Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Investor Day (December 2022)
137 slides from Indivior Pharmaceuticals's investor day presentation, Dec 7, 2022
Slide 1: Indivior
ae INDIVIOR’ | °°"
Slide 2: Capital Markets Day December 7, 2022
Capital Markets Day December 7, 2022
Slide 3: Forward-looking statements
CAPITAL MARKETS DAY – DECEMBER 7, 2022 Forward-looking statements Important Cautionary Statement This presentation contains certain statements that are forward-looking. Forward-looking statements include, among other things, statements regarding future growth and growth rates, future profitability,
Slide 4: Important Information for Investors and Stockholders
CAPITAL MARKETS DAY – DECEMBER 7, 2022 IMPORTANT INFORMATION FOR INVESTORS AND STOCKHOLDERS This communication does not constitute a solicitation of any vote or approval. Opiant intends to file with the SEC and mail to its stockholders a definitive proxy statement in connection with the proposed tra
Slide 5: Today's Agenda
CAPITAL MARKETS DAY Today’s Agenda 8:30 Welcome 11:00 R&D Pipeline Strategic Innovation to Fuel Future Growth 8:35 Company Overview & Strategy • Dr. Christian Heidbreder, Chief Science Officer Positioned for Continued Value Creation • Mark Crossley, Chief Executive Officer 11:40 ESG and Sustainabili
Slide 6: Company Overview & Strategy
Company Overview & Strategy Positioned for Continued Value Creation Mark Crossley, Chief Executive Officer Capital Markets Day — December 7, 2022
Slide 7: Context for Today's Meeting
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Context for Today’s Meeting Introduce our Focused on a clear path Why we are confident senior leadership team for value creation in the future Capital Markets Day — December 7, 2022 7
Slide 8: An Unwavering Focus on Patients Drives our Business
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION An Unwavering Focus on Patients Drives our Business Capital Markets Day — December 7, 2022 8
Slide 9: Addiction is a Global Crisis
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Addiction is a Global Crisis Opioids Cannabis Alcohol Amphetamines 61m people use opioids 209m users 108m people with & Cocaine for non-medical purposes Alcohol Use Disorder 56m users Source: UNODC, World Drug Report 2022 (United Nations
Slide 10: US Overdose Deaths Continue at High Rates
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION US Overdose Deaths Continue at High Rates 12 Month-ending Reported Number 102.8k of Drug Overdose Deaths by Drug or Drug Class (June 2022 CDC) June 2019 – June 2022 +52% Reported Total 100,570 102,842 Overdose Deaths annual overdose +64%
Slide 11: We Are Focused on a Better Future for Patients
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION We Are Focused on a Better Future for Patients Purpose To pioneer life-transforming treatments Vision That the millions of people across the globe suffering from substance use disorders and serious mental illness have access to evidence-b
Slide 12: Indivior is the Global Leader in Addiction Treatment
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Indivior is the Global Leader in Addiction Treatment Net Revenue by Geography Net Revenue by Product TTM1 (through Q3 2022) TTM1 (through Q3 2022) $XXXm $1,035m 3% CASH2 &CASH INVESTMENTS 20% 38% $882m ~XXX ~900 41% $882m EMPLOYEES EMPLOY
Slide 13: Expanded Board & Leadership with Deep Pharma Experience
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Expanded Board & Leadership with Deep Pharma Experience and Value Creation Record Graham Hetherington CHAIR NEW DIRECTORS ADDED SINCE 2021 Peter Bains Mark Crossley Thomas Lorna Parker Daniel J. Phelan Ryan Preblick Jerome Lande Jo LeCoui
Slide 14: Our Strategic Priorities to Drive Value Creation
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Our Strategic Priorities to Drive Value Creation ONE TWO THREE FOUR Grow Diversify Build & Optimize SUBLOCADE® Revenue Progress Operating >$1.5 bn1 Pipeline Model 1. Potential annual Net Revenue Capital Markets Day — December 7, 2022 14
Slide 15: Expecting Double-Digit % NR CAGR Over the Medium-term
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Expecting Double-Digit % NR CAGR Over the Medium-term1 Total Net Revenue (NR$ in USD millions) Key Drivers: Double-digit % NR CAGR • SUBLOCADE® >$1.5 bn potential annual NR – expected to reach $1 bn NR run-rate by the end of 2025 • PERSER
Slide 16: Medium-term Profitable Growth Framework
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Medium-term Profitable Growth Framework Attractive Growth Positive Operating Strengthening Profile Leverage Cash Flow Capital Markets Day — December 7, 2022 16
Slide 17: Capital Allocation Priorities
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Capital Allocation Priorities Reinvest Maintain Diversify Returns to in growth financial the business shareholders (current flexibility products) and meet obligations Capital Markets Day — December 7, 2022 17
Slide 18: Opiant: Compelling Strategic & Financial Rationale
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Opiant: Compelling Strategic & Financial Rationale Strategic Rationale Financial Rationale Expands Leadership in Addiction OPNT003 Potential Annual NR of $150m to $250m Treatment and Science Provides a Near-in Attractive Growth Avenue Att
Slide 19: A Leading Addiction Treatment and Science Platform Upon Closing
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION A Leading Addiction Treatment and Science Platform Upon Closing Leading Addiction Treatments Across the Proven Addiction-Focused Commercial Strong Addiction Science, Continuum of Care Capabilities Development & Advocacy (Commercialized &
Slide 20: Running a Responsible Business
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Running a Responsible Business Why? Our vision is that the millions of people across the globe suffering from substance use disorders The Indivior vision and serious mental illness have access to evidence-based treatment to change lives.
Slide 21: What You Will Better Understand Today
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION What You Will Better Understand Today – Visible Growth, Pioneering Science & Cash Generation We are the global leader in SUBLOCADE® is a transformational addiction treatment asset with >$1.5 bn global opportunity1 We are pursuing diversif
Slide 22: Today's Speakers
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Today’s Speakers Mark Crossley Richard Simkin Vishal Kalia Dr. Terry Horton CHIEF EXECUTIVE OFFICER CHIEF COMMERCIAL SVP, US COMMERCIAL ACCESS VP, PATIENT INSIGHTS & STRATEGY OFFICER Glenn Tyson Dr. Christian Heidbreder Nina DeLorenzo Rya
Slide 23: SUBLOCADE: Unlocking >$1.5 bn Potential Annual NR Opportunity
SUBLOCADE® Unlocking >$1.5 bn Potential Annual NR Opportunity Richard Simkin, Chief Commercial Officer Vishal Kalia, Senior Vice President, US Commercial Access Dr. Terry Horton, Vice President, Patient Insights and Advocacy Capital Markets Day — December 7, 2022
Slide 24: Unlocking >$1.5 bn Potential Annual NR Opportunity
SUBLOCADE® Unlocking >$1.5 bn Potential Annual NR Opportunity 1. Global Footprint 2. US Opioid Use Disorder (OUD) Market 3. Four Accelerators of SUBLOCADE® Expected Growth 4. SUBLOCADE® Potential 5. View From The Front-Line – Hosted Q&A with Dr. William Santoro, MD Capital Markets Day — December 7,
Slide 25: Global Footprint
1. Global Footprint Capital Markets Day — December 7, 2022
Slide 26: Indivior is the Global Leader in Addiction
SUBLOCADE® Indivior is the Global Leader in Addiction Strengthening our position Continuing to expand our Unique product pipeline expected in the US behind SUBLOCADE® footprint across Rest of World to address broader addiction types Capital Markets Day — December 7, 2022 26
Slide 27: The US is our Highest Value at Stake Market
SUBLOCADE® The US is our Highest Value at Stake Market North America has the Highest Prevalence of USA Opioid Misuse in the World1 - % of adult population - Market Dynamics: 4% 3.37 • Liberal prescribing of opioids • Less than 1 in 52 receiving BMAT3 2.29 2.44 80% treatment 2% 1.76 • Recovery model
Slide 28: US OUD Market
2. US OUD Market Capital Markets Day — December 7, 2022
Slide 29: A Significant Treatment Gap Exists in the US Today
SUBLOCADE® A Significant Treatment Gap Exists in the US Today Range of Estimates Across Key Patient Metrics 9.5m3 10.1 m1 12.0m6 Misuse opioids in US (Total Addressable Market) 2.7m4 3.5m7 3.1m 2 OUD diagnosed in US (Service Addressable Market) 1.1m5 2.4m2 1.8 m2 Patients treated with BMAT last 12 m
Slide 30: Patient Risk Increased with Synthetic Opioids
SUBLOCADE® Patient Risk Increased with Synthetic Opioids – 89% of Opioid Overdose Deaths Involved Synthetics2 US Overdose Deaths Accelerated1 June 2019 – June 2022 100,570 102,842 +52% Reported Total Overdose Deaths 82,916 +64% Reported Opioid 75,448 77,487 Overdose Deaths 69,153 68,714 67,787 69,15
Slide 31: Treatment Capacity Continues to Grow in Response to Opioid Epidemic
SUBLOCADE® Treatment Capacity Continues to Grow in Response to the US Opioid Epidemic HCP Certifications1 Waivered Prescribing HCPs1 (cumulative certifications in thousands) (in thousands) 120 120 100 100 80 80 60 60 40 40 48.6 20 41.0 47% 20 28.9 0 16.6 43% 0 2016 2018 2020 2021 • 2017 includes 4,5
Slide 32: Favorable Trends are Increasing Treatment Access
SUBLOCADE® Favorable Trends are Increasing Treatment Access and Lowering Treatment Barriers Increased Funds2 Elevated CJS Record $6.1bn in FY22 funding Focus5 Expected cascade of US DOJ has $’s from Opioid issued settlements guidance to CJS on OUD President's Unity Agenda1 treatment for Policy
Slide 33: Structural Dynamics Expected to Expand the Market through 2030
SUBLOCADE® Structural Dynamics and Underlying Growth Trends are Expected to Expand the Market through the End of this Decade BMAT Market Growth Increased Number of Patients in Treatment Sustained mid- ~2.8m1 to high-single by 2030 digits BMAT = buprenorphine medication-assisted treatment (1): See so
Slide 34: Four Accelerators of SUBLOCADE Expected Growth
3. Four Accelerators of SUBLOCADE®’s Expected Growth to >$1.5 bn Potential Annual NR Opportunity Capital Markets Day — December 7, 2022
Slide 35: Delivered Nine Quarters of Strong Sequential Net Revenue Growth
SUBLOCADE® Delivered Nine Quarters of Strong Sequential Net Revenue Growth $108 Total SUBLOCADE® $100 $98 Net Revenue ($m) $85 $75 $75 $65 $61 $50 $43 Net Revenue $39 $33 $29 $25 $0 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Capital Markets Day — December 7, 2022 35
Slide 36: Four Key Accelerators of SUBLOCADE Growth
SUBLOCADE® Four Key Accelerators of SUBLOCADE®’s Growth to >$1.5 bn Potential Annual NR Opportunity 1 2 3 4 Transformational Accelerate Adoption in Expand Access to Enabling Infrastructure Product & Science Organized Health Treatment in the Systems (OHS) Criminal Justice System (CJS) Capital Markets
Slide 37: SUBLOCADE is a Paradigm Shift in Treatment
SUBLOCADE® SUBLOCADE® is a Paradigm Shift in Treatment 1 • SUBLOCADE® is the first buprenorphine-based long-acting injectable approved by U.S. FDA for the treatment of moderate to severe OUD • Rationally designed to deliver therapeutic levels of buprenorphine of ≥2 ng/mL over the entire monthly dosi
Slide 38: SUBLOCADE may Help Patients to Reshape their Lives
SUBLOCADE® SUBLOCADE® may Help Patients to Reshape their Lives – Patient & Provider Quotes1 ‘It saves me time and reduces the potential for me to take too much. Much ‘Every 28 days it helps to get back to a lifestyle without drugs. It less chance of misuse. Gives me peace of mind—less to worry helps
Slide 39: OHS Provides Care for the Majority of OUD Patients
SUBLOCADE® OHS Provides Care for the Majority of OUD Patients – SUBLOCADE® is Well Positioned Core Integrated Delivery Federal Health Organized Criminal Justice Prescribers Networks Systems Customers System ~3.0m Potential ~0.6m Patients2 ~1.2m Patients2 ~160k Patients2 ~1.0m Patients2 ~1.2m Patient
Slide 40: Established an Effective Ecosystem Model
SUBLOCADE® Established an Effective Ecosystem Model • Multiple and different healthcare settings serving OUD patients – majority of these interlinked • Each system has unique unmet needs and a different decision matrix and requires a distinct approach • In response, we have: - Deployed unique organi
Slide 41: OHS is the Main Growth Driver of SUBLOCADE
SUBLOCADE® OHS is the Main Growth Driver of SUBLOCADE® - Accelerating Depth of Adoption via Three Levers ✓ Three Levers of Depth Achieved access to 500+ priority OHS parents 1. OHS Facilities Activation • Translate access at HQ levels to activate the facilities • ~10-16k1 facilities 2. OHS HCPs Adop
Slide 42: Continued Progress Across the Three Levers
SUBLOCADE® Continued Progress Across the Three Levers OHS Potential Accessed(1) s OHS Prescribing Patients Facilities HCPs in OHS in OHS 1. Internal Indivior estimate Capital Markets Day — December 7, 2022 42
Slide 43: Bringing it to Life – Real World OHS Examples
SUBLOCADE® Bringing it to Life – Real World OHS Examples MAJOR NATIONAL OHS MAJOR REGIONAL 1. Internal Indivior estimate OHS Capital Markets Day — December 7, 2022 43
Slide 44: Criminal Justice System – Turning the Front Door into a Step to Recovery
SUBLOCADE® Criminal Justice System (CJS) – Turning the “Front Door” to Opioid Addiction Into a Step on the Path to Recovery Our ambition is to enable access to SUBLOCADE® in all care points within CJS Ecosystem THE “FRONT DOOR” TO ADDICTION IMPETUS TO TREATMENT EXPANSION >60% SUD patients touch crim
Slide 45: CJS is Complex and Multi-Faceted
SUBLOCADE® CJS is Complex and Multi-Faceted Transition to Community Care is Vital Overview of CJS for Patients with OUD Parole Jail/Prison (State & Federal & County & Local) Release Community Care Drug Court Probation Recidivism is a key issue within the CJS, in some states these numbers go up to 80
Slide 46: SUBLOCADE Potential by Expanding Access to Treatment
SUBLOCADE® SUBLOCADE® Potential by Expanding Access to Treatment Two Levers of CJS Potential 1. CJS Facilities • Enabling access for patients involved in the justice system • ~8k-12k Facilities1 Entry to CJS 2. OUD Patients • Enabling continuum of care for patients – behind and outside the walls • ~
Slide 47: Encouraging Start to Expanding Access in CJS
SUBLOCADE® Encouraging Start to Expanding Access in CJS – Significant Potential Ahead CJS Potential Accessed(1) Entry to CJS 1. Internal Indivior estimate Capital Markets Day — December 7, 2022 Potential patient share ~<1% 47
Slide 48: Robust Patient-Focused Treatment Infrastructure
SUBLOCADE® Established a Robust Patient-Focused Treatment Infrastructure Based on In-Depth Understanding Access to Treatment • High quality MANAGED CARE coverage • Enabling access to treatment through COMMERCIAL COPAY ASSISTANCE Continuum of Care • Providing information on federal and state OUD gran
Slide 49: In Summary…
SUBLOCADE® In Summary… 1 2 3 4 Transformational Accelerate Adoption in Expand Access to Enabling Infrastructure Product & Science Organized Health Treatment in the Systems (OHS) Criminal Justice System (CJS) Capital Markets Day — December 7, 2022 49
Slide 50: SUBLOCADE Potential
4. SUBLOCADE® Potential
Slide 51: Achieving ~12% of OHS and ~4% of CJS Patient Share
SUBLOCADE® Achieving ~12% of OHS* and ~4% of CJS Patient Share Opportunity Leads to Potential >$1.5bn NR (total patient share ~10%) * ** *Excluding CJS **Including OHS, CJS and Core Prescribers Capital Markets Day — December 7, 2022 51
Slide 52: Strategy Execution Enables SUBLOCADE Goal >$1.5 bn
SUBLOCADE® Strategy Execution Enables SUBLOCADE® Goal to Increase to >$1.5 bn Potential Annual NR Opportunity 10.1m 3.1m ~270,000 Misuse opioids in US 1 OUD diagnosed in US 2 Target SUBLOCADE® patients Market growth • Sustained U.S. market growth: mid - high single digits HCPs & patients • Penetrati
Slide 53: View From The Front-Line: Q&A with Dr. William Santoro
5. View From The Front-Line Hosted Q&A with Dr. William Santoro, MD Capital Markets Day — December 7, 2022
Slide 54: Dr. William Santoro, M.D.
CAPITAL MARKETS DAY Dr. William Santoro, M.D. • Section Chief of Addiction Medicine at Tower Health, a regional health system in Pennsylvania, since its inception in 2014. • Treatment provider to Berks County jail system in Pennsylvania. • Board Certified in Addiction Medicine since 1989. Our • Curr
Slide 55: Summary – SUBLOCADE >$1.5 bn Potential Annual NR Opportunity
Summary – SUBLOCADE® >$1.5 bn Potential Annual NR Opportunity
Slide 56: Reasons to Believe in SUBLOCADE >$1.5 bn Potential
SUBLOCADE® In Summary – Reasons to Believe in SUBLOCADE® >$1.5 bn Potential Annual NR Opportunity Favorable Market Dynamics • Funnel expansion, legislative momentum, increasing funding Bound by our unique patient centric culture – Product Delivering on Patient Needs • Built on scientific foundation
Slide 57: PERSERIS: Significant Opportunity to Differentiate in Schizophrenia
PERSERIS® Significant Opportunity to Differentiate in Schizophrenia Glenn Tyson, Senior Vice President, Sales & Marketing Capital Markets Day — December 7, 2022
Slide 58: PERSERIS Path to $200m – $300m Potential Annual Net Revenue
PERSERIS® PERSERIS® Path to $200m – $300m Potential Annual Net Revenue is Clear 1. Attractive, dynamic growing market 2. Leverage differentiated profile 3. Executional excellence Capital Markets Day — December 7, 2022 58
Slide 59: Attractive, dynamic growing market
1. Attractive, dynamic growing market
Slide 60: US LAI Antipsychotic Market Fueled by New Product Launches
PERSERIS® US Long-acting Injectable (LAI) Antipsychotic Market Fueled by New Product Launches and More Patients Moving to LAIs ($ in M) Net Revenue INVEGA HAFYERA™ 11/2021 4,500 PERSERIS® 4,000 2/2019 ARISTADA® INITIO® 3,500 6/2018 3,000 ARISTADA® Two-Month 6/2017 2,500 ARISTADA® 10/2015 2,000 INVEG
Slide 61: LAI Market is Divided: Risperidone/Paliperidone and Aripiprazole
PERSERIS® LAI Market is Divided: Risperidone/ Paliperidone and Aripiprazole PERSERIS® is well positioned in the largest segment and with optimal 1-month dosing Antipsychotic LAI Market1 1-month LAIs continue Risperidone/Paliperidone Patient Aripiprazole Patient to dominate market as (68% of LAI Rx)
Slide 62: Schizophrenia is a Lifelong Disease
PERSERIS® Schizophrenia is a Lifelong Disease Marked by Periods of Stability and Decompensation that Negatively Impact Cognitive Function Clear advantage to a product that can achieve clinically relevant levels on day one Mild Symptoms, Level of Functioning1 Premorbid Prodromal Progressive Residual
Slide 63: LAI Market is Highly Dynamic, HCPs Likely to Switch Treatments
PERSERIS® Antipsychotic LAI Market is Highly Dynamic, with HCPs Citing Significant Likelihood of Switching Treatments over Next 6 Months Likelihood to Switch Treatment in Next 6 Months (% of patient charts) Reasons for considering a treatment change are generally for one of the 38% 24% 21% 17% follo
Slide 64: LAI Market is Dynamic with Patients on Orals and Switching
PERSERIS® LAI Market is Dynamic with Patients on Orals and Switching from Other LAIs; PERSERIS® is Sourcing Growth from Both LAI market driven by large 36% of PERSERIS® patients come New-to-brand share 2.5X higher than percentage of new Rx1 from other LAIs2 average NRx share; users share strong and
Slide 65: Leverage differentiated profile
2. Leverage differentiated profile Capital Markets Day — December 7, 2022
Slide 66: Compelling Value Proposition Supports Belief in PERSERIS Potential
PERSERIS® Compelling Value Proposition Supports Belief in PERSERIS® Potential When There’s No Time to Waste, It’s Time for PERSERIS® Achieves optimal therapeutic plasma concentration (delivers 60-80% D2RO) KEY CHARACTERISTICS • First-in-market risperidone-containing LAI* for subcutaneous administra
Slide 67: Differentiated PK Profile Provides Unique Benefits
PERSERIS® Differentiated PK Profile Provides Unique Benefits – No Supplemental Oral Doses or Loading Doses Recommended Total active moiety concentrations reach clinically relevant levels after the first injection Capital Markets Day — December 7, 2022 67
Slide 68: PERSERIS Meets Key LAI Initiation Needs
PERSERIS® PERSERIS® Meets Key LAI Initiation Needs Not Delivered by Any Other Product LAI Attitude Agreement (% top 2 box) 68% 68% 53% It is critical to quickly achieve Simplifying the LAI initiation The need for oral peak plasma concentrations process could lead to better supplementation for some o
Slide 69: Differentiated Messages are Most Motivating Aspects
PERSERIS® Differentiated Messages1 are Seen as the Most Motivating Aspects of the Product Profile and Drive Intent to Prescribe Most Motivating Aspects2 of Product Profile After reviewing the core product presentation, vast majority (Ranked 1, 2, or 3) of HCPs were somewhat/very/extremely Likely to
Slide 70: Executional excellence
3. Executional excellence Capital Markets Day — December 7, 2022
Slide 71: Expanded Commercial Capacity to Penetrate Broader LAI Customer Base
PERSERIS® Expanded Commercial Capacity Designed to Drive Penetration Into Broader Base of LAI Customers LAI Market Coverage FROM TO 40% ~70% Expanded Targeted National PERSERIS® Volume Coverage Product Regional Team FROM TO Approval Launch ▼ 47% 80% ▼ ▼ 2018 2019 2020 2021 2022 Quarterly Unit Volume
Slide 72: Call Platform Built Around HCPs with Highest Likelihood to Prescribe
PERSERIS® Call Platform Built Around HCPs with Highest Likelihood to Prescribe and by Understanding Patient Journey Through Ecosystem Post-COVID restrictions continue to improve; expanded team now optimizing reach and frequency ★ Multiple points throughout treatment ecosystem where patients are in n
Slide 73: Momentum Built with Strong Field Efforts
PERSERIS® Momentum has Built with Strong Field Efforts to Deliver High-Quality Customer Engagement, Differentiation and Conversion Average minutes % of calls with compelling close Primary message differentiates Primary message per detail & commitment to action product positively relevant to patient
Slide 74: Schizophrenia Patient Funnel
PERSERIS® Schizophrenia Patient Funnel – Continued Significant Opportunity for LAI Penetration Patients with Schizophrenia ~2,800,000 2,800,000 1 Continued significant Patients in Treatment 2,300,000 opportunity for LAI penetration Patients on LAIs 300k (1) www.treatmentadvocacycenter.org (2) ncbi.n
Slide 75: Confident in Delivering $200m to $300m Potential Annual NR Goal
PERSERIS® Confident in Delivering $200m to $300m Potential Annual NR Goal Team leveraging top 5 drivers of prescribing Building Blocks to $200m – $300m Potential Annual NR HCPs Writing Rx per HCP (annual) 1. Short time to establishment of peak plasma concentrations 6,000 5,500 40 36 30 4,000 Duratio
Slide 76: Summary
Summary Capital Markets Day — December 7, 2022
Slide 77: PERSERIS Represents an Attractive Long-Term Growth Opportunity
PERSERIS® PERSERIS® Represents an Attractive Long-Term Growth Opportunity Meaningfully differentiated, PERSERIS® is becoming an important option in the LAI market Growing Branded PERSERIS®’ Commercial Path to Achieving Peak Market Differentiation Excellence Sales Objective is Clear • 15% CAGR for en
Slide 78: R&D Pipeline
R&D Pipeline Strategic Innovation to Fuel Future Growth Dr. Christian Heidbreder, Chief Science Officer Capital Markets Day — December 7, 2022
Slide 79: Pioneering the Science of Addiction Medicine
R&D PIPELINE Pioneering the Science of Addiction Medicine 1. Indivior R&D 2. SUBLOCADE® 3. PERSERIS® 4. Pipeline 5. Future Prospects Capital Markets Day — December 7, 2022 79
Slide 80: Indivior R&D
1. Indivior R&D Capital Markets Day — December 7, 2022
Slide 81: A Dedicated & Experienced Team Globally
R&D PIPELINE A Dedicated & Experienced Team Globally Main Hubs in Richmond, VA & Fort Collins, CO (USA); Hull & Slough (United Kingdom) R&D: Research & Development GMAS: Global Medical Affairs & Safety 18 31 35 108 40 79 4 Employees Employees 4 7 13 35 ◼ Chemistry, Manufacturing & Controls (CMC) | ◼
Slide 82: Longstanding Innovation Leadership in Addiction Medicine
R&D PIPELINE Longstanding Innovation Leadership in Addiction Medicine Discovery and first synthesis of Proprietary Mechanism buprenorphine at the Reckitt & Colman (R&C) labs based in Kingston upon Hull, UK 1966 • Label updates/extension • Pipeline growth in addiction • Collaboration studies • Real W
Slide 83: Philosophy & Vision
R&D PIPELINE Philosophy & Vision OUR PHILOSOPHY: OUR VISION: Opioid Use Disorder (OUD) is a Pioneer drug discovery & development treatable chronic brain disease in addiction medicine • FDA-approved medications to treat OUD • Transform world-class science into life-changing medications for (MOUD) are
Slide 84: Strategic Focus
R&D PIPELINE Strategic Focus OPIOIDS: 61 million people used opioids for non-medical purposes in 2020, corresponding to 1.2% of the global population. The number of users worldwide has nearly doubled over the past decade CANNABIS: 209 million people used cannabis in 2020 representing 4% of the Indiv
Slide 85: Current Pipeline
R&D PIPELINE Current Pipeline REGULATORY COMMERCIAL LIFECYCLE MGMT BRAND/PRODUCT NAME PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVAL LAUNCH STUDIES SUBUTEX® (buprenorphine) sublingual (SL) Tablets SUBOXONE® (buprenorphine and naloxone) SL Tablets SUBOXONE® (buprenorphine and naloxone) SL Film SUBLOCAD
Slide 86: SUBLOCADE
2. SUBLOCADE ® Capital Markets Day — December 7, 2022
Slide 87: Buprenorphine & Mu-opioid Receptor Affinity
R&D PIPELINE Buprenorphine & Mu-opioid Receptor Affinity • Very high binding affinity (a low Ki value) compared with that of other opioid ligands • High binding affinity and slow dissociation at the µ-opioid receptor result in less receptor availability for full µ- opioid receptor agonist opioids So
Slide 88: SUBLOCADE Scientific Foundation
R&D PIPELINE SUBLOCADE® Scientific Foundation Relationship Between Plasma Concentrations of Buprenorphine & μ-opioid Receptor Occupancy in the Brain 100 90 Buprenorphine plasma concentrations > 2 ng/mL 80 = >70% brain μORs are occupied μ-Opioid Receptor Occupancy (%) 70 = less μORs are available for
Slide 89: From Science to SUBLOCADE Clinical Efficacy & Safety
R&D PIPELINE From Science to SUBLOCADE® Clinical Efficacy & Safety SUBLOCADE®’s Pharmacokinetics Profile Translates Into Clinical Efficacy, Safety & Positive Patient-Centered Outcomes Blockade of hydromorphone effects 6-month clinical efficacy & safety 12-month clinical efficacy & safety Patient-Cen
Slide 90: Breaking Barriers to Treatment Access
R&D PIPELINE Breaking Barriers to Treatment Access Building the Largest Evidence-based Understanding of MOUD Adherence & Label updates (N=4) long-term recovery Collaborations (N=4) Veterans Patients at high Externally Sponsored Studies (ESS) (N=11) Health risk of opioid Administration overdose Break
Slide 91: Adherence & Long-term Recovery
R&D PIPELINE Adherence & Long-term Recovery Understanding the Long-term Outcomes of Treatment & the Journey Toward Recovery SUBLOCADE® treatment was associated with: • High levels of abstinence from opioids: 74.1% in the past 7 days and 60% in the past 30 days. • Lower odds of opioid misuse associat
Slide 92: Patients at High risk of Opioid Overdose
R&D PIPELINE Patients at High risk of Opioid Overdose Pharmacodynamic Interaction of Buprenorphine with Fentanyl in Opioid-Tolerant Subjects Source: Moss LM et al. (2022) PLoS ONE 17(1): e0256752. https://doi.org/10.1371/journal.pone.0256752 ; Olofsen E. et al. (2022) JCI Insight; 7(9):e156973. http
Slide 93: Patients at High risk of Opioid Overdose
R&D PIPELINE Patients at High risk of Opioid Overdose Distribution of Reported Non-fatal Overdose Events by Treatment Cohort in Canada 20 12 • Retrospective chart review of patients with OUD who had initiated 10.7 18 OAT with nine clinics in Canada (British Columbia [BC], Ontario 10 16 [ON]) during
Slide 94: Criminal Justice System
R&D PIPELINE Criminal Justice System SUBLOCADE® May Be a Useful OUD Treatment Option Before and After Release from Jail SUBLOCADE % SLB % 80 69 58 55.4 60 40 SUBLOCADE® Treatment: 35 35 38.5 15 • Positively impacted interactions with peers and CJS staff and quality of life during and 20 8 post-incar
Slide 95: Veterans Health Administration (VHA)
R&D PIPELINE Veterans Health Administration (VHA) SUBLOCADE® for Treatment-resistant Veterans with Medical & Psychosocial Comorbidities Study by VHA in 26 clinically complex patients at high risk for hospitalization and mortality An ongoing large-scale 52-week, 20-site, parallel group, open-label, •
Slide 96: PERSERIS
3. PERSERIS® Capital Markets Day — December 7, 2022
Slide 97: PERSERIS Scientific Foundation
R&D PIPELINE PERSERIS® Scientific Foundation From Science to Clinical Outcomes PERSERIS® delivers plasma concentrations of risperidone that Continued improvement in schizophrenia symptoms approach steady-state levels after the first subcutaneous injection following 12 months of exposure to PERSERIS®
Slide 98: Pipeline
4. Pipeline Capital Markets Day — December 7, 2022
Slide 99: AEF0117: Cannabis Use Disorder
Section 4: Pipeline AEF0117 : Cannabis * Use Disorder Selective Cannabinoid-1 Signaling Specific Inhibitors (CB1-SSI) *Aelis Farma (Indivior has exclusive license to this technology) Capital Markets Day — December 7, 2022
Slide 100: 209 Million People Worldwide Used Cannabis in 2020
R&D PIPELINE 209 Million People Worldwide Used Cannabis in 2020 The Number of Past-Year Cannabis Used Has Increased by 23% Over the Past Decade 49.6 million past-year US cannabis users among people aged 12> 14.2 million had CUD in the past year Presentation Treatment Maintenance Normalization of Use
Slide 101: CB1 Receptor Stimulation by THC Increases Brain Pregnenolone
R&D PIPELINE CB1 Receptor Stimulation by THC Increases Brain Pregnenolone AEF0117 Is the First Synthetic CB1 Signaling-specific Negative Allosteric Modulator Breakthrough science Challenge Solution: AEF0117 By binding a specific allosteric CB1 site, Pregnenolone (PREG) PREG is not a druggable compou
Slide 102: AEF0117: Phase 2A Results in Subjects with Cannabis Use Disorder
R&D PIPELINE AEF0117: Phase 2A Results in Subjects* with Cannabis Use Disorder AEF0117 Reduced the Subjective Effects of Cannabis & Cannabis Self-administration 80 90 70 80 VAS Score VAS Score 60 70 50 60 40 50 30 40 20 40 60 90 105 20 40 60 90 105 Time after cannabis (min) Placebo AEF0117 - 0.06 mg
Slide 103: AEF0117: Development Roadmap
R&D PIPELINE AEF0117: Development Roadmap Design: Phase 2b, randomized, Promising clinical Phase 1 double-blind, placebo-controlled, 4- and Phase 2A safety, tolerability, and efficacy arm, parallel-group, prospective, signals for the treatment multicenter study in treatment- of CUD WE seeking subjec
Slide 104: INDV-2000: Opioid Use Disorder
Section 4: Pipeline INDV-2000: Opioid Use Disorder Selective Orexin-1 (OX1) Receptor Antagonist 104 Capital Markets Day — December 7, 2022
Slide 105: INDV-2000: Development Roadmap of a Non-opioid Medication for OUD
R&D PIPELINE INDV-2000: Development Roadmap of a Non-opioid Medication for OUD 2019 2020-2021 2022-2023 $10.6M NIH HEAL (Helping to End Addiction Clinical Phase 1 Single Ascending Clinical Phase 1 Multiple Long-term) Initiative Grant Dose (SAD) study Ascending Dose (MAD) study Grant enables nonclini
Slide 106: INDV-1000: Alcohol Use Disorder
Section 4: Pipeline INDV-1000: Alcohol Use Disorder Selective GABA-B Positive Allosteric Modulator 106 Capital Markets Day — December 7, 2022
Slide 107: INDV-1000: Innovative Approach–GABA-B Positive Allosteric Modulator
R&D PIPELINE INDV-1000: Innovative Approach–GABA-B Positive Allosteric Modulator • Baclofen (Lioresal) approved for spasticity in 1982 From lead optimization to candidate selection • Orthosteric GABA-B agonist • Multiple generic versions • Off-label use for alcohol detoxification and treatment • A p
Slide 108: Future Prospects
5. Future Prospects Capital Markets Day — December 7, 2022
Slide 109: Strategic Framework for Balanced Pipeline Growth
R&D PIPELINE Strategic Framework for Balanced Pipeline Growth Identifying Key receptor Systems & Potential Drug Targets in Large-scale Neural Networks Mapping asset-based opportunities Basal Ganglia in addiction medicine Brain circuits involved in incentive salience (increased motivation to seek the
Slide 110: ESG and Sustainability
ESG and Sustainability How we Deliver Matters Nina DeLorenzo, Chief Impact Officer Capital Markets Day — December 7, 2022
Slide 111: ESG and Sustainability at Indivior
ESG AND SUSTAINABILITY ESG and Sustainability at Indivior Maximize Indivior’s positive global impact and shareholder value through our mission of making innovative treatments for substance use disorders and serious mental illness Meet our Transform Prioritize Conduct business Provide our environment
Slide 112: Our Sustainability Progress & Upcoming Priorities
ESG AND SUSTAINABILITY Our Sustainability Progress & Upcoming Priorities Progress MARCH ONGOING JULY Established global baseline Evolved and sustained our Certified “Great Place to data for scope 1 + 2 integrity and compliance Work” with 88%1 employee emissions for UK operations program approval AUG
Slide 113: Operational Excellence
Operational Excellence A Strong and Scalable Business Model Ryan Preblick, Chief Financial Officer Capital Markets Day — December 7, 2022
Slide 114: Key Takeaways
OPERATIONAL EXCELLENCE Key Takeaways Attractive growth Scalable business Strategic Priorities Strong cash generation profile model are well funded allows flexibility in capital allocation Capital Markets Day — December 7, 2022 114
Slide 115: New Products Powering Profitable Growth
OPERATIONAL EXCELLENCE New Products Powering Profitable Growth Net Revenue Revenue Mix (2020 vs. TTM1) $1,000 $882 $791 Global SUBLOCADE® Sublingual Film (U.S.) (Not promoted) $800 $647 PERSERIS® Sublingual film/Tablets (Rest of World) $600 $400 2020 TTM $200 $0 FY2020 2020 FY2021 2021 2022 TTM 1 3%
Slide 116: Scalable Business Model Expected to Generate Margin Expansion
OPERATIONAL EXCELLENCE Scalable Business Model Expected to Generate Margin Expansion $250 $224 50% $200 $202 $192 30% • Structural growth investments to support SUBLOCADE® OHS strategy and expand PERSERIS® $150 31% 24% 25% Selling & nationally Commercial $100 10% $50 • Disciplined and tactical comme
Slide 117: Ability to Reinvest Profits for Growth, Meet Obligations, and Return Value
OPERATIONAL EXCELLENCE Ability to Reinvest Profits for Growth, Meet Obligations, and Return Value to Shareholders $250 $216 $205 $200 $200 $165 $150 The Group is growing EBITDA and generating cash from operations Improving Adjusted $105 $100 EBITDA1 Profile $50 ($148) $0 Reported Net Income -$50 TTM
Slide 118: Capital Allocation Focused on Growth and Shareholder Returns
OPERATIONAL EXCELLENCE Capital Allocation Focused on Growth and Shareholder Returns Financial flexibility to deliver growth objectives and meet obligations SG&A • Investments to optimize SUBLOCADE® • Diversify through PERSERIS® and (Commercial execution, patient access) penetration and access in Org
Slide 119: Leading to Attractive Medium-Term Profile
OPERATIONAL EXCELLENCE Leading to Attractive Medium-Term Profile Attractive Positive Anticipated Growth Operating Strengthening Profile Leverage Cash Flow Expected Double-digit % NR CAGR Gross margin mid-80%s Capital-light business model • SUBLOCADE® building to >$1.5 bn potential annual NR Scalable
Slide 120: US Listing Update
OPERATIONAL EXCELLENCE US Listing Update Considerations Timeline Announce – Exploring Strong shareholder support – September 2022 Extraordinary General additional listing Meeting (EGM) Shareholder consultations NASDAQ chosen to be US listing venue Shareholder vote Preparation – GAAP, SOX, Governance
Slide 121: Summary
OPERATIONAL EXCELLENCE Summary Attractive Scalable growth profile business model Strategic Priorities Free cash generation allows are well funded flexibility in capital allocation Capital Markets Day — December 7, 2022 121
Slide 122: Closing Remarks and Q&A
Closing Remarks and Q&A Capital Markets Day — December 7, 2022
Slide 123: Confident in our Ability to Create Value
CLOSING REMARKS AND Q&A Confident in our Ability to Create Value We are the global leader SUBLOCADE® is a transformational in addiction treatment asset with >$1.5 bn global opportunity1 We are pursuing diversification opportunities We will maintain our operational excellence in addiction & its comor
Slide 124: SUBLOCADE Indication and Highlighted Safety Information
SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use (CIII) INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment
Slide 125: PERSERIS Indication and Safety Information
PERSERIS® (risperidone) for extended-release injectable suspension INDICATION PERSERIS® (risperidone) is indicated for the treatment of schizophrenia in adults. WARNING: INCREASED MORTALITY IN ELDERY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning
Slide 126: SUBOXONE Film Indication and Safety Information
SUBOXONE® (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM (CIII) INDICATION AND USAGE SUBOXONE® Film is indicated for treatment of opioid dependence. SUBOXONE Film should be used as part of a complete treatment plan that includes counseling and psychosocial support HIGHLIGHTED SAFETY INFORMATION Prescr
Slide 127: Appendix
APPENDIX _A INDIVIOR
Slide 128: Biographies
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Biographies Mark was appointed Chief Executive Officer in June 2020. Mark was appointed to the Board and as Chief Financial Operations in February 2017. In July 2019, Mark took on additional responsibilities and was appointed Chief Financ
Slide 129: Biographies
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Biographies Terry is responsible for developing a deep understanding of patients’ needs and translating them into an actionable strategy to ensure that all patients have access to evidence-based treatment. Terry brings over three decades
Slide 130: Biographies
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Biographies Vishal Kalia is an internationally recognized senior executive with 20+ years global experience, delivered award-winning campaigns, launched multi-million-dollar brands, worked across the globe. He has been in Indivior since 2
Slide 131: Biographies
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Biographies Ryan was appointed Chief Financial Officer and Executive Director in November 2020, having served as Interim Financial Officer since June 2020. Ryan has been in a financial leadership capacity since joining Indivior in 2012 an
Slide 132: Financial Reconciliations
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Financial Reconciliations TTM 2022 2021 2020 Actual Actual Actual ($ in mil. at Actual FX ) Net Income / (loss) 165 205 -148 Net interest (expense) / income -19 -23 -17 Taxation -34 15 25 Operating Profit / (Loss) 218 213 -156 Adjustments
Slide 133: Financial Reconciliations
CAPITAL MARKETS DAY | POSITIONED FOR CONTINUED VALUE CREATION Financial Reconciliations TTM 2022 2021 2020 Actual Actual Actual ($ in mil. at Actual FX ) Net Income / (loss) 165 205 -148 Net interest (expense) / income -19 -23 -17 Taxation -34 15 25 Depreciation, Amortization and impairment -12 -13
Slide 134: Footnotes
Footnotes Footnote Page Source 1 29 Substance Abuse and Mental Health Services Admin. (SAMHSA) 2 29 Symphony Health and Indivior analytics 3 29 0_National_v9_ForPosting.pptx (live.com) 4 29 Opioid Use Disorder | Disease or Condition of the Week | CDC 5 29 Key Substance Use and Mental Health Indicato
Slide 135: Footnotes
Footnotes Footnote Page Source 1 32 Remarks of President Joe Biden – State of the Union Address As Prepared for Delivery | The White House 2 32 Congress of the United States. Consolidated Appropriations Act, 2022, P.L. 117-103, committee prints and joint explanatory statements. March 15, 2022. Text
Slide 136: Footnotes
Footnotes Footnote Page Source 1 33 Internal Indivior research 1 39 Symphony Health and Indivior analytics 2 39 Internal Indivior research (3rd party validated) 1 41 Internal Indivior research (3rd party validated) 1 44 drugfacts-criminal-justice.pdf (nih.gov) 2 44 Treating opioid use disorder and r
Slide 137: Disclaimer – Dr. Santoro Q&A
CAPITAL MARKETS DAY Disclaimer – Dr. Santoro Q&A Before we begin, I would like to please remind us all that Dr. Santoro is speaking of his own personal experiences in this program. We are sharing this information today to help deepen understanding of patients and their journey so that investors can