NEW YORK – Sales of Bristol Myers Squibb's precision oncology products climbed in Q3 as the firm saw the benefits of its prior investments in CAR T-cell therapy manufacturing and recent acquisitions of targeted therapies.
With two new approvals this year and increased investment in manufacturing, sales of CD19-targeted autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) more than doubled in Q3. Sales of the firm's other CAR T-cell therapy, Abecma (idecabtagene vicleucel), jumped 33 percent year over year.
Breyanzi generated $224 million in worldwide revenues in the Q3 2024 compared to $92 million in the same period last year, a 143 percent jump. Sales of Abecma in Q3 2024 increased to $124 million from $93 million in the year-ago quarter.
BMS CFO David Elkins attributed Breyanzi's strong growth to "pent-up" demand in new indications, including its approvals in May for mantle cell lymphoma and follicular lymphoma, alongside improved manufacturing capacity and reliability. "We expect more modest sequential growth from third quarter to fourth quarter as demand normalizes," Elkins said during a call Thursday to discuss third quarter 2024 financials.
Also in Q3, BMS decided to end a Phase III study evaluating maintenance treatment with Abecma and the immunomodulator Revlimid (lenalidomide) in patients with newly diagnosed multiple myeloma due to low enrollment.
BMS reported Q3 revenues for its two recently acquired precision oncology drugs, KRAS G12C-mutant inhibitor Krazati (adagrasib) and TRK and ROS1 inhibitor Augtyro (repotrectinib). Krazati, which the drugmaker gained in January 2024 in its acquisition of Mirati Therapeutics, generated $34 million in the third quarter. The firm noted that sales of Krazati had more than doubled year over year when compared to Mirati's reported Q3 2023 sales of $16 million. Augtyro, which BMS gained in its 2022 acquisition of Turning Point Therapeutics, brought in $10 million in revenues in the third quarter.
For the three months ended Sept. 30, BMS's total revenue was $11.90 billion, an 8 percent increase from $10.97 billion in Q3 2023. The firm beat analysts' average revenue expectation of $11.28 billion for the quarter.
The company's growth portfolio, which includes its precision oncology products along with other newly launched products, contributed $5.81 billion to Q3 2024 revenue, an 18 percent increase from $4.95 billion in the same period last year. BMS CEO Chris Boerner said during the call that its growth portfolio products now account for about half the firm's total revenues.
BMS's top-selling oncology drug, the checkpoint inhibitor Opdivo (nivolumab), generated $2.36 billion in global sales in Q3 2024 compared to $2.28 billion in the same period last year, a 4 percent increase. The company reported $642 million in global revenue from its other checkpoint inhibitor, Yervoy (ipilimumab), an increase of 11 percent from $579 million in Q3 2023.
Looking ahead to Q4, BMS is expecting a decision in December from the US Food and Drug Administration on approval of its subcutaneous formulation of Opdivo. The company submitted the biologics license application for subcutaneous Opdivo in May, and if approved, it would make the new formulation available across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. If approved, the launch is expected in early 2025, Boerner said.
BMS Chief Commercialization Officer Adam Lenkowsky added that the firm anticipates shifting between 30 percent and 40 percent of its total US Opdivo business to the subcutaneous formula, if approved.
"[Subcutaneous Opdivo] addresses the treatment burden for patients and physicians, with a three-to-five-minute infusion time as well as an in-office injection," Lenkowsky said during the call, adding that "it will also allow us to extend our immuno-oncology franchise into the next decade."
Also in Q3, the FDA considered whether to narrow one of Opdivo's current indications in an Oncologic Drugs Advisory Committee meeting discussing the benefit of three immunotherapies, including Opdivo, in PD-L1-negative gastric and esophageal cancers. However, the regulator has not yet decided whether to change the indication.
The company's PD-1 and LAG-3 inhibiting combination drug Opdualag (nivolumab and relatlimab) recorded worldwide revenues of $233 million in the third quarter, a 40 percent increase from $166 million in the same period last year.
Boerner also highlighted during the call that the firm is expecting trial starts or data readouts for eight potentially registrational trials in oncology in the coming years. This includes trials of Krazati in KRAS-mutant colorectal cancer and PD-L1-positive and KRAS-mutant NSCLC, a trial of high-dose Opdualag in first-line PD-L1-positive NSCLC, and a Phase III trial of RYZ101 in SSTR-positive gastroenteropancreatic neuroendocrine tumors.
BMS recorded net income in Q3 2024 of $1.21 billion, or $.60 per share, compared to net income in Q3 2023 of $1.93 billion, or $.93 per share. On a non-GAAP basis, the company's EPS was $1.80, which beat the consensus Wall Street estimate of $1.49.
As of Sept. 30, BMS had $8.42 billion in cash, cash equivalents, and marketable debt securities.
BMS revised its 2024 guidance and is now expecting to report revenue growth of 5 percent for the year with non-GAAP EPS between $.75 and $.95. Previously, the company had projected a 2024 revenue increase in the upper end of the low-single-digit percent range and EPS between $.60 and $.90.