Bristol Myers Squibb : Investor Overview

Published: 2024-09-26 22:09:04 ET BMY

U.S. FDA Approval of Cobenfy

September 26, 2024

Investor Overview

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Now approved in the U.S.

for the treatment of schizophrenia in adults

First-in-class muscarinic agonist1 for the treatment of schizophrenia

First new mechanism in decades for 1.6M treated schizophrenia patients in the U.S.

Compelling efficacy and proven safety

Expected to be available in the U.S. in late-October

1Cobenfy combines xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist

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Cobenfy delivered powerful efficacy at five weeks consistently across two phase 3 pivotal studies

Change from baseline in PANSS total score at week 5

(97.7, 98.2)

EMERGENT-21,a,b

Baseline

Week 2 Week 3 Week 4 Week 5

EMERGENT-32,3,a,b

(96.7, 97.3)

Baseline

Week 2

Week 3

Week 4

Week 5

Interpreting Total PANSS Score4,5

210

-5

-10

Markedly Ill

Moderately

Ill

Placebo (-11.6)

-5

-10

Markedly Ill

Moderately

Ill

Placebo (-12.2)

≥95

markedly ill

According to one studyc, a PANSS score of ≥95 may carry an increased risk of hospitalization6

Score Change from Baseline

(LSM±SEM)

PANSS Total

-15

-20

-25

****

Cobenfy (-21.2)

Mildly Ill

LSM difference vs placebo:

-9.6 points

-15

-20

-25

****

Cobenfy (-20.6)

Mildly Ill

LSM difference vs placebo:

-8.4 points

75 to <95

moderately ill

58 to <75

mildly ill

According to one studyd, ≤59 and below may be more likely to experience remission7

P<0.0001

PANSS is a 30-item scale, with each item rated on a scale of 1 (absent)-7(extreme).

Week 2-4 data were not prespecified clinical endpoints, P-values are nominal.3

a. P-values are defined as: *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.1,3 b. All efficacy analyses performed using the mITT analysis set, defined as all randomized individuals who received ≥1 dose of trial medication and ≥1 postbaseline PANSS

assessment (EMERGENT-2: Cobenfy n=117, PBO n=119; EMERGENT-3: Cobenfy n=114, PBO n=120).3 c. Study assessed data from 1,077 patients across three 52-weekopen-label extension studies.6 d. Study longitudinally assessed 684 patients from one randomized clinical trial.6

1. Kaul I, et al. Lancet. 2024;403(10422):160-170.2. Kaul I, et al. JAMA Psychiatry. 2024:e240785. Online ahead of print. 3. Data on File. Bristol-Myers Squibb. 4. Leucht S, et al. Schizophr Res. 2005;79(2-3):231-238.5. Mortimer AM. Brit J Psychiatry. 2007;191(S50):s7-s14.6. Kozma CM, et al. Ann Gen Psychiatry. 2010;9:24. 7. Opler MG, et al. BMC Psychiatry. 2007;7:35.

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We are employing a comprehensive go-to-market strategy

Patients and their

Adults with

care teams

schizophrenia

Key prescribers

Psychiatrists,

psychiatric APNs

Care centers for

Community mental

health centers and

schizophrenia

private psychiatry

practices

Integrated

Patients and their

approach

care partners

Payors

Medicaid, Medicare,

commercial

Patients & care

partners

Administrative

Psychiatrists,

staff

psychiatric APNs

Community mental

Government and

health centers

commercial payors

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Building a strong proposition with payor engagement1

Key dynamics

1See "Forward-Looking Statements"

Medicaid

~45%

Medicare

40%

Commercial / Other

~15%

4Q24

1H25

2H25

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Cobenfy sales ramp based on monthly paid script volumes enabled by access expansion

Sampling strategy among prescribers during patient initial titration

~60K monthly NBRx1 in schizophrenia available from patients going through a new treatment decision

Analogs suggest ~50% of patients are still on drug at 6 months of therapy

Broad access expected by 2H25 as coverage is progressively secured through 1H*

Ex-U.S. launch timelines for schizophrenia expected to be behind U.S. launch by ~3 years

Expected to be available in the U.S. in late October 2024

* See "Forward Looking-Statements",1IQVIA APLD

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Cobenfy: First-in-class muscarinic agonist1 with potential to treat

numerous complex psychiatric conditions impacting 100M+ people globally2

ONGOING PROGRAMS

PLANNED PROGRAMS

Schizophrenia

Adjunctive

Alzheimer's

Bipolar I

ASD

Schizophrenia

Psychosis

Agitation

Cognition

Disorder

Irritability

FDA Approved:

Phase 3 data

Sept. 26, 2024

2025

2026

Ongoing

Planned

1Cobenfy combines xanomeline, a dual M1- and M4-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist, 2Estimated prevalence reflects World Health Organization (WHO) global estimates for schizophrenia, Alzheimer's disease, bipolar I and pediatric autism, 3Subject to positive registrational trials and regulatory approval

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Disclaimer

Bristol-Myers Squibb Company published this content on September 27, 2024 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on September 27, 2024 at 02:07:07 UTC.