Detailed Narrative
HIV Franchise Strength and Future Outlook
Gilead's HIV business demonstrated exceptional growth in FY24, with total sales up 8% to $19.6 billion, driven by Biktarvy's 13% growth and over 50% U.S. market share. The company anticipates continued volume growth, with lenacapavir for prevention expected to launch mid-2025, and a robust long-acting portfolio aiming for up to 7 new treatment and 2 prevention options by 2033. This strategy focuses on meeting diverse patient needs and evolving the standard of care beyond Biktarvy's current dominance.
Livdelzi's Strong Initial Launch
Livdelzi, for primary biliary cholangitis (PBC), achieved $30 million in sales in its first full commercial quarter, exceeding internal expectations. Its differentiation in efficacy (ALP and pruritus) and safety is driving strong week-over-week growth, with European Commission approval expected soon following a positive CHMP opinion. The ongoing Phase III IDEAL trial is enrolling patients with partial UDCA response, potentially expanding the eligible patient population to an additional 20,000-25,000 patients in the U.S. and Europe.
Oncology Portfolio Expansion
The oncology segment grew 12% to $3.3 billion in FY24, treating over 80,000 patients across its therapies. Trodelvy continues to gain adoption in metastatic breast cancer, with 6 ongoing Phase III trials and updates expected in 2025 for first-line metastatic triple-negative breast cancer (ASCENT-03 and ASCENT-04). The company is also initiating a Phase III trial for Trodelvy in extensive-stage small cell lung cancer in H1 2025, leveraging its FDA Breakthrough Therapy designation and promising Phase II data.
Cell Therapy Progress and Challenges
Kite's cell therapy sales reached $2 billion in FY24, treating over 7,000 patients. While showing durable responses with Yescarta and Tecartus, the segment faces competitive headwinds and slower-than-targeted uptake. Anito-cel (BCMA CAR T) showed promising Phase II data with a 97% overall response rate and 62% complete response in multiple myeloma, targeting a 2026 launch. Gilead is actively working to address barriers to CAR T adoption in community oncology settings, including accreditation and policy reform.
Pipeline Depth and Innovation
Gilead's pipeline has expanded to 54 clinical programs, up from 32 in 2019, reflecting a focus on innovation across HIV, oncology, and inflammation. Lenacapavir was recognized as Science's 2024 Breakthrough of the Year, highlighting its transformative potential. The company is also exploring CAR T in autoimmune diseases with KITE-363, demonstrating a commitment to addressing unmet medical needs beyond its traditional therapeutic areas.
Impact of Medicare Part D Reform and Other Headwinds
The 2025 revenue guidance incorporates an approximate $1.1 billion impact from Medicare Part D reform, with $900 million affecting HIV sales. This reform, along with FX headwinds🌐 ($250 million) and lower Veklury sales ($400 million), is expected to mask underlying demand-led volume growth, particularly in HIV, for the upcoming year. Despite these challenges, management expects continued strong underlying demand and is focused on expense discipline to drive operating income growth.