Gilead Sciences shipped its first batches of lenacapavir, a twice‑yearly injectable HIV pre‑exposure prophylaxis (PrEP), to Eswatini and Zambia on November 18 2025, marking the drug’s inaugural availability in sub‑Saharan Africa.
Lenacapavir is a first‑in‑class capsid inhibitor that received U.S. FDA approval for PrEP on June 18 2025 and has been approved in South Africa and Zambia. The drug was named Science’s 2024 Breakthrough of the Year and has shown a 96 % reduction in HIV infections in the PURPOSE 2 trial, outperforming daily oral Truvada.
The shipment was made in partnership with the Global Fund, PEPFAR, and local ministries of health. Gilead’s access strategy provides lenacapavir at no profit for up to two million people until generic manufacturers can meet demand, supported by voluntary licensing agreements with generic producers. This approach underscores the company’s commitment to global health and to strengthening its reputation among donors and partners.
By delivering lenacapavir to high‑burden countries, Gilead expands its global PrEP market and positions itself to capture a substantial share of the worldwide HIV prevention market. The move also supports regional epidemic‑control efforts and aligns with Gilead’s broader HIV strategy, which emphasizes both innovation and access.
Gilead’s Q3 2025 financial results provide context for the company’s capacity to sustain this access program. Total revenue rose 3 % year‑over‑year to $7.8 billion, and diluted earnings per share climbed to $2.43 from $1.00 a year earlier. Non‑GAAP EPS of $2.47 beat analyst expectations by 15.7 %, while revenue beat expectations by 2.3 %. Management issued a cautious full‑year revenue outlook, reflecting a measured view of near‑term demand and cost pressures, yet the strong quarterly performance demonstrates the financial strength needed to support the no‑profit strategy.
Gilead plans to roll out lenacapavir to South Africa early in 2026, indicating continued momentum in high‑burden markets and a sustained commitment to expanding access beyond the initial two countries.
Daniel O’Day, Chairman and CEO of Gilead Sciences, said the first doses in Eswatini and Zambia “mark an important milestone in HIV prevention and reflect our commitment to supporting communities with the greatest need.”
The shipment illustrates Gilead’s dual focus on cutting‑edge science and equitable access, reinforcing its role as a key player in global HIV prevention and its dedication to delivering life‑saving therapies to the world’s most vulnerable populations.
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