Oct 29, 2026 earnings call — HIV strength and updated 2026 guidance
Gilead raised full-year base business sales guidance to $30.7 billion to $31 billion, reflecting stronger HIV, Trodelvy and Livdelzi performance.
Revenue $8.3B (est $7.8B) · EPS $2.55 (est $2.19)
Key quotes
"In the third quarter, HIV sales grew 18% year-over-year. Biktarvy achieved an all-time high U.S. market share, and we had a modest initial contribution from Bixlenvo, which launched in August."
"In Cell Therapy, we are approaching an important catalyst with the potential approval of anito-cel toward the end of the year."
"CMS has informed us that it has set pricing for Biktarvy at $2,600 per 30-day supply, which represents an approximate 38% discount from the list price in the Medicare channel."
Analyst Q&A 11
How to give two oral drugs together
Q (Umer Raffat · Evercore): Analyst asked how patients could practically take the oral IL-23 together with the alpha-4-beta-7 drug given different fasting and timing needs.
A: Management said the oral IL-23 program is very early. They are still working on formulations and will share details later as the program develops.
"So please stay tuned, and we'll inform you more about those details as we move along." — Dietmar Berger
Breakdown of $1.5 billion IRA impact
Q (Akash Tewari · Jefferies): The analyst wanted the components behind the $1.5 billion IRA impact on Biktarvy: how much is Medicare pricing versus spillovers to Medicaid, 340B and other channels.
A: Management said the $1.5 billion is a preliminary, net impact on Biktarvy revenues in 2028 and includes Medicare plus spillover effects to other U.S. channels. They will not give a full split yet because the analysis is early.
"But we expect the $1.5 billion that Andy mentioned earlier, really, that's a net impact on Biktarvy revenues in 2028." — Johanna Mercier
Why MRD at 12 months is a co-primary
Q (Mohit Bansal · Wells Fargo): Analyst asked why the iMMagine-6 trial uses MRD negativity at 12 months as a co-primary endpoint and whether that could support an early filing.
A: Management said their newly diagnosed and other iMMagine trials use co-primary endpoints of MRD followed by PFS, and these designs were discussed with global regulators. They highlighted differences between transplant-eligible and -ineligible trials and MRD-guided maintenance in some studies.
"If you look at both our iMMagine-3 trial as well as our newly diagnosed trials, they are co-primary endpoints looking at MRD followed by PFS." — Cindy Perettie
Does HIV growth plan include PrEP
Q (Brian Abrahams · RBC): Analyst asked whether the company’s plan to grow the HIV franchise includes PrEP and what would need to happen to offset the $1.5 billion impact.
A: Management said they view HIV holistically and include both treatment and prevention in their portfolio planning. They said they will seek opportunities over about a year to mitigate the $1.5 billion in addition to the broader pipeline and other strategies.
"We look at our portfolio across both treatment and prevention." — Johanna Mercier
Market for weekly oral PrEP
Q (Christopher Schott · JPMorgan): Analyst asked what patient group the weekly oral PrEP will appeal to and how this launch compares to Yeztugo.
A: Management said the weekly oral aims at people who want longer-acting prevention but prefer oral options over injections, and they expect some daily oral users to switch. They also expect a fast ramp because they can build on Yeztugo’s existing pharmacy access, about 70% of channels, and will expand access after launch.
"As we think about that launch, we are thinking that, that's going to really appeal to a population that might want the longer acting, but might not like injectables, for example." — Johanna Mercier
Monthly oral 3107 clinical hold
Q (Michael Yee · UBS): Analyst asked for an update on the 3107 monthly oral program and the reason for its clinical hold.
A: Management said 3107 is a prodrug and they saw metabolites with an unexpected impact, which led to the clinical hold. They are working through the hold and developing backup molecules in parallel for the monthly oral objective.
"And with some of the prodrug compounds, as you know, we saw metabolites that have an unexpected impact, and that is really the reason for the clinical hold at this point." — Dietmar Berger
Margins outlook into 2027
Q (Terence Flynn · Morgan Stanley): Analyst asked how margins might progress into 2027 given recent deals, R&D spend, and the future Biktarvy impact.
A: Management said they continue to expect very strong margins in 2027 and beyond and will provide more detailed guidance later. They noted the company absorbed acquisition-related spend this year and remain focused on disciplined expense management.
"Look, at a high level, we continue to expect to have very strong margins not only in '27, but for the foreseeable future." — Andrew Dickinson (CFO)
PALISADES partial hold and fast manufacturing
Q (Daina Graybosch · Leerink Partners): Analyst asked about the PALISADES partial clinical hold, risks from fast manufacturing, and implications for KITE-363 in autoimmune disease.
A: Management said KITE-363 does not use rapid manufacturing and its Phase I rheumatology and neurology studies continue. Regarding PALISADES, they paused to investigate higher Grade 3 and 4 ICANS in some patients with their 3-day rapid manufacturing process and will update when they have more information; there have been no deaths or Grade 5 events.
"When you look at the partial clinical hold, we have made a decision to take a look at differences that we're seeing specifically with Grade 3 and Grade 4 ICANS in a small number of patients, and we have decided to take some time, pause and investigate that before we move forward." — Cindy Perettie
How HIV share of company may change
Q (Louise Chen · Scotiabank): Analyst asked whether the company expects HIV to remain about 70% of the commercial business as new verticals develop.
A: Management said their multi-year strategy has been to diversify beyond HIV while continuing to strengthen long-acting HIV treatments and PrEP. They highlighted progress in oncology, inflammation, and autoimmune programs that will shift the company mix over time.
"Our strategy has always been over the past 8 years or so to diversify our portfolio from a variety of different angles." — Daniel O'Day (CEO·CHAIR)
Gamgertamig data and Phase III plans
Q (Carter Gould · Cantor Fitzgerald): Analyst asked what data will be shared on gamgertamig, how many cohorts or patients will have >6 months follow-up, and if Phase III entry next year is on track.
A: Management said they will release exact data at a conference later this year and are looking forward to presenting autoimmune cytopenia and immune thrombocytopenia data. They remain committed to starting a Phase III study in autoimmune cytopenia next year.
"And we're staying firm in our commitment to bring gamgertamig into a Phase III study next year in autoimmune cytopenia." — Dietmar Berger
Q3 pricing and new patient trends
Q (Geoffrey Meacham · Citi): Analyst asked why realized prices looked stronger in 3Q and whether there are trends in new patients entering HIV treatment.
A: Management said the HIV growth included demand and an inventory increase in Q3 that may make typical Q4 inventory builds softer. They also said favorable pricing this quarter was due to channel mix shifts and that Biktarvy share is at an all-time high of 53%.
"There was also favorable pricing and the favorable pricing has to do with the channels." — Johanna Mercier