GILEAD SCIENCES SL

Gilead Sciences showcases new therapies and R&D advancements at the 7th China International Import Expo, including a recently FDA-approved treatment for primary biliary cholangitis and Phase 3 trial results for a twice-yearly HIV-1 capsid inhibitor. The company expects four additional oncology indications to be approved in China within three years, highlighting its commitment to the Chinese market and health equity.

Gilead Sciences reported 7% Q3 revenue growth, with $7.5B in earnings surpassing forecasts. The company raised its full-year product sales guidance to $27.8B-$28.1B and adjusted profit forecast to $4.25-$4.45 per share. HIV sales grew 9% to $5.1B, driven by Biktarvy's 13% surge to $3.5B. Gilead plans to file for FDA approval of twice-yearly subcutaneous PrEP lenacapavir by end of 2024, aiming to expand its reach. COVID-19 antiviral Veklury contributed $692M, while oncology drug Trodelvy missed estimates by $8M despite 17% growth. Gilead's CAR-T therapy anito-cel showed a 95% overall response rate in multiple myeloma patients.

Gilead to present over 40 HIV research studies at HIV Glasgow 2024, including late-breaking data on lenacapavir for HIV prevention and Biktarvy for HIV treatment, highlighting a robust portfolio and future-looking pipeline focused on person-centered drug development strategies.

Gilead's PURPOSE 1 trial exclusively focused on young African women and adolescent girls for an investigational HIV PrEP medication, aiming to address historical exclusion in HIV clinical trials. Enrolling thousands of cisgender women and girls aged 16-25 in South Africa and Uganda, the trial studied a six-monthly injection, with encouraging preliminary results. The trial, influenced by Global Community Accountability Groups, included pregnant and lactating women, setting a new standard for HIV prevention trials.

Gilead Sciences reported Q3 2024 revenue growth of 7% to $7.5 billion, with Biktarvy sales up 13% to $3.5 billion. Oncology sales rose 6% to $816 million. The company increased its full-year revenue, operating income, and EPS guidance. Product sales excluding Veklury grew 7% to $6.8 billion, driven by higher sales in HIV, Oncology, and Liver Disease.

The FDA's approval of Trodelvy for bladder cancer treatment has been withdrawn by Gilead Sciences due to TROPICS-04 study's failure to meet overall survival primary endpoint. This leaves fewer systemic therapy options for urothelial cancer patients, though Trodelvy remains approved for other cancer types. Patients currently on Trodelvy should consult their providers about continuing treatment.

Top 20 biopharmaceutical companies saw a 2% market cap increase to $4.3trn in Q3 2024, driven by FDA approvals and strategic alliances, despite some declines.

At CIIE, Gilead Sciences submits market application for HIV drug lenacapavir, while Organon unveils SJ02, a long-acting FSH for infertility. Pfizer announces China approval for prostate cancer treatment Talazoparib, and Johnson & Johnson's Teclistamab Injection is approved for multiple myeloma.

Kite, a Gilead Company, will present 18 studies at the 66th ASH Annual Meeting, showcasing CAR T-cell therapy's efficacy in blood cancers. Key highlights include durable responses and manageable safety profiles for anito-cel in relapsed/refractory multiple myeloma, long-term survival data for Yescarta and Tecartus in various blood cancers, and advancements in next-generation CAR T-cell therapies like KITE-753.