Bioxcel Therapeutics, Inc. · NASDAQ:BTAI
Bioxcel Therapeutics — Investor Day (October 2022)
96 slides from Bioxcel Therapeutics's investor day presentation, Oct 18, 2022
Slide 1: Commercial Day
® Commercial Day October 18, 2022 BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com
Slide 2: Forward-Looking Statements
2 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: statements regarding BioXcel Therapeutics’ commercial plan a
Slide 3: Indication and Important Safety Information
3 Indication and Important Safety Information INDICATION IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Limitations of Use: The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first d
Slide 4: Agenda and Speakers
4 Agenda and Speakers • A Disruptive Approach to the Untapped Agitation Market • Psychomotor Agitation Vimal Mehta, PhD Matt Wiley Brenden Schultek • The Front Lines Founder and CEO Chief Commercial Officer Vice President of Sales of Agitation • Hospital Process: How the System Works • IGALMI™ Comme
Slide 5: A Disruptive Approach to the Untapped Agitation Market
5 A Disruptive Approach to the Untapped Agitation Market Vimal Mehta Founder & CEO ®
Slide 6: Innovation Shaping the Agitation Market
6 Innovation Shaping the Agitation Market Similar to the Depression Market in the 1980s Depression Market IGALMI marketing and education efforts are highlighting the Innovation undervalued agitation market driving market creation “Drugs now treating depression generate more than a billion dollars in
Slide 7: Disruption is in our DNA
7 Disruption is in our DNA Building a Unique Biopharma Model Delivering Disrupting First oral film Creative Poised to innovation drug development treatment for $260m strategic capture 139- paradigm BPD/SCZ agitation financing in million-episode market April 2022 agitation market First public AI IND
Slide 8: Well-Positioned to Help Address Significant U.S. Market Opportunity
8 Well-Positioned to Help Address Significant U.S. Market Opportunity $15B Potential Market Opportunity6 16M BPD/SCZ Institutional Episodes1-3 100M Alzheimer’s* Episodes1-5 23M BPD/SCZ At-Home* Episodes1-4 BXCL501* TRANQUILITY II Top-line Data Readout BXCL501* Expected in 1H 2023 SERENITY III Pivota
Slide 9: Comprehensive Alzheimer's Disease Program Strategy
9 Comprehensive Alzheimer’s Disease Program Strategy Retail Prescription Market Agitation Spectrum Pre-Agitation Acute Agitation Intermittent Chronic Agitation Agitation Wearable + PRN PRN* BXCL501 PRN* BXCL502 Treatment Settings Spectrum Assisted Living/Nursing Homes At Home Market Entry Strategy U
Slide 10: From IND Acceptance to IGALMI Launch in 4 Years
10 From IND Acceptance to IGALMI™ Launch in 4 Years First AI-Derived, FDA-Approved Drug With Novel Mechanism of Action April 5, July 2022 2022 Q2 2021 Q1 2021 FDA Approval Mid-2020 FDA Acceptance Q4 2018 of NDA Filing for BXCL501 FDA Less than 4 months Breakthrough Schizophrenia & Therapy Bipolar Di
Slide 11: IGALMI (dexmedetomidine) Sublingual Film
11 IGALMI™ (dexmedetomidine) 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 IGALMI profile represents significant sublingual film with broad label covering mild, game-changing
Slide 12: Positive Commercial Momentum in Under 4 Months
12 Positive Commercial Momentum in Under 4 Months Well-positioned to Maximize IGALMI Market Potential • Positive market reception from key hospital stakeholders • Highly favorable market dynamics to IGALMI value proposition • Gaining market access across multiple institutions • Expanding national sa
Slide 13: Psychomotor Agitation
13 Psychomotor Agitation Sheldon Preskorn, M.D. Speaker is acting on behalf of and is a paid consultant to BioXcel Therapeutics, Inc. This material is intended for an investor audience only. The information contained in the following material is intended to provide background and educational informa
Slide 14: Personal Experience in the Emergency Department
14 Personal Experience in the Emergency Department • Witnessed two firefights in the ER • Was held hostage in the office at gunpoint • Suffered a torn ligament restraining an agitated patient who was trying to attack another physician • Personally knew 10 HCPs who were killed by agitated patients •
Slide 15: Psychomotor Agitation
15 Psychomotor Agitation Associated with Poor Outcomes in Patients with Schizophrenia or Bipolar Disorder Psychomotor agitation is characterized by motor restlessness and irritability (mild) progressing to aggressive and/or violent behavior (severe) PREVALENCE AGITATION IN HOSPITALS ASSOCIATED WITH:
Slide 16: Current Treatment Paradigm for Psychomotor Agitation
16 Current Treatment Paradigm for Psychomotor Agitation Treatment Algorithm: Determine Need for Pharmacological Intervention YES Cause of Agitation: Psychiatric Disorder YES Cooperative Patient YES NO 1. Inhaled 1. IM Antipsychotic Antipsychotic 2. IM BZD 2. Sublingual Antipsychotic 3. Oral Antipsyc
Slide 17: Current Treatment Paradigm: Unmet Needs
17 Current Treatment Paradigm for Psychomotor Agitation What are the Unmet Needs? Characteristics of Drugs Commonly Used For Treatment of Psychomotor Agitation in Patients with Schizophrenia or Bipolar Disorder Oral FACTOR Oral BZD IM BZD IM Antipsychotic Antipsychotic Calm without excessive sedatio
Slide 18: Mechanism of Action of IGALMI (Dexmedetomidine)
18 Mechanism of Action of IGALMI (Dexmedetomidine) Dexmedetomidine has Been Shown to Reduce Hyper-arousal Through Selective Agonist Activity at Alpha-2A Adrenergic Receptors Hyper-Arousal Physiology Dexmedetomidine MoA Locus Coeruleus (LC) Activation NE Stress Induced Norepinephrine (NE) (+) Agitati
Slide 19: Addressing Underlying Biology in Neuropsychiatric Symptoms
19 Addressing Underlying Biology in Neuropsychiatric Symptoms • LC neurons fire in a phasic mode. Locus Coeruleus (LC) Neurons When stressed, LC neurons fire in stress a tonic mode. PHASIC TONIC NA • Tonic firing causes anxiety-related Firing Rate inhibition behaviors • Inhibition of noradrenaline (
Slide 20: Levels of Arousal and Locus Coeruleus Activity
20 Levels of Arousal and Locus Coeruleus Activity Arousal Level Anxiety Panic Deep Sleep Relaxed Alert Drowsy Normal Hypervigilant Flight/Aggression Locus Coeruleus Firing Rate Preskorn, SH: Journal of Psychiatric Practice. 28(3):227-233, May 2022
Slide 21: Dexmedetomidine Highest Potency and Agonist Efficacy at Alpha2 Receptors
21 DEXMEDETOMIDINE: Compared With Other Clinically Useful Alpha2 Adrenergic Agonists, has Highest Potency and Agonist Efficacy at Alpha-2 Receptors DRUG ALPHA-2A ALPHA-2B ALPHA-2C EC50 % Max EC50 % Max EC50 % Max (nM) Activity (nM) Activity (nM) Activity DEXMEDETOMIDINE 3.9 89 2.8 147 14 110 Clonidi
Slide 22: Selectivity for Alpha-2 Adrenergic vs. I1-imidazoline Receptors
22 Further Differentiation Amongst Various Alpha-2 Adrenergic Agonists: Selectivity for Alpha-2 Adrenergic vs. I1-imidazoline Receptors Radioligand binding properties at I1-imidazoline and α2-adrenergic receptors (Ki, nM) Drug 1-Imidazoline (1-I) Alpha2-adrenergic alpha2/1-I Clonidine 1 3.8 0.26 Lof
Slide 23: Psychomotor Agitation in Adult Patients: Patient Population for IGALMI
23 Psychomotor Agitation in Adult Patients with Schizophrenia or Bipolar I or II Disease Patient Population for IGALMI Patient’s Feelings PEC Score • Aggressive • Sublingual thin film formulation • Violent of dexmedetomidine SEVERE 31 DEGREE OF AGITATION • Desperate • Acts on the pathway of stress-
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Slide 25: BioXcel Therapeutics
ex | bioxcel therapeutics”
Slide 26: IGALMI: Easy-to-Administer Formulation
26 IGALMI: Easy-to-Administer Formulation Proprietary, Immediate Delivery, Sublingual Thin Film Product ✓ Muco-adhesion properties designed for optimizing compliance ✓ Adaptable technology enables broad dose range ✓ Flexible for potential combination of multiple drugs on a single film ✓ Absolute bio
Slide 27: Robust Treatment Effect Observed in Two Phase 3 Studies
27 Robust Treatment Effect Observed in Two Phase 3 Studies • Highly statistically significant improvements in PEC score observed vs. placebo (p<0.0001) at two hours in the SERENITY trials for both doses tested • Statistically significant improvements in PEC score observed as early as 20-30 minutes a
Slide 28: SERENITY I & II: Two Pivotal Phase 3 Trials of IGALMI
28 SERENITY I & II: Two Pivotal Phase 3 Trials of IGALMI Evaluation Period 0 min 60 min 120 min * SERENITY I: 120 mcg Agitated Schizophrenia Patients Screening R 180 mcg N = 381* Placebo SERENITY II: 120 mcg Agitated Bipolar Patients Screening R 180 mcg N = 378* Placebo * Patients Dosed Primary Endp
Slide 29: SERENITY I: Rapid Onset of Action Observed
Schizophrenia 29 SERENITY I: Rapid Onset of Action Observed 0 Placebo Change in PEC Score from Baseline -2 120 mcg 180 mcg -4 * * (LS Mean) -6 *** *** *** -8 *** *** *** -10 *** *** -12 *** 0 10 20 30 40 60 90 120 Baseline Time Post Dose(min) * p < 0.025. *** p < 0.0001 Endpoint (120 min) Placebo 12
Slide 30: SERENITY II: Rapid Onset of Action Observed
Bipolar Disorder 30 SERENITY II: Rapid Onset of Action Observed * * * *** *** *** *** *** *** *** *** *** Baseline * p < 0.025. *** p < 0.0001 Endpoint (120 min) Placebo 120 mcg 180 mcg Time = 120 min Primary: PEC total score change from Baseline -5.0 -9.1 *** -10.4 *** (Primary Endpoint) Response°
Slide 31: Clinically Meaningful Improvement Confirmed by CGI-I
31 Clinically Meaningful Improvement Confirmed by CGI-I SERENITY I SERENITY II 100 100 Placebo Placebo 120 mcg 120 mcg 80 80 180 mcg 180 mcg % Responders % Responders 60 60 40 40 20 20 0 0 30.0 60.0 120.0 30.0 60.0 120.0 Time after Treatment (Minutes) Time after Treatment (Minutes) Response Was Defi
Slide 32: IGALMI Well Tolerated with No Serious Adverse Events
32 IGALMI Was Well Tolerated with no Serious Adverse Events Reported in Clinical Studies Integrated Safety Data From the two SERENITY Trials 180 mcg BXCL501 120 mcg BXCL501 Placebo (N=252) (N=255) (N=252) Mild 40 (15.9) 43 (16.9) 15 (6.0) Somnolence Moderate 16 (6.3) 11 (4.3) 1 (0.4) Mild 13 (5.2) 7
Slide 33: IGALMI: Sublingual Thin Film Dexmedetomidine for Acute Treatment of Agitation
33 IGALMI: Sublingual Thin Film Dexmedetomidine for Acute Treatment of Agitation in Adult Patients with Schizophrenia or Bipolar I or II Disorder Agitation: A Growing Global Healthcare Issue ($40B+) Unmet Consensus Need Opinion* ✓ Non-invasive ✓ Calmness without unarousable IGALMI: An Innovative App
Slide 34: The Front Lines of Agitation
34 The Front Lines of Agitation Karen Sands, MSN, APRN-BC, ANP, CCRN, FCCM Speaker is acting on behalf of and is a paid consultant to BioXcel Therapeutics, Inc. This material is intended for an investor audience only. The information contained in the following material is intended to provide backgro
Slide 35: 34 Years of Nursing Experience
35 34 Years of Nursing Experience Career Highlights Critical Care RN Critical Care Educator Critical Care NP Hospitalist NP 1988 - 1993 1993 - 2000 2000 - 2020 2020 - present
Slide 36: Patient Presentation & Treatment Plan
36 Patient Presentation & Treatment Plan Rapid Assessment & Diagnosis Needed Fluctuation or Inattention PLAN – Determine change in mental the cause status • Disorganized thinking • Psychiatric illness • Altered level of consciousness – Bipolar disorder – Schizophrenia • Medical illness
Slide 37: Transitioning an Agitated Lion to a Calm Kitten
37 Transitioning an Agitated Lion to a Calm Kitten! • Stabilize • De-escalation • Rapid Treatment
Slide 38: Treatment Selection Considerations
38 Treatment Selection Considerations Team Alliance & Needs • Team Needs – Nursing: calm, cooperative, and comfort – Pharmacy: clinical pharmacokinetics and cost – Physician/Advance Practice Provider: assessable, stable, and transferable • Ideal Agitation Treatment Characteristics – Easy to administ
Slide 39: Lessons Learned Over 3 Decades
39 Lessons Learned Over 3 Decades • Avoid Oversedation & Respiratory Depression That Causes: – Hypoxia – Aspiration – Leads to endotracheal intubation • Absolute Goals: – Support respiratory effort and avoid need for adjunctive airway support – Maintain hemodynamic stability – Maintain functional st
Slide 40: Managing Agitation
40 Managing Agitation Challenges and Patient Clinical Factors Patient Variables Goals & Considerations Impacting Treatment • Hospital Length of Stay can be impacted by drug selection, dosing, and treatments • Memory loss • Treating While Avoiding Over-sedation: • Confusion – Relieve anxiety and agit
Slide 41: Autonomic Hyperactivity Resulting From Catecholamine Release During Stress
41 Autonomic Hyperactivity Resulting From Catecholamine Release During Stress Agitation Symptom Symptoms Management • Tachycardia • Challenging • Hypertension • Requires frequent and • Diaphoresis close monitoring with • Tremors increased level of care • Hallucinations • Extreme resources spent to p
Slide 42: The Balancing Act – Treatment Challenges & Outcomes
42 The Balancing Act – Treatment Challenges & Outcomes Impact of Treatment Oversedation vs. Ideal Patient Comfort Negative Treatment & Oversedation Impact: • Increased ICU, ED & Hospital Length of Stay: – Increased direct medical care & staffing costs • Increased risk of complications: – Thromboembo
Slide 43: Agitation Treatment Challenges in the ED
43 Agitation Treatment Challenges in the ED ®
Slide 44: Patient Medical Complexities Presenting to the ED
44 Patient Medical Complexities Presenting to the ED • Cardiac Event: Hypertensive Crisis or Myocardial Infarction • Neurological Event • Abdominal Catastrophe • Endocrine Emergency • Respiratory Failure due to Pneumonia or Viral Illness • Polysubstance Self-Medication Abuse: Tobacco, vaping, alcoho
Slide 45: ED Challenges
45 ED Challenges Limitations & Staff Burnout Affecting Patient Care Logistics Pressures: Physician Burnout by Specialty (2021 Survey): Top 4 Reporting Burnout by % • Lack of bed availability at a crisis level • Staffing shortages limits optimal patient care • Emergency Medicine: 60% • Critical Care:
Slide 46: Case Studies: Safety Risks & Staff Injuries
46 Case Studies: Safety Risks & Staff Injuries Safety Risks From Escalation to Physical Aggression Injuries: Staff & patients Restraints: • 10% of patients with schizophrenia and bipolar disorder require confinement and restraints • Requires enhanced staff, monitoring, and documentation • Need for s
Slide 47: IGALMI – Medication Characteristics Desired by ED Staff
47 IGALMI™ – Medication Characteristics Desired by ED Staff Rapid Response Team Option for the Agitated Adult Patient with Schizophrenia or Bipolar I or II Disorder Ideal Agitation Treatment Additional Staffing Needs Characteristics • Provider education on ✓ Easy to administer IGALMI and appropriate
Slide 48: Hospital Process: How the System Works
48 Hospital Process: How the System Works Jacob Hanaie PharmD, APh, BCPP Speaker is acting on behalf of and is a paid consultant to BioXcel Therapeutics, Inc. This material is intended for an investor audience only. The information contained in the following material is intended to provide backgroun
Slide 49: Complex Institutional Structures & Functions
49 Complex Institutional Structures & Functions Practice Groups and Hospital Networks Non-integrated Group Practices & Hospitals Ancillary Independent Multi-specialty Group Practices Providers Providers Accountability Care Organizations (ACOs) • Groups of doctors, hospitals, and other healthcare pro
Slide 50: Complex Institutional Structures & Functions: Purchasing Groups
50 Complex Institutional Structures & Functions Purchasing Groups Group Purchasing Organizations (GPOs) • Entities created to leverage purchasing power of a group of businesses to obtain vendor discounts based on collective buying power of GPO members • Funded by administrative fees paid by vendors
Slide 51: Pharmacy and Therapeutics (P&T) Committee: Overview
51 Pharmacy and Therapeutics (P&T) Committee: Overview • Meets regularly to review newly available drug therapies • Stays abreast of developments in pharmacy market • Manages the formulary • Involved in quality/cost initiatives
Slide 52: Broad Functional Responsibilities
52 Broad Functional Responsibilities Policies & Procedures Reviews, Develops, Analyzes, Studies Develops, Reviews & Manages: Oversees & Approves: & Reports: • Medication usage, ensuring safe and • Drug-related educational programs • Pharmacoeconomic studies / effective drug utilization • Drug-relate
Slide 53: Performance Improvement Focus Areas
53 Performance Improvement Focus Areas PRESCRIBING DISPENSING ADMINISTRATION MONITORING • Pharmacist interventions • Medication distribution/dispensing • PRN (as needed) administration • Medication errors • Incomplete orders • After-hour medication dispensing • STAT/NOW (Immediate) order • Food-drug
Slide 54: Broad Additional Responsibilities
54 Broad Additional Responsibilities – Review and redevelop drug monograph – Coordinate drug recalls – Develop & revise treatment guidelines – Member of Medication-assisted Treatment (MAT) Committee – Communicate with Therapeutic Assessment Committee (TAC) – Communicate with Value Assessment Committ
Slide 55: Formulary Medication Management
55 Formulary Medication Management – New medications (~50 per year) – Indication expansions – Changes to package inserts – Recalled meds (~1,300 per year) – Compounding medication review – Experimental drug usage – Clinical trial studies
Slide 56: Continuous Feedback & Quality Improvement Process
56 Continuous Feedback & Quality Improvement Process FEEDBACK PRESCRIBING TRANSCRIBING DISPENSING ADMINISTERING MONITORING (physician, nurse practitioner, (pharmacist, nurse, unit clerk) (pharmacist) (nurse) (nurse, physician, pharmacist) pharmacist) Clinical decision making Receive order or retriev
Slide 57: New Drug Formulary Process
57 New Drug Formulary Process ®
Slide 58: Formulary Process: The Request Form
58 Formulary Process: The Request Form KEDREN ACUTE PSYCHIATRIC HOSPITAL Formulary Request Form The policies of the Medical Staff's P&T Committee require that this form be completed (including appropriate signatures) before a non-formulary drug may be purchased/dispensed or added to the formulary by
Slide 59: From Formulary Change Request to Medication Orders
59 From Formulary Change Request to Medication Orders 9-Step Process Formulary P&T and medical maintenance Formulary Monograph Subcommittee executive 1 change requested 2 developed using revised template 3 reviews monograph 4 committee enters medication in onboarding 5 committees approve formulary c
Slide 60: Multiple Committee Perspectives
60 Multiple Committee Perspectives Clinical & Financial Considerations Formulary Development Process Committees Therapeutic Assessment Pharmacy & Therapeutics Value Assessment (TAC) (P&T) (VAC) Clinical Considerations (no financial) Clinical & Financial • VAC uses parameters to • TAC reviews availab
Slide 61: COVID-19 Impact on P&T Committee
61 COVID-19 Impact on P&T Committee ®
Slide 62: P&T Committee in Post-COVID-19 Environment
62 P&T Committee in Post-COVID-19 Environment Might meet Might meet Might have ALL quarterly in person committee members (might not) (might not) (might not) Extended time Budgets have Priorities have Relationship discussing COVID, changed and/or changed and/or with pharma Monkey Pox, infection shift
Slide 63: You Cannot Know One and Know All
63 Each Country, Each State, Each County, Each City, and EACH & EVERY Hospital System is different. YOU CANNOT KNOW ONE AND KNOW ALL ®
Slide 64: IGALMI Commercial Overview and Updates
64 IGALMI™ Commercial Overview and Updates Matt Wiley Chief Commercial Officer ®
Slide 65: Positive Commercial Momentum in Under 4 Months
65 Positive Commercial Momentum in Under 4 Months Well-positioned to Maximize IGALMI™ Market Potential • Positive market reception from key hospital stakeholders • Highly favorable market dynamics to IGALMI™ value proposition • Gaining market access across multiple institutions • Expanding national
Slide 66: The Trauma of Agitation: One Patient's Perspective
66 The Trauma of Agitation: One Patient’s Perspective Patient Background Bipolar Disorder • Diagnosed >5 years ago • 33-year-old female Agitation Symptoms • Multiple times per month Care Summary • ~35 ED/urgent care visits per year • Has required inpatient care due to agitation episodes twice in the
Slide 67: The Trauma of Agitation: One Patient's Perspective
67 The Trauma of Agitation: One Patient’s Perspective “ I feel like there is no end to the agitation when it's happening. It's very frustrating because not only do I feel out of place mentally, but I also have physical feelings of nervousness. With the agitation, I get kind of tics where I pick at m
Slide 68: The Evolving Agitation Market
68 The Evolving Agitation Market ®
Slide 69: Agitation in Bipolar and Schizophrenia Represents $4B Market Opportunity
69 Agitation in Bipolar and Schizophrenia Represents $4B Market Opportunity 23M 16M At-Home* 39M Institutional + Rx & Self- Managed = Agitation Episodes1-3 Episodes1-4 Episodes SERENITY III Pivotal Trial *Investigational use; safety and efficacy not established 1. Wu, 2006, NAMI 2. NIMH- Prevalence
Slide 70: Market Opportunity Segmentation
70 Market Opportunity Segmentation Amalgamation of Market Research and Epidemiology-based Prevalence Publications Bipolar Disorders Outcome Schizophrenia (SCZ) Outcome I & II (BPD) US Adult Population (78%) 259,740,000 259,740,000 Adult Population (78%) BPD Prevalence (2.80%) 7,272,720 1,636,362 SCZ
Slide 71: 55% of Physicians Surveyed in ACEP Poll Have Been Assaulted
71 55% of Physicians Surveyed in ACEP Poll* Have Been Assaulted Assault-related Injuries on the Rise Experience with Assault in ED Have you ever been injured at 90% work because of an assault? 79% 35% 80% 70% 30% 60% 55% 25% 50% 20% Increase in odds of assault by 40% 33% patient with diagnosis of 15
Slide 72: 80% of Patients Administered Invasive Treatments for Agitation
72 80% of Patients Administered Invasive Treatments for Agitation Coercive Approach may Escalate Agitation Route of Administration in Hospital Setting1 Patients acknowledge their agitation 100% often escalates while in emergency- 10% care setting2 80% Needle phobic, invasive approach, don’t like 60%
Slide 73: Commercial Infrastructure & Progress
73 Commercial Infrastructure & Progress ®
Slide 74: Fully Integrated and Experienced Commercial Team
74 Fully Integrated and Experienced Commercial Team Designed to Meet Today’s Needs and Future Demands MARKETING ANALYTICS/OPERATIONS Driving Market Delivering key insights and Awareness and Interest enabling productivity MARKET ACCESS TRAINING Navigating stakeholder Optimizing commercial contracting
Slide 75: Impactful Marketing Messages and Value Proposition
75 Impactful Marketing Messages and Value Proposition IGALMI™: First and Only Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorders1 Core Message HCP Benefit IGALMI reduces norepinephrine release, a key Novel mechanism approved for treating agita
Slide 76: Stated Utilization of IGALMI Doubles With Promotional Messaging
76 Stated Utilization of IGALMI™ Doubles When Provided Within Context of Promotional Messaging Product Profile Reactions1 Detail Aid Presentation Reactions2 89% 85% 80% 78% 76% 77% Positive Impressions (Top3 Box) Advanced Psychiatrists Emergency Advanced Psychiatrists Emergency Providers Providers H
Slide 77: Marketing Efforts are Reaching Providers Through Peer Programs, Conventions, and Digital Media
77 Marketing Efforts are Reaching Providers Through Peer Programs, Conventions, and Digital Media
Slide 78: Market Access
Market Access en cee stics”
Slide 79: High-priority Focus on Key Stakeholder Groups to Generate Access
79 High-priority Focus on Key Stakeholder Groups to Generate Access GPOs IDNs HCOs • Group purchasing • Integrated delivery • Healthcare organizations networks (IDNs) are organizations (GPOs) contract with a network of providers (hospitals) have their manufacturers on that deliver coordinated own Ph
Slide 80: Working to Gain Hospital Formulary Access and Drive Demand
80 Working to Gain Hospital Formulary Access and Drive Demand Navigating Contracting and P&T Process Concurrent GPO Contract Negotiation 6-9 Months Physician Clinical review P&T committee When approved, advocate reviews clinical & IT system Demand Created: requests P&T economic case updated Institut
Slide 81: IGALMI Now Contracted with Nearly Half of Targeted U.S. Hospital Beds
81 IGALMI™ Now Contracted with Nearly Half of Targeted U.S. Hospital Beds Top 3 GPOs Influence 77% of Staffed Beds in the U.S. and >90% of IGALMI Target Beds Bed Volume by GPO GPO Contracting Process Other, 23% • Vizient contract executed and effective October 1, 2022 Vizient, 36% • ~46% of all targ
Slide 82: Corporate IDNs Have Varying Degrees of Control and Influence
82 Corporate IDNs Have Varying Degrees of Control and Influence Key Focus for Corporate Account Directors Grandparent corporate Payer Medical group Hospital Specialty pharmacy GPO Integration Influence Parent-region/division Bottom up Top down Strategy Child site-of-care
Slide 83: ~10% of IDNs Control Majority of IDN-affiliated Hospitals in U.S.
83 ~10% of IDNs Control Majority of IDN-affiliated Hospitals in U.S. Core Execution Focus Most IDNs are Small and Regional Distributions of IDNs by # of Hospitals Top 10% of IDNs control ~60% of IDN affiliated Hospitals 300 256 10% 250 200 59% 150 128 100 90% 56 50 31 11 41% 0 2-4 5-10 11-20 21-50 >
Slide 84: 59 IDNs Represent One-Third of Target Hospital Beds
84 59 IDNs Represent One-Third of Target Hospital Beds Can Affect Protocols and Pathways in Additional Network Hospitals Seattle Renton Portland Corporate Account Team Focus Minneapolis Rochester • Corporate Account Director (CAD) Team Chicag Ann Arbor Hartford Livonia o Rochester Sioux Falls Chicag
Slide 85: Unique Precision Targeting Using 81B Record Data Lake
85 Unique Precision Targeting Using 81B Record Data Lake Refined Priorities for Sales Force Expansion Factors include hospital beds, antipsychotic utilization, agitation episodes, repeat patient visits, among others Key Targeting Metrics • ~1700 priority target hospitals Hospital – Represents majori
Slide 86: Sales Force Deployment and Field Intelligence
86 Sales Force Deployment and Field Intelligence Brenden Schulek Vice President, Sales ®
Slide 87: Field Force Expansion Nearing Completion
87 Field Force Expansion Nearing Completion; Plan to Mobilize Sales Efforts Against ~1,700 Target HCOs Representing ~70% of Commercial Opportunity; Covers all Major U.S. Population Centers Wave One Target Coverage: 37% Wave Two Target Coverage: 100% 2022 2023
Slide 88: Institutional Specialists Have In-depth Hospital Experience & Expertise
88 Institutional Specialists Have In-depth Hospital Experience & Expertise Averaging 8 Commercial Launches Each 22 year 8.5 year average 250+ product launches average experience in selling in pharma/biotech sales emergency setting 8+ 14.5 year per representative 6.5 year average average experience i
Slide 89: First Wave Sales Team Has Penetrated Two-Thirds of Target Universe
89 First Wave Sales Team has Penetrated Two-Thirds of Target Universe and Continues to Expand Reach Cumulative Unique Target Hospital Reach Target Hospital Reach to Date Target account depth/penetration has doubled in the last 2 months 600 Targets Reached Total Unique HCO Targets 510 500 469 800 434
Slide 90: Providers are Enthusiastic About IGALMI
90 Providers are Enthusiastic About IGALMI™ “I could “I’m a psychiatrist have used and my mom is a this today!” schizophrenic. She has PTSD from years of force and injections. I can’t wait to get this.” – RN Response after ED Inservice - Large Community Hospital – Psych MD, Hospital and Office Pract
Slide 91: Key Performance Indicators
91 Key Performance Indicators ®
Slide 92: Early Votes at Multiple IDNs Expected in 2022
92 Early Votes at Multiple IDNs Expected in 2022 Representing 17% of Target Beds and ~50k Total Beds Additional Voting in Process with Child Accounts in Larger Systems IDN Formularies in Process IDN Reviews in Process Priority Target Beds Other IDN Target Beds 17% 35,418 14,034 83% 0 5,000 10,000 15
Slide 93: Early Votes Indicate Strong Interest, Over a Dozen Formulary Approvals
93 Early Votes Indicate Strong Interest, with Over a Dozen Formulary Approvals and ~400 Votes in Queue 16% of First Wave Targeted Hospitals in Process in Less Than 4 Months P&T Formulary Reviews in Process P&T Approvals and in Process vs. Targets Priority Targets 108 16% 391 in Process Tier 2 Target
Slide 94: Clinicians Anticipate Usage Within First Year Post-Formulary Approval
94 Clinicians Anticipate Usage Within First Year Post-Formulary Approval 100% 96% 88% 94% 97% 70% 83% 56% 37% 35% Less than 6 months 6 months - Less than 1 1 year - Less than 2 years 2 years - Less than 3 More than 3 years year years Emergency Department (ED & APP) Inpatient (PSYCHs) Source: HCP ATU
Slide 95: Environment Favors Growth in 2023
95 Environment Favors Growth in 2023 • Fully integrated commercial team built and sales team expansion under way • Market dynamics evolving and favorable to IGALMI demand • Sales interaction very positive with 71% reach and early use yielding expected results • Market access momentum building with 4
Slide 96: Thank you!
Thank you! ® BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com