Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — H1 2019 Earnings Presentation
32 slides from Indivior Pharmaceuticals's earnings presentation, Jul 31, 2019
Slide 1: Indivior PLC H1 2019 Results
Indivior PLC H1 2019 Results July 31, 2019
Slide 2: Shaun Thaxter, Chief Executive Officer
Shaun Thaxter 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 Shaun Thaxter H1 2019 Performance Overview SUBLOCADE™ Update PERSERIS™ Update Mark Crossley H1 2019 Financial Review Javier Rodriguez Legal Update Christian Heidbreder R&D Focus Question & Answers
Slide 5: H1 2019 snapshot
H1 2019 snapshot Operational Highlights Pipeline & Study Progress Financial Performance (year-over-year) H1 19 vs. H1 18 (adjusted basis(1)) SUBLOCADE™ approved for marketing in Double-digit BMAT market growth in U.S. Australia Net Rev.: $454m -13% mainly driven by government channels Canada SUBOXON
Slide 6: SUBLOCADE
SUBLOCADE™ (buprenorphine extended-release) Injection
Slide 7: 2019 SUBLOCADE key take-aways
2019 SUBLOCADE™ key take-aways • Payor access is 85% exiting H1 2019; coverage quality greatly Prescription improved (prior authorizations removed in several states) Journey • Prescription journey – sustained at 12 to 17 days Established • Dispensing yield improved to 58% Focused on Trial • Accelera
Slide 8: Unique SUBLOCADE patients injected increasing month over month
Unique SUBLOCADE™ patients injected increasing month over month; Continued improvement in dispense yield Closed case Closed Case Performance (1)(2) run-rate: 94% 96% 92% 95% 93% Cumulative Launch to 6/30/19 (1) 66% 63% 62% 58% 94% 57% 91% 55% 93% 50% 94% 48% 46% 96% 44% 93% 42% ~65% initial approval
Slide 9: SUBLOCADE KPIs – HCP data & patient treatment adherence
SUBLOCADE™ KPIs – HCP data & patient treatment adherence Repeat Injections (All patients with initial injection during March ’18 to April ‘19) 3,463 HCPs initiated prescription journeys 100% 80% 74% 2,249 HCPs administered SUBLOCADE™ 60% 40% 56% 47% 39% 35% 30% 26% 24% 21% 569 19% 20% HCPs administe
Slide 10: SUBLOCADE focus is on accelerating HCP trial and adoption
SUBLOCADE™ focus is on accelerating HCP trial and adoption Penetrating Organized Health Systems (OHS) – OHS represent ~30% of patient population / ~20K active waivered HCPs – 70% of priority Integrated Delivery Network (IDN) accounts have been engaged – Predominantly “buy & bill” Effective digital m
Slide 11: PERSERIS
PERSERIS™ (risperidone) for extended-release injectable suspension
Slide 12: PERSERIS update
PERSERIS™ update Managed Care coverage over 70% nationally; at parity with established LAIs Infrastructure working well – distribution, reimbursement, patient HUB Sales KPIs (reach & frequency) on target Continued positive patient and HCP feedback 12
Slide 13: Mark Crossley, Chief Financial & Operations Officer
Mark Crossley Chief Financial & Operations Officer
Slide 14: Profit & Loss Account
Profit & Loss Account* Q2 H1 2019 2018 % 2019 2018 % Adjusted Adjusted change Adjusted Adjusted change ($ in mil.) Net Revenues 215 268 -20% 454 524 -13% Cost of Sales (27) (35) (64) (59) Gross Profit 188 233 -19% 390 465 -16% Gross Margin (%) 87% 87% 86% 89% Selling, General and Administration Expe
Slide 15: Cash & Borrowing Position at Half Year
Cash & Borrowing Position at Half Year Half Year Full Year • Net cash of $747m at half year, ($ in mil.) 2019 2018 improvement of $66m in the period Cash & Cash $988 $924 • Continue to retain cash on balance Equivalents sheet at present: Current Borrowings (4) (4) ✓ Flexibility through commercial tr
Slide 16: Cash Conversion
Cash Conversion For the six months ended June 30th 2019 2018 Operating Profit 163 200 Cash Flows from Depreciation, amortization and impairment 13 7 Operating Activities Reversal of other non-cash items - 1 ($ in mil.) Changes in assets and liabilities (123) (82) Provisions (8) (7) Cash generated fr
Slide 17: FY 2019 guidance (revised July 11th)
FY 2019 guidance (revised July 11th) ($ in mil.) Revised Guidance Previous Guidance Net revenue $670m -$720m $525m-$575m Net (loss) / income (adjusted) $80m - $130m $(40)m-$10m Top-line: Expenses: • U.S. buprenorphine/ naloxone Film market conditions • OPEX of $440m to $460m, including current Litig
Slide 18: Javier Rodriguez, Chief Legal Officer
Javier Rodriguez Chief Legal Officer
Slide 19: Legal update
Legal update DOJ Indictment SUBOXONE® Film ANDA Litigation Braeburn v. FDA / Indivior 19
Slide 20: Christian Heidbreder, Chief Scientific Officer
Christian Heidbreder Chief Scientific Officer
Slide 21: Strategic R&D Priorities: Focus on the Treatment of OUD
STRATEGIC R&D PRIORITIES: FOCUS ON THE TREATMENT OF OUD ❶ ❷ ❸ ❹ ❺ ❻ SUBUTEX® MONDEPA Business Continuity SUBOXONE® ex-US SUBLOCADE™ US PERSERIS™ US/CAN ESAD ex-US ▪ Maintain valid ▪ Film: Filings and ▪ PMRs ▪ Launch Canada ▪ PMCs ▪ OX1 Receptor licenses RTQs in Canada, ▪ PMCs ▪ RTQs in Europe, ▪ Opt
Slide 22: SUBLOCADE
SUBLOCADE™ ▪ Long-term safety and efficacy: – Subjects who continued to receive monthly SUBLOCADE™ up to 12 and 18 months have high levels of retention in treatment and abstinence; no new safety signals emerged over time 1 ▪ Patient-Reported Outcomes research: – Participants receiving up to 6 monthl
Slide 23: SUBLOCADE (cont'd)
SUBLOCADE™ (CONT’D) ▪ The RECOVER® study: – Longer SUBLOCADE™ treatment durations are associated with higher rates of opioid abstinence over 12-months and past-week opioid use, as measured by self-reports and self-reports plus negative urine drug screen results 1 ▪ Optimal dosage of maintenance trea
Slide 24: Contribution to Disease Understanding
CONTRIBUTION TO DISEASE UNDERSTANDING ▪ Buprenorphine misuse, abuse, diversion: – Illicit buprenorphine use may often be motivated by use of buprenorphine as a form of self-treatment of OUD, such as to maintain abstinence or prevent withdrawal 1 ▪ VOTIVE (Virginia Overdose Treatment InitiatIVE) stud
Slide 25: PERSERIS
PERSERIS™ ▪ Efficacy and Safety: – Two months of treatment with PERSERIS™ (90 mg or 120 mg) significantly improved 6 of 7 individual items comprising the PANSS Positive Scale and 6 of the 16 items comprising the General Psychopathology Scale 1 – Two months of treatment at PERSERIS™ 120 mg dose resul
Slide 26: In Summary…
IN SUMMARY… ▪ SUBLOCADE™ and PERSERIS™ Long- ▪ SUBLOCADE™ and PERSERIS™ Phase III $704.78 ▪ SUBLOCADE™ optimal maintenance Term safety & efficacy HEOR endpoints dose ▪ Psychometric validation of TEA for ▪ Fentanyl blockade OUD ▪ The RECOVER® study Long-term Safety & Efficacy HEOR Prescribers’ Educat
Slide 27: Appendix
Appendix So INDIVIOR
Slide 28: Q2 Profit & Loss Account Reconciliation
Q2 Profit & Loss Account Reconciliation Q2 2019 Q2 2018 2019 2019 2018 2018 Adjustments Adjustments Actual Adjusted Actual Adjusted ($ in mil.) Net Revenues 215 215 268 268 Cost of Sales (27) (27) (35) (35) Gross Profit 188 188 233 233 Selling, General and Administration Expenses (87) (1)1 (86) (131
Slide 29: H1 Profit & Loss Account Reconciliation
H1 Profit & Loss Account Reconciliation H1 2019 H1 2018 2019 2019 2018 2018 Adjustments Adjustments Actual Adjusted Actual Adjusted ($ in mil.) Net Revenues 454 454 524 524 Cost of Sales (64) (64) (59) (59) Gross Profit 390 390 465 465 Selling, General and Administration Expenses (202) (28) 1 (174)
Slide 30: 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 support
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-cont
Slide 32: About PERSERIS indication and safety information
ABOUT PERSERIS™ (risperidone) for extended-release injectable suspension INDICATION PERSERISTM (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