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Is Gilead's Expanding HIV Portfolio a Growth Catalyst?
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Key Takeaways
Gilead's HIV business is gaining momentum, led by Biktarvy, Descovy and new Yeztugo sales.
Yeztugo's twice-yearly dosing is driving uptake, with 2026 sales expected to reach about $1 billion.
New lenacapavir-based regimens could expand Gilead's HIV treatment and prevention franchise.
Gilead Sciences, Inc. (GILD - Free Report) has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy for treatment and Descovy for prevention.
Earlier this month, the company reported better-than-expected second-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, 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 in HIV prevention.
The newly approved Yeztugo (lenacapavir) for PrEP has witnessed a robust uptake. With a twice-yearly dosing schedule, the therapy offers meaningful adherence advantages over daily oral regimens and targets a broad patient population.
Gilead expects Yeztugo sales to reach approximately $1 billion in 2026, signaling the product’s potential to achieve blockbuster status in its first full year on the market.
Driven by a $4-billion annualized PrEP business and the continued strong performance of Biktarvy, Gilead raised its full-year HIV sales growth guidance to 9-10% from 8%.
Gilead expects continued HIV growth from its expanding treatment and prevention portfolio, including potential launches of bictegravir/lenacapavir and once-weekly islatravir/lenacapavir.
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 would further bolster its HIV portfolio.
GILD has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline further.
Gilead and Merck recently announced positive phase III results from the ISLEND-1 and ISLEND-2 studies, demonstrating the potential of the investigational once-weekly oral combination of islatravir and lenacapavir in virologically suppressed adults with HIV. These data will form the basis of regulatory submissions.
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.
Gilead’s expanding lenacapavir pipeline strengthens its long-term HIV growth prospects. The company is advancing once-weekly oral combinations into phase II, while a phase III twice-yearly regimen could create a differentiated treatment option with potential launch around 2030. In PrEP, the potential approval of once-weekly oral lenacapavir by February 2027, followed by a possible once-yearly option in 2028, could further expand Gilead’s prevention franchise and reinforce its leadership in the growing HIV market.
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 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, allowing them to switch from their current HIV therapy.
GILD’s Price Performance, Valuation and Estimates
Shares of GILD have gained 13.2% year to date compared with the industry’s growth of 4.3%.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 23.60X forward earnings, higher than its mean of 12.14X and the large-cap pharma industry’s 18.51X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 earnings is pinned at a loss of 62 cents per share. The EPS estimate for 2027 has moved south to $9.65 from $9.71 in the past 60 days.
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.
View the Zacks #1 Rank List
Image: Shutterstock
Is Gilead's Expanding HIV Portfolio a Growth Catalyst?
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.
Earlier this month, the company reported better-than-expected second-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, 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 in HIV prevention.
The newly approved Yeztugo (lenacapavir) for PrEP has witnessed a robust uptake. With a twice-yearly dosing schedule, the therapy offers meaningful adherence advantages over daily oral regimens and targets a broad patient population.
Gilead expects Yeztugo sales to reach approximately $1 billion in 2026, signaling the product’s potential to achieve blockbuster status in its first full year on the market.
Driven by a $4-billion annualized PrEP business and the continued strong performance of Biktarvy, Gilead raised its full-year HIV sales growth guidance to 9-10% from 8%.
Gilead expects continued HIV growth from its expanding treatment and prevention portfolio, including potential launches of bictegravir/lenacapavir and once-weekly islatravir/lenacapavir.
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 would further bolster its HIV portfolio.
GILD has also collaborated with Merck (MRK - Free Report) to advance its HIV pipeline further.
Gilead and Merck recently announced positive phase III results from the ISLEND-1 and ISLEND-2 studies, demonstrating the potential of the investigational once-weekly oral combination of islatravir and lenacapavir in virologically suppressed adults with HIV. These data will form the basis of regulatory submissions.
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.
Gilead’s expanding lenacapavir pipeline strengthens its long-term HIV growth prospects. The company is advancing once-weekly oral combinations into phase II, while a phase III twice-yearly regimen could create a differentiated treatment option with potential launch around 2030. In PrEP, the potential approval of once-weekly oral lenacapavir by February 2027, followed by a possible once-yearly option in 2028, could further expand Gilead’s prevention franchise and reinforce its leadership in the growing HIV market.
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 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, allowing them to switch from their current HIV therapy.
GILD’s Price Performance, Valuation and Estimates
Shares of GILD have gained 13.2% year to date compared with the industry’s growth of 4.3%.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 23.60X forward earnings, higher than its mean of 12.14X and the large-cap pharma industry’s 18.51X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 earnings is pinned at a loss of 62 cents per share. The EPS estimate for 2027 has moved south to $9.65 from $9.71 in the past 60 days.
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.