tariffs and economic downturns, as demand for essential medicines tends to be inelastic [4][5] Financial Performance and Stability - Gilead Sciences has a market capitalization of around $132.66 billion, with a year-to-date stock gain of 15.3% and a low Beta of approximately 0.32, indicating defensive characteristics [11][13] - Amgen, valued at approximately $156.41 billion, reported a positive year-to-date performance of +11.6% and a Beta of 0.59, suggesting lower volatility [15][16] - AbbVie has a market capitalization of roughly $345.22 billion, achieving a 9.8% operational revenue increase in Q1 2025, with a forward P/E ratio of about 15.85 [18][19] Policy Environment - Recent U.S. government policy shifts are creating a supportive environment for domestic biotech companies, focusing on onshoring and reshoring manufacturing to enhance supply chain resilience [6][8] - Strategies include financial incentives, direct government investments, and prioritizing domestically produced medicines through 'Buy American' initiatives [7][8] Investment Appeal - The combination of strong cash flows, healthy dividends, and low Beta scores makes U.S.-focused biotech companies appealing during uncertain times [21][20] - Analysts have a Moderate Buy consensus on Gilead and AbbVie, while Amgen is rated as a Hold, reflecting confidence in their defensive qualities amidst market volatility [11][19][15]
Gilead Sciences agrees to pay $202 million to settle claims of kickbacks to doctors for HIV drug prescriptions
CNBC· 2025-04-29 17:45
Core Points - Gilead Sciences has agreed to pay $202 million to settle claims of using speaker programs to provide kickbacks to doctors for prescribing its HIV medications [1][2] - The funds were reportedly used for honoraria payments, meals, and travel expenses for doctors participating in these programs [1][3] - The U.S. Attorney's Office stated that Gilead unlawfully sought to increase sales of its HIV drugs through these kickbacks [2][3] Financial Implications - Gilead spent tens of millions of dollars on these speaker programs, including over $20 million specifically on speaking fees [3] - Additional costs included millions spent on meals, alcohol, and travel, all aimed at incentivizing doctors to prescribe Gilead's HIV drugs [3]
GILD Down on Q1 Earnings and Sales Miss, Oncology Sales Decline
ZACKS· 2025-04-25 15:45
Core Viewpoint - Gilead Sciences, Inc. reported disappointing first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.81 and total revenues of $6.7 billion, both missing consensus estimates [1][2][3] Financial Performance - Adjusted EPS of $1.81 missed the Zacks Consensus Estimate by a penny, compared to a loss per share of $1.32 in the same quarter last year [1] - Total revenues of $6.7 billion were flat year over year and missed the Zacks Consensus Estimate of $6.8 billion [1] - Total product sales decreased 1% year over year to $6.6 billion, while excluding Veklury, product sales increased 4% to $6.3 billion [3] Product Sales Breakdown - HIV product sales grew 6% year over year to $4.6 billion, exceeding both the Zacks Consensus Estimate and model estimate of $4.5 billion [3] - Biktarvy sales increased 7% year over year to $3.15 billion but missed the Zacks Consensus Estimate of $3.2 billion [4] - Descovy sales surged 38% year over year to $586 million, beating the Zacks Consensus Estimate of $479 million [5] - Liver Disease portfolio sales rose 3% to $758 million, driven by higher demand for HBV and HDV drugs [6] - Veklury sales plummeted 45% to $302 million, missing the Zacks Consensus Estimate of $387 million [7] - Cell Therapy product sales decreased 3% to $464 million, missing the Zacks Consensus Estimate of $491 million [7] Cost and Margin Analysis - Adjusted product gross margin slightly increased to 85.5% from 85.4% in the year-ago quarter [11] - Research and development expenses totaled $1.3 billion, down from $1.4 billion in the previous year [11] - SG&A expenses amounted to $1.2 billion, down from $1.3 billion [11] Dividend and Guidance - Gilead declared a quarterly dividend of $0.79 per share for Q2 2025, payable on June 27, 2025 [12] - The company reiterated its 2025 guidance, projecting product sales between $28.2 billion and $28.6 billion, with adjusted EPS anticipated in the range of $7.70-$8.10 [13] Pipeline Updates - The FDA accepted new drug application submissions for lenacapavir for HIV prevention, with a target action date of June 19, 2025 [14] - Gilead received conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis [14] Overall Performance Assessment - Gilead's first-quarter results were disappointing, particularly due to a decline in oncology drugs affecting revenue growth [15] - Despite challenges, Biktarvy maintained its dominant position in the HIV market, and Descovy showed strong performance [15] - The potential approval of lenacapavir could further strengthen Gilead's HIV franchise amid increasing competition [16]