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Will GILD's Strong HIV Portfolio Reap Rewards in 2026?
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Key Takeaways
GILD's HIV growth is driven by Biktarvy and Descovy, with Yeztugo becoming the first twice-yearly PrEP option.
GILD's injectable lenacapavir strengthens prevention as Truvada faces generic competition
GILD's bictegravir-lenacapavir single-tablet regimen met phase III endpoints, supporting regulatory filings.
Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy. Biktarvy sales and Descovy for pre-exposure prophylaxis (PrEP) have fueled GILD’s top-line growth over the past several quarters.
Earlier this year, GILD’s HIV portfolio received a boost with the FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.
The FDA approval of lenacapavir under the brand name Yeztugo solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.
Yeztugo has a competitive advantage as it needs to be taken only twice a year, unlike daily oral pills, and addresses a broad population.
The company recently reported that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the phase III ARTISTRY-2 study.
Results showed that a once-daily single tablet regimen of bictegravir and lenacapavir met the primary success criterion for non-inferiority to Gilead’s flagship HIV therapy, Biktarvy.
Last month, Gilead announced that this investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment met the primary endpoint in the late-stage ARTISTRY-1 study.
Consequently, Gilead plans to file the phase III results from the ARTISTRY studies with regulatory authorities. The results of ARTISTRY-2 will be combined with the findings from the ARTISTRY-1 study to form the basis of regulatory submissions.
Positive data from both the late-stage studies increases the likelihood of a potential approval of a single-tablet regimen combining bictegravir and lenacapavir.
According to Gilead, a single-tablet regimen combining bictegravir and lenacapavir could further reshape the HIV treatment landscape by broadening options that help people with HIV maintain virologic suppression while benefiting from one of the latest advances in HIV drug development.
Approval of additional HIV treatments should strengthen its dominant HIV franchise.
Competition in the HIV Treatment Place
The HIV treatment landscape is dominated by many bigwigs like 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 have 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, as well as part of the single-tablet combination under the brand name Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).
Merck is also evaluating 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.
The FDA has accepted MRK’s new drug application (NDA) for DOR/ISL for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen. A decision from the regulatory body is expected on April 28, 2026.
GILD’s Price Performance, Valuation and Estimates
Gilead’s shares have gained 31.2% in the past year compared with the industry's growth of 15%.
Image Source: Zacks Investment Research
From a valuation standpoint, GILD is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, GILDs’ shares currently trade at 14.32x forward earnings, higher than its mean of 10.93x but lower than the large-cap pharma industry’s 17.11X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has moved up to $8.17 from $8.07 in the past 60 days, while that for 2026 has moved south to $8.50 from $8.51 in the same timeframe.
Image: Shutterstock
Will GILD's Strong HIV Portfolio Reap Rewards in 2026?
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy. Biktarvy sales and Descovy for pre-exposure prophylaxis (PrEP) have fueled GILD’s top-line growth over the past several quarters.
Earlier this year, GILD’s HIV portfolio received a boost with the FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.
The FDA approval of lenacapavir under the brand name Yeztugo solidifies GILD’s HIV portfolio as its other prevention drug, Truvada, faces generic competition.
Yeztugo has a competitive advantage as it needs to be taken only twice a year, unlike daily oral pills, and addresses a broad population.
The company recently reported that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the phase III ARTISTRY-2 study.
Results showed that a once-daily single tablet regimen of bictegravir and lenacapavir met the primary success criterion for non-inferiority to Gilead’s flagship HIV therapy, Biktarvy.
Last month, Gilead announced that this investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment met the primary endpoint in the late-stage ARTISTRY-1 study.
Consequently, Gilead plans to file the phase III results from the ARTISTRY studies with regulatory authorities. The results of ARTISTRY-2 will be combined with the findings from the ARTISTRY-1 study to form the basis of regulatory submissions.
Positive data from both the late-stage studies increases the likelihood of a potential approval of a single-tablet regimen combining bictegravir and lenacapavir.
According to Gilead, a single-tablet regimen combining bictegravir and lenacapavir could further reshape the HIV treatment landscape by broadening options that help people with HIV maintain virologic suppression while benefiting from one of the latest advances in HIV drug development.
Approval of additional HIV treatments should strengthen its dominant HIV franchise.
Competition in the HIV Treatment Place
The HIV treatment landscape is dominated by many bigwigs like 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 have 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, as well as part of the single-tablet combination under the brand name Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).
Merck is also evaluating 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.
The FDA has accepted MRK’s new drug application (NDA) for DOR/ISL for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen. A decision from the regulatory body is expected on April 28, 2026.
GILD’s Price Performance, Valuation and Estimates
Gilead’s shares have gained 31.2% in the past year compared with the industry's growth of 15%.
Image Source: Zacks Investment Research
From a valuation standpoint, GILD is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, GILDs’ shares currently trade at 14.32x forward earnings, higher than its mean of 10.93x but lower than the large-cap pharma industry’s 17.11X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has moved up to $8.17 from $8.07 in the past 60 days, while that for 2026 has moved south to $8.50 from $8.51 in the same timeframe.
Image Source: Zacks Investment Research
GILD currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.