NEW YORK – Gilead is bracing for competition in its CAR T-cell franchise both within and outside the cell therapy class, even as sales of its CD19-directed therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) build momentum in the market, Gilead execs said Thursday on a call to discuss the company's second quarter financial results.
Foster City, California-based Gilead sells Yescarta for relapsed or refractory large B-cell lymphoma (LBCL) and follicular lymphoma and Tecartus for relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia.
Sales of Yescarta and Tecartus combined in the second quarter, marketed by Gilead's Kite Pharma, increased 11 percent to $521 million in Q2 2024, up 11 percent from $469 million in Q2 2023. Yescarta contributed $414 million to revenues during Q2 2024, up 9 percent from $380 million in Q2 2023, while Tecartus brought in $107 million in Q2 2024, up around 22 percent from $88 million in Q2 2023.
Although Gilead is pleased with the growth in sales of its CAR T-cell therapies, competition from other CAR T-cell therapies, including Novartis' Kymriah (tisagenlecleucel) and Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) threatens to blunt that growth. BMS recently garnered a new approval from the US Food and Drug Administration for Breyanzi in relapsed or refractory mantle cell lymphoma and has successfully ramped up its manufacturing capacity, leading to strong sales of the product.
Outside of the cell therapy class, bispecific antibodies, which have a reduced risk of certain immune-related adverse effects such as cytokine release syndrome, are emerging as competitors for CD19-directed CAR T-cell products. For example, Roche's CD20-directed CD3 T-cell engager Lunsumio (mosunetuzumab), approved in 2022, is an alternative to Yescarta in third-line relapsed or refractory follicular lymphoma. Meanwhile, in 2023, the FDA approved Genentech's Columvi (glofitamab) for LBCL and Genmab's Epkinly (epcoritamab) for diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma. These products now compete with CD19-directed CAR T-cell therapies in the third- or later-line therapy setting.
Gilead is working to head off these competitors by working with treatment centers, including educating providers and patients on the curative potential of cell therapies, specifically in contrast to bispecific antibodies that have not shown evidence of cure. They are also advocating for broader reimbursement with payors for their CAR T-cell therapies.
"Within the authorized treatment centers, we're making sure referrals occur between the lymphoma specialist and the CAR T specialists," Gilead Executive VP Cindy Perettie said during the call. The company expects these efforts to begin paying off in terms of sales later this year. However, Perettie said, "we are remaining cautious for the second half of this year."
In Q2 2024, Gilead's oncology business unit brought in $841 million, up 16 percent from $728 million in Q2 2023. During Q2 2024, the firm recorded $6.95 billion in total revenue, up 5 percent from $6.60 billion in Q2 2023, beating the average Wall Street revenue estimate of $6.72 billion.
For the three months ended June 30, sales of the TROP2-directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) were $320 million, up 23 percent from $260 million in the prior year's second quarter. Gilead Chief Commercial Officer Johanna Mercier said Trodelvy's sales growth was driven primarily by higher demand in the US and Europe in metastatic breast cancer. Trodelvy is a treatment for locally advanced or metastatic urothelial cancer in addition to advanced triple-negative and hormone receptor (HR)-positive, HER2-negative breast cancer.
Gilead also faces competition in the TROP2-directed ADC space from AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan. In April, the FDA accepted a biologics license application for the drug seeking its approval as a treatment for advanced, HR-positive, HER2-negative breast cancer patients who have previously received systemic therapy. The agency is expected to make a decision on approval in early 2025.
"Trodelvy is the only approved and available TROP2-directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancer," said Mercier, claiming that the drug is the leading regimen in the US and Europe for second-line metastatic triple-negative breast cancer and has growing adoption in pretreated, ER-positive, HER2-negative metastatic breast cancer. "We are working to expand Trodelvy's reach beyond the 40,000-plus patients treated to date across multiple tumor types," Mercier said.
Gilead posted net income of $1.61 billion, or $1.29 per share, in Q2 2024, compared to $1.05 billion, or $.83 per share, in Q2 2023. Gilead CFO Andrew Dickinson said that a $525 million legal settlement impacted earnings in Q2 2023 by $.32 per share, and that there was no comparable event in Q2 2024. Excluding the settlement, he said EPS grew 21 percent year over year. Non-GAAP EPS was $2.01, well above analysts' average estimate of $1.60 per share.
The firm is still expecting between $27.1 billion and $27.5 billion in total product sales in 2024. However, the company updated its guidance for EPS to a range of $0 to $.30 from a previous range of $.10 to $.50 and adjusted non-GAAP EPS to a range of $3.60 to $3.90 from a previous range of $3.45 to $3.85.
As of June 30, Gilead had $2.77 billion in cash, cash equivalents, and marketable debt securities.