NEW YORK – Gilead's cell therapy franchise faced continued headwinds in the fourth quarter of 2024 due to market challenges in the US and Europe, the company's Chief Commercial Officer Johanna Mercier said during a call Thursday afternoon to discuss the firm's financials.
Those headwinds included a number of new cell therapy product launches across indications and "slower than targeted uptake" of cell therapy as a class, Mercier said. "As expected, the fourth quarter cell therapy sales of $488 million were flat on a sequential basis and up 5 percent year over year, reflecting the continued challenging competitive dynamics in the US and Europe."
For example, Gilead's CD19-directed autologous cell therapy Yescarta (axicabtagene ciloleucel), which its subsidiary Kite Pharma markets for relapsed or refractory large B-cell lymphoma and follicular lymphoma, competes with Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) and Novartis' Kymriah (tisagenlecleucel). And in 2024, Autolus Therapeutics' Aucatzyl (obecabtagene autoleucel) became a new competitor to Kite's Tecartus (brexucabtagene autoleucel) in the relapsed or refractory B-cell precursor acute lymphoblastic leukemia space. Kite also sells Tecartus for treating mantle cell lymphoma.
"We are making progress on our goal to make cell therapies available to large integrated community oncology practices in the US," Mercier added. To achieve that goal, Foster City, California-based Gilead is working with clinics to overcome hurdles including site accreditation. Clinics delivering CAR T-cell therapy often need to be accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) for reimbursement purposes. "We are working with industry groups and other manufacturers to address barriers through policy reform and exploring accreditation with groups like FACT," Mercier said.
Over the three months ended Dec. 31, sales within Gilead's CAR T-cell therapy segment grew modestly, totaling $488 million, up 5 percent compared to $466 million in Q4 2023. Yescarta sales rose 6 percent to $390 million in Q4 2024 from $368 million in the prior year's fourth quarter. Tecartus sales were flat year over year at $98 million.
Gilead has pinned its hopes on the investigational BCMA-directed CAR T-cell product anitocabtagene autoleucel (anito-cel) to inject new momentum into its cell therapy line. The drugmaker is codeveloping anito-cel with Arcellx in several clinical trials as a treatment for relapsed or refractory multiple myeloma.
At the American Society of Hematology's annual conference in December, the firms presented preliminary results from the registrational Phase II iMMagine-1 trial, in which patients with relapsed or refractory multiple myeloma in the fourth-line or later treatment setting had an overall response rate of 97 percent and a complete response rate of 62 percent. The rate of minimal residual disease negativity was 93 percent of evaluable patients.
"We expect that the responses will likely deepen over time," said Dietmar Berger, Gilead's chief medical officer. "We remain confident in the potential for anito-cel to deliver a best-in-class profile supported by the efficacy and safety data seen to date, as well as Kite's globally leading manufacturing capabilities." Gilead expects to release further data from iMMagine-1 in 2025 and is aiming for a 2026 commercial launch for anito-cel.
Beyond the cell therapy franchise, sales of Gilead's TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) were $355 million in Q4 2024, up 19 percent from $299 million in Q4 2023. Trodelvy is approved for advanced triple-negative breast cancer and hormone receptor-positive, HER2-negative breast cancer. There was "higher demand in all regions, highlighting the important role of Trodelvy in metastatic breast cancers, including in second-line metastatic triple-negative breast cancer, where it's the standard of care," Mercier said, noting that the drug remains a market leader in metastatic triple-negative breast cancer in the US and Europe.
For Q4 2024, Gilead's total revenues were $7.57 billion, up 6 percent from $7.12 billion in Q4 2023, and exceeded the consensus Wall Street revenue estimate of $7.15 billion. The firm's oncology products brought in $843 million, a 10 percent increase from $765 million in the year-ago quarter.
Gilead posted net income of $1.78 billion, or $1.42 per share, in Q4 2024, compared to $1.43 billion, or $1.14 per share, in the prior year's fourth quarter. Non-GAAP EPS was $1.90 during the quarter, beating analysts' average estimate of $1.70 per share.
FY 2024 financials
Gilead recorded total revenue of $28.75 billion for full-year 2024, up about 6 percent from $27.12 billion in 2023. Over the same period, oncology products brought in $3.29 billion, up 12 percent from $2.93 billion in 2023.
In 2024, Gilead's cell therapies contributed $1.97 billion in revenue, up nearly 6 percent from $1.87 billion in 2023. Yescarta brought in $1.57 billion in 2024, an increase of around 5 percent from $1.50 billion in 2023. Tecartus contributed $403 million in sales, up 9 percent from $370 million in 2023.
Trodelvy sales were up 24 percent to $1.32 billion in 2024 from $1.06 billion in 2023.
For the full year, Gilead posted net income of $480 million, or $.38 per share, versus $5.61 billion, or $4.50 per share, in 2023. The decrease in diluted EPS was due to a pre-tax In-Process Research and Development impairment (IPR&D) charge of $4.2 billion, or $2.49 per share, related to assets acquired by Gilead from Immunomedics in 2020 and acquired IPR&D charges of $3.9 billion, or $3.14 per share, in the first quarter of 2024 related to the acquisition of CymaBay. Non-GAAP EPS for the full year was $4.62 per share, above the $4.41 per share that analysts had estimated for 2024.
As of Dec. 31, Gilead had $9.99 billion in cash, cash equivalents, and marketable debt securities.
Gilead estimated that its full-year 2025 revenues will be between $28.2 billion and $28.6 billion. The firm is expecting EPS between $5.95 and $6.35 and adjusted non-GAAP EPS in the range of $7.70 to $8.10.