NEW YORK – Johnson & Johnson saw strong growth in sales of its BCMA-directed CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) in the third quarter of 2024 following its approval by the US Food and Drug Administration and the European Commission in early-line relapsed or refractory multiple myeloma.
In a call to discuss the company's third quarter financial results Tuesday morning, J&J Executive VP of Innovative Medicine Jennifer Taubert called Carvykti's rollout "the most successful [CAR T-cell therapy] launch across the industry."
Sales of Carvykti grew 88 percent in Q3 2024, with revenues of $286 million compared to $152 million in Q3 2023. Taubert noted that sales of the product also grew 53 percent in the third quarter compared to the second quarter of 2024. She attributed that growth to "very strong demand" based on the new regulatory approvals as well as increased production due to expansion at the company's facilities in Raritan, New Jersey, and Ghent, Belgium, as well as production through a contract manufacturing organization in the US. Altogether, Taubert said J&J is now treating more than 4,200 patients with Carvykti.
She cautioned, however, that investors shouldn't expect to necessarily see linear growth of Carvykti sales quarter to quarter "because capacity expansion works in more of a stair-step fashion."
Taubert also said J&J also expects overall survival results for Carvykti from the Phase III CARTITUDE-4 trial released in September to further boost sales of the product. The FDA approved Carvykti based on results from CARTITUDE-4 reported in 2023 showing that median progression-free survival had not been reached in Carvykti-treated patients at 16 months follow-up compared with a median progression-free survival of 12 months for those on standard-of-care therapies. Those initial results also show that at one year of treatment, 76 percent of patients in the Carvykti arm were still alive versus 49 percent in the control arm. The overall response rate was 85 percent in patients treated with Carvykti and 67 percent in those on standard therapy. Patients in the trial had received one to three lines of prior therapy and were refractory to Bristol Myers Squibb's Revlimid (lenalidomide).
In updated long-term results from CARTITUDE-4 reported at the International Myeloma Society's annual meeting in September, median progression-free survival and median overall survival were not reached for patients on Carvykti after nearly three years, while patients on standard therapies had a median progression-free survival of almost 12 months and overall survival was not reached. At 30 months' follow-up, the overall survival rate for patients on Carvykti was 76 percent versus 64 percent for those in the control arm. The overall response rate for patients on Carvykti was 84.6 percent compared to 67.3 percent for patients on standard therapies.
Taubert said the new overall survival data was "very significant" and "further adds to the importance of this medicine for patients with multiple myeloma."
For the three months ended Sept. 30, J&J reported worldwide sales of $22.47 billion, a 5 percent increase over $21.35 billion in Q3 2023 and in line with analysts' consensus revenue estimate of $21.16 billion.
For its oncology drugs overall, Johnson & Johnson reported a nearly 19 percent increase in worldwide sales in the third quarter of 2024 compared to the same period last year.
For Q3 2024, J&J reported $5.38 billion in worldwide sales from its oncology drugs unit compared to $4.53 billion in Q3 2023.
The growth in the oncology segment was driven in part by growth in sales of the EGFR inhibitor Rybrevant (amivantamab) as the company seeks expanded indications, Jessica Moore, VP of investor relations at J&J, said during the call to discuss the company's financial performance. Rybrevant plus chemo was approved in the US in March as a first-line treatment for patients with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer. In September, the FDA approved Rybrevant combined with standard-of-care chemotherapy for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations who have progressed on or after receiving an EGFR tyrosine kinase inhibitor. Moore said J&J anticipates reporting sales of Rybrevant beginning in the first quarter of 2025.
In Q3 2024, J&J recorded net earnings of $5.88 billion, or $2.42 per share, compared to net earnings of $6.78 billion, or $2.66 per share, in Q3 2023. On an adjusted basis, J&J reported Q3 EPS of $2.41. On average, analysts had expected $2.70 per share.
J&J increased its full-year 2024 sales guidance from $88.0 billion to $88.4 billion in July 2024 to $88.4 billion to $88.8 billion as of October 2024. It also adjusted EPS expectations to between $9.88 and $9.98. In July, the firm had a projected an adjusted EPS range between $9.97 and $10.07.