GILEAD SCIENCES, INC. Q4 FY2024 earnings call

• HIV: Strong growth in HIV sales, driven by Biktarvy and Descovy. Lenacapavir filed for approval in the US and EU, with breakthrough therapy designation in the US. Plans for multiple new HIV treatment and prevention options by 2033.
• Liver Disease: Livdelzi launched in the US with strong sales, positive CHMP opinion in EU for seladelpar. Ongoing clinical trials for liver diseases.
• Oncology: Trodelvy sales growing, cell therapy with anito-cel showing promising Phase 2 results. Ongoing Phase 3 trials for various oncology indications.

HIV: Full year sales grew 8% to $19.6 billion, with Biktarvy up 13%. Fourth quarter HIV sales were $5.5 billion, up 16% year-over-year. Liver Disease: Full year sales reached $3 billion, a 9% year-over-year increase. Fourth quarter sales were $719 million, up 4% year-over-year. Oncology: Full year sales of $3.3 billion increased 12% year-over-year. Fourth quarter Trodelvy sales were $355 million, up 19% year-over-year. Cell Therapy: Full year sales were $2 billion, with fourth quarter sales at $488 million, flat sequentially. Veklury: Fourth quarter sales were $337 million, down 53% year-over-year. Full year sales were $1.8 billion, a 18% decline from 2023.

2025 total product sales expected to be $28.2 billion to $28.6 billion. Excluding Veklury, total product sales are expected to be $26.8 billion to $27.2 billion. Veklury sales expected at $1.4 billion. Margin expectations range with product gross margin 85%-86%. SG&A expected to decline. Non-GAAP EPS预计在$7.70至$8.10之间. HIV revenue expected flat in 2025 due to Medicare Part D reform, masking underlying demand-led growth.

• Impact of Medicare Part D reform on HIV revenue, expected to reduce HIV revenue by ~$900 million in 2025.
• Competitive dynamics in cell therapy, with ongoing challenges in market uptake.
• Uncertainties in COVID-19 related Veklury sales, as volumes are subject to hospitalizations trends.

Q: Afternoon, guys. In HIV, do you guys view all the different Len treatment options that you detailed as eventually replacing Biktarvy?

A: Johanna Mercier stated that Gilead's strategy is to meet patient needs, with Biktarvy as the standard of care, and lenacapavir options offering long-acting administration as potential replacements over time.

Q: In terms of lenacapavir, what is included in the 2025 revenue guide? And comment on margin expansion.

A: Andrew Dickinson mentioned lenacapavir launch mid-year with access ramping up, and margin expansion due to expense control, expecting SG&A decline and stable R&D spend.

Q: Concerns about consensus being too high relative to lenacapavir's initial launch?

A: Johanna Mercier said access will ramp up, with ~75% access by six months and ~90% by 12 months, noting injectable administration may take time initially but confident in impact.

Q: On anito-cel, how many ICANS cases had tremors, bradykinesia?

A: Cindy Perettie said she couldn't answer in detail but noted no tremors seen in those cases.

Q: Comments on lenacapavir approval in EU and reimbursement?

A: Johanna Mercier said plans are on track for US approval, and in EU, working with stakeholders for access, including EU for all initiative for low-income countries.

Q: Reflections on competitiveness of late-stage oncology portfolio, especially Trodelvy?

A: Dietmar Berger said Trodelvy is differentiated with overall survival demonstrated, and TIGIT's domvanalimab has potential with ongoing Phase 3 studies.

Q: Sales growth for HIV quarter-over-quarter, inventory dynamics?

A: Johanna Mercier said strong demand, with seasonal inventory dynamics, heavier in Q4 2024 vs prior years.

Q: Livdelzi use pattern, prescriber base?

A: Johanna Mercier said strong early uptake, exceeding expectations, with favorable payer access and second-line patients as primary users.

Q: Factors in 16% year-over-year PrEP market growth and lenacapavir launch?

A: Johanna Mercier said market development efforts and momentum from PURPOSE 1/2 studies will support lenacapavir launch.

Q: Enrolment in IDEAL study for Livdelzi and label expansion?

A: Dietmar Berger said IDEAL study is on track, assessing partial UDCA responders, potentially expanding Livdelzi's reach.

Q: Thoughts on small cell lung cancer and TROP2 targets?

A: Dietmar Berger said TROP2 ADC has potential in second-line small cell lung cancer, with Phase 3 trial starting in 2025, and other targets competitive but TROP2 is foundational.