Gilead Sciences’ top money maker Biktarvy has been the company’s crown jewel for years now, but with the HIV med inching toward a 2033 patent cliff, the drugmaker at its HIV investor event laid out an analyst-lauded plan to extend its HIV dominance into the next decade and beyond.
The star player in Gilead’s roadmap is lenacapivir, a multidrug-resistant HIV treatment that’s currently on the market as Sunlenca. With “unprecedented efficacy” in phase 3 studies proving its potential as a long-acting pre-exposure prophylaxis (PrEP) option, the company is racing toward a summer 2025 launch with filings expected this year. Out of more than 9,000 participants across its lenacapivir trials, over 99.5% of those who received the drug didn’t contract HIV, Gilead pointed out in its presentation (PDF).
The HIV drugmaker has been positioning the twice-yearly option as a game-changer for the PrEP market and will take a “thoughtful and creative approach” to reach beyond existing consumers and overall “revolutionize HIV prevention.” While Citi analysts expect the drug to pick up revenues of $125 million in 2025 and $500 million in 2026, “targeted approaches” will be especially needed to unlock the under-penetrated PrEP markets Gilead is aiming for overseas, the analysts wrote in a note to clients.
Leerink analysts foresee similar challenges, considering the PrEP market is currently largely limited to white men who have sex with other men and are treated by HIV providers. To expand the pool, the company may have to engage in societal destigmatization of the disease and work around changing care infrastructure in certain countries, the analysts noted, which is a goal Gilead already has a game plan for with unique strategies for separate global markets.
The company has already moved to overcome the current market limitations with a first-of-its-kind study in transgender men, transgender women and gender non-binary individuals as well as cisgender men. Still, in the U.S. alone, Gilead has an eye on the 44% of people with HIV who have not achieved viral suppression through PrEP and set a goal of cranking up the U.S. PrEP market to encompass more than 1 million people by the mid-2030s. Despite the high goal post, Leerink considers it an attainable mission considering lenacapivir is an “exceptional” product.
Outside of solo lenacapivir, Gilead has pegged up to 7 new treatment options for HIV by the end of 2033, which includes 12 new molecules and 11 combination programs, one of which leans on Merck’s islatravir. The seven approvals would “significantly shield” against Biktarvy’s upcoming loss of exclusivity, Citi analysts acknowledged, and while it may be ambitious, Leerink analysts maintain that the company is “uniquely positioned to execute such a broad and diverse HIV development plan and R&D engine” given its proven anti-viral expertise and capabilities.
That expertise stretches back to the early 2000s, the California-based drugmaker reminded investors during its presentation, starting with the first PrEP medicine, Truvada, in 2012 and extending through Biktarvy’s spot as the most prescribed HIV treatment regimen “ever.” Now with lenacapivir waiting in the wings, Gilead could snatch long-acting leadership from GSK, which currently markets an every-two-month PrEP option in its Apretude. Mizuho analysts previously put peak sales for lenacapivir at around $4 billion.