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Can Gilead Sciences' HIV Business Fuel Sustainable Long-Term Growth?

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Key Takeaways

  • Gilead's HIV franchise benefits from Biktarvy's 53% U.S. treatment share and growing Yeztugo demand.
  • Yeztugo sales reached $305 million, up 31% sequentially, with full-year sales projected at $1 billion.
  • Gilead raised its 2026 HIV sales growth outlook to 12%, supported by Biktarvy, Descovy and Yeztugo.

Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy for treatment and Descovy for prevention.

Last month, the company reported better-than-expected third-quarter results, driven by strong HIV breast cancer drug Trodelvy and liver disease drug Livdelzi sales.

HIV business continues to maintain momentum, driven by solid Biktarvy and Descovy performances, and incremental contributions from Yeztugo.

Biktarvy continues to be a dominant player in the HIV treatment market, commanding a market share of more than 53% in the United States.

Gilead’s HIV pre-exposure prophylaxis (PrEP) portfolio comprises daily oral Descovy and the first and only twice-yearly injectable Yeztugo.

Descovy’s performance continues to be strong, primarily driven by higher demand and average realized price. PrEP sales continue to account for approximately 80% of total Descovy sales.

Yeztugo is emerging as a key growth driver, supported by strong demand in the long-acting injectable PrEP market, which doubled year over year. With a twice-yearly dosing schedule, the therapy offers meaningful adherence advantages over daily oral regimens and targets a broad patient population.

Sales reached $305 million, up 31% sequentially, making it the leading injectable prevention regimen. The company expects Yeztugo to generate approximately $1 billion in full-year sales.

Encouragingly, more than 70% of users have returned for their second injection, highlighting strong patient adherence and reinforcing Yeztugo's differentiated persistence profile. Growth is being supported by new patient initiations, primarily involving switches from existing PrEP regimens, while the proportion of PrEP-naive patients increased during the quarter. A potential once-weekly oral version of Yeztugo could further expand patient access and support long-term growth.

The FDA approval of Bixlenvo, a daily oral combination of bictegravir and lenacapavir for virologically suppressed adults with HIV, has strengthened the company's HIV portfolio. It was launched toward the end of the third quarter following its U.S. approval in August.

Gilead now expects total HIV sales to grow approximately 12% year over year in 2026, up from its earlier projection of 9-10%, reflecting strong performances from Biktarvy, Yeztugo and Descovy.

GILD is advancing a broad HIV pipeline spanning weekly oral and long-acting injectable treatments. The company expects to file its once-weekly oral islatravir/lenacapavir regimen with the FDA in 2026, with a regulatory decision in 2027.

It has also initiated mid-stage studies of additional lenacapavir-based combinations and phase III studies of twice-yearly injectable treatment candidates. In HIV prevention, the FDA is reviewing once-weekly oral lenacapavir for PrEP, with a decision expected in February 2027. Meanwhile, phase III data for once-yearly injectable lenacapavir are expected in 2027, with a potential launch in 2028.

These programs could expand Gilead's HIV treatment and prevention options, creating additional long-term growth opportunities.

Competition for GILD’s HIV Business

The HIV treatment landscape is dominated by many bigwigs, such as GSK plc (GSK - Free Report) and Merck (MRK - Free Report) , apart from GILD.

HIV sales account for a major chunk of GSK’s Specialty Medicines portfolio. GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.

MRK markets doravirine for treating adults with HIV-1 in the United States, either as a monotherapy under the brand name Pifeltro or as part of the single-tablet combination regimen under the brand name Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).

MRK won FDA approval for Idvynso, a once-daily, two-drug single-tablet regimen containing doravirine (100 mg) and islatravir (0.25 mg), for adults living with HIV-1 who are virologically suppressed on a stable antiretroviral regimen. The approval covers patients with no history of treatment failure and no known resistance-associated mutations to doravirine. 

GILD’s Price Performance, Valuation and Estimates

Shares of GILD have gained 38.3% year to date compared to the industry’s decline of 10.2%.

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Going by the price/earnings ratio, GILD’s shares currently trade at 19.68X forward earnings, higher than its mean of 12.43X but lower than the large-cap pharma industry’s 19.88X.

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The Zacks Consensus Estimate for 2026 loss per share has widened to 80 cents from 47 cents over the past 30 days. Meanwhile, the 2027 earnings estimate has risen to $10.09 per share from $9.91.

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While Gilead’s recent aggressive dealmaking strategy strengthens its long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.

GILD currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.



 

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