Can Gilead Sciences HIV Franchise Drive Long-Term Growth?

Gilead Sciences, Inc. GILD 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 first-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 performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.

Biktarvy continues to be a dominant player in the HIV treatment market, holding more than 52% market share and retaining its position as the most prescribed therapy for both treatment-naïve and switch patients across major markets.

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.

The FDA approval of injectable lenacapavir, a first-in-class capsid inhibitor (under the brand name Yeztugo), solidifies GILD’s HIV portfolio. With a twice-yearly dosing schedule, the therapy offers meaningful adherence advantages over daily oral regimens and targets a broad patient population.

Following better-than-expected first-quarter results and improving market trends, Gilead raised its 2026 sales guidance for Yeztugo to $1 billion, signaling the product’s potential to achieve blockbuster status in its first full year on the market.

Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8% year over year, up from its prior guidance of 6% issued in February. The updated outlook includes an estimated 2% headwind related to the U.S. government’s Medicaid drug pricing agreement and proposed Affordable Care Act changes.

The FDA accepted Gilead’s new drug application for bictegravir/lenacapavir (BIC/LEN) for virologically suppressed people living with HIV under priority review, setting a target action date of Aug. 27, 2026.  A potential approval of BIC/LEN will further bolster its HIV portfolio.

Looking ahead, with no significant loss-of-exclusivity (LOE) events expected until 2036, Gilead’s HIV franchise is well positioned for sustained long-term growth, supported by the potential launch of up to seven new HIV therapies by 2033.

GILD has also collaborated with Merck MRK to advance its HIV pipeline further.

Gilead and Merck recently announced positive data from two late-stage studies, ISLEND-1 and ISLEND-2, evaluating investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir.

The investigational regimen combines Merck's islatravir, a next-generation nucleoside analog that inhibits HIV replication through multiple mechanisms, including reverse transcriptase translocation inhibition, with Gilead's lenacapavir.

Both studies met the primary efficacy endpoint at week 48. Following the positive phase III results, Gilead and Merck intend to submit the ISLEND trial data to regulatory authorities worldwide and present detailed study findings at an upcoming scientific conference.

Gilead presented encouraging phase I data for the long-acting integrase inhibitor GS-3242 in February. Additional data expected later this year could support the development of a twice-yearly injectable regimen combining GS-3242 with lenacapavir.

Approval of additional treatments should strengthen its dominant HIV franchise.  

Competition for GILD’s HIV Business

The HIV treatment landscape is dominated by many bigwigs, such as GSK plc GSK and Merck, 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 recently won FDA approval of 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, allowing them to switch from their current HIV therapy.

Merck is also evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in treatment-naïve adults with HIV-1 infection.

GILD’s Price Performance, Valuation and Estimates

Shares of GILD have gained 2.3% year to date against the industry’s decline of 3.1%.

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Going by the price/earnings ratio, GILD’s shares currently trade at 33.39X forward earnings, higher than its mean of 11.87X and the large-cap pharma industry’s 17.59X.

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The consensus estimate for 2026 has deteriorated sharply over the past 30 days, shifting to a loss of 79 cents per share from projected earnings of $4.32 per share. The estimate for 2027 has also edged lower to $9.53 per share from $9.57 during the same period.

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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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