Gilead's HIV Drug Sales Fuel Q3 Beat; Raises Full-Year Guidance
Key Insights
Gilead Sciences reported a 7% year-over-year revenue increase in Q3, exceeding analyst expectations, driven primarily by strong HIV (search) drug sales, particularly Biktarvy.
The company has raised its full-year product sales guidance to $27.8-$28.1 billion and anticipates filing for FDA approval of its twice-yearly PrEP, lenacapavir, by year-end.
Veklury, Gilead's COVID-19 (search) antiviral, also contributed significantly to the Q3 results, while oncology drug Trodelvy showed growth but slightly missed consensus estimates.
Gilead Sciences has reported a robust third quarter, driven by strong sales of its HIV (search) drugs, particularly Biktarvy, leading to a 7% year-over-year revenue growth. The company's Q3 revenue reached $7.5 billion, surpassing the forecasted $7 billion. Non-GAAP diluted earnings per share (EPS) were $2.02, exceeding analysts' expectations of $1.51 per share.
HIV Drug Performance
Gilead's HIV (search) sales saw a 9% increase in Q3, totaling $5.1 billion. This growth was largely fueled by Biktarvy, a once-daily antiretroviral pill, which experienced a 13% surge, generating $3.5 billion in sales. The pre-exposure prophylaxis (PrEP) pill Descovy also contributed significantly, bringing in $586 million, a 15% increase from the same period in 2023.
According to Jefferies analyst Michael Yee, Gilead's continued focus on HIV (search) is a positive sign, with increasing attention on long-acting programs set to launch next year. CEO Daniel O’Day announced the company is on track to file an application for FDA approval of twice-yearly subcutaneous PrEP lenacapavir before the end of 2024, potentially impacting global public health.
Veklury and Oncology Updates
Beyond HIV (search), Gilead's COVID-19 (search) antiviral Veklury also contributed to the company's strong performance, growing 9% in Q3 to $692 million, more than double its projected sales of $272 million. In oncology, the antibody-drug conjugate Trodelvy delivered 17% year-on-year growth with $332 million in Q3 sales, though it slightly missed consensus estimates.
The recent Phase II iMMagine-1 trial results for Gilead's investigational CAR-T therapy anito-cel (search) showed a 95% overall response rate in patients with relapsed or refractory multiple myeloma (search), including a 62% complete response rate or better. The safety profile was also notable, with no delayed neurotoxicities. These data suggest that anito-cel could be competitive with existing therapies like Carvykti from Legend Biotech and Johnson & Johnson.