Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Gilead Sciences Inc (GILD, Financial) reported a strong quarter with a 9% growth in HIV sales year-over-year, driven by higher demand and pricing.
- The company increased its 2024 guidance across multiple metrics, including revenue, non-GAAP gross margin, operating income, and EPS.
- Lenacapavir received breakthrough therapy designation from the FDA, with plans to file for approval by the end of the year, highlighting its potential impact on HIV prevention.
- Livdelzi, a new therapy for primary biliary cholangitis, exceeded internal expectations in its initial launch, indicating strong market demand.
- Gilead Sciences Inc (GILD) demonstrated robust growth in its oncology segment, particularly with Trodelvy, which saw a 17% year-over-year increase in sales.
Negative Points
- The company faced competitive headwinds in its cell therapy segment, impacting sales and expected to continue into 2025.
- Gilead Sciences Inc (GILD) recorded a $1.8 billion impairment charge related to the IPR&D assets acquired from Immunomedics, affecting GAAP financial results.
- Sequentially, liver disease sales declined 12% due to inventory dynamics and fewer patient starts in HCV.
- The company is discontinuing development of Trodelvy in second line plus metastatic non-small cell lung cancer due to regulatory feedback.
- Despite strong overall performance, non-GAAP diluted EPS decreased to $2.02 per share from $2.29 per share in the same period last year, primarily due to higher acquired IPR&D and tax expenses.
Q & A Highlights
Q: Can you discuss the in-class versus out-of-class impacts on your CAR T therapies this quarter, particularly regarding Breyanzi?
A: Cindy Perettie, Executive Vice President of Kite, explained that in-class competition was due to new indications in follicular and mantle cell lymphoma and increased manufacturing capacity. Out-of-class competition came from bispecifics, with a roughly 50/50 impact. Gilead remains confident in its strategy to expand class and brand share, focusing on community expansion and anticipating anito-cel's arrival in 2026.
Q: How do you foresee the launch of lenacapavir for PrEP next year, and what are the market dynamics?
A: Johanna Mercier, Chief Commercial Officer, expressed excitement about lenacapavir's potential, highlighting growth opportunities in market size, prescriber base, and geographic reach. The twice-yearly subcutaneous profile is expected to impact both Descovy and generic oral markets. Gilead is preparing for a seamless launch experience, with more details to be shared at the upcoming HIV analyst event.
Q: Regarding anito-cel, what explains the lack of delayed neurotoxicity, and do you have sufficient data to rule it out in larger trials?
A: Cindy Perettie attributed the absence of delayed neurotoxicity to the construct's compact DD domain. With over 100 patients' data showing no neurotoxicity, Gilead is confident in anito-cel's best-in-class profile. Further data will be presented at the ASH conference.
Q: Can you discuss the potential for scaling anito-cel manufacturing upon launch?
A: Cindy Perettie stated that learnings from Yescarta and Tecartus have been applied to anito-cel production, with successful tech transfer to the Maryland facility. Turnaround times are similar to current commercial products, and there are no concerns about scaling or FDA feedback requiring a different approach.
Q: How should investors gauge expectations for the upcoming HIV analyst event?
A: Daniel O'Day, CEO, indicated that the event will provide both qualitative and quantitative insights into lenacapavir's commercialization plans and the long-acting treatment combinations. While peak sales guidance will come later, the event will highlight the progress and future of Gilead's HIV portfolio.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
