Bristol Myers Squibb Q1 2025 Financial Summary

Bristol Myers Squibb reported first quarter 2025 revenues of $11.2 billion, down 6% year-over-year (4% decline excluding foreign exchange). Growth Portfolio revenues rose 16% to $5.6 billion (18% excluding FX).

GAAP earnings per share were $1.20; non-GAAP EPS came in at $1.80.

The company raised its full-year 2025 outlook:
- Revenue guidance is now ~$45.8 billion to $46.8 billion
- Non-GAAP EPS guidance is increased to $6.70 to $7.00

Management attributed the results to strong momentum in its Growth Portfolio and disciplined execution.

Bristol Myers Squibb announces topline results from Phase 3 ARISE trial evaluating Cobenfy as an adjunctive treatment in schizophrenia

Bristol Myers Squibb reported topline results from the Phase 3 ARISE trial evaluating Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled schizophrenia symptoms. The primary endpoint was not met.

In the trial, adjunctive treatment with Cobenfy showed a 2.0-point reduction in the PANSS total score at Week 6 compared to placebo plus an atypical antipsychotic (p = 0.11), falling short of statistical significance. However, numerical improvements were observed, and safety and tolerability were consistent with earlier trials.

A post-hoc subgroup analysis revealed a statistically significant benefit in patients using non-risperidone background therapies, with a 3.4-point difference in PANSS score (p = 0.03), but no benefit in the risperidone subgroup.

The key secondary endpoints, PSP and CGI-S, also showed numerical but not statistically significant differences.
- PSP score change: -0.6 difference (p = 0.52)
- CGI-S score change: -0.1 difference (p = 0.14)

Cobenfy was generally well-tolerated, with a safety profile consistent with prior studies. The company plans to further evaluate the data and consult with regulators on potential next steps.

The ARISE trial enrolled adults aged 18 to 65 with schizophrenia who were already on a stable antipsychotic regimen. Eligible participants are offered the opportunity to continue in a 52-week open-label extension study.

Cobenfy combines xanomeline, a muscarinic receptor agonist, and trospium chloride, a peripheral muscarinic antagonist. It is approved in the U.S. as a monotherapy for schizophrenia and is also being investigated for conditions such as Alzheimer’s disease, bipolar disorder, and autism spectrum disorder.

Cobenfy carries warnings related to urinary and gastric retention, liver and biliary disorders, narrow-angle glaucoma, and anticholinergic CNS effects. It is contraindicated in patients with moderate/severe hepatic or renal impairment and those with a history of angioedema from its components.

Bristol Myers Squibb plans to present full ARISE trial data at a future medical conference.

FDA Updates Label for CAMZYOS®, Simplifying Monitoring and Expanding Patient Access

Bristol Myers Squibb announced that the U.S. Food and Drug Administration has updated the prescribing information for CAMZYOS® (mavacamten), easing treatment requirements for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Key changes include reducing required echocardiography monitoring from every 12 weeks to every 6 months for eligible patients in the maintenance phase, and relaxing certain contraindications related to drug interactions. Specifically, moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors are now reclassified as drug interactions, broadening patient eligibility.

These updates are supported by long-term clinical trial data and real-world evidence, reflecting the strong safety profile of CAMZYOS. The therapy remains subject to a Risk Evaluation and Mitigation Strategy (REMS) due to risks of heart failure related to reduced systolic function.

With more than 15,000 patients treated in the U.S., CAMZYOS continues to be recognized as a standard-of-care therapy in clinical guidelines for oHCM. Bristol Myers Squibb emphasized that the changes will enhance both the patient and physician experience while maintaining careful safety oversight.

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with Unresectable or Advanced Hepatocellular Carcinoma

Bristol Myers Squibb Announces Dividend
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that its Board of Directors has declared a quarterly dividend of sixty-two cents ($0.62) per share on the $0.10 par value common stock of the company. The dividend is payable on May 1, 2025, to stockholders of record at the close of business on April 4, 2025.

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable on June 2, 2025, to stockholders of record at the close of business on May 6, 2025.