Gilead Stock Earnings Reports

Strong Financial Performance:

• Full-year total product sales were $28.6 billion, an increase of 6% from 2023, exceeding the provided guidance of $27.8 to $28.1 billion.
• Excluding Veklury (COVID-19 treatment), total product sales reached $26.8 billion, reflecting an 8% year-over-year growth, driven primarily by the HIV, oncology, and liver disease portfolios.

HIV Portfolio Growth:

• Full-year HIV sales increased 8% to $19.6 billion, led by Biktarvy, which recorded a 13% growth.
• The company anticipates a temporary revenue impact from Medicare Part D reform in 2025, which is expected to impact HIV revenues by approximately $900 million. This reform will likely showcase a 'reset' in revenue growth, stating that demand continues to remain strong despite this setback.

Upcoming Product Launches:

• Lenacapavir, recently filed for approval as a twice-yearly HIV prevention option in the U.S. and undergoing accelerated review in Europe, is considered a significant growth driver. A launch is anticipated in mid-2025.
• Livdelzi, a new treatment for primary biliary cholangitis (PBC), generated approximately $30 million in its first full quarter, indicating strong demand and a successful market entry.

Oncology Developments:

• Sales in the oncology segment reached $3.3 billion, up 12% year-over-year, with Trodelvy maintaining its status as a standard-of-care option for certain breast cancers. There are ongoing trials expected to provide updates in 2025.
• Gilead reported positive findings from its cell therapies, with Kite's associated sales hitting $2 billion.

Financial Guidance for 2025:

• Gilead anticipates total product sales between $28.2 billion and $28.6 billion for 2025, reflecting expectations for strong performance but tempered by known external headwinds.
• Expected non-GAAP EPS for 2025 is projected to be between $7.70 and $8.10.

Investment in Pipeline and Expense Management:

• Gilead's pipeline boasts 54 ongoing clinical programs, and the company plans to maintain disciplined spending, with operating expenses expected to remain stable.
• The company returned $5.1 billion to shareholders in 2024, with plans for continued investment in both internal and external business opportunities.

Management Transition:

• Dietmar Berger was introduced as the new Chief Medical Officer. His experience is anticipated to enhance Gilead's R&D efforts.

Regulatory Landscape:

• Gilead is actively engaging with regulatory bodies like the FDA and EMA to ensure smooth approval processes for new products, with an emphasis on global health equity.

Considerations for Investors:

• Watch for the impact of Medicare Part D reform: The potential headwinds could mask underlying growth in core areas like HIV.
• Monitor Lenacapavir’s launch: This product is viewed as a key growth driver, and its market reception will be crucial for future revenue projections.
• Oncology drug updates: Keep an eye on the outcomes of ongoing trials, particularly for Trodelvy and Kite's therapies, which could significantly influence market position and sales growth.
• Financial management: Gilead's focus on maintaining expense discipline while driving growth may enhance long-term profitability.
• Future guidance expectations: Assess Gilead's performance against the guidance provided, particularly after the first quarter 2025, which may reflect typical seasonal patterns and headwinds.