GILEAD SCIENCES (GILD) Company Report

Gilead reports that Purpose 1/2 trials of long-acting HIV prevention showed 96% participant retention, and its move to an intramuscular (IM) formulation supports development of once-yearly dosing in the Purpose 365 study.
The company prioritized its long-acting integrase inhibitor GS-3242 over GS-1219 based on pharmacokinetics and tolerability, while its wholly owned once-weekly integrase plus lenacapavir prodrug combination is on clinical hold pending investigation of transient CD4⁺ T-cell decreases.
The bictegravir-lenacapavir (BIC-Len) two-drug regimen demonstrated high efficacy and low resistance emergence in Artistry-1, and is positioned for the switch setting with Artistry-2 readout expected soon.
An oral α4β7 integrin inhibitor for inflammatory bowel disease in the Phase II Swift trial has data due next year and aims to replicate or improve upon Entyvio-like efficacy with the convenience of oral dosing.
Gilead unveiled a next-generation bicistronic CD19/CD20 CAR-T candidate designed for enhanced safety and efficacy to succeed Yescarta/Tecartus and highlighted early in vivo CAR-T programs supported by strategic acquisitions.

1 day ago

Transcript

Gilead presents R&D pipeline at Evercore HealthCONx conference

GILD

Gilead’s shift to intramuscular Sunlenca aims for a once-per-year HIV prevention regimen (Purpose 365), addressing subcutaneous nodules and improving compliance with low-frequency dosing.
Prioritized GS-3242 over GS-1219 for a longer-acting integrase inhibitor; the wholly owned weekly combination of GS-1720 and a lenacapavir prodrug is on clinical hold due to CD4⁺ T cell declines likely linked to metabolites.
BIC + Lenacapavir (BIC-Len) Phase III ARTISTRY-1 (treatment-experienced) and ARTISTRY-2 (switch setting, including Biktarvy) trials nearing readouts, with ARTISTRY-1 demonstrating high efficacy despite pre-existing resistance.
Advancing next-gen CD19/CD20 CAR-T to potentially replace Yescarta/Tecartus, with Imagine-1 myeloma data at ASH; investing in in vivo CAR-T via Interius acquisition and PreGene collaboration to secure future leadership.

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Gilead outlines R&D progress across HIV, inflammation, and cell therapy

GILD

Product Launch

Dietmar Berger has led R&D at Gilead for one year, focusing on virology, oncology, and inflammation with multiple ongoing launches and positive clinical data.
Gilead’s long-acting HIV program includes Sunlenca, a subcutaneous injection every six months with >95% patient retention, and an annual intramuscular formulation under study (Purpose 365) for vaccine-like prevention.
The treatment pipeline prioritized GS-3242 as the lead long-acting integrase inhibitor over GS-1219, and advanced bictegravir + lenacapavir (BIC-Len) in two Phase III Artistry trials targeting switch settings and complex regimens.
In inflammation, a Phase II oral α4β7 antagonist is enrolling IBD patients in the Swift study (data due in 2026), and a Phase I oral GLP-1 candidate is being evaluated for obesity/metabolism with partnership potential.
In cell therapy, Gilead highlighted a next-generation bicistronic CD19/CD20 CAR-T with potential for improved safety and outpatient use, and will present fourth-line+ myeloma data from Arcelix Imagine-1 at ASH.

1 day ago

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Gilead Sciences outlines HIV prevention launch progress and pipeline at Citi conference

GILD

Product Launch

Guidance Update

Sunlenca HIV prevention launch: J-code effective October 1 and 75% payer coverage achieved ahead of schedule; guided $150 M in H1 FY25 sales (including <$100 M in Q4), and the combined HIV prevention business grew 42% YoY in Q3 FY25.
Extended exclusivity & deep HIV pipeline: Patent settlement pushes Biktarvy U.S. exclusivity to 2036, and Gilead has eight clinical programs in HIV prevention and treatment—six long-acting and one annual injectable—supporting multiple future launch opportunities.
Oncology developments: Anito-cel (BCMA-directed cell therapy) pivotal Phase III data to be presented at ASH with a targeted fourth-line-plus launch by end-2026; Trodelvy label expansion for first-line metastatic triple-negative breast cancer expected in 2026.
Selective BD & improving leverage: Executes $800 M–$1.2 B in annual ordinary course BD, sourcing over 50% of deals from China; operating margin rebounded to ~50% in Q3 FY25 from sub-40% lows, reflecting leverage from new products.

2 days ago

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Gilead Sciences highlights robust HIV prevention launch and diversified pipeline

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Product Launch

M&A

Sunlenca 6-month PrEP launch is off to a strong start, achieving 75% coverage, securing J-code reimbursement by October 1, and guiding to ~$150 million in H1 sales, including nearly $100 million in Q4.
Combined HIV prevention business grew 42% YoY in Q3, driven by Descovy (32% growth in PrEP) and initial Sunlenca uptake.
Biktarvy U.S. exclusivity extended to 2036, supported by a deep HIV pipeline with eight long-acting treatment/prevention programs, including a yearly alternative.
Anito-cel BCMA-directed cell therapy phase III data to be presented at ASH, targeting a fourth-line+ multiple myeloma launch in late 2026, with potential best-in-class safety.
Maintains selective BD strategy, focusing on de-risked late-stage assets (e.g., Livdelzi) and sourcing 50% of deal interests from increasingly innovative China biotech.

2 days ago

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Gilead discusses Sunlenca launch and pipeline at Citi Healthcare Conference 2025

GILD

Product Launch

Guidance Update

Gilead’s PrEP launch of Sunlenca is off to a robust start with J-code reimbursement effective October 1, 75% lives covered, and guidance of ~$150 million in H1 sales, including <$100 million in Q4 2025.
The HIV prevention business grew 42% YoY in Q3 2025 (Sunlenca’s first full quarter), led by 32% growth in Descovy PrEP sales and strong uptake from both naive and switched patients.
Biktarvy’s U.S. exclusivity is extended to 2036 via patent settlement; Gilead is advancing a pipeline of long-acting HIV therapies—including weekly/monthly orals and biannual injectables—with eight programs in clinical development.
Gilead plans to launch BCMA-targeted cell therapy Anito-cel in fourth-line+ multiple myeloma by end-2026 and expects Trodelvy’s first-line triple-negative breast cancer label expansion next year; operating margins have rebounded to ~50% in Q3 2025.

2 days ago

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Gilead outlines growth strategy and Yeztugo launch at Jefferies London Healthcare Conference 2025

GILD

Product Launch

M&A

Gilead’s base business revenues (ex-COVID) grew 7% in 2023, 8% in 2024, and 5% in 2025 despite a $1.1 billion Medicare Part D headwind, implying 9–10% underlying growth.
The company commits ~$1 billion annually to business development, targeting late-stage de-risked assets that fit its existing commercial infrastructure; 2025 deals include a STAT6 degrader partnership with Leo Pharma and acquisition of cell therapy firm Interius.
Yeztugo (six-month subcutaneous HIV prevention) generated $54 million in Q3 2025 and is guided to ~$100 million in Q4 2025, achieving >75% unrestricted payer access and driving 42% year-over-year HIV prevention revenue growth in Q3 2025.
Gilead is advancing multiple late-stage regimens, including a yearly lenacapavir injection in phase III (data 2027, launch 2028) and novel HIV treatment combos (bictegravir + lenacapavir), plus the BCMA cell therapy anito-cel targeting launch end 2026.

Nov 19, 2025, 2:00 PM

Transcript

Gilead discusses growth, M&A strategy and Yeztugo launch at Jefferies London Healthcare Conference

GILD

Product Launch

M&A

Revenue Acceleration/Inflection

Gilead’s base business revenue grew 7% in 2023, 8% in 2024 and is up 5% in 2025 despite a $1.1 billion Medicare Part D headwind, implying 9–10% underlying growth and reflecting diversification across virology, HIV, oncology and inflammation.
The company allocates ~$1 billion annually to business development, targeting late-stage, de-risked assets that leverage existing commercial infrastructure; examples include the CymaBay (Livtencity) and Leo Pharma STAT6 degrader deals.
China has become a major source of innovation, with >50% of 2025 BD priorities coming from Chinese biotech vs 5% five years ago, prompting regular senior team visits and partnerships.
The Yeztugo (lenacapavir) six-month HIV prevention injection launched with $54 million in Q3 sales (Q2+Q3) and is guided to < $100 million in Q4, achieving >75% covered-lives access and driving a 42% year-over-year increase in combined HIV prevention revenue.
Gilead highlighted upcoming pipeline catalysts, including a once-yearly lenacapavir PrEP injection (phase III data 2027, launch 2028), daily bictegravir–lenacapavir treatment readouts and the late-stage anito-cel BCMA cell therapy with potential for best-in-class safety and scalable manufacturing capacity.

Nov 19, 2025, 2:00 PM

Transcript

Gilead outlines growth strategy and product launches at Jefferies London Healthcare Conference 2025

GILD

Product Launch

M&A

New Projects/Investments

Gilead’s base revenues grew 7% in 2023, 8% in 2024, and are on track for 5% growth in 2025 despite a $1.1 B Medicare Part D headwind, implying 9–10% underlying growth.
The company commits $1 B+ annually to business development, prioritizing late-stage, de-risked assets that fit its commercial infrastructure and faces no major patent expirations until 2036.
Yeztugo, the six-month subcutaneous HIV prevention injection, has achieved $54 M in sales through Q3 2025, reached >75% covered lives, and drove 42% year-over-year PrEP revenue growth.
Gilead’s pipeline features a phase III annual lenacapavir PrEP injection (data in 2027, launch in 2028) and multiple late-stage HIV treatments, including a daily bictegravir + lenacapavir regimen for both switch and complex-patient populations.
The BCMA cell therapy anito-cel (with Arcellx) is slated for a U.S. filing by year-end 2025 and a late-2026 launch in fourth-line multiple myeloma, leveraging manufacturing capacity of up to 24,000 treatments in 2026.

Nov 19, 2025, 2:00 PM

Transcript

Gilead Sciences reports Phase 3 success for BIC/LEN HIV regimen

GILD

Product Launch

ARTISTRY-1 Phase 3 showed once-daily BIC/LEN is non-inferior to multi-tablet regimens with HIV-1 RNA <50 copies/mL at Week 48 and no new safety concerns
Single-tablet regimen may reduce pill burden (baseline 2–11 pills/day; ~40% dosed >1×/day), improving adherence and quality of life
Gilead will pursue regulatory submissions and present detailed findings at upcoming scientific meetings; ARTISTRY-2 top-line data expected by year-end
Maintains strong financials with 38.34% operating margin, 27.88% net margin, and stock trading near a 52-week high

Nov 13, 2025, 1:37 PM

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