Gilead beat consensus estimates in Q4 with $7.6 billion in revenue, driven largely by its HIV drug Biktarvy and CAR T therapies Trodelvy and Yescarta.
As it awaits FDA approval, Gilead is laying the groundwork for the launch of its antiretroviral drug lenacapavir as a pre-exposure prophylactic for HIV by mid-2025.
The pharma made the announcement during its fourth-quarter and full-year earnings call on Tuesday, with Chief Commercial Officer Johanna Mercier saying that preparations “are well underway” in the U.S. Gilead expects to make lenacapavir available “this summer,” she added.
Demand for lenacapavir is expected to be high. In a note to investors on Tuesday, Jefferies analysts wrote that the HIV community is already “educated” regarding PrEP, as per Gilead. Patients are ready for lenacapavir and the pharma is “already seeing increases in HIV doc appointments scheduling” in anticipation of the drug’s potential approval in June, according to the Jefferies note.
The FDA is currently reviewing Gilead’s drug application for lenacapavir, which it filed in December 2024 and backed with data from the Phase III PURPOSE clinical development program. Lenacapavir was awarded the FDA’s Breakthrough Therapy designation in October 2024, which would accelerate its review process, though Gilead has yet to disclose a target action date for the antiviral drug.
Late-stage data paint a strong efficacy profile for lenacapavir. A readout from PURPOSE 1, released in June 2024, showed that in a cohort of 2,134 women, a twice-yearly regimen of lenacapavir led to zero cases of HIV infection. This 100% prevention efficacy surpassed even that of the oral Truvada and Descovy, both also from Gilead.
A few months later, in September, the pharma released data from PURPOSE 2, touting a 96% risk reduction against HIV infection in cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth.
“Access will play out over the next few months of the launch. We’re assuming about 75% or so access by six months, maybe about 90% by 12 months,” Mercier said on the investor call, though she noted that roll-out might “take a little bit of time in the first early months.”
“We feel incredibly confident that lenacapavir is going to have an impact in our communities in 2025 and, obviously, even more meaningful in ‘26 and beyond,” she added.
In the fourth quarter, Gilead reported a 6% year-on-year increase in revenue to $7.6 billion, surpassing the consensus of $7.1 billion. For the full year, the pharma’s revenue jumped 6% to $28.8 billion. Key growth drivers include the HIV pill Biktarvy, which earned $3.77 billion in the quarter versus the $3.47 billlion consensus, and the CAR T therapies Trodelvy and Yescarta, which raked in $365 million and $390 million, respectively.
In an investor note on Tuesday, analysts at BMO Capital Markets called Gilead’s Q4 performance “a solid end to 2024” that gives the pharma a strong positioning into 2025, “with a focus on the launch of long-acting PrEP.” In particular, the BMO analysts noted that the 16% year-on-year growth of Gilead’s HIV franchise points to its “continued dominance in the space.”
Looking ahead to the year, Gilead projects product sales of between $28.2 billion and $28.6 billion.
