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 ...

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]

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, ...

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]

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]

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]

Summary of Gilead Sciences Conference Call Company Overview - **Company**: Gilead Sciences (NasdaqGS:GILD) - **Event**: Jefferies Healthcare London Conference - **Date**: November 19, 2025 Key Points Industry and Company Performance - Gilead has experienced significant growth in its base business over the past three years, with base revenues (excluding COVID antiviral) growing 7% in 2023 and 5% in the current year despite a $1.1 billion headwind from Medicare Part D reform, indicating a potential 9%-10% growth in the base business [3][4] - The company has diversified its portfolio into virology, HIV, oncology, and inflammation, with a notable increase in R&D spending, which has more than doubled since 2016 [2][3] Capital Allocation and M&A Strategy - Gilead is focused on building a commercial infrastructure around assets rather than pursuing bolt-on acquisitions, with an annual business development budget of over $1 billion for partnerships and small acquisitions [5][6] - Recent acquisitions include a STAT6 degrader for inflammation and an in vivo cell therapy company, Interius, for a couple hundred million dollars [6] - The company is prioritizing late-stage, de-risked assets that synergize with its existing commercial infrastructure, with no major patent cliffs until 2036 [7][8] Market Dynamics and Opportunities - Gilead is increasingly looking to China for partnerships and acquisitions, with over half of its business development priorities for 2025 coming from Chinese companies, a significant increase from 5% five years ago [9][10] - The launch of Yeztugo, a long-acting HIV prevention drug, is underway, with $54 million in sales reported and guidance of nearly $100 million for the fourth quarter [11][14] - The HIV prevention market is transitioning from daily oral medications to long-acting injectables, with over 75% of covered lives having unrestricted access to Yeztugo [15][16] Product Launch and Market Potential - Yeztugo is positioned to open a new chapter in HIV prevention, with groundbreaking studies showing 100% and 99.9% prevention rates in different populations [12][13] - The CDC has recently doubled its estimates for the addressable PrEP market from 1.2 million to 2.2 million, indicating significant growth potential [33] - Gilead expects the market to be split 50% oral and 50% injectables by 2030, with ongoing development of a once-yearly injectable version of Yeztugo [32][35] Future Pipeline and Innovations - Gilead is advancing multiple late-stage trials in its HIV treatment portfolio, including a new daily combination regimen and a six-month infusion treatment for patients not controlled on existing therapies [38][41] - The company is also developing anito-cel, a BCMA cell therapy for multiple myeloma, with plans to file for approval by the end of 2025 and launch by late 2026 [44][46] Manufacturing and Competitive Advantage - Gilead has built a robust manufacturing infrastructure for cell therapies, with the capacity to treat up to 24,000 patients by 2026, providing a competitive edge in reliability and speed compared to competitors [46][47] Additional Insights - The company emphasizes the importance of adherence in HIV prevention, noting that long-acting injectables guarantee adherence, which is a significant advantage over daily oral medications [36] - Gilead's approach to market growth is characterized by steady, durable, and consistent growth rather than rapid spikes, reflecting a long-term strategy for its product launches [27][28]

Core Insights - Gilead Sciences, Inc. announced that its investigational single-tablet regimen (STR) of bictegravir and lenacapavir for HIV-1 treatment met the primary endpoint in the late-stage ARTISTRY-1 study [1][5] Study Results - The ARTISTRY-1 study is a multicenter phase II/III trial comparing the once-daily combination of bictegravir and lenacapavir against current therapy in HIV patients who are virologically suppressed on complex regimens [2][4] - The study showed that the STR met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens, with the primary efficacy endpoint being the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at week 48 [5][8] - The combination was generally well tolerated, with no significant or new safety concerns identified [5][8] Market Performance - Gilead's shares have surged 35.6% year to date, outperforming the industry growth of 15.4% [3] Future Plans - Gilead plans to file the late-stage data from the ARTISTRY trials with regulatory authorities [6][10] - The company is also conducting the double-blind, phase III ARTISTRY-2 trial, evaluating the safety and efficacy of switching from Biktarvy to the fixed-dose combination of bictegravir and lenacapavir in virologically suppressed people with HIV-1, with top-line data expected before the end of 2025 [10] HIV Franchise Strength - Gilead has a market-leading HIV franchise, with Biktarvy and Descovy as flagship therapies driving top-line growth [11] - Biktarvy accounts for over 52% of the treatment market in the U.S., while Descovy holds more than 45% of the U.S. PrEP market [11][12] - The FDA approval of lenacapavir under the brand name Yeztugo for twice-yearly PrEP has further strengthened Gilead's HIV portfolio [12][13] - Yeztugo generated $39 million in sales in the third quarter, achieving a 75% coverage goal ahead of schedule, with a target of 90% coverage by mid-2026 [14] Competitive Landscape - Positive data from the ARTISTRY studies is expected to bolster Gilead's position amid increasing competition from companies like GSK, which is expanding its HIV business with long-acting injectable medicines [15]

Core Insights - Gilead Sciences, Inc. has reached settlement agreements with generic manufacturers to resolve patent litigations regarding its HIV treatment Biktarvy, which generated $6.7 billion in sales in the first half of 2025 [1][4][7] - The company's shares have increased by 25.6% year to date, outperforming the industry growth of 10.1% [2] Patent Settlements - Gilead has settled with Lupin Ltd., Cipla Ltd., and Laurus Labs Ltd., preventing generic versions of Biktarvy from entering the U.S. market before April 1, 2036 [4][5][7] - These agreements provide nearly a decade of patent protection for Biktarvy, which holds over 51% of the U.S. HIV treatment market [5][7] HIV Portfolio Growth - Gilead's HIV portfolio has been bolstered by the FDA approval of lenacapavir (Yeztugo), the first twice-yearly injectable HIV-1 capsid inhibitor for prevention [6][8] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue growth, driven by strong performances from Biktarvy and Descovy [8] Competitive Landscape - The European Commission has granted marketing authorization for lenacapavir under the brand name Yeytuo, enhancing Gilead's competitive position [9] - Gilead's innovation efforts are crucial for maintaining growth amid competition from GSK, which has strong demand for its HIV products [9] Collaborations and Future Developments - Gilead is collaborating with Merck to evaluate a combination treatment for HIV, with a phase III update expected in 2026 [10] - Merck has also submitted a new drug application for a once-daily oral regimen for HIV treatment, with a target action date set for April 28, 2026 [11]

Core Insights - Gilead Sciences, Inc. (GILD) has demonstrated strong performance in 2025, with shares rising 26.5% year to date, significantly outperforming the industry growth of 6% [1][9] - The FDA approval of lenacapavir, branded as Yeztugo, for HIV prevention has been a pivotal event, marking it as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option in the U.S. [3][7] Gilead's HIV Portfolio - Gilead holds a leading position in the HIV treatment market, with its flagship drug Biktarvy commanding over 51% market share in the U.S. [4] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue, driven by strong performances from Biktarvy and Descovy [5] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as Truvada faces generic competition [6] Oncology and Cell Therapy - Gilead's oncology portfolio includes Trodelvy, which has shown strong performance in treating metastatic triple-negative breast cancer, with plans for further approvals [11] - However, the Cell Therapy franchise, including Yescarta and Tecartus, is facing competitive pressures in the U.S. and Europe [12] - Gilead's subsidiary Kite has acquired Interius BioTherapeutics for $350 million, enhancing its capabilities in CAR T-cell therapies [13] Liver Disease Portfolio - The FDA approval of seladelpar, branded as Livdelzi, for primary biliary cholangitis (PBC) has strengthened Gilead's liver disease portfolio [14][15] Financial Performance and Estimates - Gilead's shares are currently trading at a price/earnings ratio of 13.62x forward earnings, lower than the large-cap pharma industry's average of 14.83x [16] - Earnings estimates for 2025 have increased to $8.10 from $8.02, while the estimate for 2026 has slightly decreased to $8.50 from $8.53 [17] Strategic Collaborations - Gilead has partnered with the U.S. State Department to deliver lenacapavir, indicating a commitment to expanding its HIV prevention efforts [10] - The company is also collaborating with Merck to evaluate a combination treatment for HIV, with updates expected in 2026 [20] Dividend and Cash Position - Gilead has maintained a strong cash position, with $7.1 billion in cash and equivalents as of June 30, 2025, supporting its sustainable dividend yield of 2.76% [22] - In Q2 2025, Gilead paid out $994 million in dividends and repurchased $527 million of common stock, reflecting its commitment to returning value to shareholders [21]