Gilead Sciences' Yeytuo: A Paradigm Shift in HIV Prevention and a Catalyst for Long-Term Profitability

The approval of Gilead Sciences' Yeytuo® (lenacapavir) by the European Commission in August 2025 marks a pivotal moment in the global fight against HIV. As the first and only twice-yearly injectable pre-exposure prophylaxis (PrEP) option authorized in the European Union, Yeytuo represents not just a scientific breakthrough but a strategic redefinition of how preventive medicine is delivered. For investors, this innovation signals a seismic shift in the $38.47 billion HIV drugs market, with PrEP alone poised to grow at a compound annual rate of 6.21% through 2034.

A Clinical and Commercial Milestone

Yeytuo's clinical profile is unparalleled. In the Phase 3 PURPOSE 1 and PURPOSE 2 trials, it demonstrated 100% efficacy in preventing HIV infections among cisgender women in sub-Saharan Africa and 99.9% efficacy in a broader population of men and gender-diverse individuals. These results, published in The New England Journal of Medicine, outperform existing oral PrEP options like Truvada and Descovy. The drug's twice-yearly dosing addresses a critical limitation of daily regimens—adherence challenges—while its capsid-inhibitor mechanism offers resistance-free protection.

The European Medicines Agency's accelerated approval, coupled with an additional year of market protection in the EU, underscores regulatory confidence in Yeytuo's public health value. This is not merely a product launch but a reimagining of HIV prevention. For Gilead, the drug's EU authorization complements its U.S. approval (as Yeztugo) and WHO endorsement, creating a global footprint that spans 27 EU member states, Norway, Iceland, and Liechtenstein.

Market Dynamics and Competitive Edge

The PrEP market is highly competitive, with ViiV Healthcare's Cabenuva (monthly injections) and Gilead's oral PrEP dominating. However, Yeytuo's biannual dosing offers a unique value proposition. Over 75% of trial participants expressed a preference for Yeytuo over daily pills, citing reduced stigma and convenience. This aligns with broader trends in healthcare: patients increasingly favor long-acting therapies that minimize daily routines.

Financially, Yeytuo is positioned to capture a significant share of the $30 billion PrEP market. Analysts project peak sales of $5 billion by 2030, driven by its clinical superiority and Gilead's aggressive global access strategy. The company's partnership with the Global Fund to supply lenacapavir to two million people in low- and middle-income countries (LMICs) further expands its addressable market. In LMICs, where 70% of the global HIV burden resides, voluntary licensing agreements with six generic manufacturers ensure rapid scale-up.

Strategic Risks and Opportunities

While Yeytuo's potential is vast, challenges remain. In the U.S., its $28,000 annual price tag has drawn scrutiny from insurers, who cite cost concerns compared to generic oral PrEP. However, Gilead's tiered pricing model and no-profit supply in LMICs mitigate this risk, ensuring long-term sustainability. Additionally, regulatory approvals in Argentina, Mexico, and Peru—key markets with high HIV prevalence—will determine its global reach.

The broader HIV drugs market is also evolving. As oral PrEP faces generic competition, Gilead's pivot to injectables like Yeytuo diversifies its revenue streams. The company's HIV portfolio already generated $5.1 billion in sales in Q2 2025, with Yeytuo expected to drive further growth.

Investment Implications

For investors, Yeytuo represents a high-conviction opportunity. Its clinical excellence, regulatory tailwinds, and global access strategy position Gilead as a leader in the transition from daily pills to long-acting injectables. The drug's dual role in prevention and treatment (approved for multi-drug-resistant HIV) further enhances its value.

However, success hinges on reimbursement decisions in EU countries and continued public health adoption. Gilead's $7.1 billion cash reserves as of June 2025 provide financial flexibility to navigate these hurdles.

In the long term, Yeytuo could redefine HIV prevention, much like antiretroviral therapy transformed treatment in the 1990s. For investors seeking exposure to a market-transforming innovation with durable profitability, Gilead's HIV portfolio—anchored by Yeytuo—is a compelling bet.