Summer is creeping closer, and for Gilead Sciences that only means one thing: the much-anticipated launch of long-acting HIV pre-exposure prophylaxis (PrEP) med lenacapavir.
The twice-yearly PrEP candidate has been the focal point of Gilead’s dialogue for several quarters now, but the next time we hear from Gilead in a quarterly earnings setting, launch will be well underway. At this point, the team is just “counting days” until the FDA’s decision clears the way for an expected launch, chief commercial officer Johanna Mercier said, with June 19 circled on its calendar.
“We are absolutely ready for launch,” Mercier emphasized on Gilead’s first-quarter earnings call.
The company hasn’t yet offered specific guidance on its expectations for the drug, which it previously said could “revolutionize HIV prevention.” Still, hype is already building up and the company has heard rumblings that many PrEP-naïve people are “hanging in there” until lenacapavir is approved, Mercier said, leaving Gilead to expect the current PrEP market to grow “quite rapidly” and help to facilitate a speedy launch, Mercier said.
The drugmaker is continuing in its “very targeted” approach to launch, which features a plan for the first 30 days and 90 days and a team focused on marketing and sales as well as nurse education “ready to go."
While potential policy changes, looming tariffs and sweeping cuts throughout federal drug and health agencies is posing a concern for the broader industry, Gilead may be uniquely impacted by policy and funding uncertainty at federal HIV programs.
Workers within several HIV-related offices have been laid off, and the HHS Office of Infectious Disease & HIV/AIDS Policy and the CDC’s Division of HIV Prevention were slashed entirely. Meanwhile, the Supreme Court is weighing whether to overturn a policy requiring private insurers to cover certain cost-free preventive services through the Affordable Care Act marketplace or in employer-based coverage.
These events could impact U.S. HIV drug access overall, and Gilead is staying “very closely attuned to” them, CEO Daniel O’Day said. The company is engaging with policymakers to stress the importance of lenacapivir for PrEP, particularly in its relation to the Trump administration’s stated goals of addressing rising chronic disease rates.
So far, Gilead hasn’t spotted anything that would prompt changes in its plans or expectations for the launch, O’Day clarified. Plus, the company is separately doing many of the functions of federal HIV initiatives by itself, such as HIV surveillance, education and awareness.
“We’re talking about HIV,” Mercier noted, commenting on the dangers of HIV access barriers and Gilead’s approach to supporting HIV drug awareness and access. “These are individuals that, if they need access to HIV medicines, they will find other channels for coverage. Because if they don't, unfortunately, HIV will turn into AIDS and they will die.”
Many recent efforts on the screening and diagnosis side were reflected in the 16% PrEP market growth Gilead reported during the first quarter, Mercier pointed out.
That market growth helped boost sales of Gilead’s popular daily PrEP Descovy by 38% from last year’s first quarter to $586 million. The encouraging performance for Descovy bodes well for PrEP-to-be lenacapivir, Citi Research analysts flagged in a note to clients.
Descovy currently holds on to more than 40% of the PrEP market, according to Gilead, a market share that has grown based on increased access and “focused commercial execution,” Mercier said.
U.S.-focused footprint
As for the impacts of current and future potential tariffs, Gilead isn’t sweating.
The costs of tariffs that have been imposed thus far have already been absorbed into the company’s guidance without a change on its full-year outlook of between $28.2 billion and $28.6 billion in sales, O’Day noted.
For tariffs that stand to hit pharmaceuticals specifically, Gilead is set apart from many of its peers in that it’s already largely U.S.-based, leaving less exposure to tariffs that would be placed on drug imports. The “vast majority” of its intellectual property is based in the U.S. and more than 80% of its profits come from the country, according to O’Day.
Many of Gilead’s peers have been busy pouring billions of manufacturing investments into the U.S., and while Gilead leverages global manufacturing as well, the U.S. is already home to the company’s “strongest footprint,” leaving it “well positioned overall,” O’Day noted.
While Gilead’s bread-and-butter HIV portfolio raked in the lion’s share of the company’s $6.7 billion quarterly haul, with HIV meds contributing $4.6 billion in sales and 6% growth, oncology drug sales took a downturn with falling sales for its cell therapy Tecartus and antibody-drug conjugate Trodelvy.
The drugmaker attributed Trodelvy’s yearly and quarterly sales dip to “inventory dynamics” and a stronger fourth quarter but maintains that the drug is still the market leader in second-line metastatic triple-negative breast cancer.
The company also saw momentum for its recently launched liver disease med Livdelzi, which is growing “incredibly rapidly,” Mercier said. Still, first-quarter product sales overall fell 1% for Gilead, although that becomes 4% growth when excluding the COVID drug Veklury.