Gilead Sciences reported a strong third quarter in 2025, with total product sales reaching $7.3 billion. Excluding Veklury, sales grew 4% year-over-year to $7.1 billion, driven by robust performance in HIV and liver disease portfolios. Non-GAAP EPS surged 22% to $2.47, or 10% excluding a one-time IP benefit, highlighting significant operating leverage. Key growth drivers included Biktarvy ($3.7B, +6% YoY) and Descovy ($701M, +20% YoY), while the new PrEP therapy Yeztugo generated $39M in its first full quarter. Management raised full-year HIV growth guidance to approximately 5% and increased EPS guidance to $8.05-$8.25. Strategic milestones included the submission of Trodelvy for first-line breast cancer and Livdelzi surpassing $100M in quarterly sales.
| Metric | Value | Change |
|---|---|---|
| Total Product Sales | $7.3 billion | -2% YoY / +4% QoQ |
| Product Sales (ex-Veklury) | $7.1 billion | +4% YoY |
| Non-GAAP EPS | $2.47 | +22% YoY |
| HIV Sales | $5.3 billion | +4% YoY |
| Biktarvy Sales | $3.7 billion | +6% YoY |
| Descovy Sales | $701 million | +20% YoY |
| Yeztugo Sales | $39 million | Launch Quarter |
| Livdelzi Sales | >$100 million | +35% QoQ |
| Cell Therapy Sales | $432 million | -11% YoY |
| Veklury Sales | $277 million | -60% YoY |
HIV Franchise Resilience and Durability: Gilead's HIV business demonstrated exceptional resilience, growing 4% year-over-year to $5.3 billion despite a $900 million headwind from the Medicare Part D redesign. Management raised full-year HIV growth guidance to 5%, driven by Biktarvy's market leadership (52% share) and Descovy's 20% growth. The strategic signal here is the extension of Biktarvy exclusivity to 2036, which removes a major patent cliff overhang and secures long-term cash flows, allowing the company to focus on growth drivers like Yeztugo.
Yeztugo Launch Execution and Market Penetration: The launch of Yeztugo (lenacapavir for PrEP) is progressing faster than anticipated, achieving 75% payer coverage nearly three months ahead of schedule. This rapid access, combined with high unrestricted coverage rates (similar to Descovy), positions Gilead to capture significant share in the growing PrEP market (14-15% growth). Management's focus on logistics (white bagging vs. buy-and-bill) and the recent J-code implementation suggests a strategic pivot to capture broad market access quickly.
Oncology Pipeline Maturation and Expansion: The oncology segment is transitioning from R&D to commercial catalysts. The submission of Trodelvy for first-line metastatic TNBC, based on strong ASCENT-03 data (38% reduction in disease progression), targets a launch in 2026. Additionally, the anito-cel multiple myeloma program remains on track for a 2026 launch. These moves signal Gilead's strategy to diversify revenue beyond HIV into high-value oncology indications.
Liver Disease Portfolio as a Growth Driver: The liver disease segment is becoming a significant growth driver, with Livdelzi sales exceeding $100 million in Q3 (+35% sequentially) and capturing the #1 position in second-line PBC. The filing of bulevirtide for HDV, with a potential 2026 launch, further leverages Gilead's existing liver infrastructure to address rare diseases with high unmet needs.
Capital Allocation and Operating Leverage: Gilead is effectively balancing investment in innovation with shareholder returns. The company returned $1.4 billion to shareholders in Q3 while maintaining disciplined expense control (SG&A down 4%). The 22% EPS growth (10% ex-items) highlights significant operating leverage, demonstrating management's ability to drive profitability while funding late-stage pipeline assets like in vivo cell therapies.
Cell Therapy Commercial Headwinds: Kite's cell therapy sales declined 11% year-over-year and sequentially to $432 million due to continued competitive pressure from both in-class and out-of-class therapies. Management guided for a roughly 10% decline in the full year, indicating that these headwinds are persistent and may dampen near-term oncology growth expectations despite the pipeline potential.
Veklury Revenue Decline: Veklury sales plummeted 60% year-over-year to $277 million due to fewer COVID-19 hospitalizations. While this was expected, the rapid decline of what was once a multi-billion dollar product creates a significant revenue gap that other growth drivers must fill to meet overall company targets.
Yeztugo Launch Logistics Complexity: While access is high, the commercial rollout of Yeztugo involves complex logistics (white bagging vs. buy-and-bill) that are slowing the conversion from prescription to administration. Management noted that the approval process has dropped from over a month to 'more than half' that time, but the remaining friction and the need to integrate J-codes could delay the revenue ramp relative to bullish investor expectations.
Tariff and Policy Risks: Management acknowledged the impact of known tariffs and ongoing drug pricing policy discussions with the administration. While they believe the impact is 'manageable,' the $900 million hit from Medicare Part D redesign in 2025 serves as a reminder of the vulnerability of Gilead's portfolio to government reimbursement changes.
Overall: Management displayed a high degree of confidence and discipline throughout the call. They consistently emphasized 'strong execution,' 'momentum,' and 'outperformance,' particularly regarding the HIV franchise and the rapid payer coverage for Yeztugo. The tone was assertive on guidance raises and future growth potential, while remaining measured and transparent about headwinds in cell therapy and Veklury.
Confidence: HIGH - Management raised guidance for HIV revenue and EPS, cited specific achievements ahead of schedule (Yeztugo access), and provided detailed clinical data to support their optimism. The language was definitive regarding current performance ('underscores the growing momentum') and specific about future targets ('targeting a potential commercial launch in 2026').
$27.4 billion - $27.7 billion
$28.4 billion - $28.7 billion
$8.05 - $8.25
$6.65 - $6.85
~5%
~$1.0 billion
~-10%
Hedging & Uncertainty: Management used specific, confident language regarding achieved milestones ('exceeded $100 million,' 'achieved our 75% coverage goal') but employed more temporal hedging around future regulatory approvals and launches ('potential regulatory decision,' 'targeting a potential commercial launch,' 'expect to provide an update'). For example, regarding Trodelvy, they used 'potential' and 'targeting' when discussing the 2026 launch, acknowledging the regulatory uncertainty. However, they reduced hedging on Yeztugo access, moving from 'targeting' to 'thrilled' and 'ahead of schedule,' signaling increased certainty in that specific commercial execution.
Our third quarter earnings underscore the growing momentum you're seeing from Gilead today, which is driven by our strong portfolio and the impressive execution of our teams. - Daniel O'Day, Chairman and CEO
We are raising the low end of our product sales range by $100 million to reflect our strong performance year-to-date. - Andrew Dickinson, CFO
I'm thrilled that we have already achieved 75% access in the U.S., almost 3 months ahead of our target. - Johanna Mercier, Chief Commercial Officer
We anticipate these headwinds to continue in the near future. - Johanna Mercier, Chief Commercial Officer
We continue to target commercial launch for anito-cel for multiple myeloma in 2026. - Daniel O'Day, Chairman and CEO
Analyst Sentiment: Analysts were highly focused on the specifics of the Yeztugo launch (patient numbers, switching dynamics, logistics) and the sustainability of HIV growth rates. Questions were probing but generally constructive, seeking clarity on the ramp-up curve and competitive positioning.
Management Responses: Management, particularly Johanna Mercier, provided detailed, granular responses regarding Yeztugo access and logistics, demonstrating deep operational oversight. They deflected questions about specific patient numbers by focusing on access metrics and sales guidance, maintaining control over the narrative. They confidently addressed policy risks by highlighting Gilead's US footprint and constructive dialogue.
Yeztugo launch dynamics (access, switching, logistics)
HIV growth sustainability and Part D impact
Cell therapy headwinds
Oncology pipeline (Trodelvy, Anito-cel)
M&A appetite (Liver disease)
Gilead is successfully executing a multi-pronged growth strategy that is finally bearing fruit. The core HIV franchise is proving more resilient than expected, growing 5% despite significant policy headwinds, and the exclusivity extension for Biktarvy to 2036 secures the base business. The launch of Yeztugo is off to a strong start with rapid payer coverage, positioning it as a mega-blockbuster driver in the PrEP market. Meanwhile, the oncology and liver portfolios are transitioning from high burn to potential revenue generators with Trodelvy's label expansion and Livdelzi's rapid uptake. The 22% EPS growth demonstrates strong operating leverage. While cell therapy headwinds persist, the risk/reward is attractive given the diversified pipeline and reduced patent cliff risk.
Management noted constructive engagement with the administration regarding drug pricing, emphasizing Gilead's role in ending epidemics (PEPFAR partnership) and its heavy US R&D footprint ($32B commitment) which may mitigate tariff impacts compared to peers.