PEPFAR and The Global Fund Make Additional Investment in Gilead’s Lenacapavir for HIV Prevention to Further Expand Access

FOSTER CITY, Calif.--( BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. State Department, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and The Global Fund will further invest in Gilead’s twice-yearly injectable HIV prevention medicine, lenacapavir, to expand access for up to an additional 1 million people, bringing the total commitment up to 3 million people in high-incidence, resource-limited countries through 2028.

“Lenacapavir represents one of the most important breakthroughs ever seen in HIV prevention, and Gilead’s priority is to ensure broad access as quickly as possible,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.

Bringing together the resources and expertise of both PEPFAR and The Global Fund is a key component of Gilead’s larger coordinated efforts to advance access to lenacapavir for HIV PrEP. These partners are experts in country delivery and distribution, with the reach and infrastructure to ensure these supplies reach those with the greatest need as quickly as possible. Lenacapavir is the first HIV prevention therapy to reach communities in sub-Saharan Africa in the same year it was approved in the United States, with initial shipments arriving at the end of 2025.

“Lenacapavir represents one of the most important breakthroughs ever seen in HIV prevention, and Gilead’s priority is to ensure broad access as quickly as possible,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “We expect large-scale generic rollout starting in 2027 and, in the meantime, Gilead is providing lenacapavir at no profit to the Global Fund and PEPFAR in countries with the most urgent need today. This additional commitment further expands access to lenacapavir as we build toward broad, affordable access and global impact.”

Gilead’s broader global access strategy includes voluntary licensing agreements with six generic manufacturers. Gilead has significantly accelerated the steps required to support generic manufacturing with large-scale generic rollout expected in 2027. Many countries and program implementers have already begun engagement with these manufacturers in preparation for generic availability.

With approximately 1.3 million new HIV infections globally each year, expanding access to highly effective, long-acting prevention options remains critical to changing the trajectory of the epidemic and reducing the long-term burden on health systems worldwide.

There is currently no cure for HIV or AIDS.

About Lenacapavir

Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

U.S. Indication for Yeztugo ®

Yeztugo ® (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.

U.S. Important Safety Information for Yeztugo

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

About Gilead HIV

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the collaboration with PEPFAR and The Global Fund; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead’s earnings; Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

U.S. full Prescribing Information for Yeztugo, including Boxed Warning, is available at www.gilead.com.

Yeztugo, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).