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Gilead Sciences Q4 Cell Therapy Sales Increase 47 Percent

NEW YORK – Gilead Sciences announced after the close of the market on Tuesday a 47 percent increase in its cell therapy product sales in the fourth quarter of 2021 compared to the same period in 2020.

For the three-month period ending Dec. 31, sales from the firm's cell therapy products — which include the CD19-directed autologous cell therapies axicabtagene ciloleucel (Yescarta; axi-cel) and brexucabtagene autoleucel (Tecartus; brexu-cel) — totaled $239 million versus $163 million in Q4 2020.

The increase reflects continued demand for axi-cel as a third-line treatment among diffuse large B-cell lymphoma patients and new uptake among follicular lymphoma patients, as well as increased adoption of brexu-cel among mantle cell lymphoma patients.

Sales of the firm's triple-negative breast cancer drug sacituzumab govitecan (Trodelvy) more than doubled in Q4 2021, reaching $118 million in Q4 2021, up from $49 million during the same quarter the prior year. The drug came into Gilead's pipeline in the latter half of 2020 with its acquisition of Immunomedics.

Despite the revenue growth in the cell therapy segment and within its oncology division, the Foster City, California-based firm's total Q4 2021 revenues declined 2 percent to $7.24 billion compared to $7.42 billion in Q4 2020. The company's product sales also declined 2 percent to $7.16 billion in Q4 2021 compared to $7.33 in Q4 2020. Despite the revenue dip, the company still beat analysts' consensus Q4 revenue estimate of $6.66 billion.

Gilead reported net income of $382 million, or $.30 per share, compared to $1.55 billion in Q4 2020, or $1.23 per share. On a non-GAAP basis, the firm's EPS was $.69, falling short of analysts' consensus estimate of $1.59.

The firm's R&D costs increased 28 percent in Q4 2021 to $2.03 billion from $1.58 billion in the year-ago period. Selling, general, and administrative spending decreased around 5 percent to $1.65 billion from $1.73 billion during Q4 2020.

For the full year in 2021, the firm's revenues increased 11 percent to $27.31 billion from $24.69 billion in 2020, beating analysts' consensus revenue estimate of $26.69 billion. Product sales in 2021 increased 10 percent to $27.01 billion compared to $24.36 billion.

Revenues from the cell therapy segment for the full year totaled $871 million, a 43 percent increase from $607 million in 2020. Sales of Trodelvy in 2021 amounted to $380 million compared to $49 million in 2020.

"We expect robust growth in the coming years," Johanna Mercier, Gilead's chief commercial officer, said of the firm's oncology sales during a call to discuss the company's quarterly and 2021 financial performance.

Gilead's net income for 2021 was $6.23 billion, or an EPS of $4.93, up from $123 million in 2020, or an EPS of $.10. On a non-GAAP basis, the firm's EPS was $7.28, falling short of analysts' consensus estimates of $8.16.

Gilead's R&D costs for 2021 increased 6 percent to $5.36 billion compared to $5.04 billion in 2020, while its SG&A costs inched up 2 percent to $5.25 billion from $5.15 billion.

During the call, Mercier noted that the strong performance seen with axi-cel and brexu-cel and their expanding indications "reinforces our belief that cell therapy adoption will continue with positive momentum as more physicians understand the benefits for appropriate patients and therefore increase referral rates to treatment centers."

Gilead is eagerly awaiting the US Food and Drug Administration's decision to approve a supplemental biologics application for axi-cel for second-line LBCL based on positive ZUMA-7 data presented during the American Society of Hematology annual meeting in December. A decision on that approval — which would greatly increase the eligible patient population for the therapy by moving it earlier in the course of treatment — is expected on April 1.

In the meantime, Gilead subsidiary Kite is "ramping up manufacturing capacity to meet the anticipated demand," Mercier said, noting that a new Maryland-based cell therapy manufacturing facility is expected to begin commercial operations by the second quarter of this year. Combining the Maryland facility with the existing facilities, the firm expects to increase its cell therapy production capacity by as much as 50 percent by the end of 2022.

With regard to sacituzumab govitecan, Gilead's chief medical officer, Merdad Parsey, said the firm will share top-line progression-free survival data as well as the first overall survival data form a planned interim analysis from the Phase III TROPICS-02 clinical trial in March. That ongoing study is evaluating the antibody-drug conjugate versus physician's choice of treatment in hormone receptor-positive, HER2-negative metastatic breast cancer patients. Gilead expects to file for regulatory approval for this indication during the second half of 2022.

"If the data are positive, we believe that Trodelvy could represent a very important treatment option for HR-positive, HER2-negative patients who are hormone refractory and have very limited options," Parsey said.

The firm is also looking to expand the agent's global footprint. The European Commission approved sacituzumab govitecan for metastatic triple-negative breast cancer in late November 2021, and Mercier said the firm plans to launch the agent in new countries following key reimbursement decisions.

Gilead plans to study sacituzumab govitecan in a number of Phase III trials in breast, lung, and bladder cancers this year, too. Three of these trials — including two in metastatic TNBC and one in non-small cell lung cancer — will be led by Gilead collaborator Merck and explore the activity of sacituzumab govitecan with pembrolizumab (Merck's Keytruda). These trials will begin enrolling patients this year.

As of the end of Dec. 31, Gilead had $7.83 billion in cash, cash equivalents, and marketable securities.

Gilead provided guidance for the full year in 2022 and said it is expecting product sales to fall between $23.8 billion and $24.3 billion and EPS in the range of $4.70 and $5.20.