After Gilead Sciences was given the green light for Yeztugo (lenacapavir) in the US and Europe, CCO Johanna Mercier said it is “well ahead of expectations” in a Q2 investor call.
The twice-yearly pre-exposure prophylaxis (PrEP) therapy has made headlines for its capacity to prevent 100% of HIV cases in a trial involving South African and Ugandan women – resulting in the jab’s approval in June.
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While Gilead did not reveal how much the flagship drug has made for the company thus far, Mercier noted that unaided awareness on Yeztugo was “at about 72%,” which is “more than double that you’d see in industry at launch”.
Looking forward, GlobalData, parent company of Pharmaceutical Technology, has forecasted that the star HIV drug will bring in just under $5bn in 2031, making it one of the company’s most lucrative assets.
However, some analysts had concerns about the drug’s future uptake following the Supreme Court’s ruling to allow Robert F. Kennedy Jr. (RFK Jr.) free rein over the US Preventive Services Task Force’s (USPSTF) staffing and decision-making.
Though the USPSTF currently recommends the use of Yeztugo as a preventive therapy for HIV, analysts feared that the division’s restructure or complete overhaul could impact guidelines around the PrEP’s usage, though Mercier believes that Gilead could “work through it” by collaborating closely with its payers if this were to occur.
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By GlobalDataThe World Health Organisation (WHO) also recently announced new guidelines, which shift the agency’s focus to preventive treatments, while prioritising the lowering of barriers to patient care for HIV management.
Gilead has pledged to allow affordable Yeztugo in low-and middle-income countries after UNAIDS’ executive director, Winnie Byanyima, called upon Gilead to allow for the immediate production of Yeztugo generics, as the drug’s $40k US price tag could leave many in lower-income countries unable to afford treatment.
HIV portfolio drives Gilead’s overall growth
On top of the early-stage success enjoyed by Yeztugo, Gilead has reported positive results for its HIV portfolio as a whole, with sales in this indication totalling $4.15bn this quarter.
Blockbuster antiretroviral Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) also had “one of its best quarters ever,” with sales jumping 9% to $3.5bn – constituting nearly half of the pharma’s overall profits in the second quarter.
Though the drug’s patent is set to expire in October 2027, GlobalData’s infectious disease analyst Anaelle Tannen noted that no HIV therapy is likely to be superior to Biktarvy in terms of commercial success.
This is supported by GlobalData’s forecast of a sales drop for Biktarvy’s main competitor Dovato (dolutegravir and lamivudine), produced by ViiV Healthcare, which GlobalData forecasts will drop from $3.4bn in 2027 to $1.6bn in 2031, in part due to patents likely being made available in 2031.
Though the HIV market is highly lucrative, with GlobalData predicting the HIV market will surpass $32bn across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan). There are more than 40 drugs now approved for use in the indication, meaning pharma companies will have to differentiate themselves substantially to get a slice of this crowded market.
One way companies are trying to differentiate is through the development of an HIV vaccine. While none have yet shown great promise, with two trials by Scripps Research, IAVI and additional collaborators across the US and Africa showing proof of concept at Phase I.
