With Gilead Sciences' long-acting lenacapavir unlocking a reinvigorated focus on the pre-exposure prophylaxis (PrEP) market and growth in its three therapeutic areas driving momentum beyond HIV, the company appears to be firing on all cylinders as it approaches a crucial summer HIV launch.
The California-based drugmaker posted a total sales increase of 7% in the fourth quarter, generating $7.5 billion in quarterly revenues and beating analyst consensus estimates of $7.1 billion.
Thanks to Biktarvy's $3.8 billion in quarterly sales, Gilead's HIV franchise delivered a 16% sales increase during the fourth quarter. The HIV division, with $5.5 billion in quarterly sales, represented around 73% of the company's overall top line.
Much of the company's excitement these days centers on lenacapavir, its twice-yearly HIV PrEP candidate that’s currently marketed as multidrug-resistant HIV treatment Sunlenca. Launch preparations for the med's PrEP use are “well underway," Gilead CEO Daniel O’Day told analysts on a Tuesday conference call.
After lenacapavir last year delivered a 96% reduction in HIV infections compared with background HIV incidence in one study—and previously showed 100% efficacy in another—the company is setting its sights on a summer U.S. launch, followed by a European rollout later in the year.
In addition, through the European Medicines Agency’s EU-Medicines for all program, Europe’s review of the drug can help speed up access in more than 100 countries, Gilead's chief commercial officer Johanna Mercier pointed out on the call.
Outside of HIV, Gilead's oncology franchise ended the year in the growth category, as well. The company's cancer treatments pulled down $843 million in fourth-quarter sales, representing a 10% jump from the same period in 2023.
In oncology, much of the growth can be attributed to antibody-drug conjugate Trodelvy, which is benefiting from increased demand and continued market leadership in second-line metastatic triple-negative breast cancer, according to a company presentation (PDF) on Tuesday.
Meanwhile, the company's once fast-growing cell therapies have slowed their roll lately due to “competitive headwinds," Mercier explained. Those factors include several new launches within the class and a “slower than targeted” uptake of cell therapies overall, she said.
Despite the slowdown, the company is committed to boosting the availability of its cell therapy products at integrated community oncology practices in the U.S., which would help address an access barrier that has long plagued uptake. Overall, Gilead's cell therapy sales increased 5% to $488 million during the quarter.
Elsewhere, Gilead's newly launched primary biliary cholangitis treatment Livdelzi is “definitely exceeding our internal expectations,” Mercier said. The August approval marked Gilead’s first in the inflammatory field, but, so far, the company is hearing “really positive feedback” on its medicine and expects the launch momentum to continue to gather, Mercier said.
Gilead forecasts it will generate between $28.2 billion and $28.6 billion in full-year sales in 2025. The company didn't reveal how the lenacapavir PrEP rollout will play into that total number.