NEW YORK – Sales of Gilead Sciences' TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) reached blockbuster status during 2023 and grew 56 percent, even as the firm's revenues declined overall compared to 2022.
Sales of Trodelvy were $1.06 billion in 2023, up from $680 million in 2022. For the three months ended Dec. 31, Trodelvy sales were $299 million, up 53 percent from $195 million in the prior year's fourth quarter.
Trodelvy is approved for certain patients with advanced breast and bladder cancer, including hormone receptor-positive, HER2-negative metastatic breast cancer. Gilead attributes much of the antibody-drug conjugate's growth to continued uptake among breast and bladder cancer patients. However, the firm did recently share news that Trodelvy did not meet its primary endpoint of overall survival in a new indication — second-line non-small cell lung cancer — in the Phase III EVOKE-01 clinical trial.
During a call to discuss Gilead's Q4 and full-year 2023 financial performance after the close of market Tuesday, Gilead Chief Medical Officer Merdad Parsey said that despite EVOKE-01's failure, the firm is not changing its current approach to developing Trodelvy in NSCLC. For instance, Gilead is moving ahead with its Phase III EVOKE-03 trial designed to evaluate first-line Trodelvy plus Merck's immune checkpoint inhibitor Keytruda (pembrolizumab) in patients with PD-L1-high NSCLC.
"Additional analyses [from EVOKE-01], including TROP2 expression analyses, are ongoing, and [we] will share these data as quickly as possible," Parsey said. He added that the firm is planning to discuss the EVOKE-01 data with regulators to "determine the best path forward" for the intended use population in that study and continue to enroll patients into EVOKE-03.
Beyond Trodelvy, during Q4 2023, the Foster City, California-based firm brought in $7.12 billion in revenue, down around 4 percent from $7.39 billion in Q4 2022 but slightly better than the Wall Street consensus revenue estimate of $7.10 billion.
Gilead attributed the dip in Q4 revenue to declining sales of its COVID-19 medication Veklury (remdesivir). Excluding the negative impact of Veklury, the firm said that Q4 revenue was flat year over year at around $6.30 billion.
In Q4 2023, Gilead's oncology business unit brought in $765 million, up 24 percent from $614 million in Q4 2022. Revenues from its cell therapies, marketed by Gilead's Kite Pharma for certain patients with hematologic malignancies, were $466 million during Q4 2023, up 11 percent from $419 million in Q4 2022.
The CD19-directed autologous CAR T-cell therapy Yescarta (axicabtagene ciloleucel) contributed $368 million to revenues during Q4 2023, up 9 percent from $337 million in Q4 2022. The firm's other autologous CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), brought in $98 million in Q4 2023, up around 20 percent from $82 million in Q4 2022.
Although cell therapy revenues grew year over year, the firm did note a slight dip in Yescarta and Tecartus sales sequentially due to increased competition, uptake challenges, and difficulties expanding bespoke cell therapies into new centers, including community oncology settings. "Growth continues to be slower than anticipated, despite the compelling clinical data that suggests these therapies are potentially transformative for many patients," Gilead Chief Commercial Officer Johanna Mercier said.
Since the Kite Pharma team has been undergoing strategic restructuring — which in November resulted in 7 percent of the Kite team being laid off — Mercier said that business "has been focused on extending the reach of cell therapies from primarily academic medical centers to community practices, especially in the US."
To accomplish this, she said, Gilead has established partnerships with community networks spanning more than 1,750 physicians nationally. "We are certifying affiliated practices to become authorized treatment centers to provide Kite cell therapies," she said.
During the fourth quarter last year, the US Food and Drug Administration issued a warning about the potential risk of developing secondary malignancies after patients receive autologous CAR T-cell therapies, including Yescarta and Tecartus. More recently, the FDA acted further on this concern by asking manufacturers to put boxed warnings on their drug labels reflecting these risks.
During the call, Gilead executives all but dismissed these warnings. "There is no change to our confidence in the benefit-risk profile of Yescarta and Tecartus," Parsey said. "Based on [our] analysis of our global safety database, with over 16,800 patients treated with Yescarta, there has been no causal link established between Yescarta and those reported to the FDA public safety dashboard."
"No cases of T-cell malignancies have been reported with Tecartus," Parsey continued. "Yescarta and Tecartus continue to generate some of the longest follow-up and most robust datasets for cell therapies with the potential to transform patient lives."
Along those lines, Gilead talked up its recent announcement that it has shaved two days off its expected manufacturing time for Yescarta, going from 16 days to 14 days from the time a patient has their cells harvested for the cell therapy and the time they receive the engineered cells as a one-time infusion.
Gilead also mentioned that it is anticipating a readout from its Phase II iMMagine-1 clinical trial of its newer autologous cell therapy, anitocabtagene autoleucel, in multiple myeloma during the second half of 2024. The firm is developing that therapy, which targets the B-cell maturation antigen, in partnership with Arcellx.
Gilead posted net income of $1.42 billion, or $1.14 per share, in Q4 2023, compared to $1.63 billion, or $1.30 per share, in Q4 2022. Non-GAAP diluted EPS was $1.72, falling short of Wall Street analysts' average estimate of $1.76 per share.
2023 financials
During 2023, Gilead revenues were $27.12 billion, down around 1 percent from $27.28 billion during 2023. Over the same period, oncology sales were $2.93 billion, up 37 percent from $2.14 billion in 2022.
In 2023, Gilead's cell therapies brought in $1.87 billion, up 28 percent from $1.46 billion in 2023. Yescarta brought in $1.50 billion in 2023, up 29 percent from $1.16 billion in 2022. Tecartus contributed $370 million in sales, up 24 percent from $299 million in 2022.
For the full year, Gilead posted net income of $5.61 billion, or $4.50 per share, versus $4.57 billion, or $3.64 per share, in 2022. Non-GAAP diluted EPS for the full year was $6.72 per share, slightly below the $6.76 per share that analysts had estimated for 2023, on average.
As of Dec. 31, Gilead had $8.43 billion in cash, cash equivalents, and marketable debt securities.
In 2024, Gilead is estimating it will bring in between $27.1 billion and $27.5 billion in total product sales. The firm expects its diluted EPS will fall in the range of $5.15 and $5.55, and that its non-GAAP diluted EPS will be between $6.85 and $7.25.