Gilead’s HIV-Prevention Licensing Deal Tops $440M in Volume as Global Partnerships Expand Access

Gilead Sciences (GILD) fell 0.19% on Sept. 4, with a trading volume of $0.44 billion. The biopharma giant announced a partnership with the U.S. State Department and PEPFAR to distribute lenacapavir, its twice-yearly HIV-1 capsid inhibitor, for pre-exposure prophylaxis (PrEP) in low- and lower-middle-income countries. The initiative, aligned with the Global Fund, aims to provide access to up to 2 million people over three years. The collaboration allows generic manufacturers to produce lenacapavir at no profit for 120 high-burden countries, with regulatory submissions targeting 70% of the HIV-affected region by year-end.

A positive opinion from the European Medicines Agency’s CHMP for lenacapavir as a PrEP option in the EU could lead to European Commission approval later this year. The drug, marketed as Yeytuo, would be the first twice-yearly injectable HIV prevention treatment in the region. Clinical trials showed zero infections in 2,134 participants in sub-Saharan Africa and 99.9% efficacy in a broader cohort. The CHMP also endorsed an EU-M4all pathway to streamline WHO prequalification, accelerating access in resource-limited countries.

Gilead is prioritizing regulatory approvals in 18 countries, leveraging the EU-M4all framework to expedite submissions. WHO prequalification is expected by year-end, while the company has already filed in South Africa. Supply chain agreements with PEPFAR and the Global Fund aim to ensure vial production for two million people until generic alternatives meet demand. The firm is also exploring partnerships with the Pan American Health Organization to expand access beyond its voluntary licensing scope.

In the U.S., where lenacapavir is approved as Yeztugo, Gilead is collaborating with insurers and healthcare systems to ensure insurance coverage. Its Advancing Access program offers co-pay savings and free medication for uninsured individuals. The company remains focused on global partnerships to address HIV prevention gaps, with lenacapavir named Science’s 2024 “Breakthrough of the Year.”

Backtest results indicate that the stock’s recent decline may reflect market skepticism over the long-term profitability of its no-profit licensing model, despite the strategic value of expanding global HIV prevention access.