Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — FY2021 Earnings Presentation
21 slides from Indivior Pharmaceuticals's earnings presentation, Feb 16, 2022
Slide 1: Q4 / FY 2021 Results
Indivior PLC Q4 / FY 2021 Results February 16, 2022
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: US opioid crisis worsening with elevated overdose deaths
US opioid crisis worsening with elevated overdose deaths US Overdose Deaths Accelerated During COVID US Opioid Use Disorder (OUD) Disease State (2015 – June 2021) 101,263 +21% YOY Total Overdose 10 mil.+ people(1) 76,002 +24% YOY Engage in non-medical misuse & illicit 70,122 Opioid Overdose opioid u
Slide 5: FY 2021 execution against our Strategic Priorities
FY 2021 execution against our Strategic Priorities • Strong FY 2021 results ✓ Total NR +22% to $791m; total adj. op. income* +113% to $187m Financial ✓ SUBLOCADE® FY 21 NR +88% to $244m; FY 21 PERSERIS® NR +21% to $17m ✓ Ending cash of $1.1 bn; net cash of $853m; refinanced debt maturity to 2026 • F
Slide 6: Strategic Priorities report card: FY 2021
Strategic Priorities report card: FY 2021 1 2 3 4 Grow SUBLOCADE® >$1 bil. Diversify Revenue Build Our Pipeline Optimize Operating Model • FY 2021 NR: $244m • PERSERIS® Q4 21 NR: $5m • SUBLOCADE®: Publication of • Cash: $1.102 bn +88% vs. FY 2020 flat vs. Q3 21; +25% vs. Q4 results from Buprenorphin
Slide 7: SUBLOCADE: Extending our Leadership Position in OUD with OHS Platform
SUBLOCADE®: Extending our Leadership Position in OUD with a Differentiated Organized Health Systems (OHS) Platform ▪ 400+ OHS accessed (vs. ▪ Dedicated Criminal Justice $704.78 ▪ Translating science into relevant System team (National patient benefits (fentanyl study) 500+ target) coverage) ▪ Pursui
Slide 8: PERSERIS: Peak NR Objective $200m to $300m
PERSERIS®: Peak NR Objective $200m to $300m Diversification opportunity: What we are doing: • First commercial expansion outside OUD • Doubled salesforce to achieve national commercial coverage • Co-morbid condition with OUD ✓ Focused institutional sales team added as part of the ✓ Patients with OUD
Slide 9: Rest of World: bringing new technologies to market
Rest of World (ROW): bringing new technologies to market Current major ex.-US drug approvals (Feb. 2022) SUBLOCADE® SUBOXONE® PERSERIS® (SUBUTEX® PR) Film North Canada * America EU Recently Launched Products France ROW SUBLOCADE Italy (SUBUTEX® PR) Europe / Germany • Q4 21 NR: $5m Middle East Nordic
Slide 10: Exploring optimal listing structure for Indivior shares
Exploring optimal listing structure for Indivior shares Preliminary view of Board is that an additional listing in the US is likely to be beneficial Better aligned with Group strategy and structure ✓ Improved visibility in largest market (~80% of NR generated in US) ✓ US market is the Group’s highes
Slide 11: Indivior: Compelling Investment Case
Indivior: Compelling Investment Case Strong Market Transformational Investing for Committed to Fundamentals LAI Treatments Growth Value Creation • Unmet need / low • Extending No. 1 • Balanced capital allocation treatment position in OUD demonstrated prevalence • Accelerating • First choice remains
Slide 12: R&D Update FY-2021
R&D UPDATE FY-2021 FEBRUARY 16TH, 2022 Christian Heidbreder, Chief Scientific Officer
Slide 13: Unprecedented number of reported drug overdose deaths in the US
UNPRECEDENTED NUMBER OF REPORTED DRUG OVERDOSE DEATHS IN THE US: → GROWING IMPACT OF FENTANYL & SYNTHETIC OPIOIDS 12 Month-ending Predicted Provisional Number of Drug Overdose Deaths by Drug or Drug Class (June 2020-June 2021) 120,000 FOR THE FIRST TIME EVER, THE US EXCEEDED 100,000 OVERDOSE DEATHS
Slide 14: Our response to the opioid crisis: new evidence generation for SUBLOCADE
OUR RESPONSE TO THE OPIOID CRISIS: NEW EVIDENCE GENERATION IN SUPPORT OF SUBLOCADE® Approval of US Label updates: → Buprenorphine-Fentanyl interaction: Open-label, cross-over study showing that treatment-relevant plasma concentrations of buprenorphine significantly decreased respiratory depression a
Slide 15: Our response to the opioid crisis: new R&D investment in 2022
OUR RESPONSE TO THE OPIOID CRISIS: NEW R&D INVESTMENT IN 2022 ▪ Generate further evidence regarding the use of SUBLOCADE®: → Fentanyl and synthetic opioids’ users → Initiation in CJS to determine if decreases the risk of overdose after release and improves linkage to care → Early initiation at ED to
Slide 16: Progress our pipeline activities in OUD, AUD & CUD
PROGRESS OUR PIPELINE ACTIVITIES IN OPIOID USE DISORDER (OUD), ALCOHOL USE DISORDER (AUD) & CANNABIS USE DISORDER (CUD) CUD Clinical Phase 2b OUD Clinical Phase 1 AUD Nonclinical AEF0117 INDV-2000 INDV-1000 CB1 -VE ALLOSTERIC MODULATOR SELECTIVE OX1 RECEPTOR ANTAGONIST GABA-B +VE ALLOSTERIC MODULATO
Slide 17: Ryan Preblick, Chief Financial Officer
Ryan Preblick Chief Financial Officer
Slide 18: Full Year 2021 financial highlights
Full Year 2021 financial highlights* FY 2021 vs. FY 2020 ($m actual F/X) 2021 2020 Change US Net Revenue $603 $456 32% ROW Net Revenue $188 $191 -2% Top- and bottom-line improvement Total Net Revenue $791 $647 22% Key product NR: Maintained strong financial position SUBLOCADE NR PERSERIS NR $244 $17
Slide 19: Cash & Borrowing position
Cash & Borrowing position FY FY • Net cash growth to $853m: ✓ Stronger FY operating performance ($ in mil.) 2021 2020 ✓ SUBOXONE Film resiliency = stable government payables balance Cash & Cash Equivalents $1,102 $858 ✓ BUPREX® / BUPREXX / Temgesic® sale proceeds • Maintaining disciplined & balanced
Slide 20: FY 2022 guidance introduced
FY 2022 guidance introduced FY 22 Guidance 1 ($ in mil.) Total Net Revenue $840m to $900m FY 2022 Assumptions Key LAI products: • SUBLOCADE NR • $360m to $400m (+56% at mid-point vs. FY21) • Near-term constraints in the US healthcare system ease as • PERSERIS NR • $27m to $32m (+74% at mid-point vs.
Slide 21: ANS INDIVIOR
Nz ANS INDIVIOR