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Can Gilead's Efforts to Develop New Treatments Solidify HIV Franchise?
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Key Takeaways
Gilead raised 2026 HIV sales growth guidance to about 8% on strong HIV performance and Yeztugo guidance.
GILD and Merck reported positive phase III data for a once-weekly oral HIV regimen supporting filings.
Gilead expects no major HIV exclusivity losses until 2036 and sees up to seven new HIV therapies by 2033.
Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy for treatment and Descovy for prevention.
The company’s HIV business continues to maintain momentum, driven by solid performances 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 approval of injectable lenacapavir, a first-in-class capsid inhibitor (under the brand name Yeztugo), has solidified 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.
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.
Gilead continues to make efforts to strengthen its HIV portfolio further. The company has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline.
Gilead and Merck recently announced positive phase III results from the ISLEND-1 and ISLEND-2 studies evaluating their investigational once-weekly oral HIV regimen, islatravir plus lenacapavir. At week 48, the regimen was non-inferior to daily standard-of-care treatments, including Biktarvy, in maintaining virologic suppression and demonstrated a comparable safety profile with no new safety concerns. Patients receiving the once-weekly therapy also reported higher treatment satisfaction and lower treatment burden.
The data will support regulatory submissions for what could become the first once-weekly oral HIV treatment.
The FDA had earlier 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.
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.
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 - Free Report) 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 6.2% year to date compared with the industry’s growth of 1.4%.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 25.56X forward earnings, higher than its mean of 14.92X and the large-cap pharma industry’s 17.29X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2026 has deteriorated sharply over the past 60 days, shifting to a loss of 77 cents per share from projected earnings of 8 cents per share. The estimate for 2027 has moved north to $9.73 per share from $9.58 during the same period.
Image Source: Zacks Investment Research
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.
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Image: Shutterstock
Can Gilead's Efforts to Develop New Treatments Solidify HIV Franchise?
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy for treatment and Descovy for prevention.
The company’s HIV business continues to maintain momentum, driven by solid performances 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 approval of injectable lenacapavir, a first-in-class capsid inhibitor (under the brand name Yeztugo), has solidified 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.
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.
Gilead continues to make efforts to strengthen its HIV portfolio further. The company has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline.
Gilead and Merck recently announced positive phase III results from the ISLEND-1 and ISLEND-2 studies evaluating their investigational once-weekly oral HIV regimen, islatravir plus lenacapavir. At week 48, the regimen was non-inferior to daily standard-of-care treatments, including Biktarvy, in maintaining virologic suppression and demonstrated a comparable safety profile with no new safety concerns. Patients receiving the once-weekly therapy also reported higher treatment satisfaction and lower treatment burden.
The data will support regulatory submissions for what could become the first once-weekly oral HIV treatment.
The FDA had earlier 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.
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.
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 - Free Report) 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 6.2% year to date compared with the industry’s growth of 1.4%.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 25.56X forward earnings, higher than its mean of 14.92X and the large-cap pharma industry’s 17.29X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2026 has deteriorated sharply over the past 60 days, shifting to a loss of 77 cents per share from projected earnings of 8 cents per share. The estimate for 2027 has moved north to $9.73 per share from $9.58 during the same period.
Image Source: Zacks Investment Research
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.