Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — FY2019 Earnings Presentation
38 slides from Indivior Pharmaceuticals's earnings presentation, Feb 13, 2020
Slide 1: Indivior PLC FY 2019 Results
Indivior PLC FY 2019 Results February 13, 2020
Slide 2: 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 3: Agenda
AGENDA Shaun Thaxter CEO Perspective / SUBLOCADE® / PERSERIS® Mark Crossley Financial Review Javier Rodriguez Legal Update Christian Heidbreder R&D Update Shaun Thaxter Conclusion Q&A
Slide 4: CEO perspective: FY 2019
CEO perspective: FY 2019 Established strong foundation for future growth while maintaining financial stewardship • Unique growth platform established for SUBLOCADE® (buprenorphine extended-release) Injection in core U.S. market, including organized health system (OHS) foundation Strategy • Market pe
Slide 5: SUBLOCADE®
SUBLOCADE® (buprenorphine extended-release) Injection
Slide 6: SUBLOCADE® priorities focused on accelerating towards $1bn NR target
SUBLOCADE® priorities focused on accelerating towards $1bn NR target 2018 - 2019 2020 - beyond Foundation Established Accelerating Penetration • Dispense yield: consistently over 60% • New promotional drivers • Simple or no PA(1) access – 83% of lives ✓ Recognized new science • Channel expansion – C
Slide 7: SUBLOCADE® promotional drivers in place
SUBLOCADE® promotional drivers in place ▪ 6 Peer-reviewed ▪ Translating science into $704.78 ▪ Direct-to-consumer (DTC) publications patient benefits ▪ Digital / Online ▪ 13 Conference ▪ Consistent with OPDP(1) ▪ Public relations presentations feedback ▪ Policy (Federal & State) Recognized New Scien
Slide 8: Hil ant Uist
Hil ant Uist
Slide 9: OHS strategy: taking treatment closer to patients
OHS strategy: taking treatment closer to patients Prioritized OHS Prioritizing 320 highest value OHSs Universe Access in place with 80+ organizations ✓ Veterans Health Administration (VA), Boston Medical Integrated Delivery Networks (Consolidated hospital groups) Expanding dedicated OHS access team
Slide 10: Actively engaged in bipartisan action to combat the opioid epidemic
Actively engaged in bipartisan action to combat the opioid epidemic Overarching strategic outcome includes: “…drastically reducing the number of Americans losing their lives to drug addiction…” (1) $34.6bn+ requested to help states, communities, and law enforcement respond to the drug crisis and cur
Slide 11: Pursuing select ex-U.S. opportunities
Pursuing select ex-U.S. opportunities ROW ✓ SUBLOCADE® approved for marketing in Australia and Canada; select EU regulatory review ongoing ✓ SUBOXONE® Film NDA under regulatory review in the EU and Canada , Israel and New Zealand (among others) U.S. ✓ Remains most compelling growth opportunity ✓ Dri
Slide 12: PERSERIS®
PERSERIS® (risperidone) for extended-release injectable suspension
Slide 13: PERSERIS® diversification delivered against first year expectations
PERSERIS® diversification delivered against first year expectations • Payor access – 80% parity with exiting LAIs Objectives • Traditional sample program established Achieved • New HCPs – indications that the product profile is attractive is further endorsed by recent market research(1) and anecdota
Slide 14: Mark Crossley
Mark Crossley Chief Financial & Operations Officer
Slide 15: Income statement
Income statement* FY Q4 2019 2018 % 2019 2018 % Adjusted Adjusted change Adjusted Adjusted change ($ in mil.) Net Revenues $785 $1,005 -22% $133 $236 -44% Cost of Sales (140) (128) (43) (35) Gross Profit $645 $877 -26% $90 $201 -55% Gross Margin % 82% 87% 68% 85% Selling, General and Administration
Slide 16: Achieved targeted OPEX savings of $120m to $140m
Achieved targeted OPEX(1) savings of $120m to $140m $143m of adj. OPEX savings achieved vs. FY 2017 baseline • Captures actions completed in 2018 and 2019 $586m(2) ✓ Reduced headcount by ~30% ✓ Reprioritized R&D $443m(2) ✓ Reduced third-party expenditures • Includes incremental growth investments fo
Slide 17: Cash & borrowing position
Cash & borrowing position FY FY ($ in mil.) 2019 2018 • Net cash of $821m at end of FY19, Cash & Cash Equivalents 1,060 924 improvement of $140m in the period • Retaining cash on balance sheet: Current Borrowings (4) (4) ✓ Flexibility until resolution of legal matters Long-term Borrowings (233) (237
Slide 18: FY 2020 guidance introduced
FY 2020 guidance introduced FY 2020 Guidance ($ in mil.) Net Revenue $525m - $585m Net loss ($50m) – ($20m) Top-line: Expenses: • U.S. buprenorphine/ naloxone film market conditions • Incremental growth investments to drive the progression of ✓ Continued double-digit underlying BMAT market growth SU
Slide 19: Growth in SUBLOCADE® OHS business impacting KPI accuracy
Growth in SUBLOCADE® OHS business impacting KPI accuracy Prescription journey time at target levels Dispense yield consistently above Future SUBLOCADE® KPIs injectable benchmark(1) and in-line with (FY 2020 – beyond) SUBOXONE® Film(2) OHS penetration is expected to accelerate Total Units Dispensed i
Slide 20: Javier Rodriguez
Javier Rodriguez Chief Legal Officer
Slide 21: DOJ matter
DOJ matter On April 9, 2019, a federal grand jury in the Western District of Virginia indicted Indivior PLC and Indivior Inc. on charges of health care fraud, wire fraud, mail fraud, and conspiracy, in connection with the marketing and promotion practices, pediatric safety claims, and overprescribin
Slide 22: Christian Heidbreder
Christian Heidbreder Chief Scientific Officer
Slide 23: SUBLOCADE® US strategic pillars
SUBLOCADE® US STRATEGIC PILLARS Post-Marketing Post-Marketing Long-term Safety LEGO Publication Themes Requirements Commitments ▪ Rapid Induction ▪ Longer inter-dose ▪ PK/UDS (INDV- ▪ RECOVER ▪ SUBLOCADE™ (INDV-6000-403) interval 6000-402) (NCT03604861) Safety & Efficacy (NCT03993392) + ▪ Transition
Slide 24: SUBLOCADE® 2019 publication highlights
SUBLOCADE® 2019 PUBLICATION HIGHLIGHTS 24
Slide 25: SUBLOCADE® and SUBOXONE® Film ex-US regulatory filings
SUBLOCADE® AND SUBOXONE® FILM EX-US REGULATORY FILINGS SUBLOCADE® SUBOXONE® FILM Regulatory Filing Region Region Regulatory Filing Date Date Canada Approved Israel Q3 – 2018 Australia Approved Europe Q1 – 2019 Israel Q3 – 2018 New Zealand Q3 – 2018 Canada Q2 – 2019 France + DCP (Belgium; New Zealand
Slide 26: PERSERIS® US strategic pillars
PERSERIS® US STRATEGIC PILLARS PMC Drug optimization CANADA PUBLICATION THEMES ▪ Clinical PMC (PMC ▪ Further improving ▪ NDS submitted to ▪ PANSS/CGI-S re- 3451-1): 180 mg dose shelf-life: support 24 Health Canada on analysis (eq. 6 mg oral) (INDV- Mo Cold + 1 week RT November 7, 2019 ▪ PANSS indivi
Slide 27: Early stage asset development (ESAD)
EARLY STAGE ASSET DEVELOPMENT (ESAD) INDV-2000 (OX1 receptor antagonist) ▪ NIH HEAL Grant awarded September 26, 2019 ▪ Pre-IND meeting request submitted on September 20, 2019 ▪ FDA feedback received on January 2, 2020. ▪ First-In-Human protocol finalized and IND filed on January 17, 2020 ▪ Presentat
Slide 28: Shaun Thaxter
Shaun Thaxter Chief Executive Officer
Slide 29: Strategy for long-term value creation
Strategy for long-term value creation Short-to-medium Longer-term Expected benefits term focus aspiration Renewed profitable Resolve overhangs Early stage assets growth Depot technologies Diversification ex.-U.S. Better balance (product/geographic) U.S. core market Other substance use disorders Scal
Slide 30: SUBOXONE® 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 31: 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 32: 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 33: Appendix
Appendix So INDIVIOR
Slide 34: SUBLOCADE® KPIs – unique patients injected
SUBLOCADE® KPIs – unique SUBLOCADE® patients injected increasing month over month; dispense yield consistently w/in target range Closed Case Performance (1)(2) Cumulative Launch to 12/31/19 (1) Closed case 93% 94% 94% 94% 94% 95% 85% run-rate: 39% 43,074 42% 36% 48% Unique prescriptions initiated Ca
Slide 35: SUBLOCADE® KPIs – HCP data and patient treatment adherence
SUBLOCADE® KPIs – HCP data and patient treatment adherence Cumulative Launch to 12/31/19 (1) Treatment Adherence (2) (All patients with initial injection during March ’18 to Oct ‘19) 4,338 100% HCPs initiated prescription journeys 80% 74% 57% 3,083 60% HCPs administered SUBLOCADE™ 47% 39% 40% 34% 29
Slide 36: Income Statement: FY 2019 vs. FY 2018
Income Statement: FY 2019 vs. FY 2018 FY 2019 FY 2018 Δ 2019 2019 Y-o-Y 2018 2018 Adjustments Adjustments Actual Adjusted (adjusted) Actual Adjusted ($ in mil. at Actual FX) Net Revenues 785 785 -22% 1,005 1,005 Cost of Sales (140) (140) (128) (128) Gross Profit 645 645 -26% 877 877 Gross Margin (%)
Slide 37: Income Statement: Q4 2019 vs. Q4 2018
Income Statement: Q4 2019 vs. Q4 2018 Q4 2019 Q4 2018 Δ Q4 2019 Q4 2019 Y-o-Y Q4 2018 Q4 2018 Adjustments Adjustments Actual Adjusted (adjusted) Actual Adjusted ($ in mil. at Actual FX ) Net Revenues 133 133 -44% 236 236 Cost of Sales (43) (43) (35) (35) Gross Profit 90 90 -55% 201 201 Gross Margin
Slide 38: Capital Markets Agenda 2020
Capital Markets Agenda 2020* Date Event Feb. 13th & 14th FY 2019 Results (London Presentation) & Investor Meetings April 30th Q1 2020 Results (Conference Call) May 7th Annual General Meeting (London) June 2nd & 3rd Jefferies US Healthcare Conference (New York City) June 16th & 17th Citi One-on-One C