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Gilead Sciences More Than Doubles Q1 Trodelvy Sales

NEW YORK – Gilead Sciences announced after the close of the market on Thursday that sales of its antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) more than doubled in the first quarter of 2022 compared to the year-ago period.

For the three-month period ending March 31, Foster City, California-based Gilead reported $6.59 billion in total revenues, up 3 percent from $6.42 in the first quarter of 2021, beating analysts' consensus revenue estimate of $6.28 billion.

"Our growing oncology portfolio performed well with Trodelvy revenue doubling compared to the first quarter of 2021 and cell therapy delivering another strong quarter of growth," said Gilead Chairman and CEO Daniel O'Day in a call to discuss the firm's financial results.

Trodelvy, which is sold as a triple-negative breast cancer drug in the US and other markets and for urothelial cancer in the US, brought in $146 million in revenues in Q1 2022, up 103 percent from $72 million in the prior year's first quarter. Gilead garnered the Trop-2-directed agent through its 2020 acquisition of Immunomedics and described its increased uptake in Q1 as a "strong start."

"We're encouraged by the adoption of Trodelvy not only in the US, but notably in Germany and France, and continue to work with health authorities and reimbursement bodies to extend Trodelvy's reach to patients globally," said Gilead Chief Commercial Officer Johanna Mercier.

Last month, Gilead announced plans to expand the breast cancer indication for Trodelvy after the agent met its primary endpoint in the Phase III TROPiCS-02 clinical trial for hormone receptor (HR)-positive, HER2-negative, heavily pretreated metastatic breast cancer. The firm reported a significant improvement in progression-free survival in Trodelvy-treated patients compared to those on physician's choice of chemotherapy. The firm will detail the results from TROPiCS-02 at the American Society of Clinical Oncology's (ASCO) annual meeting and has said it will discuss expanding the drug's indication with regulators.

According to Gilead Chief Medical Officer Merdad Parsey, the firm is expecting final overall survival data from this study in 2024. "In the meantime, we are engaging with regulatory authorities to explore potential pathways given the high unmet need," Parsey said, highlighting that Gilead is planning a pivotal trial to evaluate Trodelvy as a front-line treatment for HR-positive, HER2-negative breast cancer patients, too.

Additionally, Gilead is beginning front-line trials of Trodelvy in non-small cell lung cancer, and both PD-L1 positive and PD-L1-negative TNBC.

"We are in the earliest stages of evaluating how Trodelvy, either alone or in combination, could bring new options to people with cancer," Parsey said. "In total, we're studying more than 25 combinations, including seven Phase III combination studies."

Meanwhile, revenues from the firm's cell therapy products increased 43 percent in Q1 2022 to $274 million compared to $191 million from the same period in 2021.

The two autologous CAR T-cell therapies in this segment are Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). Yescarta contributed $211 million in Q1 2022, up 32 percent from $160 million in Q1 2021. Tecartus revenues more than doubled to $63 million from $31 million in the year-ago quarter.

Earlier this month, the firm netted FDA approval for Yescarta as second-line treatment for large B-cell lymphoma.

Gilead is aiming for oncology sales to make up one-third of its total revenue by 2030.

The firm's R&D spending increased 12 percent during the first quarter to $1.19 billion compared to $1.06 billion in Q1 2021. Selling, general, and administrative spending inched up 2 percent in Q1 2022 to $1.08 billion from $1.06 billion during the same period in 2021.

Gilead's GAAP net income for the first quarter was $12 million, or $0.02 per share, compared to $1.72 billion in Q1 2021, or $1.37 per share. The year-over-year decrease was primarily due to a $2.7 billion in-process R&D impairment charge related to assets acquired from Immunomedics in 2020. Non-GAAP diluted EPS was $2.12, which beat analysts' consensus estimate of $1.81.

As of March 31, Gilead had $6.75 billion in cash, cash equivalents, and marketable securities.

The company maintained its full-year revenue guidance of between $23.8 billion and $24.3 billion. However, due to the Immunomedics in-process R&D impairment, the firm lowered its EPS guidance for 2022 to between $3.00 and $3.50 from the previously projected EPS range of $4.70 to $5.20. On a non-GAAP basis, Gilead is still projecting EPS of between $6.20 and $6.70.