Gilead Sciences Sees Yeztugo Powering HIV Growth as Oncology Pipeline Advances

Key Points

• Yeztugo is exceeding launch expectations, with Gilead forecasting at least $1 billion in sales during its first full year. The six-month HIV prevention injection is benefiting from demand among new and existing PrEP users, while more than 70% of patients returned for a second injection.
• Gilead is expanding its HIV franchise beyond Biktarvy through Bixlenvo and planned weekly oral and longer-acting treatment regimens. The company raised its HIV growth outlook to 10% and expects additional PrEP options, including a weekly pill next year and a once-yearly injection targeted for 2028.
• Oncology and inflammation programs are advancing, led by the potential launch of anito-cel for later-line multiple myeloma and additional antibody-drug conjugate programs. Phase II readouts for inflammation and immunology candidates are expected later this year, supporting management’s view that Gilead is at an “inflection point” for growth.

Gilead Sciences NASDAQ: GILD executives outlined plans to expand the company’s HIV prevention and treatment franchises while advancing oncology and inflammation programs, with Chairman and Chief Executive Officer Dan O’Day describing the company as being at an “inflection point in value.”

Speaking at a Morgan Stanley event, O’Day said Gilead has its most robust portfolio of his more than seven years leading the company. He highlighted a cadence of launches across HIV, oncology and inflammation, along with the company’s expectation that it faces no major patent expirations until 2036.

“We are in a unique position to drive value and growth,” O’Day said, citing Gilead’s operating model, cash flow generation and commitment to industry-leading margins.

HIV prevention growth and Yeztugo launch

Chief Commercial and Corporate Affairs Officer Johanna Mercier said the launch of Yeztugo, Gilead’s every-six-month HIV prevention option, has exceeded expectations. The company expects Yeztugo to generate $1 billion in its first full year on the market, according to Mercier.

Mercier said the HIV pre-exposure prophylaxis, or PrEP, market is expanding at roughly 14% to 15%, supported by awareness efforts and new treatment choices. Gilead’s total prevention portfolio exceeded $1 billion in quarterly sales, representing an annualized run rate of about $4 billion, she said.

The company is seeing uptake among both people new to PrEP and patients switching from other prevention options. Mercier added that growth through buy-and-bill channels has been faster than anticipated, which she said could signal that clinics are preparing to treat more patients with the six-month regimen.

Gilead reported that more than 70% of patients returned for their second Yeztugo injection, based on the company’s longitudinal claims analysis. Mercier said Gilead is supporting persistence through specialty pharmacy and clinic outreach, digital reminders and a nurse call center program called Ready to Go.

• Gilead expects to launch a weekly oral PrEP option in the first quarter of next year.
• The company is targeting a once-yearly injectable version of Yeztugo for 2028.
• Mercier said the weekly oral option is expected to draw mainly from Descovy and generic Truvada users, while the six-month injection has a broader potential source of demand, including new PrEP users, daily oral users and users of other long-acting products.

Mercier said the Centers for Disease Control and Prevention estimates that 2.2 million people in the U.S. could be candidates for PrEP, compared with a current user base of about 550,000. She said Gilead believes the opportunity could be larger, noting that the U.S. records approximately 13 million sexually transmitted disease diagnoses annually.

Outside the U.S., Mercier said Gilead is working with The Global Fund and the U.S. Department of State in lower- and middle-income countries, particularly in sub-Saharan Africa. In developed markets, she said reimbursement discussions can be challenging because health technology assessment systems often compare newer long-acting therapies with daily generic oral options.

HIV treatment portfolio expansion

O’Day and Mercier also described Gilead’s strategy to broaden its HIV treatment business beyond Biktarvy. The company recently launched Bixlenvo, a daily oral treatment intended to help Gilead participate more extensively in the treatment-switch market.

Mercier said Biktarvy remains the leading global HIV treatment, with more than 50% market share and more than two-thirds of the market among treatment-naive patients. However, she said new options are needed for patients seeking to move from Biktarvy to another regimen.

Bixlenvo has indications for virally suppressed patients and for patients on complex regimens, Mercier said. The latter group represents about 5% to 6% of the overall HIV patient population and may be able to reduce multi-pill regimens to one pill daily.

Gilead also expects to launch a weekly oral treatment regimen combining lenacapavir and islatravir next year through its collaboration with Merck. Longer-term development includes potential every-four-month and every-six-month treatment regimens built around lenacapavir and the investigational integrase inhibitor GS-3242.

Mercier said Gilead increased its HIV growth outlook during its second-quarter update to 10% from a prior 8% to 9% range. She attributed a temporary slowing in market growth during the second quarter partly to Affordable Care Act-related effects, but said the company expects the overall HIV market to return to historical growth of 2% to 3% over the next several quarters.

Oncology and inflammation pipeline

In oncology, executives highlighted anito-cel, Gilead’s planned cell therapy launch for fourth-line and later multiple myeloma. O’Day described the product profile as potentially “best in disease” and said Gilead is focused on enabling longer treatment-free periods for patients.

The company has fully enrolled a second-line-plus multiple myeloma study, with data expected next year. Mercier said Gilead had just under 180 authorized treatment centers for anito-cel and expects to reach about 200 by its December PDUFA date. She said the company estimates the fourth-line multiple myeloma market represents a $3.5 billion opportunity.

Executives also pointed to Gilead’s antibody-drug conjugate work, including Trodelvy in first-line triple-negative breast cancer and the recently acquired Tubulis ADC platform, initially targeting platinum-resistant ovarian cancer.

In inflammation and immunology, O’Day said Gilead expects Phase II readouts later this year for programs targeting alpha-4 beta-7 and IRAK4. The company also has a STAT6 program and acquired a BCMA T-cell engager, gamgertamig, for potential use in rare diseases where B-cell depletion may be beneficial.

O’Day said Gilead remains open to external collaborations in immunology, similar to its partnerships in HIV, particularly when combinations of differentiated medicines could accelerate patient access.

About Gilead Sciences (NASDAQ:GILD)

Gilead Sciences, Inc is a biopharmaceutical company that discovers, develops and commercializes medicines for serious and life-threatening diseases. The company's research focuses primarily on virology, oncology, inflammation and related areas, with products serving patients in the United States and international markets.

Gilead is best known for its HIV treatments, including Biktarvy, Genvoya, Descovy and other antiretroviral therapies. Its portfolio also includes medicines for viral hepatitis, such as Epclusa and Vemlidy, and Veklury (remdesivir), an antiviral treatment for COVID-19.

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