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    GILD
    Earnings call· Sep 2025(Q3 FY25)

    GILEAD SCIENCES, INC. GILD

    Oct 30, 2025 Source

    Executive summary

    Gilead Q3 FY25 — Strong HIV and Livdelzi Performance Drives Raised Full-Year Outlook

    Gilead delivered a strong Q3 FY25, driven by robust performance in its HIV franchise and Livdelzi, leading to an increased full-year HIV revenue growth outlook despite Medicare Part D redesign headwinds. The company is making significant pipeline progress across HIV, oncology, and liver disease, with key regulatory filings and clinical readouts expected, while navigating competitive pressures in cell therapy. Management emphasized disciplined expense management and a strong position with no major patent expiries until 2036.

    Highlights

    5

    • HIV therapies grew 4% year-over-year, with Biktarvy up 6% year-over-year and Descovy up 20% year-over-year.

    • Livdelzi sales exceeded $100 million for the first time, growing 35% sequentially and contributing to 12% year-over-year growth in the liver portfolio.

    • Non-GAAP EPS grew 22% year-over-year, or 10% excluding a nonrecurring accounting item.

    • Yeztugo achieved 75% payer coverage, nearly 3 months ahead of its target, setting a strong foundation for 2026.

    • Full-year HIV revenue growth expectations were increased to approximately 5%.

    Concerns

    4

    • The HIV business faced a $900 million headwind in 2025 associated with the Medicare Part D redesign.

    • Veklury sales were down 60% year-over-year to $277 million due to fewer COVID-19 hospitalizations.

    • Cell therapy sales were down 11% year-over-year and sequentially, with competitive headwinds expected to continue.

    • Trodelvy sales were down 2% sequentially due to unfavorable inventory dynamics and lower ex-U.S. average realized price.

    Guidance & targets

    17
    CategoryTargetConfidence
    Full-year HIV revenue growth
    approximately 5%
    high materiality
    High
    Full-year total product sales (excluding Veklury)
    $27.4 billion and $27.7 billion
    high materiality
    High
    Full-year total product sales (including Veklury)
    $28.4 billion to $28.7 billion
    high materiality
    High
    Full-year Veklury revenue
    approximately $1 billion
    medium materiality
    High
    Full-year cell therapy sales decline
    approximately a 10% decline
    medium materiality
    High
    Full-year acquired IPR&D
    $900 million
    medium materiality
    High
    Full-year non-GAAP EPS
    $8.05 and $8.25
    high materiality
    High
    Full-year GAAP EPS
    $6.65 to $6.85
    medium materiality
    High
    Yeztugo payer coverage goal
    90%
    high materiality
    High
    BIC/LEN (bictegravir and lenacapavir) launch
    early 2027
    high materiality
    High
    Bulevirtide U.S. launch
    2026
    medium materiality
    High
    Trodelvy first-line metastatic TNBC launch
    2026
    high materiality
    High
    Anito-cel multiple myeloma launch
    2026
    high materiality
    High
    PURPOSE-365 regulatory filing
    potential for approval in 2028
    medium materiality
    Medium
    Yescarta in primary CNS lymphoma PDUFA date
    February 2026
    medium materiality
    High
    KITE-753 pivotal Phase II initiation
    first quarter of 2026
    low materiality
    High
    KITE-363 Phase I study in neuroinflammatory conditions
    expected to start in the first quarter of 2026
    low materiality
    High

    Segment performance

    5
    SegmentRevenueYoYQoQMargin
    HIV
    Driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price. Full-year HIV revenue growth guidance increased to ~5%.
    Biktarvy sales: $3.7 billionBiktarvy growth YoY: 6%Biktarvy market share (U.S.): ~52%Descovy sales: $701 millionDescovy growth YoY: 20%Descovy for PrEP market share (U.S.): >45%PrEP market growth YoY: ~14%
    		$5.3 billion4%4%—
    Liver Disease
    Growth almost entirely driven by Livdelzi, with strong commercial execution and competitor withdrawal.
    Livdelzi sales: >$100 millionLivdelzi growth sequential: 35%Livdelzi market leadership: #1 treatment for second-line PBC in U.S.
    		$819 million12%3%—
    Oncology (Trodelvy)
    Trodelvy's growth driven by higher demand, offset by unfavorable inventory dynamics and lower ex-U.S. average realized price. Year-over-year strength offset bladder cancer withdrawal impact.
    		$357 million7%-2%—
    Cell Therapy
    Continued competitive headwinds from in and out of class therapies. Efforts to lower hurdles to community adoption are progressing.
    Authorized treatment centers: >570 globallyAuthorized treatment centers added YTD: >40
    		$432 million-11%-11%—
    Veklury
    Reflects fewer COVID-19 related hospitalizations.
    		$277 million-60%——

    Operational metrics

    28
    Non-GAAP EPS growth
    22%YoY
    Q3 FY25

    Driven by strong performance and disciplined operating expense management.

    Non-GAAP EPS growth (excluding nonrecurring item)
    10%YoY
    Q3 FY25

    Excluding a $0.25 benefit from a nonrecurring accounting item.

    Base business growth (excluding nonrecurring item)
    4%YoY
    Q3 FY25

    Base business growth year-over-year, highlighting leverage in the business model.

    Yeztugo sales
    $39 million
    Q3 FY25

    Sales for the third quarter.

    Yeztugo launch revenue
    $54 million
    June-Q3 FY25

    Total revenue from launch in mid-June to the end of Q3, including initial launch-related stocking.

    HIV business headwind
    $900 million
    FY25

    Associated with the Medicare Part D redesign.

    Product sales (excluding Veklury)
    $7.1 billionup 4% YoY, up 2% sequentially
    Q3 FY25

    Driven by strength across the HIV portfolio, offset in part by lower oncology revenue.

    Total product sales (including Veklury)
    $7.3 billionup 4% sequentially, down 2% YoY
    Q3 FY25

    Primarily reflecting lower Veklury sales associated with fewer COVID-19-related hospitalizations.

    Royalty, contract and other revenues
    $400 million
    Q3 FY25

    Recognized as future royalty and milestone payments could be reasonably estimated; does not reflect cash received during the quarter.

    Product gross margin
    86%vs 87% in Q3 2024
    Q3 FY25

    In line with prior year.

    R&D expenses
    $1.3 billiondown 3% compared to Q3 2024
    Q3 FY25

    Year-to-date R&D expenses were $4.1 billion, in line with 2024, on track for full year goal.

    Acquired IPR&D expenses
    $170 million
    Q3 FY25

    Includes upfront payment for a research and licensing collaboration in in vivo cell therapy.

    SG&A expenses
    $1.4 billiondown 4% compared to Q3 2024
    Q3 FY25

    Modestly lower than expected due to timing of spending.

    Operating margin
    50%
    Q3 FY25

    Reflecting continued focus on operating expense discipline and leverage.

    Non-GAAP effective tax rate
    18%
    Q3 FY25

    Slightly below expectations due to a tax settlement.

    Non-GAAP diluted EPS
    $2.47
    Q3 FY25

    Reported for the quarter.

    Non-GAAP diluted EPS (excluding nonrecurring other revenue)
    $2.22
    Q3 FY25

    Excluding the $400 million nonrecurring other revenue.

    Capital returned to shareholders
    $1.4 billion
    Q3 FY25

    Includes share repurchases.

    Share repurchases
    $435 million
    Q3 FY25

    Intended to offset equity dilution at a minimum, used opportunistically.

    Patent expiries
    no major LOEs until 2036
    N/A

    Reinforces strong position.

    HDV patients in U.S.
    40,000
    N/A

    Patients with chronic untreated HDV infection can experience accelerated development of cirrhosis or severe scarring of the liver and have higher risk of liver cancer.

    Trodelvy ASCENT-03 median progression-free survival
    9.7 monthsvs 6.9 months for standard of care chemotherapy
    N/A

    Demonstrated a statistically significant and clinically meaningful 38% reduction in disease progression or death versus standard of care chemotherapy.

    Trodelvy first-line mTNBC patient population
    almost twice as many patientscompared to second line
    N/A

    Patients typically have a longer duration of therapy in the first-line setting.

    Domvanalimab EDGE-Gastric median overall survival
    26.7 months
    N/A

    Results from Arm A1 of the Phase II EDGE-Gastric study; findings were simultaneously published in Nature Medicine. Needs confirmation in ongoing Phase III STAR-221 trial.

    HCPs trained for Yeztugo
    >7,000
    N/A

    Trained to ensure proper injection technique and pre/post-treatment.

    Accounts trained for Yeztugo
    >1,500
    N/A

    Trained to ensure proper injection technique and pre/post-treatment.

    Yeztugo training satisfaction rate
    98%
    N/A

    Satisfaction rate with training provided by nurse educator team.

    Descovy access
    ~99%
    September

    Percentage of lives covered, with 88% unrestricted access.

    Industry KPIs

    5
    MetricValueDetails
    Launch access metrics75%%
    Therapeutic drug market share~52%%
    Prescription volume new starts~14%%
    Clinical trial efficacy safety data9.7 monthsmonths
    Collaboration milestone royalty revenue$400 millionUSD

    Product announcements

    3
    ProductTypeDetails
    Yeytuo (lenacapavir for PrEP)milestone
    Yescartamilestone
    CD19 CAR-T products (including Yescarta)milestone

    Deals & partnerships

    3
    InteriusAcquisition of Interius team and novel in vivo platform.

    Adds a novel in vivo platform and strong IP portfolio to Kite's capabilities, aiming to unlock broad access to cell therapies.

    Pregene BiopharmaNew research and licensing collaboration in the in vivo cell therapy space.$120 million

    Aims to accelerate exploration of opportunities in early-stage in vivo cell therapies.

    The Global Fund and U.S. State Department (PEPFAR)Agreement to supply lenacapavir for PrEP.Over 3 years

    To supply enough doses to reach up to 2 million people in certain low and lower middle-income countries, as part of broader commitment to access.

    Risks & headwinds

    5
    Medicare Part D redesign impact on HIV businessFY25

    $900 million headwind for full year 2025

    Mitigation: Strong performance of Biktarvy and Descovy, leading to increased full-year HIV revenue growth expectations.

    Lower Veklury sales due to fewer COVID-19 hospitalizationsQ3 FY25, full year 2025

    Down 60% YoY to $277 million in Q3 FY25

    Competitive headwinds in cell therapyNear future

    Sales down 11% YoY and sequentially in Q3 FY25

    Mitigation: Increasing adoption and utilization, expanding authorized treatment centers, progressing next-generation pipeline (KITE-753, KITE-363), investing in in vivo cell therapies, developing anito-cel.

    Unfavorable inventory dynamics and lower ex-U.S. average realized price for TrodelvyQ3 FY25

    Sales down 2% sequentially in Q3 FY25

    Mitigation: Continued strength in U.S. and international markets, potential launch in first-line mTNBC.

    Expected step-up in R&D and SG&A expensesQ4 FY25

    Expected step-up in Q4

    Mitigation: Normal end-of-year trends, accounted for in guidance.

    What to watch in Q4 FY25

    5

    BIC/LEN ARTISTRY studies update

    Q4 FY25
    TargetData readout

    Why it matters

    Key update for next-generation HIV treatment, targeting an early 2027 launch, which could significantly impact the HIV franchise.

    We look forward to sharing progress on one of our next-generation HIV treatments before the end of the year with an update on the ARTISTRY-1 and ARTISTRY-2 studies.

    Q&A highlights

    6

    Seeking color on whether Yeztugo patients are switching from other PrEP treatments or are new to PrEP, and what demand drivers are expected for 2026.

    Yeztugo sourcing is primarily from switches, including from long-acting injectables, oral branded products like Descovy, and oral generics. Naive patient population is expected to grow over time as market awareness increases. The 75% payer coverage achieved ahead of schedule and the upcoming J-code are strong foundations for 2026 growth.

    “the source of business is actually coming from the long-acting injectable currently on the market, also the oral branded such as Descovy, but also oral generics.”

    asked by Geoffrey Meacham · answered by Johanna Mercier

    2 min read6 chapters

    Detailed Narrative

    01

    HIV Franchise Momentum

    Gilead's HIV business demonstrated strong growth, with Biktarvy sales up 6% year-over-year to $3.7 billion and Descovy sales reaching a record $701 million, up 20% year-over-year, primarily driven by PrEP demand. The company raised its full-year HIV revenue growth guidance to approximately 5%, overcoming a $900 million headwind from Medicare Part D redesign. Yeztugo, a new HIV prevention therapy, achieved $39 million in Q3 sales and secured 75% payer coverage ahead of schedule, setting a strong foundation for 2026.

    02

    Oncology Pipeline Advancements

    Significant clinical progress was highlighted in oncology, particularly with Trodelvy. Detailed ASCENT-03 data showed a 9.7 months median progression-free survival in first-line metastatic triple-negative breast cancer, leading to sBLA submissions and a targeted commercial launch in 2026. The company also expects updates on the iMMagine-1 study for anito-cel in multiple myeloma and ASCENT-07 for Trodelvy in HR+/HER2- metastatic breast cancer by year-end.

    03

    Liver Disease Expansion

    The liver portfolio saw 12% year-over-year growth, largely driven by Livdelzi, which surpassed $100 million in quarterly sales for the first time and became the market leader in second-line PBC in the U.S. Gilead also filed for FDA approval of bulevirtide for chronic hepatitis delta virus, with a potential U.S. launch in 2026, leveraging its existing footprint in hepatitis B.

    04

    Cell Therapy Challenges and Innovation

    Cell therapy sales for Yescarta and Tecartus declined 11% year-over-year and sequentially due to competitive headwinds. Despite this, Kite expanded its authorized treatment centers to over 570 globally and is investing in next-generation in vivo cell therapies through acquisitions and collaborations to improve accessibility and safety. Key regulatory milestones include priority review for Yescarta in primary CNS lymphoma.

    05

    Financial Performance and Outlook

    Gilead reported a 4% year-over-year increase in base business product sales (excluding Veklury) to $7.1 billion. Non-GAAP diluted EPS was $2.47, benefiting from a $400 million nonrecurring accounting item related to an IP asset sale. The company raised the low end of its full-year product sales and non-GAAP EPS guidance, reflecting strong year-to-date performance and disciplined operating expense management.

    06

    Strategic Pipeline Development

    The company is advancing 56 clinical programs across its therapeutic areas, with a focus on long-acting HIV regimens, including a BIC/LEN single-tablet regimen targeting a 2027 launch and a twice-yearly injectable treatment. In HDV, beyond bulevirtide, GS-4321, a next-generation antibody, is in Phase I. Oncology efforts include domvanalimab in gastric and non-small cell lung cancers.

    AI-generated summary of the company’s earnings call. Not investment advice.