Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Q4 2023 Earnings Presentation
31 slides from Indivior Pharmaceuticals's earnings presentation, Feb 22, 2024
Slide 1: Q4 / FY 2023 Results
Q4 / FY 2023 Results February 22, 2024
Slide 2: Forward-looking Statements
Q4 / FY 2023 Results | February 22, 2024 Forward-looking Statements This presentation contains certain statements that are forward-looking. Forward-looking statements include, among other things, statements regarding the Indivior Group’s financial guidance including operating and profit margins for
Slide 3: Mark Crossley, Chief Executive Officer
Mark Crossley Chief Executive Officer
Slide 4: Agenda
Q4 / FY 2023 Results | February 22, 2024 Agenda Highlights & Strategic Update………………………………………........................................................Mark Crossley, CEO R&D & Pipeline Update……………………………………….............................................................................Christian Heidbreder
Slide 5: Key Messages and FY 2023 Financial Highlights
Q4 / FY 2023 Results | February 22, 2024 Key Messages ➔ Strong FY 2023 results – double-digit NR1 growth led by SUBLOCADE as well as adj. op. profit2 growth and margin expansion, including growth investments (Opiant, SUBLOCADE field expansion) ➔ Excellent progress against our strategic priorities to
Slide 6: Executing Well Against our Strategic Priorities
Q4 / FY 2023 Results | February 22, 2024 Executing Well Against our Strategic Priorities Grow SUBLOCADE >$1.5Bn Diversify Revenue ➔ FY 2023 SUBLOCADE NR +54% YoY driven by continued ➔ Acquisition and integration of Opiant OHS1 and CJS2 penetration ➔ 136,900* SUBLOCADE patients at the end of FY 2023
Slide 7: Business Fundamentals and Performance are Strong
Q4 / FY 2023 Results | February 22, 2024 Business Fundamentals and Performance are Strong Growing Unmet Need Enabling Backdrop Strong Performance Attractive Growth Platform Total NR ($ in mil.) 23% increase in worldwide $50 bil.+ in global opioid FY 23 $1,093m Drug use in the past decade settlement
Slide 8: Our Mission is More Important and Relevant than Ever
Q4 / FY 2023 Results | February 22, 2024 Our Mission is More Important and Relevant than Ever 12 Month-ending Predicted Number A Significant U.S. of Drug Overdose Deaths by Drug or Drug Class OUD Treatment Gap Remains (Dec. 2019 – Aug. 2023) Since 2019: 112,127 109,179 111,036 +55% Total Overdose De
Slide 9: SUBLOCADE: OHS Momentum Continues and Accelerating CJS Penetration
Q4 / FY 2023 Results | February 22, 2024 SUBLOCADE: OHS Momentum Continues – Increasing Prescriber Depth and Accelerating CJS Penetration Three Levers of Depth 1. OHS Facilities Activation OHS Key Metrics ◆ Translate access at HQ levels to activate the facilities ◆ ~10 - 16k1 facilities 2. OHS HCPs
Slide 10: U.S. SUBLOCADE Resourcing—ASOC, CJS, Medical
Q4 / FY 2023 Results | February 22, 2024 U.S. SUBLOCADE Resourcing—ASOC1, CJS, Medical Added field capabilities: U.S. Counties with One or More Alternative Sites of Care (~1,160 ASOCs across 20 states) +40 field force +8 CJS acct. directors +10 MSLs2 10 1 ASOC = alternate sites of care 2 MSL = medic
Slide 11: Diversifying Our Portfolio to Deliver Our Mission
Q4 / FY 2023 Results | February 22, 2024 Diversifying Our Portfolio to Deliver Our Mission (emergency treatment of known or (schizophrenia) suspected opioid overdose) Product profile uniquely suited for today’s Clinically relevant product profile: fentanyl (synthetic) overdose crisis ◆ Initial peak
Slide 12: Confident in Medium-term Performance: Double-Digit % NR CAGR & Margin Expansion
Q4 / FY 2023 Results | February 22, 2024 Confident in Medium-term Performance: Double-Digit % NR CAGR & Margin Expansion Total Net Revenue Key Top-line Drivers: (NR$ in USD millions) ◆ SUBLOCADE >$1.5 bn potential annual NR – expected to reach $1 bn NR run-rate by the end of 2025 FY 24 Guidance ◆ PE
Slide 13: R&D Update
R&D Update Christian Heidbreder, Ph.D. Chief Scientific Officer
Slide 14: Current Pipeline
Q4 / FY 2023 Results | February 22, 2024 Current Pipeline REGULATORY COMMERCIAL BRAND/PRODUCT NAME PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVAL LAUNCH SUBUTEX® (Opioid Use Disorder) (buprenorphine) sublingual (SL) Tablets SUBOXONE® (Opioid Use Disorder) (buprenorphine and naloxone) SL Tablets SUBOXO
Slide 15: Opioid Use Disorder / Opioid Overdose Rescue
OPIOID USE DISORDER OPIOID OVERDOSE RESCUE
Slide 16: Support SUBLOCADE & SUBUTEX Prolonged Release
Q4 / FY 2023 Results | February 22, 2024 Support SUBLOCADE® & SUBUTEX Prolonged Release® Label updates Evidence Product Access expansion Generation & optimization Publications Label Submissions Evidence generation: Oxygen absorber Geo-expansion Rapid induction & Phase 4 studies + long- desiccant (OA
Slide 17: Support OPVEE
Q4 / FY 2023 Results | February 22, 2024 Support OPVEE® − Biomedical Advanced Research and Development Authority (BARDA) alliance Fentanyl use continues to rise across the U.S., most − Initiation of Post Marketing Requirements dramatically in Pacific and Mountain regions (PMRs): pediatric and dodecy
Slide 18: Support OUD Pipeline
Q4 / FY 2023 Results | February 22, 2024 Support OUD Pipeline INDV-2000 (SELECTIVE OREXIN-1 RECEPTOR ANTAGONIST) INDV-6001 (3-MONTH LONG-ACTING INJECTABLE November 3, 2023: Successful end-of-Phase 1 meeting with BUPRENORPHINE) the FDA and agreement on major aspects of clinical and October 11, 2023:
Slide 19: Alcohol Use Disorder
ALCOHOL USE DISORDER
Slide 20: Support INDV-1000 (GABA-B Positive Allosteric Modulator) Development
Q4 / FY 2023 Results | February 22, 2024 Support INDV-1000 (GABA-B Positive Allosteric Modulator) Development ▪ Selection of two lead compounds for comprehensive in vitro and in vivo characterization. ▪ Formulation work to optimize drug formulation over the anticipated dose range. 29.5M past-year AU
Slide 21: Cannabis Use Disorder
CANNABIS USE DISORDER
Slide 22: Cannabis Legalization has Become More Prevalent Over the Past Decade
Q4 / FY 2023 Results | February 22, 2024 Cannabis Legalization has Become More Prevalent Over the Past Decade AEF0117 (CB1 SIGNALING-SPECIFIC INDV-5004 (DRINABANT – CB1 INHIBITOR) RECEPTOR ANTAGONIST) Positive clinical Phase 1 and Phase 2A Program currently funded by studies: Haney M et al. Signalin
Slide 23: Ryan Preblick, Chief Financial Officer
Ryan Preblick Chief Financial Officer
Slide 24: FY 2023 Financial Highlights
Q4 / FY 2023 Results | February 22, 2024 FY 2023 Financial Highlights Key Takeaways: Operating Results: (vs. FY 2022) (Reported and Adjusted1) ➤ FY 2023 total NR growth of 21% (21% at constant FX) $ mil FY 23 FY 22 Change ▪ U.S. NR up 25% Net Revenue (NR): 1,093 901 21% ▪ ROW NR up 6% (6% at constan
Slide 25: Cash & Borrowing Position
Q4 / FY 2023 Results | February 22, 2024 Cash & Borrowing Position Cash & Borrowings: Key Takeaways: Cash & investments of $451m1 ($ in mil.) ➤ Anti-trust MDL settlement payments totaling $518m Dec. 31, 2023 Dec. 31, 2022 in FY 2023 ($415m in escrow in “Other Assets”) Cash & Cash Equivalents 316 774
Slide 26: FY 2024 Guidance
Q4 / FY 2023 Results | February 22, 2024 FY 2024 Guidance FY 2024 Updated Guidance1: ($ in mil.; Comparisons to FY 2023) Top-Line Assumptions: ➤ Underlying U.S. BMAT3 market growth of mid- to high-single digits Total Net Revenue $1,240m to $1,330m (up 18% at mid-point) ➤ OPVEE NR inclusive of $8m fr
Slide 27: Capital Allocation Priorities
Q4 / FY 2023 Results | February 22, 2024 Capital Allocation Priorities Cash: Existing and Generated Organic Growth and Business Needs: • Maintain flexibility and meet obligations1 • Reinvest in growth (current products) • R&D / Supply Business Development and/or Shareholder Returns / Acquisitions 1
Slide 28: U.S. Listing Considerations
U.S. Listing Considerations
Slide 29: Initiating Shareholder Consultations to Potentially Transition to a U.S. Primary Listing in 2024
Q4 / FY 2023 Results | February 22, 2024 Initiating Shareholder Consultations to Potentially Transition to a U.S. Primary Listing in 2024 Net Revenue by Geography Background & Context Expected Benefits Next Steps • Elevate profile as addiction • Initiating consultations • U.S. NR represents 84% of w
Slide 30: Appendix
APPENDIX
Slide 31: Financial Reconciliations
Q4 / FY 2023 Results | February 22, 2024 Financial Reconciliations 2023 2022 2021 2020 For the twelve months ended December 31 $m $m $m $m Gross profit 907 742 664 550 Exceptional items and other adjustments in cost of sales 8 — — 5 Adjusted gross profit 915 742 664 555 2023 2022 2021 2020 For the t
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