Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — FY2020 Earnings Presentation
34 slides from Indivior Pharmaceuticals's earnings presentation, Feb 18, 2021
Slide 1: Indivior PLC FY 2020 Results
Indivior PLC FY 2020 Results February 18, 2021
Slide 2: Mark Crossley, Chief Executive Officer
Mark Crossley Chief Executive Officer
Slide 3: Forward-looking statements
Forward-looking statements This announcement contains certain statements that are forward-looking. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from
Slide 4: Agenda
AGENDA FY 2020 Overview & Strategic Update Mark Crossley R&D Update Christian Heidbreder FY 2020 Financials & FY 2021 Guidance Ryan Preblick Conclusion Mark Crossley Q&A
Slide 5: CEO perspective: FY 20
CEO perspective: FY 20 Looking past COVID-19 & legacy issues; focused on realizing our potential • Results were good considering ongoing COVID-19 challenges ✓ Positive adj. net income* in Q4 and FY ✓ SUBLOCADE® FY 20 NR was better than expected at $130m (+81% vs. FY 19); FY 20 PERSERIS® NR was $14m
Slide 6: SUBLOCADE: Why we are confident
SUBLOCADE®: Why we are confident 1. Tremendous unmet need 2. Novel treatment paradigm 3. Right strategy
Slide 7: There is a tremendous urgent & unmet need
There is a tremendous urgent & unmet need 12 MONTH-ENDING PROVISIONAL NUMBER OF US DRUG CHANGE ALL FATAL DRUG OVERDOSES OVERDOSE DEATHS BY DRUG OR DRUG CLASS (AS OF JUNE 2020) JUNE 2019 - MAY 2020 (Data collected from 50 states, the District of Columbia, and New York City) Pandemic lockdowns Begin i
Slide 8: Buprenorphine is a cornerstone of medically assisted treatment
Buprenorphine is a cornerstone of medically assisted treatment World Health Organization list of essential medications Tightly binds to the mu-opioid receptor due to particularly high receptor affinity ✓ preventing other opioids with lower affinity (e.g. heroin) from binding Buprenorphine is a safe
Slide 9: SUBLOCADE is a paradigm shift in treatment
SUBLOCADE®(1) is a paradigm shift in treatment SUBLOCADE® Attributes SUBLOCADE® Total Net Revenue SUBLOCADE® is the first buprenorphine-based long-acting ($ in millions) injectable approved by U.S. FDA for the treatment of moderate to $225 $185 to severe OUD $210(2) $200 Rationally designed to deliv
Slide 10: Ensuring SUBLOCADE is accessible by penetrating Organized Health Systems
Ensuring SUBLOCADE is accessible to all patients by penetrating Organized Health Systems Core Prescribers Organized Health Systems (Single HCP & Clinics) Integrated Delivery Networks Federal Health Systems Organized Customers (Consolidated hospital groups) (VA, DOD, Justice System) (Multi-site and m
Slide 11: Indivior has the right strategy
Indivior has the right strategy Path to $1bn+ goal is clear and achievable >10 mil. >3.0 mil. ~180,000 Misuse opioids in US (1) OUD diagnosed in US (2) Target SUBLOCADE® patients Market growth • Sustained U.S. market growth: high single to low double-digits HCPs & patients • Penetrating OHS (includi
Slide 12: BMAT treatment continues to grow in response to the opioid epidemic
BMAT treatment continues to grow in response to the opioid epidemic Strong, consistent market expansion… Driven by growing treatment capacity Total buprenorphine market in mg(1,2) (millions) No. of HCP certifications (cumulative certifications in thousands) 5,000 5 Yr. Waivered 97.9 5 Yr. CAGR: 100
Slide 13: OHS strategy is working
OHS strategy is working ($ in millions) $25 US SUBLOCADE® NR Progression (Core vs. OHS) 62% $20 65% 69% 62% 80% 85% $15 $10 95% 90% 31% 35% 38% 38% >70% of SUBLOCADE® growth coming $5 20% from OHS channel 10% 15% exiting FY 2020 5% $0 Q1-2019 Q2-2019 Q3-2019 Q4-2019 Q1-2020 Q2-2020 Q3-2020 Q4-2020 O
Slide 14: Increasing relevance and generating evidence to support OUD treatment
Increasing relevance and generating evidence to support OUD treatment Relevance Evidence Buprenorphine plasma concentrations (approximately The likelihood of continuous 12-month abstinence 2 ng/mL and 6 ng/mL) were effective in reducing the after cessation of SUBLOCADE® treatment increases frequency
Slide 15: Diversify Revenue
Diversify Revenue 1. PERSERIS® 2. Ex.-US 3. Pipeline
Slide 16: PERSERIS: 2020 accomplishments
PERSERIS®: 2020 accomplishments Notable accomplishments in the face of significant COVID impact Increasing hybrid selling effectiveness to adapt to the COVID environment Monthly sequential growth in the number of HCPs prescribing Average share of 13% amongst HCPs actively prescribing, demonstrating
Slide 17: Ex.-US NR trajectory returning to growth
Ex.-US NR trajectory returning to growth Current major ex.-US drug approvals (Feb. 2021) SUBLOCADE® SUBOXONE® PERSERIS® (SUBUTEX® PR) Film North Canada * America Availability EU SUBLOCADE® (SUBUTEX® PR) France • Available in Australia, Canada, Israel Italy • Nordics in 2021 Europe / Germany • Awaiti
Slide 18: FY 2020 Science Update
FY 2020 SCIENCE UPDATE Christian Heidbreder, Chief Scientific Officer
Slide 19: SUBLOCADE US: Evidence Generation
SUBLOCADE® US: EVIDENCE GENERATION 12-month treatment with SUBLOCADE® is clinically safe and The likelihood of continuous 12-month abstinence increases with length of SUBLOCADE® treatment Studies to support effective for patients with moderate or severe OUD SUBLOCADE® label changes: ▪ Rapid inductio
Slide 20: PERSERIS US: Evidence Generation
PERSERIS® US: EVIDENCE GENERATION PERSERIS® (120 mg) significantly improved all 5 A new analysis of Phase 3 data revealed that PERSERIS® 120 mg may be useful in addressing difficult-to-treat Marder subscales vs. Placebo: Positive and Studies to support Negative symptoms, Disorganized thought, negati
Slide 21: Early-Stage Asset Development (ESAD)
EARLY-STAGE ASSET DEVELOPMENT (ESAD) INDV-2000 (selective OX1 receptor antagonist): A non-opioid strategy for OUD treatment – NIH HEAL Grant enables clinical, nonclinical and pharmaceutical development activities – FDA approval of IND in February 2020 – Phase 1 Single Ascending Dose (SAD) started Ju
Slide 22: 2021 Key Congress Calendar
2021 Key Congress Calendar 22
Slide 23: Ryan Preblick, Chief Financial Officer
Ryan Preblick Chief Financial Officer
Slide 24: Income statement
Income statement* FY Q4 2020 2019 % 2020 2019 % Adjusted Adjusted change Adjusted Adjusted change ($ in mil.) Net Revenues $647 $785 -18% $185 $133 +39% Cost of Sales (92) (140) (29) (43) Gross Profit $555 $645 -14% $156 $90 +73% Gross Margin % 86% 82% +4 pp 84% 68% +16 pp Selling, General and Admin
Slide 25: Cash & borrowing position
Cash & borrowing position FY FY • Net cash of $623m at end of FY20 reflects: ($ in mil.) 2020 2019 ✓ $103m payment to DOJ required by resolution Cash & Cash Equivalents $858 $1,060 ✓ Change in net working capital • Maintaining prudent and balanced cash stance: ✓ Deliver against SUBLOCADE® net rev. g
Slide 26: FY 21 guidance introduced
FY 21 guidance introduced FY 21 Guidance(1) ($ in mil.) FY 2021 NR Assumptions • Base case NR: Currently assumes the operating backdrop Total Base Case NR Up to $625m will improve in H2 2021, as COVID-19 pandemic • SUBLOCADE NR base case • $185m to $210m • PERSERIS NR base case • $17m to $20m restri
Slide 27: Capturing significant OPEX savings
Capturing significant OPEX(1) savings Over $155m of adj. OPEX savings achieved vs. FY 2017 • Captures actions completed from FY18 to FY20 $586m(2) ✓ Reduced headcount by 20%+ ✓ Realigned and reinvested in US business, with $430m(3) primary focus on OHS channel ✓ Refocused R&D on supporting LAI techn
Slide 28: Concluding Remarks
Concluding Remarks SZ INDIVIOR AS
Slide 29: SUBOXONE Sublingual Film indication and highlighted safety information
SUBOXONE® (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM (CIII) INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBOXONE® Film is indicated for the treatment of opioid dependence. SUBOXONE Film should be used as part of a complete treatment plan that includes counseling and psychosocial suppo
Slide 30: SUBLOCADE indication and highlighted safety information
SUBLOCADE® (BUPRENORPHINE EXTENDED-RELEASE) INJECTION FOR SUBCUTANEOUS USE (CIII) INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE® is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-co
Slide 31: About PERSERIS indication and safety information
ABOUT PERSERIS® (risperidone) for extended-release injectable suspension INDICATION PERSERIS® (risperidone) is indicated for the treatment of schizophrenia in adults. WARNING: INCREASED MORTALITY IN ELDERY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed w
Slide 32: Appendix
Appendix So INDIVIOR
Slide 33: Income Statement: Q4 2020 vs. Q4 2019
Income Statement: Q4 2020 vs. Q4 2019 Q4 2020 Q4 2019 Δ Q4 2020 Q4 2020 Y-o-Y Q4 2019 Q4 2019 Adjustments Adjustments Actual Adjusted (adjusted) Actual Adjusted ($ in mil. at Actual FX ) Net Revenues 185 185 +39% 133 133 Cost of Sales (23) (6) (1) (29) (43) (43) Gross Profit 162 156 +73% 90 90 Gross
Slide 34: Income Statement: FY 2020 vs. FY 2019
Income Statement: FY 2020 vs. FY 2019 FY 2020 FY 2019 Δ 2020 2020 Y-o-Y 2019 2019 Adjustments Adjustments Actual Adjusted (adjusted) Actual Adjusted ($ in mil. at Actual FX) Net Revenues 647 647 -18% 785 785 Cost of Sales (97) 5 (1) (92) (140) (140) Gross Profit 550 555 -14% 645 645 Gross Margin (%)