Gilead Sciences, Inc. (GILD) Q3 2025 Earnings Call Transcript

Gilead Sciences reported a robust Q3 2025, with base business product sales increasing 4% year-over-year to $7.1 billion, contributing to a 10% rise in non-GAAP EPS, excluding a non-recurring accounting item. The company raised its full-year HIV revenue growth forecast to approximately 5%, driven by strong performance from Biktarvy (+6%) and Descovy (+20%), alongside Yeztugo's successful launch which achieved 75% payer coverage ahead of schedule and generated $39 million in Q3 sales. Livdelzi (PBC) surpassed $100 million in quarterly sales, growing 35% sequentially, while oncology efforts advanced with Trodelvy's sBLA filings for first-line metastatic TNBC and anticipated 2026 launch for anito-cel in multiple myeloma, despite ongoing competitive headwinds in cell therapy. Gilead emphasized its strong clinical pipeline, including upcoming data for next-generation HIV treatments and the FDA filing for bulevirtide in HDV, reinforcing its long-term growth prospects with no major loss of exclusivity until 2036.

Analysis

Gilead Sciences (GILD) reported a strong Q3 2025, with base business product sales increasing 4% year-over-year to $7.1 billion, contributing to a 10% rise in non-GAAP EPS, excluding a non-recurring $0.25 accounting benefit. This performance led to an upward revision of the full-year HIV revenue growth forecast to approximately 5%, despite a significant $900 million headwind from Medicare Part D redesign. The HIV segment was primarily driven by Biktarvy's 6% year-over-year growth and Descovy's 20% year-over-year growth, with Descovy for PrEP achieving a record 45% U.S. market share.

The new HIV prevention therapy, Yeztugo, demonstrated a successful initial launch, generating $39 million in Q3 sales and achieving 75% payer coverage nearly three months ahead of target, establishing a robust foundation for 2026. Livdelzi also significantly contributed to the liver portfolio, exceeding $100 million in quarterly sales for the first time with 35% sequential growth, and becoming the market leader in second-line PBC in the U.S.

In oncology, Trodelvy's sBLA filings for first-line metastatic TNBC, supported by positive ASCENT-03 data showing a 9.7 months median PFS, position it for a potential 2026 commercial launch. Anito-cel for multiple myeloma is also targeting a 2026 launch, with pivotal iMMagine-1 study data expected soon, though cell therapy sales declined 11% year-over-year due to competitive pressures.

Gilead's pipeline remains robust, with an FDA filing for bulevirtide in HDV expected to lead to a 2026 approval, and progress on next-generation HIV treatments like BIC/LEN targeting a 2027 launch. The company's strong intellectual property position, highlighted by no major loss of exclusivity until 2036, underpins its long-term growth strategy and ability to navigate market dynamics.

Key Decisions for Investors

• Investors should consider Gilead's strong Q3 performance and raised HIV guidance as indicators of robust commercial execution and market leadership in its core franchises.
• Monitor the continued uptake of new products like Yeztugo and Livdelzi, as their early success and market positioning are critical for sustained growth.
• Evaluate the progress of the oncology pipeline, particularly Trodelvy's expanded indications and the upcoming anito-cel data, while acknowledging competitive headwinds in the cell therapy segment.
• Assess the long-term implications of Gilead's pipeline advancements and strong IP position (no major LOE until 2036) against potential regulatory and market challenges.