Emtricitabine/Tenofovir Alafenamide Fumarate

Gilead Sciences’ HIV prevention business reached a milestone, exceeding $1 billion in quarterly sales for the first time. But despite the record revenue, as highlighted Tuesday by CEO Daniel O’Day, one group of analysts is raising doubts about the long-term growth of Yeztugo, the company’s much-touted long-acting PrEP option. Gilead’s PrEP sales more than doubled year over year to $1.03 billion in the second quarter of 2026, far outpacing the U.S. PrEP market’s overall growth of 14%, commercial chief Johanna Mercier said on Tuesday’s call. The strong growth was led by Gilead’s daily pill Descovy, whose PrEP sales jumped 60% year over year to $801 million. Yeztugo’s $232 million also topped analysts’ consensus by $17 million (8%). Despite the beat, Gilead has kept its Yeztugo full-year forecast unchanged at about $1 billion, which, to the Leerink team, spells “measured confidence.” Yeztugo’s launch momentum looks strong so far. Merely four full quarters into its debut, the twice-yearly injection is now the leader across the entire PrEP switch market, Mercier said. More than 70% of users have returned for their reinjection at six months, a persistence rate that Mercier said tracks “well above available PrEP options.” In a recent U.S. real-world study of nearly 1,700 individuals, the persistence rate for GSK’s bimonthly Apretude was reported at 57% over time. With about 40% of PrEP takers still on first-generation generic Truvada or any meds offered for free under a federal mandate, Leerink analysts “see meaningful headroom for Gilead’s branded portfolio,” including Yeztugo. Despite the positive sign, Leerink also spotted several uncertain signals related to Yeztugo’s long-term growth. Even with enthusiasm around twice-yearly Yeztugo injections, Gilead has developed a weekly oral formulation based on the same lenacapavir ingredient, which is now under FDA review for PrEP with a decision expected by Feb. 2, 2027. Explaining the rationale, Mercier said about 80% to 85% of the PrEP market consists of daily oral medications, calling that a “huge opportunity” for a weekly oral option. To Leerink’s analysts, this comment equates to Gilead “tacitly admitting that a sizable portion of the market prefers the convenience and on-off optionality of orals.” The analysts also questioned whether the 70%-plus return rate will be maintained over time and in later adopters. Gilead is leveraging existing healthcare systems, such as electronic health records, to implement several programs that set up reminders for reinjection, “to make sure that they’re part and parcel of your logistics,” Mercier said on the call. “I think they're all going to be very positive to continue to support our persistency rates,” she said. Whether the overall PrEP market will keep growing at a fast pace remains to be seen, even though Gilead management confirmed to Leerink that the company sees double-digit category expansion into the next decade. “We believe Gilead['s] efforts to expand into communities with high HIV incidence but low PrEP use—Black, Latino, cisgender women—may have diminishing returns, as these populations may have shorter persistence compared to groups with high PrEP awareness and usage,” the Leerink team said, citing a recent survey. Not all analysts see a problem down the road. In their Tuesday note, Jefferies’ analysts put their Yeztugo peak sales estimate at $9.5 billion, even higher than their previous projection of $8.9 billion back in March. In contrast, Wall Street’s consensus prediction dropped from $7.7 billion to $6.7 billion during the period. Thanks to better-than-expected performance from the entire HIV franchise, Gilead’s overall second-quarter sales, at $7.6 billion, came 3% above consensus.

Gilead Sciences announced late Tuesday that quarterly sales of its HIV prevention drugs crossed the $1 billion threshold for the first time, as overall revenue increased 10% to $7.8 billion, topping analyst expectations of $7.4 billion. "PrEP sales growth of over 100% has once again significantly outpaced the market, driven by strong commercial execution," said Johanna Mercier, the company's chief commercial and corporate affairs officer.Revenue from PrEP products jumped 101% in the second quarter, with preventative sales of once-daily Descovy growing 60% to $801 million and the twice-yearly injection Yeztugo — first approved in the US in June last year — reaching $232 million, up 40% quarter-on-quarter and above analyst forecasts of $219 million."Yeztugo has quickly become the leading long-acting PrEP option for new patient starts," CEO Daniel O'Day said. "With a $4 billion annual run rate for our PrEP business and Biktarvy's continued strength, we are raising our full-year HIV growth expectations to 9 to 10% year-over-year from prior guidance of 8% growth."The company also bumped up the lower end of its overall sales guidance for the year from an earlier estimate of $30 billion to a new figure of $30.1 billion — the top end was reaffirmed at $30.4 billion. Meanwhile, Gilead expects an adjusted loss this year of $0.65 to $0.30 per share, revised from a prior forecast of a loss of $1.05 to $0.65 per share.In the second quarter, sales of HIV drugs lifted 12% to $5.7 billion, with Biktarvy growing 7% to $3.8 billion, boosted by higher average realised price, favourable inventory dynamics and increased demand. Sales in Gilead's liver disease portfolio lifted 10% to $877 million, mainly due to higher demand for Livdelzi and Hepcludex.The company added that quarterly sales of Trodelvy climbed 26% to $457 million, primarily driven by increased demand across metastatic breast cancer indications. In June, regulators in both the EU and US approved Trodelvy as monotherapy for first-line patients with unresectable or metastatic triple-negative breast cancer (TNBC) who cannot receive PD-(L)1 inhibitors. "Following NCCN guideline updates earlier this year and our recent approvals in first-line metastatic TNBC, we have seen increasing breadth and depth in the adoption of Trodelvy," Mercier explained.