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iStock, Overearth Analysts believe that Gilead’s new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say about it. Gilead is mounting a bid to tighten its grip on the HIV market. Having secured approval for twice-yearly HIV prevention product Yeztugo, the company has a shot at wresting more market share from GSK and generics manufacturers. HIV products generated $19.6 billion for Gilead last year. Biktarvy, a once-daily pill for treating HIV, is the cornerstone of the portfolio, generating $13.4 billion in 2024. Descovy, a once-daily drug to treat and prevent HIV, is Gilead’s other main HIV product. The company reported $2.1 billion in Descovy sales last year, most of which came from its use in HIV prevention. Descovy competes with GSK’s Apretude, an injectable preventive given every two months, in the pre-exposure prophylaxis (PrEP) market. Talking on an earnings call in April, Johanna Mercier, Gilead’s chief commercial officer, said Descovy maintained an “over 40% market share and grew more than 2% year-over-year.” An HIV doctor told Mizuho analysts that 45% to 50% of their 125 PrEP patients are on Descovy. One-third of the doctor’s patients take Apretude, although the analysts said the average could be 20% to 25% in the northeast U.S. and varies with the commercial insurance rates of individual practices. Around 20% of patients take Truvada, Gilead’s old PrEP drug, or generic copies of the off-patent molecule. Yeztugo’s Path to $4.5B Peak Sales The analyst consensus is that Yeztugo will achieve peak sales of around $4.5 billion. Talking at a Goldman Sachs event in June, Gilead CEO Daniel O’Day outlined three pools of patients the big biotech will target as it seeks to grow Yeztugo sales. First, the company will seek to convert the 400,000 to 450,000 current PrEP users in the U.S. to Yeztugo, O’Day said. The new drug could improve treatment compliance, which O’Day said is around 50% for daily pills. The HIV doctor expects Yeztugo to be popular with current PrEP users, telling Mizuho analysts the “vast majority” of Apretude users and the “majority” of daily oral PrEP users could switch to the new drug. Up to 10% of the doctor’s patients may want to stay on an oral regimen because of needle aversion. Another doctor Mizuho spoke with, however, was more conservative, estimating that just 30 to 40% of their private practice PrEP patients will switch. If the first doctor is right, Yeztugo will rapidly reshape the PrEP market. That doctor said “most” patients who want to switch to Yeztugo will be able to do so within 12 months. O’Day has predicted Yeztugo will have 70% to 75% payer coverage after six months, rising to 90% by the end of the drug’s first year on the HIV market. Gilead’s second group of target patients is the 750,000 to 800,000 people in the U.S. who could benefit from PrEP but do not currently take a drug to prevent HIV. O’Day said most PrEP users are men who have sex with men who live in large urban areas. Gilead has been less successful at reaching other groups of at-risk individuals, O’Day said. The company will target the current and potential U.S. PrEP patients from the start of the Yeztugo launch. The HIV doctor said some patients, mainly men who have sex with men, who do not currently take a PrEP drug have contacted them about Yeztugo. O’Day said it will take time to raise awareness and drive demand among underserved communities. Gilead’s third group of patients is a longer-term play. PrEP is largely a U.S. phenomenon today, O’Day said, but Gilead believes Yeztugo represents good value to payers in other countries. Preventing a case of HIV in the U.S. saves about $1.1 million in eventual lifetime healthcare costs, according to the CEO. Gilead plans to talk to health ministries about programs where Yeztugo could serve targeted populations. GSK Gears Up for Market Share Fight The anticipated reshaping of the PrEP market is a threat to one of GSK’s growth drivers. Developed by the U.K. pharma’s HIV joint venture ViiV Healthcare, Apretude sales rose around 90% last year to hit 279 million pounds ($383 million). A wholesale switch to Yeztugo, as the HIV doctor foresees, could cause Apretude sales to contract. GSK sees things differently. ViiV Chairman David Redfern said on an earnings call in February that the company “certainly [expects] Apretude to continue to grow this year,” arguing that the market is still “significantly underdeveloped” and that the launch of another long-acting PrEP drug will “help grow the market for all of us.” Redfern also expects some patients to prefer Apretude to Yeztugo. “The competitive product definitely won’t be for everyone,” Redfern said. “We now know that there’s quite a high frequency of nodules that people experience in their abdomen, where the two injections are given. For potential PrEP users who are body image conscious, which will be quite a proportion of them, I think that potentially is an issue.” Given the relative size of the HIV treatment and prevention markets, GSK could still have a big franchise even if Gilead starts dominating the PrEP sector. Redfern has valued the total HIV market at 22 billion pounds ($30.2 billion), with treatments accounting for 90% of all sales. Gilead’s Mercier said Biktarvy has a 51% share of the U.S. treatment market but GSK is advancing molecules to challenge the incumbent. GSK’s pipeline includes VH184, an integrase strand transfer inhibitor the company said has the best resistance pro to date, and broadly neutralizing antibody N6LS. Those drug candidates, plus the capsid inhibitor VH499, are part of GSK’s plans to launch a twice-yearly HIV treatment between 2028 and 2030. GSK is aiming to launch a twice-yearly PrEP drug, matching the Yeztugo regimen, in the same timeframe. While GSK is seeking to use its long-acting injectable capabilities to win market share, Gilead is also moving next-generation candidates through the clinic. Gilead has 12 clinical programs in HIV lined up to help defend its empire through potential launches including a once-yearly version of the active ingredient in Yeztugo.

A recent ruling from the Supreme Court upheld the protected status of preventive health services, such as pre-exposure prophylaxis medicines, offered in the Affordable Care Act. As Gilead Sciences gets underway with the key launch of its twice-yearly pre-exposure prophylaxis (PrEP) HIV med, the company is doing so with a key potential overhang removed. Friday, the U.S. Supreme Court decided that appointments for members of the U.S. Preventive Services Task Force, which makes recommendations for coverage requirements under the Affordable Care Act (ACA), are made within the bounds of the U.S. Constitution. The case was heard after an employer, Braidwood Management, argued that the task force’s recommendations were invalid because its members were chosen in a way that stepped on the Appointments Clause of the Constitution.Importantly, Braidwood—and the organizations that sided with it—were challenging the ACA’s preventive service protections, opposing coverage for HIV PrEP resources on religious grounds. With the 6-3 ruling from the Supreme Court, a potential headwind to Gilead’s PrEP portfolio is “largely removed,” BMO Capital Markets analyst Evan David Seigerman wrote in a recent note to clients.Gilead markets oral PrEP drugs Truvada and Descovy, but the company just won FDA approval for its twice-yearly Yeztugo. The injectable PrEP option scored FDA approval last month after demonstrating a strong ability to prevent HIV and forms a key pillar in Gilead’s plan to “redefine the PrEP market.”As the company gets going with its much-anticipated rollout, the SCOTUS decision protects critical insurance dynamics, which are especially crucial in the early launch period, Seigerman explained in the note. The analyst pointed out that Gilead has previously said it expects to reach about 75% patient coverage for Yeztugo at six months and about 90% by the end of its first year on the U.S. market.“Today's decision clears the path forward for a launch with maintained protected coverage,” Siegerman wrote. Gilead hasn’t offered specific guidance on its revenue expectations for the drug, but the company expects its new offering will help grow the PrEP market “quite rapidly,” Chief Commercial Officer Johanna Mercier previously said. The company is specifically looking to expand the 400,000-person U.S. PrEP market to more than 1 million people by the mid-2030s and touts an access strategy that’s designed to enable “broad uptake and availability for individuals with and without insurance coverage,” the company said in a recent press release.The company’s Advancing Access medication assistance program is set up to provide the PrEP free of charge to U.S. users without insurance, while eligible commercially insured people can use Gilead’s copay savings program.While many Wall Street analysts have placed a peak sales target of $4 billion to $5 billion on the new PrEP medicine, Mizuho analysts see the drug delivering as much as $8 billion annually at peak. Last year, Gilead's full HIV portfolio generated $19.6 billion in sales, driven by Descovy and HIV treatment Biktarvy. Outside of the implications for Gilead, the SCOTUS decision was applauded by HIV advocacy organizations, with a national coalition of several groups—including PrEP4All and the Equality Federation—praising that providers can now “continue offering preventive care services as before, confident that insurers must continue covering evidence-based preventive services without cost-sharing,” the coalition said in a statement. However, advocates must still “remain prepared to call on members of Congress to demand accountability on the enforcement of the preventive service protections,” the group noted.