Gilead Prepares for Mid-Year Launch of Lenacapavir PrEP Amid Strong Q4 Performance

Gilead Sciences is gearing up for a potential mid-2025 launch of its groundbreaking HIV prevention drug, lenacapavir, as the company reports robust financial results for the fourth quarter of 2024. The pharmaceutical giant is positioning itself to capitalize on the anticipated FDA approval of lenacapavir as a pre-exposure prophylactic (PrEP) for HIV, while its existing portfolio continues to drive growth.

Lenacapavir PrEP: A Game-Changing HIV Prevention Strategy

Gilead's Chief Commercial Officer, Johanna Mercier, announced during the company's fourth-quarter earnings call that preparations for the U.S. launch of lenacapavir as PrEP are "well underway." The company expects to make the drug available by summer 2025, pending FDA approval.

The excitement surrounding lenacapavir is well-founded, with late-stage clinical data demonstrating impressive efficacy. The PURPOSE 1 trial, involving 2,134 women, showed that a twice-yearly regimen of lenacapavir resulted in zero HIV infections, surpassing the prevention efficacy of Gilead's oral PrEP options, Truvada and Descovy. Furthermore, the PURPOSE 2 trial reported 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.

Gilead filed its drug application for lenacapavir in December 2024, supported by data from the Phase III PURPOSE clinical development program. The FDA granted Breakthrough Therapy designation to lenacapavir in October 2024, potentially expediting the review process.

Strong Financial Performance and Market Outlook

Gilead's fourth-quarter results exceeded expectations, with revenue reaching $7.6 billion, a 6% year-on-year increase that surpassed the consensus estimate of $7.1 billion. For the full year 2024, the company reported a 6% jump in revenue to $28.8 billion.

Key growth drivers for Gilead include:

1. Biktarvy: The HIV pill generated $3.77 billion in Q4, outperforming the $3.47 billion consensus.
2. CAR T therapies: Trodelvy and Yescarta brought in $365 million and $390 million, respectively.
3. HIV franchise: A 16% year-on-year growth underscores Gilead's continued dominance in this therapeutic area.

Looking ahead to 2025, Gilead projects product sales between $28.2 billion and $28.6 billion. The company anticipates a gradual rollout for lenacapavir, with Mercier estimating "about 75% or so access by six months, maybe about 90% by 12 months."

Analysts from BMO Capital Markets described Gilead's Q4 performance as "a solid end to 2024," noting that it positions the company strongly for 2025, with a focus on the launch of long-acting PrEP. The HIV community's readiness for lenacapavir is evident, with Jefferies analysts reporting increases in HIV doctor appointment scheduling in anticipation of the drug's potential June approval.

As Gilead continues to solidify its position in the HIV market and expand its oncology portfolio, the potential addition of lenacapavir to its PrEP offerings could mark a significant milestone in the company's growth trajectory and in the global fight against HIV.