Gilead partners with PEPFAR to expand HIV prevention access

Published 04/09/2025, 19:22
©  Reuters

FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD), a biotechnology giant with $28.86 billion in annual revenue and an impressive 78.53% gross margin, announced a partnership with the U.S. State Department and PEPFAR to deliver lenacapavir, its twice-yearly injectable HIV prevention medication, to high-incidence, resource-limited countries. According to InvestingPro analysis, Gilead maintains a GREAT financial health score, positioning it well for such large-scale initiatives.

The collaboration aims to provide lenacapavir for pre-exposure prophylaxis (PrEP) to up to two million people over three years, according to a company press release. Gilead, currently valued at $139.95 billion in market capitalization, will supply the medication at no profit as part of coordinated efforts with both PEPFAR and the Global Fund. For detailed insights into Gilead’s financial outlook and 8 additional ProTips, visit InvestingPro.

"Lenacapavir is one of the most important scientific breakthroughs of our time and the result of nearly two decades of work by Gilead scientists," said Daniel O’Day, Chairman and CEO of Gilead Sciences.

The company has secured royalty-free agreements with six generic manufacturers to cover 120 high-incidence, resource-limited countries. By the end of 2025, Gilead plans to complete regulatory submissions for lenacapavir for PrEP in 18 countries representing approximately 70% of the HIV burden in regions covered by the voluntary license.

In July 2025, the European Medicines Agency adopted a positive EU-Medicines for all opinion for lenacapavir, which enables streamlined assessment for World Health Organization prequalification. Gilead submitted lenacapavir for WHO prequalification in August 2025, with the process expected to conclude by year-end.

Lenacapavir works by inhibiting HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes. The medication is administered as an injection every six months, potentially offering a convenient alternative to daily oral PrEP medications. This innovation has contributed to Gilead’s strong market performance, with the stock delivering a 24.06% return year-to-date. InvestingPro’s comprehensive analysis indicates that Gilead is currently trading near its Fair Value, with extensive research reports available for deeper insight.

The drug is currently approved in the United States as Yeztugo for PrEP to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. It carries a boxed warning regarding the risk of drug resistance with use in undiagnosed HIV-1 infection.

Gilead is also exploring options with partners, including the Pan American Health Organization, to support countries outside the voluntary license scope.

In other recent news, Gilead Sciences has made several significant announcements. The U.S. State Department revealed a plan to introduce Gilead’s HIV drug lenacapavir to high-burden countries, aiming to reach 2 million people over three years by offering the drug "at cost" through the Global Fund and PEPFAR program. In addition, Gilead has broken ground on a new Pharmaceutical Development and Manufacturing Technical Development Center at its Foster City headquarters, marking a step in its $32 billion investment in U.S. innovation through 2030. Meanwhile, Kite, a Gilead company, has agreed to acquire Interius BioTherapeutics for $350 million, which will add Interius’s in vivo CAR therapeutic platform to its cell therapy portfolio. However, CVS Health has decided not to cover Gilead’s new HIV prevention drug Yeztugo in its commercial plans, citing clinical, financial, and regulatory factors. On the analyst front, Mizuho has raised its price target for Gilead Sciences to $131 from $117, maintaining an Outperform rating, driven by increased sales estimates for anito-cel, a treatment for relapsed/refractory multiple myeloma.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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