Detailed narrative
HIV Business Performance and Prevention Market Expansion
Gilead's HIV business demonstrated robust growth in 2025, with sales up 6% year-over-year to $20.8 billion, driven by strong demand for Biktarvy and a 47% increase in the HIV prevention portfolio. This performance was achieved despite an estimated $900 million headwind from Medicare Part D redesign.
The launch of Yeztugo has been particularly successful, exceeding 90% payer coverage ahead of target and contributing $150 million in sales in 2025, with an expected $800 million in 2026. The company anticipates continued growth in HIV prevention, with Yeztugo expanding the addressable population and potentially becoming the market leader.
Oncology and Liver Disease Momentum
Trodelvy sales increased 6% to $1.4 billion in 2025, primarily due to higher demand in metastatic triple-negative breast cancer, offsetting the bladder cancer withdrawal. Positive Phase III data from ASCENT-03 and ASCENT-04 have led to NCCN guideline updates, positioning Trodelvy as the only ADC recommended for first-line PD-L1 positive and negative, as well as second-line metastatic TNBC.
In liver disease, Livdelzi achieved remarkable sequential growth of 42% in Q4 to $150 million, securing over 50% market share in second-line PBC following a competitor's withdrawal. Updates from the Phase III IDEAL study are expected in 2026.
Cell Therapy Headwinds and Future Opportunities
Cell therapy sales declined 7% year-over-year to $1.8 billion in 2025, attributed to ongoing in-class and out-of-class competition, and the impact of a growing number of clinical trials. A further decline of approximately 10% is projected for 2026. Despite these headwinds, the company is preparing for the potential launch of anito-cel in the second half of 2026 for fourth-line or later relapsed/refractory multiple myeloma, based on strong Phase II data showing 96% overall response and 74% complete response.
Future opportunities include a Phase III study for anito-cel in earlier lines of multiple myeloma.
Robust Pipeline and Upcoming Catalysts
Gilead boasts a strong pipeline with up to 10 ongoing and potential new launches through 2027, including four targeted commercial launches and five Phase III readouts in 2026. Key upcoming milestones include Phase III updates for islatravir plus lenacapavir in HIV, Trodelvy in metastatic non-small cell lung cancer and advanced endometrial cancer, and Livdelzi in PBC.
The company also anticipates five FDA decisions in 2026, covering Bulevirtide, BIC/LEN, Trodelvy in first-line TNBC, and anito-cel.
Strategic Diversification and Financial Discipline
The company's diversification strategy over the past six years has resulted in a robust internal portfolio built through original research, early-stage partnerships, and M&A. Gilead remains committed to operating expense and M&A discipline, investing approximately $1 billion annually in early-stage opportunities.
Management emphasized a proactive and disciplined approach to later-stage acquisitions, aiming to add synergistic, de-risked assets to turbocharge top-line growth, while noting no major product LOEs until 2036.
Long-Acting HIV Treatment Development
Gilead is advancing a comprehensive HIV pipeline, with lenacapavir as a backbone, aiming for up to seven additional product launches by 2033, including daily, weekly, monthly, twice-yearly, and yearly treatments. The company has prioritized GS-3242, a long-acting INSTI, for development as a potential twice-yearly HIV treatment in combination with lenacapavir, citing its favorable tolerability and resistance profile.
Development of GS-1219 and GS-1614 has been discontinued to focus on the most promising programs.