Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

iStock, Sundry Photography 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.

The launch of Gilead’s groundbreaking HIV prevention shot is progressing “well ahead of our expectations,” the company’s chief commercial officer said Thursday. Yeztugo, the first-ever twice-yearly prevention shot available in the US, was approved in June for pre-exposure prophylaxis (PrEP) in adults and adolescents. The first prescription was written hours after the approval, and the first injection was administered within days, Gilead chief commercial officer Johanna Mercier told investors on the company’s second-quarter earnings call. “The team has been executing what I consider to be the best-planned commercial launch I have seen to date,” she said, adding later that Gilead “hit the ground running.” Yeztugo is also known as lenacapavir, which was first approved by the FDA in 2022 as Sunlenca for the treatment of HIV. Other options for prevention include ViiV Healthcare’s shot Apretude, which is administered every two months, or daily pills for PrEP. In an effort to differentiate Yeztugo, Gilead has positioned the injection as a more convenient option that could drive stronger patient adherence. The company declined to provide exact figures on the number of Yeztugo prescriptions written or the number of doses administered so far. But Mercier said on the call that Gilead is “extremely pleased with the feedback from both clinicians and consumers, as well as the progress of our early discussions with payers.” Gilead’s HIV product sales increased 7% in the second quarter, compared to the same period in 2024, reaching $5.1 billion. That includes a 35% sales spike for Descovy, a tablet that can be used for HIV prevention and in combination with other medicines to treat the virus. Biktarvy, Gilead’s other oral treatment for HIV, saw a 9% sales increase. The company now expects HIV sales to grow about 3% in 2025, as opposed to prior expectations of flat year-over-year revenue, partly driven by strong sales of Biktarvy and Descovy. CFO Andrew Dickinson said Gilead isn’t updating its assumptions for Yeztugo revenue in the second half of 2025 “at this time,” despite being “very encouraged by the launch dynamics” so far. Gilead raised its full-year sales guidance to $28.3 billion to $28.7 billion, slightly up from prior expectations of $28.2 billion to $28.6 billion. That takes into account lowered expectations for the company’s Covid-19 antiviral Veklury, as the company reports lower rates of Covid-related hospitalizations. Elsewhere in its news release, Gilead reported a $190 million impairment charge related to assets from its $1.7 billion acquisition of MYR in 2020. Hepcludex, MYR’s hepatitis delta virus treatment approved in Europe, was at the center of the buyout. However, the FDA rejected the drug in 2022 over “manufacture and delivery” concerns, Gilead said at the time. It now has a biologics license application pending, according to Gilead’s second-quarter earnings slides . When asked for more details, a Gilead spokesperson said the partial impairment charge was “related to the changing competitive dynamics in indications Hepcludex is being developed for.”