Slide 1: Limitations of Use: IGALMI safety and effectiveness beyond 24 hours
Limitations of Use: The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this presentation include but are not limited to the timing of commercial launch of IGALMI, the benefits of tre
Slide 3: Agitation Associated with Schizophrenia & Bipolar Disorders: A Significant Unmet Need
Agitation Associated with Schizophrenia & Bipolar Disorders: A Significant Unmet Need for a Large Population • Approximately 7.3 million estimated diagnosis in adult patients1, 2 • Up to 25 million agitation episodes per year based on diagnosed prevalence in the U.S.3 • Characterized by recurring ep
Slide 4: IGALMI Sublingual Film
IGALMI™ Sublingual Film Approved for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults First and only FDA-approved orally dissolving sublingual film for adults with mild, moderate or severe agitation. If agitation persists, up to two additional doses ma
Slide 5: Basis for Final Label and Approval: SERENITY I and II Trials
Basis for Final Label and Approval: SERENITY I and II Trials Demonstrated Onset of Action as Early as 20 Minutes and High Response Rate SERENITY I: Change in PEC Score from Baseline SERENITY II: Change in PEC Score from Baseline 0 0 Placebo Placebo (N=126) (N=126) 120 mcg 120 mcg Change in PEC Score
Slide 6: Commercial Readiness: Launch Field Force in 2Q, Focus on High Value Targets
Commercial Readiness: Launch Field Force in 2Q, Focus on High Value Targets ~1,700 target institutions represent ~75% in volume • Includes 59 high-control, high-potential integrated delivery networks High Value Provider targets at launch within these institutions Primary focus on Emergency Medicine
Slide 7: Integrated Sales Rollout With Expected Trade Launch in Q3
Integrated Sales Rollout With Expected Trade Launch in Q3 Approval Purchase & Use Field Launch Commences Train and • Onboard Sales Reps and • Launch Meeting and Launch Market Access Field Team Field Execution • Complete Training Field Personnel • Establish Wholesale Acquisition Cost Price Trade Laun
Slide 8: Land and Expand Strategy
Land and Expand Strategy Broad Indications Under Investigation* Market Expansion* (Alzheimer’s Agitation / MDD) (Outpatient Schizophrenia / Bipolar) 1. Target opportunity increases Market Entry significantly (Inpatient Schizophrenia / Bipolar) 1. Targeting Evolution 2. Fulsome branded and disease 2.
Slide 9: Important Safety Information
Important Safety Information WARNINGS AND PRECAUTIONS Hypotension, Orthostatic Hypotension, and Bradycardia: IGALMI ca uses dose-dependent hypotension, orthostatic hypotension, a nd bradycardia. Because IGALMI decreases sympathetic nervous system activity, hypotension a nd/or bradycardia may be more
Slide 10: Thank You!
Scie sf Thank You!