Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — H1 2018 Earnings Presentation
32 slides from Indivior Pharmaceuticals's earnings presentation, Jul 25, 2018
Slide 1: Strengthening our global leadership in treatment of addiction
Strengthening our global leadership in treatment of addiction Half Year Results 2018 July 25th 2018
Slide 2: Shaun Thaxter, Chief Executive Officer
Shaun Thaxter Chief Executive Officer
Slide 3: Forward Looking Statements
Forward Looking Statements This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forwar
Slide 4: Agenda
AGENDA Shaun Thaxter H1 2018 Performance Overview SUBLOCADE™ Update Javier Rodriguez Legal Update Mark Crossley H1 2018 Financial Review FY 2018 Cost Actions Shaun Thaxter Conclusion Question & Answers
Slide 5: H1 2018 Overview & FY 2018 Guidance
H1 2018 Overview & FY 2018 Guidance
Slide 6: Indivior Half Year 2018 Overview
Indivior Half Year 2018 Overview H1 2018 Performance Operational Overview Pipeline Progress % Δ vs. H1 17 (actual FX) Double-digit US market growth; continues to SUBLOCADE™ new drug submissions be driven by Medicaid made in Canada and Australia Net Revenue (NR) $524m -5% H1 2018 Suboxone® Film avera
Slide 7: SUBLOCADE Update
SUBLOCADE™ Update SZ INDIVIOR AS
Slide 8: SUBLOCADE Fundamentals are Strong, Prescription Journey and HCP Trial Improving
SUBLOCADE™ Fundamentals are Strong, Prescription Journey and HCP Trial Improving Strengths Challenges • Patient experience and satisfaction (1) • Duration of prescription journey • Payor coverage (quantity and quality) • Prescription journey success rate • Number of prescription journey initiations
Slide 9: SUBLOCADE Prescription Initiation to Injection is New and More Complex
SUBLOCADE™ Prescription Initiation to Injection (Prescription Journey) is New and More Complex SUBOXONE® Film (Retail) SUBLOCADE™ Injection (SP) Specialty Pharmacy Two highly automated & Over 30 touch points in a paper-driven standardized touch points manually administered process • Physician initia
Slide 10: First SUBLOCADE Prescription Journey Timeline – Journey Process Reduction
First SUBLOCADE™ Prescription Journey Timeline – Journey Process Reduction Calendar Days to Dispense 60 43 to 62 27 to 36 Drivers of Journey Time Reduction 3-5 • Education of HCP office staff by Controllable 50 10-15 Field Reimbursement (FRS) team 40 10-15 • Accuracy of patient application 30 5-10 1
Slide 11: Specialty Low Success Rates for First Prescription - Dispense Conversion Improving
Specialty has Low Success Rates for First Prescription - Dispense Conversion Rate(1) Improving 17% 21% 22% Cumulative to H1 2018 (1) 6,400+ Unique patient prescription initiations 70% 48% 43% 1,000+ Unique patient injections 36% 56% Payor coverage (currently 67%) 31% 13% April May June Unique Patien
Slide 12: SUBLOCADE KPIs – HCP Data & Patient Treatment Adherence
SUBLOCADE™ KPIs(1) – HCP Data & Patient Treatment Adherence Treatment Adherence(1) (All patients injected in March) 79% Prompted awareness 100% 90% 80% 77% 1,300+ HCPs initiated prescription journeys 70% 60% 59% 50% 384 40% HCPs administered SUBLOCADE™ 30% 20% 10% 30 HCPs administered ≥ 5 patients 0
Slide 13: What Patients and HCPs are Saying
What Patients and HCPs are Saying (1) Patients HCPs • Pre-treatment anxiety • Positive feedback from HCPs who have • Frustration with the process and time administered SUBLOCADE™ to patients from prescription to injection • Reports of safety cases consistent with • Injection site pain transmucosal b
Slide 14: SUBLOCADE Next Steps
SUBLOCADE™ Next Steps • Sustained focus to maintain the momentum on reducing the prescription journey duration and improving success rates • Increase rate of HCP trial and initiation of new prescription journeys Remain confident in annual peak net revenue goal of $1 billion+ 14
Slide 15: Javier Rodriguez, Chief Legal Officer
Javier Rodriguez Chief Legal Officer
Slide 16: Major Litigation
Major Litigation The Group carries a provision for investigative and antitrust litigation matters of $438m. Substantially all of the provision relates to the US Department of Justice investigation. The Group is in advanced discussions with the Department of Justice about a possible resolution to its
Slide 17: ANDA Litigation Update
ANDA Litigation Update DRL Preliminary Injunction • On June 14th, DRL received approval for all 4 strengths of its generic buprenorphine/naloxone film product and launched its product “at risk” • On June 15th and July 13th, respectively, Indivior obtained a temporary restraining order (TRO) and a Pr
Slide 18: Key ANDA Litigation Milestones
Key ANDA Litigation Milestones Event Estimated Date Federal Circuit Court ruling in DRL PI appeal (expedited basis) Q4 2018 Federal Circuit Court ruling in appeal of ‘514 patent non-infringement ruling Q2 2019 Federal Circuit Court ruling in DRL PI appeal (non-expedited basis) Q2/Q3 2019 District Co
Slide 19: Mark Crossley, Chief Financial Officer
Mark Crossley Chief Financial Officer
Slide 20: Profit & Loss Account
Profit & Loss Account* Q2 H1 2018 2017 % 2018 2017 % Adjusted Adjusted change Adjusted Adjusted change ($ in mil.) Net Revenues 268 288 -7% 524 553 -5% Cost of Sales (35) (25) (59) (45) Gross Profit 233 263 -11% 465 508 -8% Gross Margin (%) 87% 91% 89% 92% Selling, General and Administration Expense
Slide 21: Net Revenue – By Region
Net Revenue – By Region Net Revenue Commentary Half Half % USA % Change • Market growth continues in low double digits, mainly ($ in mil.) Year Year Change Const. 2018 2017 driven by Medicaid channel growth from increased FX government funding • Suboxone® Film share was resilient in H1 2018 (54% avg
Slide 22: Operating Costs & Margins
Operating Costs & Margins Operating Costs H1 2018 Margins H1 2018 ($ in mil.) H1 18 H1 17 % ch H1 18 H1 17 H1 18 H1 17 SG&A (adjusted) (248) (195) 27% Reported Reported Adjusted Adjusted R&D (34) (44) -23% Gross margin 89% 92% -- -- Exceptional items -- (25) -- Depreciation & Amortization (7) (4) --
Slide 23: Targeting At Least $25m of Pre-tax Savings in FY 2018
Targeting At Least $25m of Pre-tax Savings in FY 2018 • Actions already initiated with savings expected to be fully captured in FY 2018 • SUBLOCADE™ launch remains fully funded • Maintaining strong compliance across the organization • Savings concentrated in non-critical SG&A ‒ Targeted areas includ
Slide 24: Cash & Borrowing Position at Half Year
Cash & Borrowing Position at Half Year Half Year Full Year • Net cash of $469m at half year, ($ in mil.) 2018 2017 improvement of $93m in the period Cash & Cash $951 $863 • Continue to retain cash on balance Equivalents sheet at present: Current Borrowings (5) (5) ✓ Flexibility until resolution of l
Slide 25: Summary
Summary “2 INDIVIOR ASN
Slide 26: Indivior PLC – Priorities for 2018
Indivior PLC – Priorities for 2018 Build on our Leadership Position in Global Addiction Treatment 1.SUBOXONE® Film 2. Ensure Successful 3. Expand Global 4. Focus on Capital Resilience US Launch for Treatment Allocation Pipeline Products • Preserve leading • SUBLOCADE™ monthly • Expand treatment acce
Slide 27: Appendix
Appendix “2 INDIVIOR ASN
Slide 28: Q2 Profit & Loss Account Reconciliation
Q2 Profit & Loss Account Reconciliation Q2 2018 Q2 2017 2018 2018 2017 2017 Adjustments Adjustments Actual Adjusted Actual Adjusted ($ in mil.) Net Revenues 268 268 288 288 Cost of Sales (35) (35) (25) (25) Gross Profit 233 233 263 263 Gross Margin (%) 87% 87% 91% 91% -- Selling, General and Adminis
Slide 29: H1 Profit & Loss Account Reconciliation
H1 Profit & Loss Account Reconciliation H1 2018 H1 2017 2018 2018 2017 2017 Adjustments Adjustments Actual Adjusted Actual Adjusted ($ in mil.) Net Revenues 524 524 553 553 Cost of Sales (59) (59) (45) (45) Gross Profit 465 465 508 508 Gross Margin (%) 89% 89% 92% 92% Selling, General and Administra
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: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment