NEW YORK – Gilead Sciences announced after the close of the market on Thursday a 51 percent increase in sales of its cell therapies during the third quarter versus Q3 2020.
The company's marketed cell therapies, which include CD19-directed autologous CAR T-cell therapies axicabtagene ciloleucel (Yescarta/axi-cel) and brexucabtagene autoleucel (Tecartus/brexu-cel) together brought in $222 million in Q3 2021 compared to $147 million in Q3 2020.
Growth in this unit was driven by demand among large B-cell lymphoma (LBCL) patients and strong launches in both mantle cell lymphoma and follicular lymphoma, Johanna Mercier, Gilead's chief commercial officer, said on a conference call discussing quarterly financial results. This growth "more than offset" the commercial entry of competing autologous cell therapies in LBCL, she added.
Overall, for the three-month period ending Sept. 30, Foster City, California-based Gilead reported $7.42 billion in total revenue, up 13 percent from $6.57 billion in Q3 2020, and beating analysts' consensus estimate of $6.25 billion.
Company executives attributed the revenue growth largely to remdesivir (Velkury) sales, fueled by COVID-19 demand. Excluding that, Gilead's total product sales fell 3 percent to $5.43 billion last quarter versus $5.62 billion in Q3 2020.
Individually, sales of axi-cel and brexu-cel both saw growth this quarter. Axi-cel sales increased 27 percent, rising to $175 million versus $138 million in Q3 2020. Brexu-cel sales grew more than fivefold to $47 million in Q3 2021 from $9 million in the prior year's quarter. The therapy garnered US Food and Drug Administration approval in July 2020 for relapsed or refractory mantle cell lymphoma. Earlier this month, the FDA expanded brexu-cel's indication to relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Going forward, the firm is working to move its cell therapies into earlier-line treatment settings. Just this month, Gilead filed a supplemental biologics application with the FDA to extend axi-cel's LBCL approval — which is currently indicated for patients in the third- or later-line treatment setting — into the second-line treatment setting.
To support additional expected growth across the cell therapy unit, Mercier shared Gilead will open a cell therapy manufacturing facility in Maryland in mid-2022. This facility, she said, will "automate many of our manual processes and reduce cost."
Another major oncology growth driver for Gilead in Q3 was the antibody-drug conjugate sacituzumab govitecan-hziy (Trodelvy), which the firm brought into its pipeline with the Immunomedics acquisition toward the end of 2020. Sales of sacituzumab govitecan-hziy climbed to $101 million. Gilead couldn't report a year-over-year sales comparison due to the timing of the Immunomedics acquisition but did note sacituzumab govitecan sales were up 13 percent versus Q2 2021.
The agent, which is designed to target Trop-2 expression on the surface of cancer cells, has seen US-based uptake among metastatic triple-negative breast cancer patients as well as metastatic urothelial cancer patients. In April, the FDA converted an accelerated second-line TNBC approval into a full approval, and Gilead already estimates roughly 15 percent of TNBC patients are receiving sacituzumab govitecan-hziy in the second-line setting. In the third- or later-line setting, Gilead estimates about a third of TNBC patients are receiving the drug. As for urothelial cancer patients, Mercier said one in four patients in the third- or later-line setting start treatment with sacitzumab govitecan-hziy.
The agent, Mercier said, is now included as a preferred regimen in second-line metastatic TNBC in both the National Comprehensive Cancer Network (NCCN) breast cancer and European Society for Medical Oncology (ESMO) guidelines, and Gilead believes this will help drive continued uptake. The firm also expects to see greater global demand for sacituzumab govitecan-hziy. The firm has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is awaiting a decision from the European Commission later this year on whether to approve sacituzumab govitecan-hziy for previously treated metastatic TNBC patients.
Since Trop2 is highly expressed on a variety of cancers, Gilead hopes to expand the drug's use to other tumor types. Merdad Parsey, Gilead's chief medical officer, said on the call that the firm is "eagerly awaiting" the readout from the randomized Phase III TROPiCS-02 trial, evaluating the therapy in hormone receptor-positive, HER2-negative metastatic breast cancer patients versus physician's choice of treatment. Gilead expects the topline data readout for this trial in late January or early February 2022.
Gilead's R&D spending in Q3 2021 amounted to $1.15 billion in the quarter compared to $1.16 billion in Q3 2020. Selling, general, and administrative spending increased 7 percent during the quarter to $1.19 billion, compared to $1.11 billion last year.
Gilead's GAAP net income for the third quarter was $2.59 billion, or $2.05 per share, compared to $360 million in Q3 2020, or $0.29 per share, in Q3 2020. Non-GAAP diluted EPS was $2.65, which exceeded analysts' consensus estimates of $1.74.
As of September 30, Gilead had $6.84 billion in cash, cash equivalents, and marketable securities.
The company also raised and narrowed its full-year guidance. It expects 2021 product sales of between $26 billion and $26.3 billion. It previously had estimated sales between $24.4 billion and $25.0 billion. The company is also estimating non-GAAP EPS in the range of $7.90 and $8.10 compared to a previous range between $6.90 and $7.25.