The U.S. Preventive Services Task Force makes recommendations for preventive services—including Gilead’s twice-yearly HIV PrEP Yeztugo—that insurers must cover. A recently postponed meeting has raised concerns that Health Secretary RFK Jr. could abolish or overhaul the group.
Gilead executives are confident that the pharma can “work through” any potential access difficulties that could arise from the recent uncertainties surrounding the U.S. Preventive Services Task Force.
The company had its first earnings call since the landmark FDA approval of its long-acting HIV PrEP drug Yeztugo in June. And PrEP was the undoubted star of Gilead’s Q2, with almost all analysts congratulating the pharma on the strong launch of Yeztugo, opening up a twice-yearly injection option for the prevention of HIV. Gilead did not provide sales figures for the PrEP product and chief commercial officer Johanna Mercier declined to reveal specific uptake figures on the call.
She did, however, commend the company’s launch teams. “The hour we got the approval, everything was basically ready to turn key and get going,” Mercier told investors. Gilead’s teams have so far executed around 25,000 customer calls since approval. Many potential customers “have seen . . . a medical sales representative more than once,” Mercier added.
Analysts on the call raised the possibility that uptake of the drug might be affected by changes made to the Preventive Services Task Force. The USPSTF was established in 1984 and consists of independent scientific experts in preventive medicine. The group makes recommendations on certain preventive services, such as screenings and counseling, which insurance providers need to cover. In June, the Supreme Court ruled that the Health Secretary has power over the panel’s composition and recommendations.
Weeks after the ruling, Robert F. Kennedy Jr. postponed a scheduled meeting of the USPSTF, raising concerns that he could abolish or overhaul the group, and subsequently affect a recommendation it would make on covering Yeztugo.
Having the Task Force’s recommendation for Yeztugo would be “ideal,” Mercier told investors during the company’s Q2 call, but in case that falls through, she also noted that “these guidelines didn’t really have legs until probably less than a year ago, probably about two, three quarters ago.”
Before that, even without the USPSTF’s endorsement, the prevention market was “growing very strong,” she added. If the Task Force guidelines were to change in any way, Mercier said Gilead can “just work closer with our payers to make sure that people have access to HIV prevention moving forward, just as they do today.”
In the second quarter, Gilead’s total revenue hit $7.1 billion, a 1% beat versus consensus estimates. The company’s HIV portfolio drove its topline beat, surging 7% year-on-year to bring in $5.1 billion. The daily HIV-1 antiretroviral pill Biktarvy emerged as Gilead’s best-selling product, with $3.53 billion in sales worldwide.
Gilead on Thursday also slightly lifted its full-year outlook. The company now expects to make $28.3 billion to $28.7 billion in 2025, versus its prior guidance of $28.2 billion to $28.6 billion.
