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GILD Exercises Option to License Assembly Bio's Herpes Programs
ZACKS· 2025-12-23 16:45
Key Takeaways GILD will exclusively license and advance ASMB's HSV candidates ABI-1179 & ABI-5366 for genital herpes.Interim data on ABI-1179 & ABI-5366 showed strong antiviral activity and reduced virus-positive lesions.ASMB will receive $35M upfront and may earn up to $330M in milestones plus tiered royalties on sales.Gilead Sciences (GILD) recently announced that it has exercised its combined option to exclusively license Assembly Biosciences’ (ASMB) herpes simplex virus (HSV) helicase-primase inhibitor ...
Will GILD's Strong HIV Portfolio Reap Rewards in 2026?
ZACKS· 2025-12-19 14:16
Core Insights - Gilead Sciences, Inc. (GILD) maintains a leading position in the HIV market, primarily driven by its flagship therapies Biktarvy and Descovy, which have significantly contributed to the company's revenue growth in recent quarters [1][9] Gilead's HIV Portfolio - The FDA approved lenacapavir, branded as Yeztugo, as the first and only twice-yearly injectable HIV-1 capsid inhibitor for prevention, enhancing GILD's HIV portfolio amid generic competition for Truvada [2][9] - Yeztugo's competitive edge lies in its biannual dosing, appealing to a broader population compared to daily oral medications [3] - Gilead's investigational single-tablet regimen combining bictegravir and lenacapavir has met primary endpoints in phase III studies, indicating potential for regulatory submission [4][5] Competitive Landscape - The HIV treatment market includes major competitors like GSK and Merck, with GSK's HIV portfolio benefiting from strong demand for long-acting injectables and Dovato, while Merck markets doravirine in various formulations [7][8][10] Financial Performance - Gilead's stock has increased by 31.2% over the past year, outperforming the industry average growth of 15% [11] - The company's shares are trading at a price/earnings ratio of 14.32x forward earnings, which is above its historical mean of 10.93x but below the large-cap pharma industry's average of 17.11x [12] - Earnings estimates for 2025 have risen to $8.17 from $8.07, while the estimate for 2026 has slightly decreased to $8.50 from $8.51 [13]
GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal
ZACKS· 2025-12-16 14:56
Key Takeaways GILD's ARTISTRY-2 showed once-daily BIC/LEN was non-inferior to Biktarvy at week 48.GILD randomized virologically suppressed patients 2:1 to switch to BIC/LEN or stay on Biktarvy.GILD plans regulatory filings combining phase III results from ARTISTRY-1 and ARTISTRY-2.Gilead Sciences, Inc. (GILD) announced that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the late-stage ARTISTRY-2 study.ARTISTRY-2 is a multicenter, ...
Gilead Sciences, Inc. (GILD) Presents at Citi Annual Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-12-03 06:23
Core Insights - Gilead Sciences has had a strong performance in 2025, leading to an increase in guidance for the year [2] - The company boasts a durable portfolio, with flagship HIV therapies Biktarvy and Descovy driving significant growth, alongside promising new launches [3] - Gilead has the strongest pipeline in its history, indicating a steady flow of clinical data that could enhance product offerings [4] Financial Performance - The third quarter results reflect a terrific start to 2025, showcasing overall business momentum [2] Product Portfolio - The base business is significantly supported by Biktarvy and Descovy, with new products like Yeztugo and Livdelzi showing strong initial performance [3] - Yeztugo is highlighted as a transformational HIV prevention medicine with a unique six-month injection schedule [3] Pipeline Development - Gilead's pipeline is described as the deepest and broadest in the company's history, suggesting ongoing clinical developments that may lead to new product introductions [4]
Gilead(GILD) - 2025 FY - Earnings Call Transcript
2025-12-02 17:17
Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for market expansion [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel in terms of clinical development? - Management confirmed that there are plans to move Anito-cel into earlier lines of treatment, with significant market opportunities identified [25][26] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects to receive an updated label for Trodelvy next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]
Gilead(GILD) - 2025 FY - Earnings Call Transcript
2025-12-02 17:17
Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for growth in the market [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel and its market potential? - Management indicated that Anito-cel is expected to launch in the fourth-line plus market by the end of next year, with significant growth opportunities in multiple myeloma [24][25] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects updated label expansion filings for Trodelvy in the U.S. next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards more innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]
Gilead(GILD) - 2025 FY - Earnings Call Transcript
2025-12-02 17:15
Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of FY 2025, with less than $100 million expected in Q4 [2] - The operating margin improved to roughly 50% in Q3, up from just below 40% previously, indicating strong operational leverage [34][36] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, driven by the launch of Sunlenca and the growth of Descovy, which saw a 32% increase in the same period [6][10] - Biktarvy, a key HIV treatment, generated $3.5 billion in sales in Q3, showcasing its strong market position [3][15] Market Data and Key Metrics Changes - The HIV prevention market is estimated to have around 500,000 patients currently on therapy, with the CDC estimating that at least 2.2 million people in the U.S. could benefit from HIV prevention [7][11] - The company noted that the market opportunity for HIV prevention could be much larger, with 10-12 million people diagnosed with sexually transmitted diseases annually in the U.S. [7] Company Strategy and Development Direction - The company is focused on building awareness and changing prescriber habits to promote the shift from daily oral medications to long-acting injectables [2][5] - A patent settlement extended the exclusivity of Biktarvy until at least 2036, allowing the company to plan long-term without immediate competitive pressures [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the steady growth of the HIV prevention market and the potential for Sunlenca to capture a significant share [3][10] - The company is confident in its pipeline, with multiple launches expected in the coming years, which will support diversification and growth [29][36] Other Important Information - The company is actively pursuing business development opportunities, particularly in China, where it has seen a shift towards more innovative assets [31][32] - The company plans to continue investing in R&D while maintaining a disciplined approach to operational expenses [34][36] Q&A Session Summary Question: Can you discuss the early demand for Sunlenca? - Management noted that early demand is coming from naive patients and those switching from generic Truvada, with a significant portion also switching from other long-acting injectables [9][10] Question: What is the strategy for educating patients and physicians about Sunlenca? - The company is building a sales force and healthcare educators to work directly with physicians and is planning advertising campaigns to raise awareness [5][11] Question: How does the patent settlement for Biktarvy influence long-term planning? - The extended exclusivity until 2036 allows for strategic planning without immediate concerns about competition, supporting the development of next-generation treatments [14][15] Question: What are the growth opportunities for Anito-cel in multiple myeloma? - The company plans to move Anito-cel into earlier lines of treatment, targeting a sizable market opportunity in both second-line and first-line therapies [24][25] Question: What is the outlook for Trodelvy in triple-negative breast cancer? - Trodelvy is expected to continue growing, especially with label expansion anticipated next year, contributing to sustained growth over time [27]
艾滋病攻防50年:一部未完待续的创新史
3 6 Ke· 2025-12-01 23:13
Core Viewpoint - The global fight against HIV/AIDS is facing significant setbacks, with 40.8 million current HIV infections worldwide and 9.2 million individuals not receiving treatment, leading to an estimated 1.3 million new infections in 2024 [1] Group 1: Vaccine Development Challenges - Despite nearly 40 years of research and billions spent, no effective HIV vaccine has been developed due to the virus's high mutation rate and complexity [2][4] - The ideal HIV vaccine should stimulate the production of neutralizing antibodies, but the high mutation rate of HIV's envelope proteins makes this difficult [3][4] - The presence of glycoproteins on HIV's surface further complicates the ability of neutralizing antibodies to recognize and bind to the virus [4][5] - The immune system's destruction by HIV makes it challenging to mount an effective immune response, as CD4 cells, which are targeted by the virus, are crucial for signaling immune reactions [6][7] - The failure of major clinical trials, such as Johnson & Johnson's, highlights the difficulties in developing an effective HIV vaccine [8] Group 2: Advances in Antiviral Drugs - While vaccine development has stalled, antiviral drugs have significantly improved, now playing a crucial role in HIV prevention [8] - Oral antiretroviral drugs have become the cornerstone of HIV treatment, with established guidelines for pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) [8] - Adherence to medication remains a challenge, with only 58.4% adherence reported by the end of 2022, limiting the effectiveness of prevention strategies [8] - Gilead Sciences' long-acting antiviral drug, lenacapavir, has shown promising results in clinical trials, achieving 100% prevention in one study and 96% risk reduction in another [9] - Lenacapavir has been approved by the FDA for HIV prevention, marking a significant advancement in the field, although its high cost and regulatory uncertainties may affect widespread adoption [9] Group 3: Future Directions - The ongoing battle against HIV/AIDS has not yet yielded a definitive solution, but innovative technologies are paving the way for better prevention and treatment strategies [10][11] - The focus on long-acting, low-frequency dosing regimens represents a potential breakthrough in addressing the core challenges of HIV prevention [9][10]
Gilead (GILD) Earns Buy Rating at Truist as HIV Franchise Continues to Deliver
Yahoo Finance· 2025-11-30 18:58
Core Insights - Gilead Sciences, Inc. (NASDAQ:GILD) is recognized as one of the 15 Best Boring Dividend Stocks to Buy, indicating a stable investment opportunity in the dividend space [1] - Truist initiated coverage of Gilead with a Buy rating and a price target of $140, citing the strength of its HIV portfolio and promising next-generation programs as key factors for a positive long-term outlook [2] - The company's HIV treatment Biktarvy generated $3.7 billion in sales, reflecting a 6% increase year-over-year, while Descovy's revenue rose 20% to $701 million, showcasing robust performance in its core business [3] - Gilead's liver disease treatments also contributed to growth, with sales increasing 12% year-over-year to $819 million, supporting the company's diversification strategy [4] Business Performance - Gilead's underlying business remains solid, with a focus on broadening its portfolio beyond the HIV segment to reduce dependence on it over time [4] - The ongoing strength of the HIV franchise and advancements in oncology efforts are viewed as significant drivers for future growth [2][3]
Bristol Myers vs Gilead Sciences: Which Biotech Stock Is a Better Bet Now?
ZACKS· 2025-11-28 14:36
Core Insights - Bristol Myers Squibb (BMY) and Gilead Sciences, Inc. (GILD) are prominent biotechnology companies with diverse portfolios and global reach [1][2] - GILD is a leader in the HIV market, with significant revenue contributions from its key drugs [4][10] - BMY has a strong oncology portfolio, with drugs like Opdivo driving revenue despite facing generic competition [12][17] Gilead Sciences (GILD) - GILD's flagship HIV drug, Biktarvy, holds over 52% of the U.S. treatment market and is the most prescribed regimen for HIV-1 infection [4][10] - The company has received FDA approval for lenacapavir, a twice-yearly injectable HIV prevention drug, which generated $39 million in sales in Q3 [5][6] - GILD forecasts a 5% revenue growth in HIV for 2025, up from a previous estimate of 3% [7] - The liver disease portfolio has been bolstered by the FDA approval of Livdelzi, which exceeded $100 million in quarterly sales for the first time [9] - GILD's oncology portfolio includes Trodelvy and a Cell Therapy franchise, although the latter faces competitive pressures [10][11] - GILD's total debt-to-total-capital ratio was 53.8% as of September 30, 2025, with $9.4 billion in cash and $25 billion in long-term debt [11] Bristol Myers Squibb (BMY) - BMY's growth portfolio includes drugs like Opdivo, which is the top revenue generator and shows strong sales momentum [12][13] - The approval of Opdivo Qvantig has further strengthened BMY's immuno-oncology portfolio, with projected global sales growth [14] - BMY's Reblozyl and Breyanzi have also contributed significantly to revenue, with Reblozyl annualizing over $2 billion in sales [15] - BMY is facing challenges from generic competition for legacy drugs, impacting overall revenue growth [17] - The company announced the acquisition of Orbital Therapeutics for $1.5 billion, which will enhance its pipeline with promising candidates [18][19] - BMY's total debt-to-total-capital ratio was 72.5% as of September 30, 2025, with $15.7 billion in cash and $44.5 billion in long-term debt [20] Financial Estimates and Performance - The Zacks Consensus Estimate for BMY's 2025 sales indicates a decrease of 0.82%, while EPS is expected to increase by 466.96% [21] - GILD's 2025 sales are projected to grow by 1.05%, with EPS expected to improve by 76.84% [22] - GILD has outperformed BMY in price performance, gaining 38% compared to BMY's loss of 12.9% [24] - GILD's shares trade at a forward P/E ratio of 15.15, while BMY's is at 8.17, indicating GILD is more expensive [25] - BMY offers a higher dividend yield of 5.04% compared to GILD's 2.48% [26] Investment Outlook - Both companies hold a Zacks Rank 3 (Hold), making the choice between them complex [29] - GILD's innovation in the HIV portfolio and recent approvals position it for growth [29] - BMY's efforts to stabilize revenue amid generic competition are noted, but significant challenges remain [30]