Inflammation pipeline and combinations
Q: Umer Raffat asked about the practical feasibility of combining alpha 4 beta 7 and IL-23 given their specific fasting requirements.
A: Dietmar Berger responded that the company is excited about the IBD portfolio and is currently working on different formulations for the early-stage IL-23 program.
Biktarvy IRA impact
Q: Akash Tewari asked for a breakdown of the $1.5 billion IRA impact on Biktarvy.
A: Dan O'Day stated the CMS price does not reflect the medicine's value and discourages innovation, while Joanna Mercier clarified the $1.5 billion is a net impact inclusive of Medicare and spillover effects to other channels.
Cell therapy (Anidocell)
Q: Mohit Bansal asked about the rationale for the MRD negativity co-primary endpoint in the newly diagnosed multiple myeloma trial.
A: Cindy Perettie explained this was based on discussions with global regulatory agencies and involves looking at quad therapy upfront and MRD-guided maintenance.
HIV franchise growth and IRA offset
Q: Brian Abrahams asked if the HIV growth outlook includes PrEP and how the company plans to offset the IRA impact.
A: Joanna Mercier noted that the HIV business is viewed holistically and the company will look for opportunities to mitigate the financial impact.
Weekly oral PrEP launch
Q: Chris Schott asked about the market appeal for the weekly oral PrEP launch.
A: Joanna Mercier stated it will appeal to patients who want long-acting options but prefer to avoid injectables, and the company will leverage existing access from Yeztugo.
HIV pipeline (3107)
Q: Michael Yee asked for an update on the 3107 monthly oral clinical hold.
A: Dan O'Day explained that metabolites showed an unexpected impact, leading to the hold, and the company is working through it while developing backup molecules.
Margin progression
Q: Terence Flynn asked about margin progression into 2027 given recent business development.
A: Andrew Dickinson stated the company expects strong margins and will continue to manage operating expenses with discipline.
Kite cell therapy (PALISADE)
Q: Daina Graybosch asked about the PALISADE clinical hold and risks for Kite in autoimmune disease.
A: Cindy Perettie clarified that KITE363 in autoimmune continues, while the PALISADE hold is to investigate Grade 3 and Grade 4 ICANs in a small number of patients.
Long-term portfolio diversification
Q: Louise Chen asked about the long-term view on HIV concentration versus new verticals.
A: Dan O'Day and Dietmar Berger emphasized the strategy of diversification, noting that the HIV pipeline remains robust while oncology and inflammation pipelines are beginning to show significant potential.
Gambertamic update
Q: Carter Gould asked for an update on Gambertamic and the timeline for registrational studies.
A: An executive responded that data will be released at an upcoming conference and the company remains committed to starting Phase III studies next year.
HIV Q3 trends
Q: Geoff Meacham asked about Q3 realized price trends and new patient growth.
A: Joanna Mercier attributed pricing trends to inventory and channel mix, and noted Biktarvy market share reached 53% while the Bixlenvo launch is on track.
