Gilead Sciences Sees Strong Q4 Growth, Prepares for Landmark HIV PrEP Launch

Gilead Sciences, the California-based pharmaceutical giant, has reported a robust fourth quarter performance, setting the stage for a pivotal year ahead in HIV prevention. The company's financial results and strategic focus on long-acting pre-exposure prophylaxis (PrEP) signal significant developments in the pharmaceutical landscape.

HIV Franchise Drives Revenue Growth

Gilead's fourth-quarter revenues reached $7.5 billion, marking a 7% increase and surpassing analyst expectations of $7.1 billion. The company's HIV franchise was the primary driver of this growth, with sales jumping 16% to $5.5 billion, accounting for approximately 73% of total revenue. Biktarvy, Gilead's flagship HIV treatment, contributed $3.8 billion to the quarterly sales, underlining its market dominance.

Lenacapavir: A Game-Changer in HIV Prevention

The spotlight is now on lenacapavir, Gilead's innovative twice-yearly HIV PrEP candidate. Currently marketed as Sunlenca for multidrug-resistant HIV treatment, lenacapavir is poised for a summer launch in the United States as a PrEP option, with a European rollout planned for later in the year.

Lenacapavir's potential as a long-acting PrEP medication is supported by impressive clinical data. In one study, it demonstrated a 96% reduction in HIV infections compared to background incidence, while another trial showed 100% efficacy. These results have heightened anticipation for the drug's launch, with CEO Daniel O'Day confirming that preparations are "well underway."

Johanna Mercier, Gilead's chief commercial officer, highlighted the potential for accelerated global access through the European Medicines Agency's EU-Medicines for all program, which could expedite availability in over 100 countries.

Diversification Beyond HIV

While HIV remains Gilead's primary focus, the company is making strides in other therapeutic areas:

1. Oncology: The cancer treatment portfolio grew by 10%, generating $843 million in Q4 sales. Antibody-drug conjugate Trodelvy is leading this growth, particularly in second-line metastatic triple-negative breast cancer.

2. Cell Therapies: Despite facing "competitive headwinds" and slower-than-expected uptake, cell therapy sales increased by 5% to $488 million. Gilead is working to improve access by expanding availability in integrated community oncology practices.

3. Inflammatory Diseases: The newly launched Livdelzi for primary biliary cholangitis is exceeding internal expectations, marking Gilead's entry into the inflammatory disease market.

Looking ahead, Gilead projects full-year 2025 sales between $28.2 billion and $28.6 billion, although the specific impact of the lenacapavir PrEP launch on these figures remains undisclosed.