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BMS Reports Growth in Immunotherapy, CAR T-Cell Products in Q4

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NEW YORK – Bristol Myers Squibb on Friday reported revenue increases for checkpoint inhibitors Opdivo (nivolumab) and Opdualag (nivolumab and relatlimab) and CAR T-cell therapy Breyanzi (lisocabtagene maraleucel), while overall revenues dropped slightly in Q4.

For the three months ended Dec. 31, BMS reported total revenues of $11.48 billion, a 1 percent increase from Q4 2022 revenues of $11.41 billion. The firm beat analysts' average revenue expectation of $11.19 billion for the quarter.

BMS's top-selling oncology drug, checkpoint inhibitor Opdivo, generated $2.39 billion in sales in Q4 compared to $2.22 billion in the same period last year, an 8 percent increase. The company reported $566 million in revenue from its other checkpoint inhibitor Yervoy (ipilimumab), nearly flat with sales of $568 million in Q4 2022.

The company's PD-1 and LAG-3 combination drug Opdualag had revenues of $190 million in revenue in Q4, an 83 percent increase from $104 million in the same period last year.

Growth in Opdivo sales was driven by demand in first-line lung and upper gastrointestinal cancers along with adjuvant bladder cancer, according to BMS CFO David Elkins. Opdivo continued to see demand drop in melanoma where Opdualag was approved in the US in March 2022 and in Europe for a biomarker-defined patient population in September 2022.

Going into this year, BMS is looking at potential approval for Opdivo in first-line bladder cancer and said in December that it planned to discuss with health authorities data from the Phase III CheckMate-8HW trial of Opdivo plus Yervoy in metastatic microsatellite instability-high or DNA mismatch repair deficient colorectal cancer.

BMS's autologous CAR T-cell therapies Breyanzi and Abecma (idecabtagene vicleucel) reported mixed revenues in Q4. Breyanzi had revenues of $101 million in Q4 compared to $55 million in Q4 2022, as the drug continues to ramp up sales from its approval as a third-line treatment of large B-cell lymphoma in 2021. Meanwhile. Abecma, approved for relapsed or refractory multiple myeloma, had revenue of $100 million in Q4 2023 compared to the $125 million recorded by BMS in the year-ago quarter, a 20 percent drop. Elkins noted that Abecma experienced "competitive impacts" in the US.

In Q4, BMS gained approval for Breyanzi in the US as a second-line treatment for large B-cell lymphoma. The firm also submitted an application seeking approval for Breyanzi for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Adam Lenkowsky, BMS chief commercialization officer, noted on a call to discuss Q4 2023 financial results on Friday that if Breyanzi is approved for CLL and SLL, it would "double the addressable patient population for Breyanzi."

"We will see [vector] supply materialize even further in Q2 and expand to support our new indications for Breyanzi, and we're making good progress in reducing turnaround time and product capacity," Lenkowsky said. "As we move through the first half of the year with this broad label large B-cell lymphoma and now with three FDA priority reviews in the first half of the year, Breyanzi has the potential to treat the broadest array of B-cell malignancies of any CAR T."

BMS's newest drug on the market, tyrosine kinase inhibitor Augtyro (repotrectinib), brought in $1 million in Q4 sales. The drug was approved in the US in November for patients with advanced non-small cell lung cancer whose tumors harbor ROS1 gene alterations. BMS gained the rights to Augtyro when it bought Turning Point Therapeutics in a $4.1 billion deal in 2022.

In Q4, BMS spent $2.48 billion on R&D, a 1 percent increase from Q4 2022 when it spent $2.51 billion. The company also spent $2.07 billion on marketing, selling, and administrative expenses, a 9 percent decrease from $2.27 billion in Q4 2022.

BMS's net earnings in Q4 2023 were $1.76 billion, or $.87 per share, compared to $2.02 billion, or $.95 per share, in Q4 2022. The company's adjusted EPS for Q4 was $1.70, exceeding the consensus Wall Street EPS estimate of $1.53.

Full-year 2023 revenues were $45.01 billion, a 2 percent decrease from 2022 revenues of $46.16 billion, but higher than analysts' consensus expectations of $44.71 billion.

In 2023, BMS's full-year net income was $8.03 billion, or $3.86 per share, compared to $6.33 billion, or $2.95 per share, in 2022. The company's adjusted EPS for 2023 was $7.51, beating analysts' average estimate of $7.39.

The firm also provided financial guidance for 2024. BMS expects a low-single-digit increase in total revenues and operating expenses in the coming year. Full-year 2024 EPS is expected to fall between $7.10 and $7.40. The firm expects additional costs in the coming year due to previously announced acquisitions of cancer-focused firms Mirati Therapeutics and radiopharmaceutical developer RayzeBio, along with other deals.

As of Dec. 31, BMS had $12.64 billion in cash, cash equivalents, and marketable debt securities.