New Data Show Twice-Yearly Lenacapavir Achieved Nearly Twice the One-Year Persistence of Daily Oral F/TDF in HIV Prevention

Gilead Sciences (GILD) raised its quarterly dividend to $0.82, with a full-year payout of $3.28, despite a negative trailing EPS of -$3.13. The company's third-quarter revenue was $8.30B, with HIV sales up 18% and Yeztugo sales at $305M. Free cash flow covered the dividend 4.6x, and adjusted EPS is expected to be $8.75-$9.10. Risks include Medicare pricing impacts and acquisition-related charges.

Gilead Sciences' lenacapavir, a twice-yearly HIV-prevention injection, offers nearly full protection but faces supply shortages. The FDA tentatively approved a generic version for 120 low-income countries at US$40/year. The Global Fund aims to reach 3M people by 2028, but Doctors Without Borders calls for broader access. Uganda's demand has outpaced supply.

Gilead Sciences (GILD) reported that its PURPOSE 5 trial showed twice-yearly lenacapavir had significantly higher persistence (85.6%) for HIV prevention compared to daily oral F/TDF (46.3%) over 52 weeks. No HIV acquisitions occurred in the lenacapavir group. The study included 267 participants in the UK and France. Gilead aims to address persistence challenges in HIV prevention with long-acting options.

Gilead's twice-yearly lenacapavir showed 85.6% persistence at 52 weeks vs. 46.3% for daily F/TDF in HIV prevention study. No HIV acquisitions occurred in the lenacapavir group. The study highlights the potential of long-acting HIV prevention options to improve persistence and effectiveness.

Gilead Sciences reported that its Phase 2 PURPOSE 5 trial showed higher 52-week persistence with lenacapavir compared to F/TDF for HIV prevention. No HIV cases occurred in the lenacapavir group, while one case was reported in the F/TDF group. This adds to Gilead's lenacapavir data but is not a regulatory or commercial milestone.

The FDA granted tentative approval to a $40 generic version of lenacapavir, an HIV prevention injection, developed by Dr. Reddy’s Laboratories. The branded version costs over $28,000 annually in the U.S. The generic could reach 120 low- and middle-income countries under licensing agreements with Gilead Sciences. The UK approved the branded version but faces NHS coverage hurdles.