Gilead (GILD) Q1 FY26 earnings call: guidance and Q&A

What drives the NPV of the Tubulis deal, specifically the split between ovarian cancer opportunity for TUB-040 and potential in lung cancer, and what additional validation is needed for ADC combinations with PD-1 VEGFs?

Management stated that the ovarian cancer opportunity for TUB-040 alone justifies the acquisition price, citing unprecedented data in platinum-resistant ovarian cancer. They also highlighted the value of the next-generation ADC platform (P5 linker and Alco5 platforms) for developing novel payloads and its broader potential in other tumor types like lung cancer. They are closely following PD-1 VEGF mechanisms for targeted combinations.

“The financial return for our company and the shareholders on ovarian cancer alone, and justify the transaction price. You're absolutely right. There is upside in lung cancer potentially.”

asked by Akash Tewari · answered by Andrew Dickinson

Can you provide the latest mix of Switch versus naive patients for Yeztugo and comment on the adherence assumption embedded in the $1 billion guidance?

The Yeztugo launch shows strong performance across all metrics, with growing confidence from healthcare professionals and 95% access with $0 co-pay. Switch share is greater than naive, but naive is growing. Persistency is encouraging in early days and expected to be the highest in the HIV prevention category, though not 100% due to the nature of the prevention market.

“We do expect Yeztugo's persistency to keep growing over time and to be the highest in the overall HIV prevention market.”

asked by Terence Flynn · answered by Johanna Mercier

What is driving users not returning for a second dose of Yeztugo, and what is the impact of DTC efforts?

While specific claims data on reasons for not returning is not fully detailed, management sees good comeback rates for the second dose. DTC efforts, launched in late February, are increasing brand awareness and encouraging return for injections, with full impact expected in 6-12 months. Specialty pharmacies are also leveraged for reminders.

“What we are seeing, however, is really good comeback on the second dose and within a certain time frame.”

asked by Salveen Richter · answered by Johanna Mercier

What is the market opportunity for BIC/LEN, particularly in the Switch market, given its upcoming launch?

BIC/LEN presents two opportunities: simplifying regimens for the 5-6% of virally suppressed patients on complex multi-pill regimens, and capturing share in the dynamic HIV Switch market (20% of patients). It offers an option for patients switching off Biktarvy to remain within Gilead's portfolio, leveraging two orthogonal mechanisms with high resistance and no cross-resistance. Revenues are expected to be modest in 2026 with a ramp in 2027 and beyond.

“We believe with BIC/LEN, there's an opportunity to play in that Switch market, which we haven't had in the past and moved them from Biktarvy, if they're going to switch anyway to BIC/LEN.”

asked by Mohit Bansal · answered by Johanna Mercier

Will anito-cel's safety advantage among CAR-Ts narrow or widen when treating less heavily pretreated patients in earlier lines?

Management agrees that the safety advantage, combined with efficacy, will be particularly important in earlier lines of therapy, including newly diagnosed multiple myeloma. They are excited about the potential for anito-cel to offer a differentiated profile for patients in these settings.

“We actually agree with the statement you just made. We're really excited about the potential for anito-cel going into earlier lines, whether it's newly diagnosed multiple myeloma or even in smoldering where patients aren't technically diagnosed with the disease. So safety really matters at that point.”

asked by Geoffrey Meacham · answered by Cindy Perettie

How should we think about margins in the near-term and long-term, particularly for 2027-2028, given multiple integrations and commercial launches?

Gilead's Q1 operating margin was 47%, and the company has demonstrated an ability to absorb the incremental expenses from three recent acquisitions through revenue outperformance and disciplined expense management. They expect to find room in the P&L for these in 2027 and beyond, with strong financial performance and potential for margin strengthening over time, as they needed to add to the portfolio anyway.

“You see our ability with the revenue outperformance and the disciplined expense management to pull those in and offset that when you look -- when you exclude the IPR&D and kind of look at our EPS expectation on an apples-to-apples basis.”

asked by Alexandria Hammond · answered by Andrew Dickinson

Your competitor suggests a 2030 time-to-market for their long-acting HIV treatment, while Gilead states 2031-2033 for GS-3242. Can you explain this difference?

The 2031-2033 timeline for GS-3242 is a conservative reflection of ongoing trial designs and clinical plans. Gilead is currently in dose escalation, comfortable with Q4 month dosing, and ambitious for twice-yearly dosing. They aim to bring the product to patients as quickly as possible, believing a once every 6-month injectable treatment will make a significant difference.

“But what I do want to assure you about is we will try to bring this forward to patients as quickly as possible because we feel once every 6-month injectable treatment on the basis of 3242 will really be able to make a difference for patients.”

asked by Michael Yee · answered by Dietmar Berger

Will the second-line iMMagine-3 data be necessary for broad practice conversion for anito-cel, or can it ramp based on initial later-line approvals?

Management is confident in anito-cel's launch based on its 'one-and-done' treatment with stellar efficacy and safety, which is important across all lines. They expect to ramp based on initial fourth-line approval, with strong enthusiasm from KOLs and authorized treatment centers, as evidenced by faster-than-expected enrollment in iMMagine-3 and plans for majority ATC activation within Q1 2027.

“We think that it's going to offer the one-and-done treatment that cell therapy has with stellar efficacy but also with not compromising on safety, and that matters in every line.”

asked by Christopher Schott · answered by Cindy Perettie