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J&J Gearing up for Carvykti Sales Boost After FDA Approval in Second-Line Multiple Myeloma


NEW YORK – Johnson & Johnson anticipates strong revenue growth for its BCMA-directed CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) in multiple myeloma after a recent US Food and Drug Administration approval in the second-line setting, company executives said during a call to discuss the company's Q1 2024 financial results.

For the three months ended March 31, J&J reported worldwide sales of $21.38 billion, a 2 percent increase over $20.89 billion in Q1 2023 and in line with analysts' consensus revenue estimate of $21.4 billion.

Oncology pharmaceutical products contributed $4.81 billion to Q1 2024 revenues, a 17 percent increase over $4.11 billion in the year-ago period. Over the same period, Carvykti's worldwide sales more than doubled to $157 million from $72 million in Q1 2023.

"Multiple myeloma continues to be a true stronghold for us, and we had significant performance and growth across the board in those assets during the quarter," Jennifer Taubert, executive VP of innovative medicine, said during the call.

Taubert attributed Carvykti's growth to "very strong demand" and noted that the FDA's approval of the product in earlier lines of therapy in late March "bodes very well" for its continued sales growth.

Carvykti was originally approved in 2022 as a treatment for multiple myeloma patients who have received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. That limited the product to only about 15 percent of multiple myeloma patients who survive to receive a fifth-line treatment. Now that Carvykti is approved for patients in the second- and later-line setting, many more patients will have access to it.

The FDA decided to approve Carvykti in the earlier-line setting after reviewing data from the Phase III CARTITUDE-4 trial, in which median progression-free survival was not reached in Carvykti-treated patients at 16 months of follow-up compared with 12 months for patients on standard-of-care therapies. After a 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 the Carvykti arm and 67 percent in the control arm.

In preparation for a surge of multiple myeloma patients who will now be eligible for Carvykti as early as their first therapeutic relapse, Taubert said, J&J has doubled its manufacturing capacity since the beginning of 2023 for cell therapy processing and is "continuing to work on our [Ghent, Belgium] facility to have that as a secondary source of supply." Taubert said the company has also engaged some contract manufacturers and has "completely transformed and expanded lentivirus production, so that's not a rate-limiting step for us."

Taubert noted that revenues for Carvykti were "roughly flat" sequentially, from Q4 2023 to the Q1 2024, due to the lag between when doctors and hospitals order the treatments and when they bill for them.

"We do anticipate continued growth for this asset, particularly [in the] second half versus [the] first half, as we continue to add more slots and expand our capacity," Taubert said.

J&J executives also highlighted during the call the company's acquisition of Ambrx Biopharma in January for approximately $2 billion. The acquisition brings to J&J a pipeline of investigational antibody-drug conjugates (ADCs), including PSMA-targeted ARX517 in metastatic castration-resistant prostate cancer (mCRPC), HER2-targeted ARX788 in HER2-positive breast cancer, and CD-70-targeted ARX305 in renal cell carcinoma.

In the ongoing Phase I/II APEX-01 trial of ARX517 in patients with mCRPC who had received at least two prior therapies, Ambrx reported that 12 out of 13 patients who received doses in the therapeutic range had a reduction in prostate specific antigen (PSA) levels of 50 percent or more, and 81 percent of patients in that group had a reduction of 50 percent or more in circulating tumor DNA.

The La Jolla, California-based company is also evaluating ARX788 in advanced breast cancer and other solid tumors, including within the Phase II ACE-Breast-03 trial. And Ambrx's development partner NovoCodex is seeking marketing approval in China for ARX788 based on results from the Phase II ACE-Breast-02 trial.

"With its promising pipeline and ADC platform, Ambrx will further strengthen our oncology portfolio and ability to deliver enhanced precision biologics that treat cancer," Joseph Wolk, J&J executive VP and CFO, said during the call. The acquisition is expected to close in the first half of 2024.

In Q1 2024, J&J recorded net earnings from continuing operations of $5.35 billion, or $2.20 per share, compared to a net loss from continuing operations of $491 million, or $.19 per share, in Q1 2023. On an adjusted basis, J&J reported Q1 EPS of $2.71. On average, analysts had expected $2.64 per share.

For the full year, J&J expects to report sales in the range of $88.0 billion to $88.4 billion in 2024 and a 2024 adjusted EPS of between $10.57 and $10.72. That's an update from January, when J&J said it was expecting between $87.8 billion and $88.6 billion in sales in 2024 and EPS in the range of $10.55 and $10.75.