For the last several quarters, Gilead Sciences’ earnings calls have been colored by anticipation for the launch of the California drugmaker's long-acting HIV pre-exposure prophylaxis (PrEP) option. This week, Gilead had a chance to share some early returns on the med's market debut after its FDA approval five months ago.
Since Yeztugo's U.S. launch in June, the drug has garnered $54 million in sales, Gilead reported on Thursday, with $39 million generated specifically during the third quarter. The company has already secured 75% U.S. payer access for Yeztugo, some three months ahead of its original targeted timeframe of six months post-launch, with 90% expected by the end of the first half of 2026, Gilead said in its third-quarter earnings presentation (PDF).
Gilead expects $150 million to come from Yeztugo this year, but Citi analysts call this guidance “conservative,” citing broad update and rapid payer coverage as “hallmarks of a strong launch” that the drug has already demonstrated, the analysts wrote in a note to clients.
On the flip side, Mizuho analysts note that the Yeztugo's quarterly haul was a "slight miss."
In another factor supporting Yeztugo's quick adoption, updated PrEP recommendations have already poured in from key health bodies across the globe, including the U.S. Centers for Disease Control (CDC) and the World Health Organization, Gilead noted, helping cement Yeztugo’s place as a crucial option in the PrEP arsenal.
While Yeztugo may be the most-discussed asset in Gilead’s all-star lineup of HIV meds, combo treatment pill Biktarvy is still the standout earner of the drugmaker's portfolio.
HIV gains
Of Gilead’s $7.3 billion in third-quarter sales, $5.3 billion came from the company's HIV franchise, with Biktarvy alone pulling in $3.7 billion. As it stands, the drug holds 52% of the U.S. HIV treatment market share, according to the company. And after Gilead inked settlements that prevent generics from launching until 2036, Biktarvy doesn’t appear to be slowing down anytime soon.
Both Biktarvy and Yeztugo were preceded by Descovy, Gilead’s older once-daily pill that competes with several other PrEP options. Yet, the older drug locked down a record 45% of the U.S. PrEP market share over the third quarter, according to Gilead, and delivered a 20% year-over-year sales spurt.
The higher demand reflected the “incredible momentum” in the PrEP market, driven by growing awareness and increased access, Gilead's chief commercial officer Johanna Mercier explained on a call with investors. The strong showing prompted the company to boost its overall HIV sales growth forecast for the year from 3% to 5%.
While one of Gilead’s main goals with the Yeztugo launch is to expand the U.S. PrEP market to PrEP-naïve people, it's also anticipating many users to switch over from once-daily oral meds. As it turns out, switches are coming from “across the board,” including from those previously using GSK’s competing long-acting injectable, Apretude, according to Mercier. The PrEP-naïve user population, meanwhile, will “grow with time,” Mercier said.
Yeztugo makes for hefty competition to Apretude given its longer dosing window. Even so, Apretude has been carving out its own share of the PrEP market for years, with GSK reporting £120 million ($157 million) for its product during the third quarter, a 75% increase from the same period last year.
The company has long maintained that Yeztugo won’t fully push Apretude out of the market due to unfavorable injection-site reactions reported with Yeztugo, given its status as a subcutaneous injection versus Apretude’s intramuscular administration.
Gilead, meanwhile, dismisses the injection site reaction point as a “normal” response to an injectable that can be managed by “short-term ice,” Mercier said. Still, the company made sure to train health practitioners across the country on Yeztugo administration in a mission to reach “every single clinic,” she added.
Demonstrating the enormous investor interest in the drug, Mercier fielded questions on Yeztugo for nearly the entire duration of the time that Gilead allotted to Q&A during its third-quarter earnings conference call.
Cell therapy struggles
Balancing out the HIV sector’s growth, however, were lower sales of cell therapy products Yescarta and Tecartus. Declines for those drugs—as well as Gilead’s COVID-19 med Veklury—prompted a companywide 2% slide in product sales compared to the same period last year, although total revenue, accounting for royalties and other incomes, increased 3%.
The cell therapy sales slowdown has been a running theme for several quarters now, as “competitive headwinds from in- and out-of-class therapies” have stifled the growth of the Gilead meds, Mercier said. During the quarter, Yescarta logged a 10% sales decline, falling to $349 million, while Tecartus sales slipped 15% to $83 million.
The company expects these headwinds to carry on in the future, but it has established some 40 approved treatment centers this year and remains “committed to increasing the adoption and utilization of cell therapies,” Mercier said.
On the bright side, liver disease med Lizdelvi is becoming a growth star of its own, putting up 35% sequential growth to $105 million. After just over a year since its approval in primary biliary cholangitis, the drug is now the No.1 product for second-line treatment of the liver disease, according to the company.