Bristol Myers Squibb (BMS) exceeded analyst expectations for overall Q3 2025 sales with $12.2 billion but reported underwhelming sales for the newly launched schizophrenia drug Cobenfy, which generated $43 million, slightly below consensus estimates of $45-46 million12.
Cobenfy, approved by the FDA in September 2024 as the first new drug class for schizophrenia in 35 years, faces market resistance due to 'deeply ingrained D2 [dopamine] prescribing habits' among physicians, who are accustomed to prescribing generic, dopamine-targeting atypical antipsychotics123.
Cobenfy works via a novel mechanism as a muscarinic acetylcholine M1 and M4 receptor agonist (xanomeline) paired with a peripheral antimuscarinic (trospium), distinguishing it from dopamine and serotonin-targeting drugs and offering a different side-effect profile with potentially lower risk of EPS and weight gain35.
Despite positive physician feedback and steady patient growth, Cobenfy’s adoption has been limited mainly by prescriber inertia, payer restrictions, higher annual costs ($22,500 vs. ~$540 for generic antipsychotics), and the need for twice-daily dosing35.
BMS is focused on physician education to shift prescribing behaviors and is optimistic about ongoing uptake, especially as patients switching to Cobenfy are typically those with prior atypical antipsychotic experience who may have struggled with side effects15.
BMS is also running multiple studies (ADEPT-2, ADEPT-4, ADEPT-1) to evaluate Cobenfy in Alzheimer's disease psychosis, aiming for regulatory approval if two of the three studies succeed. These results are anticipated as part of BMS's growth strategy2.
Cobenfy's market entry is further challenged by pharmacy benefit managers prioritizing lower-cost generics and potentially requiring patients to have tried and failed other antipsychotics before reimbursement for Cobenfy is approved3.
Despite Cobenfy missing sales forecasts, CEO Chris Boerner underscored the drug's potential, citing clinical differentiation and steady growth as BMS aims to build Cobenfy's market presence amid competitive pressure12.
Sources:
1. https://www.biospace.com/business/bms-battles-deeply-ingrained-prescribing-habits-in-schizophrenia-as-cobenfy-misses-q3-estimates
2. https://www.noahai.co/discover/article/12029
3. https://www.clinicaltrialsarena.com/analyst-comment/cobenfy-bms-schizophrenia-win/
5. https://www.earnestanalytics.com/insights/cobenfy-launch-in-schizophrenia-is-off-to-a-strong-start-in-2025