NEW YORK – Johnson & Johnson on Tuesday broke out for the first time sales of its autologous CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) in reporting first quarter 2023 revenue.
For the three months ending March 31, J&J reported worldwide sales of $24.75 billion, a 6 percent increase over $23.43 billion in Q1 2022, and beat analysts' consensus revenue estimate of $23.67 billion.
Oncology pharmaceutical products contributed $4.11 billion to Q1 2023 revenues, a 4 percent increase over $3.95 billion in the year-ago period. Carvykti in particular netted $72 million in sales worldwide during the first quarter. Most of those sales were in the US market, where the BCMA-directed CAR T-cell therapy comarketed by J&J pharma subsidiary Janssen and Legend Biotech gained regulatory approval last year as a fifth-line treatment for refractory multiple myeloma patients.
In a call to discuss the company's Q1 financials, J&J executives highlighted that the company is continuing to study Carvykti in other indications. For example, during the quarter, the firm unblinded the Phase III CARTITUDE-4 study at the recommendation of an independent data monitoring committee after it met its primary endpoint. An interim analysis showed that Carvykti improved progression-free survival in lenalidomide-refractory multiple myeloma patients compared to standard regimens with Takeda's Velcade (bortezomib), pomalidomide, and dexamethasone, or Janssen's Darzalex (daratumumab), pomalidomide, and dexamethasone.
"We have really tremendous demand" for Carvykti, J&J CFO Joseph Wolk said during the call. The company has previously acknowledged that demand for Carvykti has challenged its manufacturing processes. To address the issue, J&J and Legend have made further investments to grow manufacturing capacity at the cell manufacturing site in Raritan, New Jersey, where Carvykti is currently produced, and is constructing another facility in Ghent, Belgium.
In Q1 2023, J&J recorded a net loss of $68 million, or $.03 per share, compared to net earnings of $5.15 billion, or $1.93 per share, in Q1 2022. On an adjusted basis, J&J reported Q1 EPS of $2.68. On average, analysts had expected $2.50 per share.
J&J adjusted its 2023 earnings outlook, and said it is now expecting to report sales in the range of $97.9 billion to $98.9 billion. Previously, the firm had projected 2023 revenue in the range of $96.9 billion to $97.9 billion. The company is expecting 2023 adjusted EPS to be between $10.60 and $10.70. Previously, the firm had a predicted EPS range between $10.45 and $10.65.
At the end of the first quarter, J&J had $33 billion in cash and marketable securities, $7.7 billion of which was restricted cash.