GSK (GSK) Q4 FY25 earnings call: guidance and Q&A

How does GSK segment its overlapping respiratory products (Nucala, Exdensur, IL-33, TSLP) given multiple competitors, and how should investors think about potential double-counting?

Tony Wood explained the strategy for COPD by stratifying patients into high EO, intermediate T2, and low T2 populations, positioning different long-acting mechanisms (IL-5, Exdensur, Nucala, TSLP, IL-33) accordingly. Luke Miels added that the company will not shy from internal competition and is prioritizing long-acting Exdensur for COPD, noting strong early uptake for Nucala COPD in the U.S.

“I think what's important to understand about COPD, James, obviously, huge opportunity there, 300 million individuals globally and significant cost to the U.S. health care system, as I outlined in the presentation. But it's a complex disease. It's a heterogeneous disease. And that's why we're placing ourselves across a range of different long-acting mechanisms.”

asked by James Gordon · answered by Tony Wood

When will 6-monthly HIV treatment and PrEP Phase III trials start, what are the commercial implications for the Total Addressable Market (TAM), and does the $40 billion+ revenue target include recent acquisitions?

Deborah Waterhouse confirmed Q6M treatment Phase II will start this year for a 2028-2030 launch, and Q6M PrEP Phase I will start this year. She detailed how longer-acting options significantly expand the addressable market (Q2M: 15%, Q4M: 30%, Q6M: 50% of patients). Julie Brown clarified that the $40 billion+ target includes IDRx and Hengrui, but not the recently announced Rapp acquisition.

“The addressable market for Q2M is about 15% of patients. When we get to 4%, we get to 30% of patients. And then you've got with Q6M in treatment, 50% of patients who would be very willing to take a long-acting injectable.”

asked by James Gordon · answered by Deborah Waterhouse

Given early feedback and the response to the REMS program, how should investors think about the launch trajectory for Blenrep?

Nina Mojas explained that Blenrep's launch is systematic but slower due to the required coordination with eye care professionals. She noted positive feedback on REMS simplification and active education of 18,000 eye care professionals in the U.S., compared to 5,000-6,000 previously. She expects a slow but robust ramp-up, prioritizing positive initial patient experience over rapid volume.

“To your question, what can we expect? -- what we said before, it is not going to be a quick ramp-up. It's going to be a slow ramp-up, but the positive initial experience is more relevant than starting a high number of patients very early and then having a negative experience.”

asked by Simon Baker · answered by Nina Mojas

Is the reported reduction in R&D staff part of a broader program or normal attrition, and what is the context?

Luke Miels stated that the company manages its business with discipline, reallocating resources to more promising programs and culling less promising ones to maximize return and generate compelling assets. He emphasized dynamic and disciplined resource allocation, noting that this is part of accelerating R&D and simplifying work processes.

“I mean we're going to manage the business -- and where we say success, we'll reinforce it. If we have programs that are less promising or Tony and Nina in managing the portfolio decide to cull something, then we're going to be very dynamic and shift resources behind to where we can get the best return, generate assets that are most compelling.”

asked by Michael Leuchten · answered by Luke Miels

What is the launch curve for Exdensur, and will it target treatment-experienced or bio-naive patients?

Nina Mojas clarified that the strategy focuses on bio-naive patients, given the low biopenetration (mid-20s%) and high discontinuation rates (65% in 12 months) among existing biologic users in severe asthma. She highlighted the enthusiasm for 6-monthly dosing to drive preferential use and initiate new patients who might not have started on biologics otherwise.

“Our main objective, I think Luke mentioned that when we talk about our sales force is going for bio-naive patients. It's very legitimate to expect there will be some switching, and there will be switching very likely from Nucala, hopefully also from other agents in severe asthma as well.”

asked by Michael Leuchten · answered by Nina Mojas

Will GSK disclose HIV business financials through the Dolutegravir LOE, what is the expected rate of decline relative to consensus, and will Q6M be included in the midterm guide if Phase III starts?

Deborah Waterhouse confirmed that Q6M will be included in the long-range forecast once it reaches Phase II (mid-year). She described the Dolutegravir LOE as a 'glide path' starting April 2028, with a shift to newer long-acting regimens already underway. She anticipates a dip in the franchise in 2029-2030 due to erosion, followed by significant growth from Q6M in the 2030s, driven by new molecules with IP into the 2040s.

“So you see a dip in '29 and '30 for the franchise as we face into the largest erosion through the exclusivity loss. And then we come back out into growth in 2031 and beyond. And that growth in that decade is going to be a significant contributor to GSK's success in the 2030s because we are incredibly confident in the value to patients that the Q6M will bring.”

asked by Sachin Jain · answered by Deborah Waterhouse

If GSK needs two positive trials to file for Camlipixant, what is the purpose of the pooled analysis, and has the FDA confirmed it will accept filing based on pooled data even if one trial is negative?

Tony Wood declined to get into the details of regulatory strategy but stated that the pooled analysis provides the option to take an approach with both independent and ultimately pooled studies. He reiterated confidence in the outcomes for both KALM-1 and KALM-2 trials.

“Steve, I'm not going to get into details of regulatory strategy. But as you define, what it's giving us is the option to take the approach, both as independent and ultimately pooled studies. However it's worth saying that we remain confident in the outcomes for both KALM-1 & KALM-2...”

asked by Steve Scala · answered by Tony Wood