Gilead's HIV PrEP Franchise Thrives Amid Regulatory Uncertainties

Gilead Sciences, a leading player in the HIV treatment and prevention market, remains confident in its pre-exposure prophylaxis (PrEP) franchise despite recent regulatory uncertainties. The company's newly approved long-acting HIV PrEP drug, Yeztugo, has shown promising early adoption rates, while its established HIV portfolio continues to drive revenue growth.

Yeztugo Launch Success and Market Potential

Gilead's twice-yearly injectable PrEP drug, Yeztugo, received FDA approval in June, marking a significant milestone in HIV prevention. Although specific sales figures were not disclosed, Johanna Mercier, Gilead's chief commercial officer, praised the company's launch efforts, revealing that approximately 25,000 customer calls have been made since the drug's approval.

The launch of Yeztugo has been met with enthusiasm from healthcare providers and potential users alike. Mercier noted that many customers have already had multiple interactions with Gilead's medical sales representatives, indicating strong interest in the new prevention option.

Regulatory Uncertainties and Access Concerns

Recent developments surrounding the U.S. Preventive Services Task Force (USPSTF) have raised questions about potential access issues for HIV prevention drugs, including Yeztugo. The USPSTF, established in 1984, makes recommendations for preventive services that insurers must cover. However, a recent Supreme Court ruling granted the Health Secretary power over the panel's composition and recommendations.

The postponement of a scheduled USPSTF meeting by Health Secretary Robert F. Kennedy Jr. has fueled speculation about possible changes to the task force's structure or recommendations. This uncertainty has led to concerns about future coverage for HIV prevention drugs.

Despite these challenges, Gilead executives remain optimistic about their ability to navigate any potential access difficulties. Mercier emphasized that even without USPSTF endorsement, the HIV prevention market had been growing strongly in recent years. She expressed confidence in Gilead's ability to work closely with payers to ensure continued access to HIV prevention options.

Financial Performance and Outlook

Gilead's Q2 2025 financial results demonstrate the company's strong position in the HIV market. Total revenue reached $7.1 billion, surpassing consensus estimates by 1%. The HIV portfolio was a key driver of this success, growing 7% year-on-year to $5.1 billion.

Biktarvy, Gilead's daily HIV-1 antiretroviral pill, emerged as the company's best-selling product, generating $3.53 billion in worldwide sales. This strong performance has led Gilead to revise its full-year outlook upward, with expected revenue now ranging from $28.3 billion to $28.7 billion for 2025.

As Gilead continues to navigate the evolving landscape of HIV prevention and treatment, the company's robust product portfolio and strategic approach to market challenges position it well for continued growth in the coming years.