Q2 2024 Earnings Summary
- Gilead expects quarterly variability in its HIV business due to average realized price associated with channel mix, which may impact revenue predictability in this core segment.
- There is uncertainty in cell therapy sales due to continued competitive headwinds from both in-class and out-of-class competition, which could affect growth in this area.
- The company faces uncertainty associated with Trodelvy bladder cancer revenue following the TROPiCS-04 trial, potentially affecting sales in this indication.
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Lenacapavir and Biktarvy
Q: Could lenacapavir plus bictegravir replace Biktarvy?
A: Management believes that while Biktarvy remains the standard of care for daily oral HIV treatment, the combination of lenacapavir with bictegravir offers an optimized, simplified regimen. As they advance into Phase III trials, they see an opportunity to broaden the label to include all virologically suppressed patients, especially in the switch segment of the market. This presents an additional opportunity to expand Gilead's presence in HIV treatment. -
Purpose II Trial and PrEP Growth
Q: What are expectations for the Purpose II trial?
A: The Purpose II trial involves a different population from Purpose I, focusing on cisgender men, transgender women and men, and gender non-binary people. Management is optimistic that combining positive results from Purpose II with Purpose I will allow them to file lenacapavir for PrEP quickly. They see significant growth opportunities in the PrEP market by expanding the user base beyond current demographics, increasing market share with Descovy's over 40% share and the addition of lenacapavir, and enhancing adherence through lenacapavir's twice-yearly subcutaneous dosing. -
TIGIT and STAR 121 Program
Q: How do you view the opportunity for TIGIT?
A: Management highlights their differentiated approach in the TIGIT space with an Fc silent molecule, resulting in a different adverse event profile compared to competitors using Fc active molecules. They are focusing on areas with the best chance of activity, such as non-small cell lung cancer and gastric cancer, and have completed enrollment of their Phase III trial. They remain cautiously optimistic and are proceeding in a data-driven manner based on their generated data. -
IMAGINE Trials and Bridging Therapy
Q: Have you completed enrollment in IMAGINE 1?
A: The enrollment target for IMAGINE 1 has been met. Regarding follow-up time for data presentation at ASH, they will provide exact details later. In iMMagine-3, they plan to supply therapy from their Maryland facility, applying learnings from existing products. The current protocol allows for bridging therapy if necessary, aiming to avoid higher risk observed in competitor trials soon after enrollment.
Research analysts covering GILEAD SCIENCES.