Bristol Myers Squibb reported a Phase 3 success and a pipeline cut as part of its second-quarter earnings Friday morning.
The company said a pivotal trial for cendakimab, an anti-IL-13 monoclonal antibody, met both of its primary endpoints in eosinophilic esophagitis (EoE), an allergic and inflammatory condition that sends excess white blood cells into the esophagus.
Additionally, Bristol Myers said it took an impairment charge for the discontinuation of alnuctamab, a T cell engager program targeting BCMA and CD3 being studied in late-line multiple myeloma. A Phase 3 readout had been anticipated for 2025.
Chris BoernerThe dueling pipeline updates come after new CEO Chris Boerner undertook a sweeping $1.5 billion cost-cutting program in April. Boerner’s move entailed laying off 2,200 employees, terminating about a dozen experimental drugs and closing a cell therapy manufacturing site.
In the cendakimab study, BMS said the drug reduced the number of days in which patients reported food getting stuck in their throats as well as esophageal white blood cell counts by statistically significant margins after 24 weeks. No new safety signals were reported.
Samit HirawatDuring Friday morning’s earnings call, BMS executives said it was too early to disclose a timeline for an FDA filing, noting the company wants to first present data at a medical conference. CMO Samit Hirawat also said it’s not prudent to compare the results to Regeneron and Sanofi’s Dupixent, which was approved for EoE in 2022, because the studies measured outcomes differently.
The trial represented one of BMS’ immunology milestones in 2024, in addition to other readouts for approved drugs Sotyktu (psoriatic arthritis) and Zeposia (ulcerative colitis) that are anticipated as early as later this year. Bristol Myers is also studying cendakimab in eosinophilic gastroenteritis.
Alnuctamab, meanwhile, will see all trials discontinued. BMS previously presented Phase 1 data at ASH in 2022 and was attempting to push the drug forward in at least two studies: a Phase 3 looking to read out in 2025 and a Phase 1/2 recruiting for a 2027 readout.
“While the science remains compelling for this program, multiple myeloma is an evolving landscape and there are many factors that must be considered when prioritizing to make the biggest impact,” a Bristol Myers spokesperson told Endpoints News in an email.
On top of alnuctamab, BMS removed the antibody-drug conjugate farletuzumab ecteribulin after it handed back the rights to Eisai earlier this month. The company also added a new program to Phase 1, called BMS-986495, for neurodegenerative diseases.
Raising guidance slightly
In addition to the two pipeline updates, Bristol Myers also slightly raised its financial guidance for 2024 revenues. Previously, the company expected a “low single-digit increase” but now anticipates the “upper end of [the] low single-digit range.” BMS’ stock price $BMY rose more than 8% Friday morning.
Boerner said the cost-cutting measures enacted in April are proceeding smoothly, and BMS is still on pace for growth starting in 2026. He reiterated that bolt-ons and partnerships will be the focus of any deals going forward, emphasizing BMS will focus on the areas it knows best and likely won’t spread out into something else like obesity.
“We’re going to continue to be disciplined there,” Boerner said.
Second-quarter revenues totaled $12.2 billion worldwide, up 9% from the same time period in 2023. Revenues from BMS’ “growth portfolio,” which includes newer drugs like Sotyktu, Krazati and Abecma, as well as the blockbuster cancer drug Opdivo, came in at $5.6 billion, an 18% increase from Q2 2023.
R&D expenses also increased by 28% to $2.9 billion, primarily due to the impairment charge for discontinuing alnuctamab.
Editor’s note: This story has been updated with information from Friday morning’s earnings call. An earlier version of this story incorrectly said BMS removed an SHP2 inhibitor from the pipeline. A spokesperson confirmed it has not been removed.