Can Bixlenvo Unlock New Growth for Gilead's HIV Business?

Gilead Sciences, Inc. GILD recently won FDA approval for Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed.

The approval makes Bixlenvo the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs.

Bixlenvo combines bictegravir, a guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with a novel mechanism of action and no cross-resistance to existing antiretrovirals.

Bixlenvo’s approval strengthens Gilead’s HIV portfolio. The expanded treatment choice could help Gilead address an underserved segment of the HIV market, support patient retention and reinforce its competitive position in HIV treatment.

Gilead’s HIV business continues to gain momentum, led by Biktarvy, Descovy and the rapidly growing Yeztugo. The company raised its 2026 HIV sales growth outlook to 9-10%, supported by a roughly $4 billion annualized PrEP business. Meanwhile, Bixlenvo and the expanding lenacapavir pipeline offer additional growth opportunities, with potential daily, weekly and longer-acting treatments strengthening Gilead’s long-term HIV leadership.

Gilead has a market-leading HIV franchise anchored by flagship therapies, Biktarvy for treatment and Descovy for prevention. The business continues to provide a strong foundation for growth, with Biktarvy maintaining its position as a leading HIV treatment across major markets, while Descovy benefits from continued demand in HIV prevention.

The recent launch of Yeztugo (lenacapavir) provides another important growth opportunity. As the first and only twice-yearly injectable HIV pre-exposure prophylaxis (PrEP) option, Yeztugo offers a significant adherence advantage over daily oral therapies and could expand Gilead’s reach across the growing HIV prevention market. Gilead expects Yeztugo sales to approach $1 billion in 2026, highlighting its potential to become a major contributor to revenues.

Strong performance across the portfolio has already prompted Gilead to raise its 2026 HIV sales growth outlook to 9-10% from 8%. The company’s approximately $4 billion annualized PrEP business, combined with sustained Biktarvy growth, provides a solid base for continued expansion.

Gilead’s pipeline offers additional upside. The approval of Bixlenvo strengthens its treatment portfolio by providing a once-daily single-tablet option for people with HIV looking to switch or simplify therapy. Meanwhile, Gilead and Merck’s MRK positive phase III results for the once-weekly oral combination of islatravir and lenacapavir could pave the way for another differentiated treatment option.

Gilead’s expanding lenacapavir pipeline could support multiple future growth opportunities across HIV treatment and prevention. Potential once-weekly and longer-acting formulation could help extend the commercial opportunity for lenacapavir well into the next decade.

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 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 20.3% year to date compared with the industry’s growth of 8.7%.

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Going by the price/earnings ratio, GILD’s shares currently trade at 22.82X forward earnings, higher than its mean of 12.18X and the large-cap pharma industry’s 18.55X.

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The Zacks Consensus Estimate for 2026 earnings is pinned at a loss of 49 cents per share. The EPS estimate for 2027 has moved north to $9.88 from $9.68 in the past 60 days.

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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 sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.



 

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