NEW YORK – Gilead Sciences reported after the market closed on Thursday that revenues from its oncology unit increased 59 percent in Q1 2023 compared to the year-ago quarter, driven by strong sales of its TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) and CAR T-cell therapies.
Gilead's total revenue for the three months ended March 31 was $6.35 billion, a 4 percent decrease from $6.59 billion during the prior year's first quarter. The drugmaker attributed the decrease to slowing sales of its COVID-19 treatment Veklury (remdesivir). Excluding Veklury, product revenue for the first quarter increased 15 percent to $5.73 billion compared to nearly $5 billion during the same period of 2022. The firm beat analysts' average revenue expectation of $6.33 billion.
The firm's oncology unit contributed $670 million to Q1 2023 revenues, a 59 percent increase from $420 million in the prior year's quarter.
Sales of Trodelvy, which is approved for metastatic breast and advanced bladder cancers, jumped 52 percent to $222 million in Q1 2023 from $146 million during Q1 2022. During the quarter, Trodelvy netted another approval in the US for hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.
Gilead CEO Daniel O'Day said on a call to discuss the company's financial results that the launch of Trodelvy in the new indication was "very strong" so far in the US, and the firm is expecting an approval in the same indication in Europe later this year.
"We've been seeing strong initial uptake in fourth line-plus, with some share even in third line, and that's really important for us as we think about even earlier trials moving up lines of therapy," said Johanna Mercier, chief commercial officer at Gilead. "We've had strong awareness of Trodelvy in the community as well as in academic centers, and the extended field teamwork that we did last year has really helped us make sure that we solidify the launch in HR-positive, HER2-negative breast cancer."
The firm expects to begin a trial exploring Trodelvy in the chemotherapy-naïve HR-positive, HER2-negative breast cancer setting in the second half of this year, according to Merdad Parsey, Gilead's chief medical officer.
Gilead also reported an increase in sales of its cell therapy products Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). Global Yescarta sales increased 70 percent in Q1 2023 to $359 million from $211 million in Q1 2022. Sales of Tecartus grew 41 percent to $89 million versus $63 million over the same period.
This month, the National Institute for Health and Care Excellence (NICE) made both Yescarta and Tecartus available in the UK through the Cancer Drugs Fund for second-line diffuse large B‑cell lymphoma and B-cell acute lymphoblastic leukemia patients, respectively. The institute and Gilead will continue to collect data that NICE will use to decide whether to recommend these drugs for routine use within the National Health Service.
In January, NICE recommended Yescarta as a third-line treatment for patients with relapsed or refractory diffuse large B-cell lymphoma.
Gilead posted net income of $1.01 billion during Q1 2023, or $.80 per share, compared to $19 million in Q1 2022, or $.02 per share. The non-GAAP diluted EPS was $1.37, below analysts' average EPS estimate of $1.54.
The drugmaker spent $1.45 billion on R&D during Q1 2023, up 22 percent from $1.18 billion in Q1 2022. Gilead spent $1.32 billion on selling, general, and administrative expenses compared to $1.08 billion in the year-ago quarter, a 22 percent increase.
As of March 31, Gilead had $7.2 billion in cash, cash equivalents, and marketable securities.
For the full year, Gilead maintained its prior guidance for product sales of between $26 billion and $26.5 billion. The company is now expecting diluted EPS in the range of $4.75 and $5.15; previously it had projected diluted EPS in the range of $5.30 and $5.70. It expects non-GAAP EPS of $6.60 to $7.00, unchanged from prior guidance.