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]

Core Insights - Gilead Sciences, Inc. has received marketing authorization from the European Commission for its HIV prevention drug lenacapavir, branded as Yeytuo, which is administered twice a year [1][8] - The approval follows an accelerated review process by the European Medicines Agency, highlighting the drug's significance for public health [3][8] - Lenacapavir has shown superior efficacy in preventing HIV infections compared to daily oral Truvada, with clinical trial data supporting its effectiveness [5][10] Regulatory Approvals - Lenacapavir was also approved by the FDA in June 2025 for the same indication, branded as Yeztugo [2] - The European Commission's approval was based on positive recommendations from the CHMP and data from late-stage trials [3][4] Clinical Efficacy - In the phase III PURPOSE 1 study, lenacapavir demonstrated a 100% reduction in HIV infections among 2,134 participants [5] - The phase III PURPOSE 2 study reported only two HIV infections among 2,179 participants, indicating a 99.9% prevention rate [6] Market Position - The approval of lenacapavir strengthens Gilead's HIV portfolio, especially as its other prevention drug, Truvada, faces generic competition [10] - Gilead holds a leading market share in HIV treatments, with its flagship drug Biktarvy accounting for over 51% of the U.S. treatment market [12] Competitive Landscape - Lenacapavir is positioned as a long-acting injectable PrEP, addressing barriers associated with daily oral medications [11] - The competitive landscape includes ViiV Healthcare's Apretude, which is also a long-acting injectable approved for PrEP [13][14] Pricing and Coverage Issues - Gilead's Yeztugo has a U.S. list price exceeding $28,000 per year, and negotiations with CVS Health regarding coverage are ongoing [15]

Core Insights - Gilead Sciences, Inc. (GILD) shares fell 2.2% following CVS Health's decision not to include GILD's new HIV prevention drug, Yeztugo, in its commercial plans for the time being [1][8] - CVS Health's decision was influenced by clinical, financial, and regulatory factors, and Yeztugo will not be covered under its Affordable Care Act formularies [2] - GILD is negotiating with CVS regarding Yeztugo, which has a U.S. list price exceeding $28,000 annually [2] Gilead's Product Developments - Yeztugo received FDA approval in June 2025 for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg, and it is the first and only twice-yearly HIV PrEP option available in the U.S. [3][5] - GILD aims to secure 75% insurer coverage for Yeztugo by year-end 2025 and 90% within 12 months [3] Market Context - Currently, GILD markets two FDA-approved daily oral medications for PrEP: Truvada and Descovy [4] - GILD's shares have increased by 25.7% year-to-date, outperforming the industry growth of 4% [5] Acquisition Activity - Gilead's subsidiary, Kite, announced an agreement to acquire Interius BioTherapeutics for $350 million, which focuses on developing in vivo CAR therapeutics [7][9] - This acquisition is expected to impact GILD's earnings per share by approximately $0.23-$0.25 [8][9] Competitive Landscape - Gilead currently holds a Zacks Rank 3 (Hold), while CorMedix (CRMD) and ANI Pharmaceuticals (ANIP) have better rankings with Zacks Rank 1 (Strong Buy) [10] - CorMedix's earnings per share estimates have increased significantly, and its shares have rallied 49.1% year-to-date [11] - ANI Pharmaceuticals has also seen a slight increase in earnings estimates and a year-to-date share increase of 29.4% [12]

Core Insights - Gilead Sciences, Inc. reported better-than-expected Q2 2025 results, with adjusted EPS of $2.01 surpassing the Zacks Consensus Estimate of $1.95 and remaining flat year over year [1] - Total revenues reached $7.1 billion, exceeding the Zacks Consensus Estimate of $6.9 billion, marking a 2% year-over-year increase driven by higher sales in HIV, Livdelzi, and Trodelvy [1] Financial Performance - Product sales increased 2% year over year to $7.1 billion; excluding Veklury, product sales rose 4% to $6.9 billion [5] - HIV product sales grew 7% year over year to $5.1 billion, driven by increased demand and higher average realized prices, beating estimates [5][6] - Biktarvy sales increased 9% year over year to $3.5 billion, holding over 51% market share in the U.S. treatment market [6] - Descovy sales surged 35% year over year to $653 million, maintaining over 40% market share in pre-exposure prophylaxis (PrEP) [7] - Liver Disease portfolio sales decreased 4% to $795 million, primarily due to lower chronic HCV sales impacted by Medicare Part D redesign [9] - Veklury sales plummeted 44% to $121 million due to reduced COVID-19-related hospitalizations [9] - Cell Therapy product sales fell 7% to $485 million, missing estimates due to competitive pressures [10] - Trodelvy sales increased 14% year over year to $364 million, driven by higher demand [11] Cost and Guidance - Adjusted product gross margin improved to 86.9% from 86% year over year [12] - R&D expenses rose to $1.5 billion from $1.3 billion due to increased clinical manufacturing activities [12] - Gilead raised its 2025 product sales guidance to between $28.3 billion and $28.7 billion, with adjusted EPS now anticipated in the range of $7.95-$8.25 [14][15] Pipeline Developments - Gilead received FDA approval for lenacapavir (Yeztugo), a twice-yearly injectable HIV-1 capsid inhibitor for prevention, marking a significant addition to its HIV portfolio [16][20] - The company entered a partnership with Kymera Therapeutics to develop a novel molecular glue degrader program targeting CDK2, with potential payments up to $750 million [18] Market Position - Gilead's strong performance in the HIV segment is expected to continue, with projected growth of approximately 3% in 2025, driven by Biktarvy and Descovy [19] - The approval of Yeztugo addresses barriers to PrEP adoption, providing a competitive advantage over daily oral medications [21] - Gilead's breast cancer drug Trodelvy is gaining market share, while cell therapies face competitive challenges [22][23]

Core Insights - The FDA approved Gilead Sciences' Yeztugo (lenacapavir) as the first and only twice-yearly PrEP option in the U.S. for HIV prevention, showing ≥99.9% efficacy in trials [1][2][5] - The European Medicines Agency's CHMP has recommended lenacapavir for PrEP, with a final decision from the European Commission expected later this year [2][3] - Positive trial results indicate lenacapavir's superiority over daily oral Truvada in preventing HIV infections [4][5] Company Developments - Gilead's Yeztugo could significantly contribute to revenue, with projections of $4.1 billion in sales by 2030 and $6.4 billion by 2035, driven by its ease of use compared to current treatments [6][7] - Needham upgraded Gilead's stock rating from Hold to Buy, forecasting a price of $133 based on positive physician feedback and market potential [6] Market Outlook - The HIV prevention market is expected to grow by approximately 49% by 2030, with Yeztugo anticipated to capture about 38% of this growth [7] - Gilead's revenue heavily relies on its HIV drugs, with around 70% coming from this segment, making Yeztugo a crucial growth driver [7]

Core Insights - Merck has initiated two late-stage clinical studies for MK-8527, a once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP) [1][8] - The studies aim to enroll nearly 9,000 participants and will compare MK-8527 with Gilead's daily oral PrEP pill, Truvada [2][8] - The initiation of these studies is backed by positive Phase II results showing similar adverse event rates between treatment and placebo [3] Company Developments - Merck is expanding its HIV portfolio, focusing on both prevention and treatment, with MK-8527 being a key component [6][10] - The FDA has accepted a regulatory filing for Merck's once-daily, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for treating HIV-1, with a decision expected by April 28, 2026 [7] - Merck is also collaborating with Gilead on a once-weekly, two-drug, single-tablet regimen of islatravir/lenacapavir (ISL/LEN) [9][10] Competitive Landscape - Merck's growing HIV portfolio positions it to compete with Gilead, which currently leads the market with its PrEP medications, Truvada and Descovy [11] - If approved, MK-8527 could challenge Gilead's dominance in the PrEP market [11] - Gilead's recent approval of lenacapavir, a twice-yearly injectable for HIV prevention, adds to the competitive pressure in the HIV therapeutic space [13] Market Context - GSK is another significant player in the HIV market, with strong sales driven by products like Cabenuva, Apretude, and Dovato [14] - The competitive dynamics in the HIV space are intensifying as companies innovate and expand their product offerings [11][14]

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]