Gilead's HIV PrEP Franchise Faces Potential Hurdles Amid Task Force Uncertainties

Gilead Sciences, a leading pharmaceutical company in the HIV prevention space, remains optimistic about its pre-exposure prophylaxis (PrEP) franchise despite recent uncertainties surrounding the U.S. Preventive Services Task Force (USPSTF). The company's confidence comes in the wake of its successful launch of Yeztugo, a long-acting HIV PrEP drug approved by the FDA in June.

Yeztugo Launch and Market Performance

Gilead's newly approved twice-yearly injectable PrEP medication, Yeztugo, has seen a strong market entry. While specific sales figures were not disclosed, Johanna Mercier, Gilead's chief commercial officer, praised the company's launch teams for their swift action following FDA approval. The company has conducted approximately 25,000 customer calls since the drug's approval, with many potential customers having multiple interactions with medical sales representatives.

The success of Yeztugo has contributed to Gilead's robust HIV portfolio performance. In the second quarter, the company's HIV portfolio grew by 7% year-on-year, generating $5.1 billion in revenue. Biktarvy, Gilead's daily HIV-1 antiretroviral pill, emerged as the company's best-selling product with $3.53 billion in worldwide sales.

USPSTF Uncertainties and Potential Impact

Recent developments regarding the U.S. Preventive Services Task Force have raised concerns about potential access difficulties for HIV prevention medications. The USPSTF, established in 1984, consists of independent scientific experts in preventive medicine and makes recommendations on preventive services that insurance providers are required to cover.

A June Supreme Court ruling granted the Health Secretary power over the panel's composition and recommendations. Subsequently, Health Secretary Robert F. Kennedy Jr. postponed a scheduled USPSTF meeting, sparking speculation about possible changes to the group's structure or even its potential abolition.

These uncertainties could affect USPSTF recommendations for covering Yeztugo and other PrEP medications. However, Gilead executives remain confident in their ability to navigate any potential access challenges. Mercier noted that while a USPSTF recommendation for Yeztugo would be "ideal," the HIV prevention market was "growing very strong" even before the Task Force guidelines gained significant influence.

Gilead's Financial Outlook

Despite the uncertainties, Gilead has reported strong financial performance. The company's total revenue for the second quarter reached $7.1 billion, exceeding consensus estimates by 1%. In light of these results, Gilead has slightly raised its full-year outlook, now expecting to generate between $28.3 billion and $28.7 billion in 2025, up from its previous guidance of $28.2 billion to $28.6 billion.

As Gilead continues to navigate the evolving landscape of HIV prevention, the company remains focused on ensuring access to its products and maintaining its strong market position in the face of potential regulatory changes.