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 has commenced the delivery of lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for HIV prevention as pre-exposure prophylaxis (PrEP) in Eswatini and Zambia [1] Group 1 - The deliveries are part of efforts to enhance equitable access to long-acting HIV prevention methods across sub-Saharan Africa [1] - Sub-Saharan Africa accounts for approximately two-thirds of all individuals living with HIV [1]

Group 1: Company Overview - Gilead Sciences, Inc. (NASDAQ:GILD) is recognized as one of the 15 Best Passive Income Stocks to Buy Right Now [1] - Gilead remains a reliable dividend payer, with shares increasing over 36% since the beginning of 2025, outperforming the broader market [3] Group 2: Financial Performance - In the third quarter, Gilead reported total revenue of $7.8 billion, reflecting a 3% increase year-over-year [3] - Oncology revenue experienced a decline of 3% year-over-year, totaling $788 million in the third quarter [4] Group 3: Market Position and Future Outlook - Gilead continues to lead the HIV drug market, which is a significant driver of its growth [3] - The company has a large and active oncology pipeline, now larger than its HIV portfolio, with expectations for label expansions and new approvals in the cancer market to boost overall sales in the coming years [4] - Scotiabank analyst Louise Chen maintains an Outperform rating on Gilead, highlighting the potential for attractive entry points in large-cap biopharma stocks before the next wave of innovation [2]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI technologies [3][7][8] Investment Landscape - Wall Street is investing hundreds of billions into AI, but there is a pressing concern regarding the energy supply needed to sustain this growth [2] - AI data centers consume vast amounts of energy, comparable to that of small cities, leading to rising electricity prices and strained power grids [2][3] - The company in focus is positioned to capitalize on the surge in demand for electricity driven by AI, making it a potentially lucrative investment opportunity [3][8] Company Profile - The company is described as a "toll booth" operator in the AI energy boom, benefiting from the increasing need for energy infrastructure [4][5] - It is involved in various sectors, including nuclear energy, LNG exportation, and renewable fuels, making it a versatile player in the energy market [7][8] - The company is noted for being debt-free and holding a significant cash reserve, which is nearly one-third of its market capitalization [8][10] Market Position - The company has an equity stake in another AI-related venture, providing investors with indirect exposure to multiple growth opportunities in the AI sector [9][10] - It is trading at a low valuation, less than 7 times earnings, which is attractive for investors looking for undervalued stocks in the AI and energy space [10][11] - The company is gaining attention from hedge funds, indicating a growing recognition of its potential in the market [9][10] Future Outlook - The ongoing AI infrastructure supercycle, combined with the onshoring trend and increased U.S. LNG exports, positions the company favorably for future growth [14] - The influx of talent into the AI sector is expected to drive continuous innovation, further enhancing the investment appeal of companies involved in AI and energy [12][13]

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. announced topline results from the Phase 3 ARTISTRY-1 trial, which evaluated the efficacy of a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) for HIV patients who are virologically suppressed [1][2] - The trial demonstrated that the BIC/LEN regimen met the primary success criterion for non-inferiority compared to baseline multi-tablet antiretroviral therapy [2] - BIC/LEN was generally well tolerated, with no significant safety concerns identified during the trial [2] Trial Details - ARTISTRY-1 is a multicenter Phase 2/3 clinical trial comparing the once-daily combination of bictegravir and lenacapavir against current therapies for HIV patients on complex regimens [3] - Participants were randomized in a 2:1 ratio to receive either the BIC/LEN combination or continue their stable baseline regimen [4] - Key secondary endpoints included virologic suppression rates, changes in CD4 cell count, and treatment-emergent adverse events (TEAEs) at week 48 [4] Future Evaluations - Further evaluation of the BIC/LEN combination is ongoing in the double-blind Phase 3 ARTISTRY-2 trial, which is assessing the safety and efficacy of switching from BIKTARVY to BIC/LEN in virologically suppressed HIV-1 patients [5] - Topline data for the primary endpoint of ARTISTRY-2 is expected before the end of the year [5] Market Reaction - Following the announcement, Gilead's stock price increased by 2.97%, reaching $127.07 [6]

Core Insights - Regeneron Pharmaceuticals stock increased by 19% over the past month due to strong third-quarter earnings and robust sales of its flagship drugs, Dupixent and Libtayo [1] - Gilead Sciences presents a more favorable investment option compared to Regeneron, with superior revenue growth and profitability metrics [3][4] Revenue Growth Comparison - Gilead Sciences reported a quarterly revenue growth of 3.0%, while Regeneron achieved only 0.9% [3] - Over the last three years, Gilead's average revenue growth was 2.3%, surpassing Regeneron's 1.4% [3] Profitability Metrics - Gilead outperformed Regeneron in profitability, with a last twelve months margin of 38.3% and a three-year average margin of 39.2% [4] Valuation and Performance Overview - A detailed comparison of financials indicates that Gilead's fundamentals are stronger in terms of growth, margins, momentum, and valuation multiples compared to Regeneron [4][5] Investment Strategy - Asset allocation is recommended as a more prudent strategy than merely selecting individual stocks, with Trefis' High Quality Portfolio showing positive results during market downturns [5][8]

Group 1: Pharmaceutical and Biotechnology Sector - Scotiabank initiated coverage on major pharmaceutical and biotech firms with "sector outperform" ratings, setting price targets of $140 for Gilead Sciences (GILD), $1165 for Eli Lilly (LLY), $105 for Merck & Co Inc (MRK), $385 for Amgen Inc (AMGN), and $230 for Johnson & Johnson (JNJ) [2][8] Group 2: Global Market Performance - The ASX 200 Index in Australia declined by 0.52%, closing at 8753.40 points, indicating mixed sentiment in the Asia-Pacific region [3][8] - The Japanese bond market showed stability as super long bond yields eased, suggesting continued demand for longer-dated Japanese government bonds following a firm auction outcome [3][8] Group 3: Energy Sector - Gerdes Energy Research raised its price target for Chevron Corp (CVX) by $1 to a new target of $171, reflecting a positive outlook for the oil major amidst ongoing market dynamics [4][8] Group 4: Currency Markets - The Euro remained stable, trading near 1.1600 against the US Dollar after the US government ended its shutdown, providing clarity for currency traders [5][8] - The Pound Yen held steady above 203.00, near a two-week high, as traders awaited further economic indicators from the UK [5][8]

Core Viewpoint - The appointment of Richard Pazdur as the new director of the FDA's Center for Drug Evaluation and Research has boosted investor confidence in the pharmaceutical sector, leading to record-high stock prices for major pharmaceutical companies [1][2]. Group 1: Appointment Details - Richard Pazdur, with 26 years of experience at the FDA, has been appointed as the new director, succeeding George Tidmarsh, who resigned following an investigation [1]. - Pazdur will continue to serve as the director of the FDA's Oncology Center of Excellence until a successor is determined [1]. Group 2: Market Reaction - The VanEck Vectors Pharmaceutical ETF, covering 25 global pharmaceutical companies, has seen a three-day rise, reaching an all-time high, with notable gains from companies like Novo Nordisk, Bristol-Myers Squibb, and Gilead [1]. - The SPDR S&P Biotech ETF also recorded a three-day increase, hitting its highest level since January 2022, with strong performances from Regeneron and BioNTech [1]. Group 3: Analyst Sentiment - Analysts generally view Pazdur's appointment positively, with Raymond James analyst Chris Mkins stating he could be the best choice for patients and the industry [2]. - The appointment may signal a significant shift in regulatory strategy from FDA leadership, according to industry experts [2]. - Medical media outlet Stat News welcomed the appointment, highlighting it as a positive development for the FDA during a turbulent period [2].

Group 1 - The company is engaged in ongoing and constructive discussions with the U.S. administration regarding Medicaid exposure, indicating a proactive approach to policy changes [1][2] - The senior team is actively meeting with key stakeholders in Washington D.C., emphasizing the importance of these relationships in navigating the regulatory landscape [2] - The administration aims to avoid actions that could harm the sector and innovation, suggesting a supportive environment for companies in the industry [3]