Gilead Beats Guidance, HIV Growth Defies Headwinds

Date of Call: Feb 10, 2026

Financials Results

• Revenue: $28.9B total product sales, up 1% YOY and above guidance, excluding Veklury $28B, up 4% YOY
• EPS: $8.15 non-GAAP diluted EPS, in line with guidance, up from $7.75 prior year excluding CymaBay impact
• Gross Margin: 86.4% product gross margin, in line with guidance
• Operating Margin: 45% overall operating margin, 48% excluding non-recurring items

Guidance:

• 2026 total product sales expected between $29.6B and $30B.
• Base business growth expected 4% to 5% YOY.
• HIV sales expected to grow approximately 6% in 2026.
• Yeztugo revenue expected ~$800M in 2026.
• Cell therapy revenue expected to decline ~10% in 2026.
• Non-GAAP operating income expected $13.8B to $14.3B.
• Non-GAAP diluted EPS expected $8.45 to $8.85.

Business Commentary:

HIV Business Growth:

• Gilead Sciences' HIV business grew 6% year-over-year in 2025, with a 7% increase in Biktarvy sales and a 47% increase in the HIV prevention portfolio.
• Despite an estimated $900 million headwind from the Part D redesign, the growth was driven by strong underlying demand and commercial execution, particularly in the prevention segment with Yeztugo's launch.

Liver Disease Segment Performance:

• The company's liver business saw 6% growth in 2025, driven by the adoption of Livdelzi for primary biliary cholangitis.
• The introduction of Livdelzi and its rapid acceptance in the market contributed significantly to this growth, with a notable 42% sequential increase in Livdelzi sales in the fourth quarter.

Oncology Progress with Trodelvy:

• Trodelvy sales grew 6% in 2025, with momentum in metastatic triple-negative breast cancer following positive Phase III updates.
• The growth was attributed to the strong clinical data supporting its efficacy, leading to recognition in treatment guidelines and increased demand in oncology settings.

Commercial Launch Strategy:

• Gilead Sciences is targeting four commercial launches in 2026, including Trodelvy for first-line metastatic triple-negative breast cancer and a new oral combination for HIV treatment.
• The strategy is supported by a robust clinical pipeline, with multiple Phase III trial updates expected, positioning the company for sustained growth and diversification.

Financial Performance and Guidance:

• Full-year total product sales reached $28.9 billion, with base business revenue up 4% from 2024, exceeding guidance expectations.
• The financial performance reflects disciplined expense management and strategic investments in new launches, with expectations for continued growth in 2026 despite anticipated headwinds.

Sentiment Analysis:

Overall Tone: Positive

• CEO Dan O'Day stated: 'another very strong set of results... a remarkable year... set the stage for a very promising 2026.' Sales outperformed guidance, key launches exceeding expectations, and a robust pipeline with 4 planned launches and 5 Phase III readouts.

Q&A:

• Question from Christopher Schott (JPMorgan Chase & Co): Elaborate on assumptions driving $800M Yeztugo 2026 guidance and refill rates.
  Response: Guidance based on strong launch momentum, 90% payer coverage, DTC campaign, and durable growth expectations; refill rates not yet a major assumption as still early.

• Question from Louise Chen (Scotiabank Global Banking and Markets): Share gains expected for anito-cel in 4L multiple myeloma upon approval.
  Response: Expect modest 2026 contributions post-approval, with full-year 2027 sales and aim to become market leader due to efficacy/safety profile and manufacturing capabilities.

• Question from Tazeen Ahmad (BofA Securities): Yeztugo growth outlook and potential cannibalization of Descovy PrEP; net price evolution.
  Response: Expect Yeztugo to build on strong momentum in 2026, with Descovy continuing to grow; Yeztugo's differentiated value supports access and pricing.

• Question from Michael Yee (UBS Investment Bank): Profile of Q6M long-acting drug (DS-3242) and comparison to competitors.
  Response: DS-3242 is a long-acting INSTI combined with lenacapavir, offering INSTI benefits; development includes two programs, with more data to come.

• Question from Brian Abrahams (RBC Capital Markets): Details on once-yearly injectable lenacapavir for PrEP (PURPOSE 365) and market positioning.
  Response: PURPOSE 365 is a PK-based study to demonstrate target coverage; once-yearly dosing could expand addressable population, with potential availability as early as 2028.

• Question from Umer Raffat (Evercore ISI Institutional Equities): Confidence in Trodelvy Phase III interim analysis in endometrial cancer and market size.
  Response: Confidence based on prior Phase II data (median OS 15 months); second-line endometrial cancer is an incremental opportunity (~5,000 addressable in US).

• Question from Geoffrey Meacham (Citigroup Inc.): Business development strategy and urgency for deals.
  Response: Continuously active in early-stage deals (~$1B annually); later-stage M&A will be disciplined and proactive, aiming to add synergistic assets.

• Question from Daina Graybosch (Leerink Partners LLC): Confidence in second half anito-cel launch and endpoint for iMMagine-3 filing.
  Response: Confidence in FDA conversations but no priority review confirmed; iMMagine-3 has dual endpoints of MRD and PFS.

• Question from Tyler Van Buren (TD Cowen): Off-label use of Trodelvy in frontline and market opportunity vs current indication.
  Response: Spontaneous use increased post-ASCENT-04; frontline market is about double second-line (~10,000 patients), with longer duration of treatment.

• Question from Courtney Breen (Bernstein Institutional Services LLC): Whether $800M Yeztugo 2026 guide is a floor given assumed price cuts.
  Response: Guidance assumes continued strong momentum from new patients and persistence, driven by access expansion and DTC campaign, not a floor.

Contradiction Point 1

Yeztugo 2026 Revenue Guidance Drivers and Growth Expectations

Statements about the durability and underlying drivers of Yeztugo's growth guidance appear inconsistent.

What assumptions underlie the $800 million Yeztugo 2026 revenue guidance, and what refill rates are anticipated for patients requiring redosing? - Christopher Schott (JPMorgan Chase & Co)

2025Q4: The $800 million guidance... assumes continued durable growth, not just for 2026 but long-term. - [Johanna Mercier](CCO)

What is the sales trajectory for Yeztogo in Q4 and 2026—gradual or step-function growth? - Christopher Schott (JPMorgan)

20251031-2025 Q3: Momentum for 2026 is supported by strong payer coverage... Recent access wins that are beginning to integrate into practices. - [Johanna Mercier](CCO)

Contradiction Point 2

anito-cel (Multiple Myeloma CAR-T) Launch Timeline and Filing Details

Specificity regarding the regulatory filing timeline for anito-cel appears to have shifted from a concrete target to a more general timeframe.

What market share is expected for anito-cel in the fourth-line multiple myeloma setting post-approval, given the competitive landscape? - Louise Chen (Scotiabank Global Banking and Markets)

2025Q4: The anito-cel launch is expected in the second half of 2026. - [Cindy Perettie](EVP of Kite)

When could the anito-cel (multiple myeloma CAR-T) filing occur, what remains to be done, and is its efficacy expected to be similar to other BCMA CAR-Ts with improved safety? - Tyler Van Buren (TD Cowen)

20251031-2025 Q3: Filing dates are not disclosed, but a launch is targeted for the second half of 2026. - [Cindy Perettie](EVP of Kite)

Contradiction Point 3

Yeztugo 2026 Revenue Guidance and Growth Trajectory

The expected sales growth pattern for Yeztugo heading into 2026 is described differently.

What is the growth outlook for Yeztugo and potential cannibalization of Descovy PrEP sales by 2026? - Tazeen Ahmad (BofA Securities)

2025Q4: Yeztugo growth is expected to build steadily in 2026... Both Yeztugo and Descovy are expected to grow in 2026... Yeztugo is expected to capture the leading share. - [Johanna Mercier](CCO)

Could you provide more details on Yeztugo's performance in Q4 and for 2026? - Christopher Schott (JPMorgan Chase & Co)

2025Q3: The sales ramp is expected to be gradual, setting up a strong platform for 2026. - [Johanna Mercier](CCO)

Contradiction Point 4

Yeztugo Sales Forecast

The full-year sales expectation for Yeztugo appears to have increased significantly.

What are the key assumptions behind the $800 million Yeztogo 2026 revenue guidance? - Christopher Schott (JPMorgan Chase & Co)

2025Q4: The $800 million guidance... assumes continued strong momentum... Growth is expected to be durable and long-term. - [Johanna Mercier](CCO)

Is the $39 million Q3 sales figure in line with your expectations? - Umer Raffat (Evercore ISI)

2025Q3: Full year sales are expected to be around $150M. - [Johanna Mercier](CCO)

Contradiction Point 5

anito-cel Launch Timing and Regulatory Strategy

Contradiction on certainty of FDA priority review status for the 2026 launch.

Does the second-half launch confidence for anito-cel depend on FDA priority review, and will the iMMagine-3 study's 2027 filing use MRD or survival as the primary endpoint? - Daina Graybosch (Leerink Partners)

2025Q4: Priority review status for anito-cel is not confirmed and will be known upon BLA acceptance. - [Cindy Perettie](EVP of Kite)

How do you maintain confidence in anito-cel's FDA approvability, given past partner feedback and recent disruptions, based on a single-arm study? - Carter Lewis Gould (Cantor Fitzgerald)

2025Q2: The company is continuing conversations with the FDA and does not anticipate any major shifts in prior communicated regulatory strategy. It remains on track for a 2026 launch following the filing of anito-cel. - [Unidentified Company Representative](likely Cindy Perettie or Dietmar Berger)