BRISTOL MYERS SQUIBB CO BMY

The U.S. approval and launch of Cobenfy for schizophrenia in late 2024 is off to a strong start, with approximately 1,000 TRxs per week and high Medicaid (90%+) and Medicare (80%+) access. Management sees significant long-term potential for Cobenfy, initiating 7 Phase III studies in 2025 across Alzheimer's disease agitation, Alzheimer's disease cognition, and bipolar I disorder, with plans for autism spectrum disorder irritability studies in 2026. The failure of emraclidine has cleared the competitive landscape, reinforcing confidence in Cobenfy's unique efficacy profile for positive, negative, and cognitive symptoms.

Bristol-Myers Squibb has significantly improved R&D productivity, accelerating several late-stage programs. Notable examples include Camzyos (ODYSSEY non-obstructive HCM study top-line results expected next quarter, 6 months ahead of schedule), Cobenfy (ADEPT-2 Alzheimer's disease psychosis readout expected H2 2025 vs. original 2026), and iberdomide (EXCALIBER trial in relapsed/refractory multiple myeloma enrollment complete with data readout opportunity in 2025, ahead of schedule due to MRD co-primary endpoint). The company expects 15 or more registrational trials to read out by the end of 2026, derisking the pipeline and providing insight into future growth.

Building on $1.1 billion in savings realized from a prior $1.5 billion initiative in 2024, the company has identified an additional $2 billion in run-rate operating expense savings. Approximately $1 billion of these incremental savings are expected in 2025, with the remainder by the end of 2027. These savings, driven by organizational design and operational efficiencies, will drop to the bottom line, aiming to make BMS a leaner, more efficient company while continuing to invest in growth drivers and promising science.

Eliquis delivered over $3 billion in Q4 sales, with U.S. sales up 19% driven by strong demand and inventory build. For FY25, Eliquis is expected to see strong double-digit growth. However, Q1 FY25 U.S. sales will be tempered sequentially due to the implementation of the 10% manufacturer responsibility in the initial coverage phase of Medicare Part D redesign. Sales are expected to steadily increase in subsequent quarters, particularly in H2, due to the elimination of the coverage gap. The company anticipates the overall impact of Part D redesign to be net neutral across its portfolio in FY25.

Camzyos sales more than doubled in Q4 FY24, benefiting from higher demand and inventory build, with approximately 9,500 patients on commercial drug. The company expects continued growth from prescriber expansion and high persistency. A PDUFA date in April for easing REMS echo monitoring requirements in the U.S. is anticipated, similar to a recent European label update reducing monitoring frequency to every 6 months in the maintenance setting. This is expected to open up additional capacity at centers of excellence, allowing physicians to treat more patients.

Bristol-Myers Squibb is excited about its novel oral drugs like iberdomide and mezigdomide in multiple myeloma, positioning them for community settings where cell therapies and bispecifics are difficult to administer. Iberdomide's EXCALIBER trial now includes MRD as a co-primary endpoint, with discussions ongoing with the FDA regarding its use for registration. The company remains committed to Abecma despite competitive intensity and is also excited about Arlo-cel (GPRC5D CAR T), which is expected to play a critical role post-BCMA CAR T with a single infusion and improved safety profile.