NEW YORK – Bristol Myers Squibb reported continued strong sales growth for its CD19-targeted autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel), which company executives attributed to expanded cell therapy manufacturing capacity during a call Friday morning to discuss second quarter 2024 financials.
BMS launched Breyanzi in 2021 as a treatment for relapsed or refractory large B-cell lymphoma, and the product has since garnered approvals in follicular and mantle cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma. However, like many manufacturers of cell-based therapies, the company faced difficulties scaling up the products to meet demand.
In 2022, for example, BMS acknowledged "lower-than-expected manufacturing success rates" had impacted Breyanzi sales but said it had addressed the issues. But then, the drugmaker also had to shut down one of its manufacturing facilities in Q2 2023 to conduct planned maintenance and prepare for the anticipated launch of its BCMA-directed autologous CAR T-cell therapy Abecma (idecabtagene vicleucel) in multiple myeloma later that year.
Now, thanks to expanded manufacturing capacity, the firm is reporting a fifth consecutive quarter in which Breyanzi's year-over-year sales growth exceeded 50 percent. In Q2 2024, Breyanzi sales increased 53 percent to $153 million, compared to $100 million in Q2 2023.
"We expect continued strong growth to be driven by our lead indication in [large B-cell lymphoma] as Breyanzi is increasingly recognized as the best-in-class [CD19-targeted CAR T-cell therapy], as well as by our expanded indications, which are off to a very good start," BMS Chief Commercialization Officer Adam Lenkowsky said during the call.
Regarding the company's expanded manufacturing capacity, Lenkowsky said, "We're now in a much stronger position to meet demand in the market."
For the three months ended June 30, BMS's total revenue was $12.20 billion, a 9 percent increase from $11.23 billion in Q2 2023. The firm beat analysts' average revenue expectation of $11.55 billion for the quarter. BMS's legacy portfolio, which includes older drugs like its cardiovascular medicine Eliquis (apixaban) and multiple myeloma drug Revlimid (lenalidomide), among others, contributed $6.61 billion in revenue, a 2 percent increase compared to $6.48 billion in the year-ago quarter.
BMS CEO Chris Boerner said the company is continuing to streamline its operations and allocate capital for long-term growth and returns and is on track to achieve the $1.5 billion in cost savings announced in Q1. "We're focusing our portfolio on transformational medicines where we have a competitive advantage," Boerner said. "This means advancing and, where possible, accelerating first- or best-in-class treatments across therapeutic areas, prioritizing pipeline assets with meaningful growth potential, and discontinuing programs that no longer meet our threshold for return on investment."
The company's growth portfolio, which includes its precision oncology products, contributed $5.60 billion to Q2 2024 revenue, an 18 percent increase from $4.74 billion in the same period last year. "The growth portfolio continued to increase as a proportion of total sales, and now represents about 46 percent of the business," BMS CFO David Elkins said on the call.
BMS's top-selling oncology drug, the checkpoint inhibitor Opdivo (nivolumab), generated $2.39 billion in sales in Q2 2024, compared to $2.15 billion in the same period last year, an 11 percent increase. The company reported $630 million in revenue from its other checkpoint inhibitor, Yervoy (ipilimumab), an uptick of 8 percent compared to $585 million in Q2 2023.
The company's PD-1 and LAG-3 inhibiting combination drug Opdualag (nivolumab and relatlimab) recorded revenues of $235 million in Q2 2024, a 53 percent increase from $154 million in the same period last year.
Meanwhile, BMS's KRAS G12C-mutant inhibitor Krazati (adagrasib), which the drugmaker acquired in January 2024 from Mirati Therapeutics, generated $32 million in the second quarter, and the TRK and ROS1 inhibitor Augtyro (repotrectinib) brought in $7 million in revenues. BMS markets Krazati for KRAS G12C-mutated colorectal and non-small cell lung cancers. Augtyro was approved in the US in June as a tissue-agnostic therapy for refractory solid tumors harboring NTRK gene fusions, and last November, it was approved for treating advanced ROS1-altered NSCLC.
Sales of Abecma, BMS's other CAR T-cell therapy for multiple myeloma, however, dropped 28 percent in Q2 2024 to $95 million from $132 million in the year-ago quarter. Elkins noted that the company saw quarter-over-quarter sales growth for Abecma, driven largely by sales outside the US. In Q1 2024, Abecma recorded $82 million in sales, which was a 44 percent drop from $147 million in Q1 2023.
"We continue to work through the competitive dynamics in multiple myeloma by discussing our KarMMa-3 data with customers," Elkins said. In the Phase III KarMMa-3 trial, patients with refractory multiple myeloma who had received between two and four lines of prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, had improved progression-free survival and improved responses on Abecma compared to standard regimens. The drugmaker has struggled with competitive pressures for Abecma in the US, where the product competes with Johnson and Johnson's CAR T-cell therapy Carvykti (ciltacabtagene autoleucel), and is affected by an unfavorable pricing environment outside the US.
BMS recorded a net income in Q2 2024 of $1.68 billion, or $.83 per share, compared to a net income in Q2 2023 of $2.07 billion, or $.99 per share. On a non-GAAP basis the company's EPS was $2.07, which beat the consensus Wall Street estimate of $1.63.
As of June 30, BMS had $7.01 billion in cash, cash equivalents, and marketable debt securities.
BMS revised its 2024 guidance and is now expecting revenue for the year to be in the upper end of the low single-digit range and diluted EPS between $.60 and $.90. Previously, the company had projected a low single-digit increase in 2024 revenue and diluted EPS between $.40 and $.70.