Gilead Sciences, Inc. Q4 FY2025 earnings call

Management Statement and Operational Highlights

• Strong Financial Results: Full-year total product sales excluding Vecluri were $28 billion, exceeding guidance. HIV, liver, and oncology segments showed growth, while cell therapy faced headwinds.
• Clinical Progress: 2026 will be catalyst-rich with phase three updates for HIV, oncology, and liver disease, including islatrovir plus lenacapavir for HIV, Trodelvy trials, and libdalzi in PBC.
• Commercial Launches: Targeting four commercial launches in 2026, including Trodelvy for first-line metastatic triple-negative breast cancer, a new HIV treatment combination, Anidocel for multiple myeloma, and bruleviratide in the US.
• Expense Discipline: Committed to operating expense and M&A discipline while investing in new launches.

Segment Performance

• HIV: Fourth quarter sales were $5.8 billion, up 6% year over year, with full-year sales of $20.8 billion, up 6% year over year. Biktarvy grew 7%, and the HIV prevention portfolio, including YES2GO, saw 47% growth. YES2GO exceeded coverage goals and is gaining market share. Excluding a $900 million headwind from Part D redesign, HIV business growth was 10% in 2025.
• Liver: Full-year sales were $3.2 billion, up 6% year over year. Fourth quarter liver sales were $844 million, up 17% year over year, driven by rapid adoption of Libelzi for primary biliary cholangitis.
• Oncology: Trodelvy had full-year sales of $1.4 billion, up 6% year over year, driven by momentum in metastatic triple-negative breast cancer. Fourth quarter sales were $384 million, up 8% year over year.
• Cell therapy: Full-year sales were $1.8 billion, down 7% year over year, reflecting ongoing competitive headwinds.

Guidance

• 2026 Outlook: Expect total product sales between $29.6 billion and $30 billion. Base business sales expected to be between $29 billion and $29.4 billion, growing 4% to 5% compared to 2025.
• HIV: Expected to grow approximately 6% in 2026, with YES2GO revenue预计 at approximately $800 million.
• Cell therapy: Expected to decline approximately 10% in 2026 compared to 2025 due to competitive headwinds.
• Other: Anticipate product gross margin of ~87% in 2026, with R&D expenses increasing a low single-digit percentage and SG&A expenses increasing mid-single-digit percentage.

Risks

• Medicare Part D Redesign: An estimated $900 million headwind in 2025 associated with Part D redesign, and potential headwinds in 2026 related to drug pricing agreements with the US government.
• Competitive Headwinds: Cell therapy faced year-over-year declines due to ongoing competitive headwinds, and potential new entrants in cell therapy markets in 2026.

Q: Can you elaborate on the assumptions driving the $800 million guidance for YES2GO?

A: Johanna Mercier mentioned strong payer coverage (90%), $0 co-pay for ~90% of covered individuals, a consumer-friendly DTC campaign, and ongoing efforts to support HCPs and clinics with injectable logistics.

Q: What type of share gains are expected for Anidocel in the fourth-line setting?

A: Cindy Perettie stated Anidocel is expected to launch in the second half of 2026, with modest contribution in 2026 but aiming to become the market leader due to its efficacy and safety profile, and with world-class manufacturing ready for launch.

Q: How should we think about the growth outlook for YES2GO and cannibalization of Descovy?

A: Johanna Mercier said YES2GO has strong growth momentum with ongoing access, DTC campaign, and market expansion, while Descovy continues to grow in 2026 and over time YES2GO will take leading share in HIV prevention, with YES2GO's value proposition recognized.

Q: What about the once-yearly injectable lenacapavir for PrEP?

A: Dietmar Berger discussed the PURPOSE 365 study to demonstrate target coverage and pharmacokinetics for lenacapavir, with potential to bring a longer-term interval benefit to patients, and Johanna Mercier highlighted the importance of less frequent dosing in HIV prevention.

Q: Confidence in Anidocel's second-half launch and trial endpoints?

A: Cindy Perettie said confidence in Anidocel's launch is based on study progress, with Imagine Three study having a dual endpoint of MRD and PFS, and BLA filing planned, but FDA priority review not confirmed yet.