Gilead Update: Pipeline Cuts and CAR-T Sales Success

2024 Q3 Financial Results

Recently, Gilead released its Q3 2024 financial results:

• 2024 year-to-date revenue reached $21.185 billion, a 6% increase year-over-year.
• Q3 revenue was $7.545 billion, up 5% from the same period last year, driven primarily by increased sales in:
  • HIV drugs ($5.1 billion, +9%)
  • Veklury ($692 million, +9%)
  • Oncology drugs ($816 million, +6%)
  • Liver disease drugs ($733 million, +4%)

Research and development (R&D) spending was $1.395 billion, down 4% year-over-year.

As of September 30, 2024, Gilead’s cash, cash equivalents, and marketable securities totaled $5.037 billion, down from $8.4 billion at the end of 2023, mainly due to the $3.9 billion acquisition of CymaBay Therapeutics.

Gilead has revised its full-year revenue guidance, raising the total sales forecast to $27.8–28.1 billion, up from the previous forecast of $27.1–27.5 billion.

Cell Therapy Performance

For Gilead’s CAR-T cell therapies, Yescarta? and Tecartus?, total sales for the first three quarters of 2024 were $1.486 billion (approx. ￥10.7 billion), reflecting a 6% year-over-year increase.

• Q3 sales totaled $485 million (approx. ￥3.482 billion), on par with Q3 2023.
  • Yescarta Q3 sales were $387 million, down 1% year-over-year and 7% sequentially.
  • CD19 CAR-T therapy Tecartus Q3 sales reached $98 million, up 2% year-over-year but down 8% sequentially.

Gilead attributed the sales slowdown to heightened competition in both U.S. and international markets, a trend expected to continue into 2025. The company plans to collaborate with government and healthcare associations to promote wider adoption of Yescarta and Tecartus.

Gilead Discontinues Three Pipeline Projects

(1) Trodelvy in Advanced or Metastatic Urothelial Carcinoma (mUC)

On October 18, 2024, Gilead announced it would voluntarily withdraw its accelerated approval request for Trodelvy? in the treatment of advanced or metastatic urothelial carcinoma (mUC) following prior platinum-based chemotherapy and PD-1/PD-L1 treatment. The decision was based on the failure of the confirmatory Phase 3 TROPiCS-04 trial to meet its primary endpoint.

Although Trodelvy showed numerical improvement in OS, certain prespecified subgroups, and secondary endpoints (PFS and ORR), more adverse events occurred in patients receiving Trodelvy than in the chemotherapy control group, primarily due to infection complications from low white blood cell counts. Gilead stated it would further investigate the data but declined to comment on the specific mortality outcomes.

Trodelvy, the world’s first TROP-2 ADC drug, was acquired by Gilead in 2020 for $21 billion through its purchase of Immunomedics. In 2023, Trodelvy’s sales reached $1.065 billion, entering blockbuster territory. Q3 2024 sales were $332 million, up 17% year-over-year and 4% sequentially, though sales growth has recently slowed.

(2) Obeldesivir in High-Risk Non-Hospitalized Severe COVID-19 Patients

Obeldesivir, an oral formulation for SARS-CoV-2, was developed as an upgraded version of remdesivir. Gilead decided to discontinue the Phase 3 BIRCH trial in high-risk, non-hospitalized severe COVID-19 patients, citing lower-than-expected COVID-19 incidence rates and related hospitalization or all-cause mortality rather than concerns over safety or efficacy. Obeldesivir continues in the Phase 3 OAKTREE trial in non-hospitalized patients without severe COVID-19 risk factors.

(3) Bulevirtide in Chronic HDV Infection

For chronic hepatitis D virus (HDV) infection, Gilead has discontinued the Phase 2b MYR204 trial for bulevirtide. Gilead remains committed to strengthening its pipeline across oncology, antiviral, and immunology areas, with 50 programs in clinical trials and 13 clinical-stage assets available for selection.