Gilead Sciences, Inc. (GILD) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights strong financial performance with in-line EPS and promising product developments like Yeztugo and Trodelvy. Despite some management hesitance on specific details, the overall guidance and strategic initiatives, including a robust pipeline and market expansion, indicate positive sentiment. The Q&A reveals optimism towards future growth and market leadership, reinforcing a positive outlook for stock price movement.
Key Financial Performance
HIV Business Growth 6% year-over-year driven by 7% growth in Biktarvy and 47% growth in the HIV prevention portfolio. The growth was despite a $900 million headwind associated with the Part D redesign. Excluding this headwind, the growth was 10%.
Liver Business Growth 6% in 2025 compared to 2024, largely driven by the rapid adoption of Livdelzi for primary biliary cholangitis.
Oncology (Trodelvy) Growth 6% in 2025 driven by momentum in metastatic triple-negative breast cancer following positive Phase III updates.
Cell Therapy Revenue Down about 7% year-over-year, reflecting continuing competitive headwinds.
Fourth Quarter Total Product Sales (Excluding Veklury) $7.7 billion, up 7% year-over-year and 9% sequentially, primarily driven by higher sales across HIV and Livdelzi.
Fourth Quarter Total Product Sales (Including Veklury) $7.9 billion, up 5% year-over-year and 8% sequentially.
Full Year Total Product Sales (Excluding Veklury) $28 billion in 2025, more than $300 million above the high end of the guidance range, driven by outperformance in the HIV business and partially offset by lower cell therapy sales.
Full Year Total Product Sales (Including Veklury) $28.9 billion, up 1% compared to 2024 or 5% excluding Medicare Part D redesign impact.
HIV Sales (Fourth Quarter) $5.8 billion, up 6% year-over-year, driven by higher demand for Biktarvy and Descovy as well as the launch of Yeztugo. Sequentially, HIV sales were up 10%.
HIV Sales (Full Year) $20.8 billion, up 6% year-over-year, driven by strong underlying demand growth. Excluding the $900 million headwind from Medicare Part D redesign, the growth was 10%.
Biktarvy Sales (Fourth Quarter) $4 billion, up 5% year-over-year, driven by higher demand, partially offset by lower average realized price.
Biktarvy Sales (Full Year) $14.3 billion, up 7% year-over-year, driven by higher demand.
HIV Prevention Business Growth 53% year-over-year, driven by favorable access, strong commercial execution, and U.S. market growth of approximately 13% year-over-year.
Descovy Sales (Fourth Quarter) Up 33% year-over-year.
Descovy Sales (Full Year) $2.8 billion, up 31% year-over-year, driven by increased demand in HIV prevention and higher average realized price.
Yeztugo Sales (Fourth Quarter) $96 million.
Yeztugo Sales (Full Year) $150 million, in line with guidance shared in the third quarter.
Liver Disease Sales (Full Year) $3.2 billion, up 6% year-over-year, primarily driven by higher demand and partially offset by lower average realized price.
Liver Disease Sales (Fourth Quarter) $844 million, up 17% year-over-year and 3% sequentially, driven by continued strength for Livdelzi in primary biliary cholangitis.
Livdelzi Sales (Fourth Quarter) $150 million, up 42% sequentially, driven by strong patient demand and the withdrawal of a competitor product in the U.S.
Trodelvy Sales (Full Year) $1.4 billion, up 6%, primarily driven by higher demand in metastatic breast cancer treatment.
Trodelvy Sales (Fourth Quarter) $384 million, up 8% year-over-year and sequentially, driven by higher demand.
Cell Therapy Sales (Full Year) $1.8 billion, down 7% year-over-year, reflecting ongoing in and out-of-class competition.
Cell Therapy Sales (Fourth Quarter) $458 million, up 6% sequentially due to higher-than-expected patient treatments in advance of holidays and one-time pricing adjustments. Year-over-year, sales were down 6%.
Veklury Revenue (Full Year) $911 million, a decline of $900 million or 49% from 2024, mostly in line with expectations given lower COVID-19-related hospitalization trends.
Product Gross Margin (Full Year) 86.4%, in line with guidance of 86%.
R&D Expenses (Full Year) $5.7 billion, down 1% compared to 2024, in line with guidance.
SG&A Expenses (Full Year) $5.6 billion, down 5% compared to 2024, reflecting lower general and administrative expenses, partially offset by sales and marketing investments to support Yeztugo's launch.
Operating Margin (Full Year) 45%. Excluding acquired IPR&D and nonrecurring other revenue, the operating margin was roughly 48%.
Non-GAAP Effective Tax Rate (Full Year) 18.3%, roughly in line with guidance of approximately 19% and down from 25.9% in 2024.
Non-GAAP Diluted EPS (Full Year) $8.15, in line with guidance of $8.05 to $8.25, driven by lower acquired IPR&D expenses, higher revenues, and lower SG&A expenses.
You have reached the limit. Sign up to access full content
Get started
Operating Highlights
Yeztugo: Twice yearly HIV prevention injectable exceeded coverage goals, rapidly gaining market share, and expanding HIV prevention reach. Expected to drive durable, steady, and long-term growth in HIV prevention business.
Livdelzi: Adopted rapidly for primary biliary cholangitis, contributing to 6% growth in liver business.
Trodelvy: 6% growth driven by metastatic triple-negative breast cancer momentum following positive Phase III updates.
BIC/LEN: New daily oral combination for HIV treatment targeting launch in the second half of the year.
Anito-cel: Potential best-in-disease BCMA CAR-T for relapsed or refractory multiple myeloma targeting launch in the second half of the year.
Bulevirtide: Targeting U.S. launch following EU approval for chronic hepatitis delta.
HIV Business: Grew 6% year-over-year, driven by 7% growth in Biktarvy and 47% growth in HIV prevention portfolio. Excluding a $900 million headwind, growth was 10%.
Liver Business: Grew 6% in 2025 compared to 2024, driven by Livdelzi adoption.
Cell Therapy: Declined 7% year-over-year due to competitive headwinds.
Revenue Growth: Total product sales excluding Veklury were $28 billion in 2025, exceeding guidance. Base business grew 8% excluding Medicare Part D redesign impact.
Expense Management: R&D expenses flat, SG&A expenses down 5%, and operating margin at 45%.
Shareholder Returns: Returned $5.9 billion to shareholders in 2025, including dividends and share repurchases.
Diversification Strategy: Shaping Gilead over the last 6 years with up to 10 ongoing and potential new launches through 2027.
Pipeline Strength: Strongest pipeline in 40-year history with 53 ongoing clinical programs and 5 FDA decisions expected in 2026.
You have reached the limit. Sign up to access full content
Get started
Risk or Challenges
Medicare Part D Redesign Impact: The company faced a $900 million headwind in 2025 due to the Medicare Part D redesign, which also poses a 2% growth headwind for 2026. This regulatory change impacts revenue growth and pricing dynamics.
Cell Therapy Competitive Headwinds: Cell therapy sales declined 7% in 2025 and are expected to decline another 10% in 2026 due to ongoing competitive pressures and new market entrants, particularly outside the U.S.
Drug Pricing Agreement and Affordable Care Act Changes: The drug pricing agreement with the U.S. government and proposed Affordable Care Act changes are expected to create a 2% headwind to HIV business growth in 2026, impacting revenue.
Veklury Revenue Decline: Veklury sales dropped by $900 million in 2025, a 49% decline, and are expected to decline further to $600 million in 2026 due to reduced COVID-19-related hospitalizations.
Supply Chain and Logistics for Yeztugo: The company faces challenges in supporting clinicians and offices to navigate the logistics of the twice-yearly injectable regimen for Yeztugo, which could impact its adoption and sales growth.
Cell Therapy Volumes and Clinical Trials: Cell therapy volumes are being impacted by a growing number of clinical trials, which, while beneficial for the industry, represent a near-term headwind for the company.
You have reached the limit. Sign up to access full content
Get started
Guidance & Outlook
HIV Business Growth: The company expects total HIV sales, including both treatment and prevention, to grow approximately 6% in 2026 compared to 2025. Excluding headwinds from drug pricing agreements and Affordable Care Act changes, growth is expected to be 8%.
Yeztugo Revenue: Yeztugo revenue is projected to reach approximately $800 million in 2026, up from $150 million in 2025, highlighting its trajectory towards achieving blockbuster status.
Cell Therapy Revenue: Cell therapy revenue is expected to decline approximately 10% in 2026 compared to 2025, due to competitive headwinds and increased clinical trial activity.
Trodelvy Expansion: Trodelvy is expected to launch in first-line metastatic triple-negative breast cancer in 2026, following FDA decisions. This expansion builds on its established position in second-line treatment.
BIC/LEN Launch: The company plans to launch BIC/LEN, a new daily oral combination for HIV treatment, in the second half of 2026, pending FDA approval.
Anito-cel Launch: Anito-cel, a potential best-in-disease BCMA CAR-T for multiple myeloma, is expected to launch in the second half of 2026.
Liver Disease Growth: The liver disease segment, led by Livdelzi, is expected to continue its growth trajectory, with updates from the Phase III IDEAL study potentially expanding its use in primary biliary cholangitis.
Pipeline Milestones: The company anticipates 5 Phase III readouts and 5 FDA decisions in 2026, including for Bulevirtide, BIC/LEN, Trodelvy, and Anito-cel.
Revenue Guidance: Total product sales for 2026 are projected to be between $29.6 billion and $30 billion, with base business sales growing 4% to 5% compared to 2025.
You have reached the limit. Sign up to access full content
Get started
Shareholder Return Plan
Dividend Payments: In 2025, Gilead returned $5.9 billion to shareholders, which included dividends. The company remains committed to returning, on average, at least 50% of its free cash flow to shareholders.
Share Repurchase Program: In 2025, Gilead repurchased $1.9 billion worth of shares, primarily to offset equity dilution and for opportunistic repurchases. Combined with dividends, this represented approximately 63% of the company's free cash flow returned to shareholders.
You have reached the limit. Sign up to access full content
Get started
Key Q&A
Q:Can you elaborate on the assumptions driving the $800 million guidance for Yeztugo and the anticipated refill rates for patients needing redosing?
A:Management expressed excitement about Yeztugo's performance, with key launch indicators tracking or exceeding expectations, including 90% payer coverage and a recent DTC campaign. They anticipate durable, sustained growth beyond 2026. However, they did not provide specific assumptions for persistency due to the early stage of the launch but are encouraged by early data and have strategies in place to ensure patients return for subsequent doses.
Q:What type of share gains do you expect for anito-cel in the fourth-line setting if approved, considering competition?
A:Management expects modest contributions in 2026 due to the launch timing and the need to activate authorized treatment centers. They aim to become the market leader over time, citing a $3.5 billion market, excellent efficacy, a differentiated safety profile, and world-class manufacturing capabilities.
Q:How should we think about the growth outlook for Yeztugo, including potential cannibalization of DESCOVY PrEP sales and the evolution of net price?
A:Management expects strong growth momentum for Yeztugo in 2026, driven by access, awareness campaigns, and market expansion strategies. They believe Yeztugo will eventually lead the HIV prevention market. DESCOVY is expected to grow through 2026 but will erode over time as Yeztugo gains share. They did not disclose specifics on net price evolution but emphasized Yeztugo's differentiated value proposition.
Q:Can you provide details on the profile of the long-acting Q6 month treatment drug (super bictegravir 3242) and how it compares to competitors?
A:Management highlighted the breadth of their program, including weekly, monthly, and every 6-month treatments. The Q6 month treatment combines lenacapavir with a long-acting INSTI (3242), emphasizing its tolerability, resistance profile, and forgiveness. They refrained from detailed competitor comparisons but noted competitors also require combination products for similar treatments.
Q:What do you need to show from PURPOSE 365 to support approval for the once-yearly injectable lenacapavir for PrEP, and how will it be positioned in the market?
A:The PURPOSE 365 study is designed to demonstrate effective prevention through pharmacokinetics and safety. Management emphasized the potential market expansion due to the convenience of a once-yearly injection, which could attract a broader population, including those with unstable housing.
Q:What is your confidence level heading into the Trodelvy Phase III interim analysis for endometrial cancer, and how does the indication size compare to triple-negative breast cancer?
A:Management is optimistic due to earlier Phase II data showing a median OS of 15 months. They view second-line endometrial cancer as an incremental opportunity, with a U.S. addressable population of about 5,000, similar to second-line metastatic TNBC.
Q:What is your perspective on larger-scale deals and the focus of your business development strategy?
A:Management emphasized their robust internal portfolio and proactive approach to partnerships and M&A. They aim to add synergistic, derisked late-stage assets to drive growth but do not feel urgency due to their strong pipeline and no major LOEs until 2026.
Q:What gives you confidence in a second-half launch for anito-cel, and will the iMMagine-3 filing be based on MRD or survival endpoints?
A:Management is confident in their conversations with the FDA but cannot confirm priority review yet. The iMMagine-3 study has dual endpoints of MRD and PFS, aligning with FDA guidance.
Q:Are you seeing off-label use of Trodelvy in the frontline setting, and what is the opportunity compared to the current indication?
A:Management noted spontaneous use in the first-line setting post-ASCENT-04 data and NCCN guidelines. The first-line setting doubles the market opportunity compared to second-line, with about 10,000 patients and longer treatment durations.
Q:How should we interpret the $800 million guidance for Yeztugo in 2026?
A:Management expects continued strong momentum for Yeztugo, driven by new patient starts and second injections. They view the $800 million as a guide, not a floor, and anticipate durable growth supported by access and awareness efforts.
Q:Review of Unclear Management Responses
A:Management avoided providing specific assumptions for persistency rates for Yeztugo, citing the early stage of the launch. They also refrained from discussing gross-to-net details for Yeztugo and did not provide detailed competitor comparisons for their Q6 month treatment drug.
You have reached the limit. Sign up to access full content
Get started
Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ARTISTRY
ASCENT GYN
Affairs Officer
BIC LEN
Bulevirtide hepatitis
Cindy Kite
Commercial Corporate
Corporate Affairs
FDA decision
GS
IDEAL study
III study
III trial
III update
ISLEND trial
NCCN breast
PBC patient
Phase III
Veklury
Yeztugo HIV
Yeztugo launch
Yeztugo sale
anito cel
bictegravir integrase
cancer guideline
catalyst
demand price
launch Slide
launch Yeztugo
lenacapavir
line PD
market launch
prevention portfolio
program anito
record
therapy sale
GILD Transcript
Gilead Sciences, Inc. (GILD) Q4 2025 Earnings Call Transcript
Positive2-10
The earnings call highlights strong financial performance with in-line EPS and promising product developments like Yeztugo and Trodelvy. Despite some management hesitance on specific details, the overall guidance and strategic initiatives, including a robust pipeline and market expansion, indicate positive sentiment. The Q&A reveals optimism towards future growth and market leadership, reinforcing a positive outlook for stock price movement.
Gilead Sciences, Inc. (GILD) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
Gilead Sciences, Inc. (GILD) Presents at Evercore 8th Annual Healthcare Conference Transcript
Neutral12-3
Gilead Sciences, Inc. (GILD) Presents at Citi Annual Global Healthcare Conference 2025 Transcript
Neutral12-3
GILD Slides
GILD Report
Frequently Asked Questions
Where does this earnings call transcript come from?
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
How soon is the transcript available after the earnings call ends?
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
Is the transcript edited or altered in any way?
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
Why do some answers appear as “Unclear” or “Inaudible”?
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
Who creates the AI Summary and Key Q&A highlights shown above the transcript?
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
