NEW YORK – Gilead Sciences reported after the market closed on Thursday that sales of its TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) soared during Q4 2022, increasing 65 percent to $195 million from $118 million during Q4 2021.
The drugmaker's total revenue for the three months ended Dec. 31 was $7.39 billion, a 2 percent increase from $7.24 billion during the prior year's fourth quarter. When Gilead excluded sales of its COVID-19 drug Veklury (remdesivir), its product revenue for the quarter increased 9 percent to $6.33 billion in Q4 2022 versus $5.80 billion during the same period of 2021. Analysts, on average, were expecting $6.64 billion in Q4 revenues.
Gilead is betting that revenues for Trodelvy, which is currently approved for metastatic triple-negative breast and advanced bladder cancers, will continue to grow in 2023 if the US Food and Drug Administration approves the drug later this month for patients with pretreated, hormone receptor-positive, HER2-negative metastatic breast cancer. The firm is also expecting to hear from European regulators about this same indication later this year.
"We estimate this represents at least 6,000 addressable patients in the US, and our US sales force is energized for the upcoming approval," Gilead Chief Commercial Officer Johanna Mercier said on a call to discuss Gilead's Q4 and full-year financials on Thursday afternoon. Regulators are reviewing data from the Phase III TROPiCS-02 study, which pitted Trodelvy against physician's choice standard-of-care therapy.
Gilead also saw a significant increase in sales of its cell therapy products Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). Combined revenue from these two autologous CAR T-cell therapies was $419 million in Q4 2022, up 75 percent from $239 million in Q4 2021. Yescarta's worldwide sales grew 85 percent to $337 million in Q4 2022 versus $182 million in the year-ago quarter.
According to Mercier, growth in the cell therapy segment was driven largely by greater use of Yescarta among patients with large B-cell lymphoma, especially in the US, where the CAR T-cell therapy is a second-line option. Tecartus sales, meanwhile, grew 44 percent to $82 million in Q4 2022 versus $57 million Q4 2021.
"We're pleased to see the building momentum of CAR T-cell therapy as a treatment class with curative potential, and Yescarta and Tecartus as the leading cell therapies of choice globally," Mercier said, adding that more patients are getting access to these treatments due to efforts by its subsidiary Kite to maintain reliable manufacturing capabilities and open authorized treatment centers around the world.
Indeed, the UK's National Institute for Health and Care Excellence recently recommended that the National Health Service provide Yescarta to LBCL patients in England, making it the first cell therapy available for commissioning in the country, Mercier pointed out.
Gilead also wants to develop cell therapies for multiple myeloma patients, and it inked a recent deal with Arcellx that will allow it to develop the investigational CAR T-cell therapy, dubbed CART-ddBCMA, in the refractory setting.
Gilead announced in December that it will acquire Tmunity Therapeutics, which offers the chance to develop a "rapid" cell therapy manufacturing platform.
Looking ahead, Gilead Chief Medical Officer Merdad Parsey expressed enthusiasm about the outlook for the anti-TIGIT molecule domvanalimab in advanced, PD-L1-high non-small cell lung cancer. Recently, Gilead and Arcus Biosciences, as codevelopers of domvanalimab, presented data from the ARC-7 trial, showing the benefit of combining the anti-TIGIT therapy and the PD-1 inhibitor zimberelimab. Gilead will present updated analysis from this trial at the American Society of Clinical Oncology's annual meeting in June.
"While these efficacy and safety data will mature over time, this … interim analysis fully supports our joint [domvanalimab-zimberelimab] clinical development program and the importance of interrupting the TIGIT pathway," Parsey said. Gilead is involved in four Phase III trials involving domvanalimab.
Gilead posted net income of $1.64 billion during Q4, or $1.30 per share, versus $382 million, or $.30 per share, in the fourth quarter of 2021. The non-GAAP diluted EPS for the fourth quarter 2022 was $1.67, which beat analysts' average EPS estimate of $1.49.
The drugmaker spent $1.55 billion on R&D during Q4 2022, up 14 percent from $1.36 billion in Q4 2021. During the same period, selling, general, and administrative expenses increased 22 percent to $2.02 billion compared to $1.65 billion in Q4 2021.
Full year financials
For the full year in 2022, Gilead's total revenues were essentially flat at around $27.28 billion compared to $27.31 billion in 2021. Excluding Veklury, full-year product sales were $23.10 billion. Analysts, on average, had projected $26.52 billion for the full year.
Trodelvy revenues were $680 million in 2022, up 79 percent from $380 million during 2021.
In 2022, Gilead's cell therapy revenues were up 68 percent to $1.46 billion — $1.16 billion from Yescarta and $299 million from Tecartus — compared to $871 million in 2021 — $695 million from Yescarta and $176 million from Tecartus.
Gilead's net income in 2022 was $4.59 billion, or $3.64 per share, versus $6.23 billion, or $4.93 per share, in 2021. Non-GAAP diluted EPS was $7.26, which beat the consensus Wall Street EPS estimate of $7.11.
The firm's R&D spend increased 8 percent to $4.98 billion in 2022 versus $4.60 billion in 2021. During the same period, selling, general, and administrative expenses also grew 8 percent to $5.67 billion from $5.25 billion.
As of Dec. 31, Gilead had $7.63 billion in cash, cash equivalents, and marketable debt securities.
The company is expecting 2023 total product sales in the range of $26.0 billion to $26.5 billion, EPS in the range of $5.30 to $5.70, and non-GAAP EPS between $6.60 and $7.00.