Gilead (GILD) Q3 2025: Yes2Go Hits 75% Coverage, Setting Up 2026 HIV Prevention Ramp

2025-10-30 | By EarningsIQ Research

Gilead’s Q3 saw disciplined expense leverage and strong HIV franchise momentum, with Yes2Go’s rapid payer access and Livdelzy’s breakout performance underpinning near-term growth. Management’s guidance raise for HIV revenue and commentary on pipeline launches signal a robust 2026 setup, while cell therapy remains a notable drag. With no major loss of exclusivity (LOE) until 2036 and multiple late-stage catalysts, Gilead’s strategic focus is firmly on execution and portfolio diversification.

Summary

• HIV Franchise Strengthens: Yes2Go’s accelerated payer coverage and Biktarvy’s market share gains reinforce Gilead’s HIV leadership.
• Liver and Oncology Momentum: Livdelzy and Trodelvy drive new growth vectors, offsetting cell therapy headwinds.
• 2026 Growth Platform: Expanded access, pipeline readouts, and delayed LOEs position Gilead for multi-year upside.

Performance Analysis

Gilead delivered 4% YoY base business growth (excluding Veklury, COVID-19 therapy), propelled by the HIV portfolio, notably Biktarvy and Descovy, and a standout quarter for Livdelzy in liver disease. Total product sales reached $7.3 billion, with HIV contributing $5.3 billion—about 73% of the base business—despite a $900 million Medicare Part D headwind. Biktarvy’s 6% YoY growth and record 52% U.S. market share, along with Descovy’s 20% YoY increase, highlight robust demand and commercial execution.

Yes2Go, Gilead’s new long-acting injectable for HIV prevention, generated $39 million in Q3 sales and achieved 75% U.S. payer coverage nearly three months ahead of plan. Livdelzy crossed $100 million quarterly sales for the first time, becoming the U.S. second-line PBC leader and driving 12% YoY liver portfolio growth. Oncology was mixed: Trodelvy grew in metastatic breast cancer but cell therapy sales fell 11% YoY, reflecting persistent competitive headwinds. Disciplined cost controls drove 22% YoY non-GAAP EPS growth, even excluding a non-recurring $400 million IP asset sale benefit.

• Margin Leverage: Operating margin held at 50%, reflecting tight SG&A and R&D expense management.
• Cell Therapy Drag: KITE’s cell therapy revenue declined 11% YoY, with management forecasting a full-year 10% drop.
• Pipeline Progress: Multiple late-stage readouts in HIV, oncology, and liver disease set up 2026 for new launches.

Gilead raised full-year HIV growth guidance to 5% and nudged up the low end of overall product sales guidance, signaling confidence in its core franchises and launch trajectory.

Executive Commentary

Strategic Positioning

1. HIV Franchise: Durable Growth and Launch Execution

Gilead’s HIV business remains the company’s engine, with Biktarvy, single-tablet regimen, extending exclusivity to 2036 and Descovy, PrEP (pre-exposure prophylaxis), gaining share as prevention adoption grows. Yes2Go, long-acting injectable PrEP, is positioned to expand Gilead’s reach through payer wins and clinical guideline endorsements, with the initial ramp focused on switches from orals and competing injectables.

2. Liver Disease: Livdelzy and Hepcludex Expand Portfolio

Livdelzy, primary biliary cholangitis therapy, delivered breakout growth, capturing U.S. second-line leadership and supporting the liver franchise’s 12% YoY expansion. Hepcludex (bulevirtide), for hepatitis delta virus, is on track for 2026 U.S. approval, leveraging Gilead’s existing hepatitis B footprint for rare disease penetration.

3. Oncology: Trodelvy and Pipeline Bets

Trodelvy, antibody-drug conjugate for breast cancer, is advancing into first-line metastatic triple-negative breast cancer (TNBC), backed by practice-changing ASCENT-03 data and pending 2026 FDA decisions. Cell therapy under KITE faces near-term headwinds, but Gilead is investing in next-generation and in vivo platforms to regain momentum and broaden outpatient adoption.

4. Pipeline and Portfolio Diversification

Gilead’s late-stage pipeline is rich in HIV, liver, and oncology assets, with multiple pivotal readouts (Artistry I/II, IMAGINE ONE, ASCENT-07) expected by year-end and early 2026. Business development focus remains on de-risked, late-stage assets, especially in liver and oncology, to supplement organic growth and offset cell therapy softness.

5. Capital Allocation and LOE Profile

With no major LOEs until 2036 and strong U.S. IP protection, Gilead’s capital allocation strategy balances disciplined share repurchases (offsetting dilution) and pipeline investments. Management returned $1.4 billion to shareholders in Q3, supporting total shareholder return through both buybacks and dividends.

Key Considerations

This quarter’s results reinforce Gilead’s disciplined execution and strategic clarity, but also highlight areas requiring close investor scrutiny:

Key Considerations:

• Yes2Go Launch Dynamics: Rapid payer access and positive clinician feedback set up a 2026 ramp, but operational hurdles (logistics, buy-and-bill adoption) require ongoing support.
• Cell Therapy Remains a Drag: Persistent market share erosion and competitive pressures in KITE’s portfolio weigh on near-term revenue, with next-gen pipeline still in early stages.
• HIV Prevention Market Expansion: PrEP market growth of 14-15% YoY is expected to continue, benefiting both Descovy and Yes2Go, but payer mix and patient journey complexity may temper near-term upside.
• Expense Discipline: SG&A and R&D controls are supporting margin leverage, with a step-up expected in Q4 due to typical year-end trends.

Risks

Gilead faces ongoing reimbursement and pricing pressure, particularly as U.S. drug pricing reform evolves and Part D redesign impacts persist. Cell therapy underperformance is a structural headwind, and pipeline execution risk remains as pivotal readouts approach. Competition in HIV prevention and oncology is intensifying, with both branded and generic entrants vying for share.

Forward Outlook

For Q4, Gilead guided to:

• Product sales (ex-Veklury) of $27.4–$27.7 billion for FY25
• Operating income of $13.1–$13.4 billion
• Non-GAAP EPS of $8.05–$8.25 (raised 10 cents at the low end)

For full-year 2025, management raised HIV growth guidance to 5% and expects continued strength in Biktarvy and Descovy, while forecasting a 10% YoY decline in cell therapy revenue. Key drivers for the next year include:

• Yes2Go ramping as payer access pulls through into 2026
• Multiple late-stage pipeline readouts and launches in HIV, liver, and oncology

Takeaways

Gilead’s Q3 highlights a business in transition from legacy HIV dominance to a more diversified, launch-driven growth model.

• HIV and Liver Growth Engines: Biktarvy, Descovy, and Livdelzy continue to outperform, with Yes2Go poised to accelerate prevention revenue as payer wins translate to volume.
• Margin and Expense Control: Operating leverage and disciplined SG&A/R&D spending are supporting EPS growth, even as non-recurring items drop out in future quarters.
• 2026 Inflection Point: Investors should watch the pace of Yes2Go ramp, cell therapy turnaround, and pivotal pipeline readouts as the next phase of Gilead’s growth story emerges.

Conclusion

Gilead’s Q3 was defined by HIV franchise resilience, rapid Yes2Go access, and margin discipline, laying the groundwork for a 2026 launch cycle and multi-year growth. While cell therapy remains a challenge, the company’s pipeline depth, late-stage catalysts, and favorable LOE profile support a constructive long-term outlook.

Industry Read-Through

Gilead’s rapid payer coverage for Yes2Go and robust PrEP momentum signal that payer and provider barriers for long-acting HIV prevention are surmountable, setting a precedent for future specialty launches in infectious disease. The company’s margin discipline and focus on diversified late-stage assets reflect a broader biopharma trend of pivoting from single-franchise dependency toward portfolio breadth. Cell therapy’s commercial struggles highlight industry-wide adoption and reimbursement challenges, reinforcing the need for next-gen platforms and outpatient-friendly models. Gilead’s experience with U.S. drug pricing reform and Part D headwinds offers a read-through for peers with high Medicare exposure and underscores the importance of U.S.-centric IP and manufacturing footprints.

GILD Healthcare Biotechnology HIV Oncology Liver Disease Pipeline Drug Pricing