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J&J Reports Strong Uptake of Carvykti and Rybrevant in Q4

NEW YORK – Johnson & Johnson on Wednesday reported strong sales of its CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) in the fourth quarter and over 2024 and said that growth in the oncology segment was bolstered by new approvals of Rybrevant (amivantamab) throughout the year.

For the three months ended Dec. 31, J&J reported worldwide sales of $22.52 billion, a 5 percent increase over $21.40 billion in the same period in 2023. Factoring in the impact of currency, revenue dipped around 1 percent over this time. Analysts, on average, were expecting J&J to record slightly less revenue at $22.42 billion.

Its Innovative Medicine segment during the quarter added $14.33 billion to overall revenue, around 4 percent more than sales of $13.72 billion in Q4 2023. During the quarter, oncology medicines contributed $5.50 billion to revenues, up 19 percent from $4.62 billion in the year-ago period. Over this same period, sales of Carvykti, a BCMA-directed autologous CAR T-cell therapy sold for treating refractory, second-line multiple myeloma, more than doubled to $334 million from $159 million. 

During a call to discuss Q4 and full-year financial results, J&J executives highlighted the performance of Darzalex (daratumumab), an anti-CD38 monoclonal antibody, and Carvykti as leading the firm's multiple myeloma franchise. "We continue to drive strong sales growth across our multiple myeloma portfolio," said Jessica Moore, J&J's VP of investor relations, highlighting the double-digit sales growth for both Darzalex and Carvykti in Q4 2024 compared to the year-ago quarter. Darzalex is J&J's first product to hit $3 billion in sales during a quarter, while Carvykti continued to gain strong market share and met the company's goal of accelerating the cell therapy's uptake in the back half of the year, Moore noted.

Rybrevant, a bispecific antibody for non-small cell lung cancer, also had a big year in 2024, netting three approvals. The treatment was first approved by the US Food and Drug Administration in 2021 for treating EGFR exon 20-mutated advanced NSCLC after progression on platinum-based chemo. But last year, J&J racked up an approval for Rybrevant plus chemo in first-line EGFR exon 20-mutated advanced NSCLC; an approval for Rybrevant plus Lazcluze (lazertinib) in first-line locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations; and an approval for Rybrevant plus carboplatin and pemetrexed for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after an EGFR tyrosine kinase inhibitor.

Moore noted that Rybrevant remains a strong contributor to revenue in J&J's "other oncology" products segment, which recorded $282 million in Q4 2024 sales, a 90 percent increase compared to $148 million in Q3 2023. She added that J&J will begin disclosing Rybrevant sales in Q1 2025.

J&J posted net earnings of $3.43 billion in Q4 2024, or $1.41 per share, compared to net earnings of $4.13 billion in Q4 2023, or $1.70 per share. On an adjusted basis, J&J's EPS was $2.04, beating analysts' EPS estimate of $2.01.

Full-year earnings

Over the full year in 2024, J&J reported $88.82 billion in revenue, around a 4 percent increase compared to $85.16 billion in 2023 but short of the $90.98 billion that analysts were expecting on average. Factoring in the impact of currency, revenue dipped around 2 percent year over year.

The Innovative Medicine segment contributed $56.96 billion in sales, a 4 percent increase compared to $54.76 billion in 2023. Oncology medicines brought in $20.78 billion in 2024, a nearly 18 percent increase from $17.66 billion in 2023. Carvykti sales increased nearly 93 percent year over year to $963 million from $500 million.

"Multiple myeloma is really an extraordinary franchise for us," said Jennifer Taubert, executive VP and worldwide chairman of J&J's innovative medicines franchise, highlighting that Carvykti is approaching blockbuster status, nearing annual revenue of $1 billion.

"We continue to see very strong demand in that second-line-plus setting, as well as very strong capacity expansion in the US, in Europe, and also with a contract manufacturer," Taubert noted, adding the company expects continued uptake in Q1 2025 and throughout the year. She added that J&J recently infused the 5,000th patient with Carvykti in and outside of clinical trials and called it the "most successful cell therapy launch in the industry."

John Reed, executive VP of innovative medicine R&D at J&J, highlighted that the company is testing Darzalex with other drugs from its pipeline in the frontline setting in multiple myeloma and seeing 100 percent minimal residual disease negativity, "showing the impressive potential of these new combinations." An FDA advisory committee last year said that MRD could serve as a surrogate endpoint supporting accelerated approval of multiple myeloma drugs. The company is also trying to move Carvykti into the frontline multiple myeloma setting and seeing if it can replace autologous stem cell transplant, Reed added.

J&J posted net earnings of $14.07 billion in FY 2024, or $5.79 per share, compared to net earnings of $13.33 billion in 2023, or $5.20 per share. On an adjusted basis, J&J's EPS was $9.98.

In 2025, the company hopes to secure FDA approval for a subcutaneous version of Rybrevant. J&J received a complete response letter from the agency for its biologics license application seeking approval of a fixed combination of Rybrevant and recombinant hyaluronidase for subcutaneous administration in patients with EGFR-mutated NSCLC. The firm said the rejection was not due to any safety or efficacy data deficiencies but due to observations the agency made during a standard pre-approval inspection at a manufacturing facility. The company is also expecting data on Rybrevant's efficacy in head and neck and colorectal cancer this year.

In 2025, J&J expects to report sales between $89.2 billion and $90.0 billion and adjusted EPS in the range of $10.50 to $10.70.