Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — H1 2017 Earnings Presentation
32 slides from Indivior Pharmaceuticals's earnings presentation, Jul 27, 2017
Slide 1: Strengthening our global leadership in treatment of addiction
Strengthening our global leadership in treatment of addiction Half Year Results 2017 July 27th 2017
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 Performance Highlights Mark Crossley Financial Review H1 17 Revised Guidance for FY 17 Javier Rodriguez Litigation Update Christian Heidbreder Pipeline Update Shaun Thaxter Outlook Question & Answers
Slide 5: Half Year 2017 Highlights
Half Year 2017 Highlights Performance Above Plan Strong Operational Execution Excellent Pipeline Progress • Net Revenues $553m 4% • US market backdrop favorable; market • RBP-6000 (Monthly Buprenorphine growth sustained in low double-digits Depot) – NDA submitted on May 30th; • Op Profit * $269m 27%
Slide 6: Mark Crossley, Chief Financial Officer
Mark Crossley Chief Financial Officer
Slide 7: Profit & Loss Account
Profit & Loss Account* Q2 H1 2017 2016 % 2017 2016 % (1) (2) (1) (2) Adjusted Adjusted change Adjusted Adjusted change ($ in mil.) Net Revenues 288 274 +5 553 531 +4 Cost of Sales (25) (23) (45) (43) Gross Profit 263 251 +5 508 488 +4 Gross Margin (%) 91% 92% - 92% 92% - Selling, Distribution and Ad
Slide 8: Net Revenue – By Region
Net Revenue – By Region Net Revenue Commentary % USA Half Half % Change ($ in mil.) Year Year Change Const. • Market growth continues in low double digits on 2017 2016 expansion of treatment capacity FX • Suboxone® Film remains resilient, but some share USA 452 433 +4% +4% erosion in price sensitive
Slide 9: Operating Costs & Margins
Operating Costs & Margins Operating Costs H1 2017 Margins H1 2017 ($ in mil.) H1 17 H1 16 % ch H1 17 H1 16 H1 17 H1 16 Reported Reported Adjusted Adjusted SD&A (adjusted) (195) (217) -10 R&D (44) (59) -25 Gross margin 92% 90% 92% 92% Exceptional items (25) (4) - Depreciation & Amortization Operating
Slide 10: Tax Rate
Tax Rate H1 2017 rate of 30% Continue to guide Working progressively towards full year rate towards FY 17 guidance One-off tax benefit of of 24%, excluding Q1 rate 32% $9m related to Q2 exceptional tax charges exceptional items in SD&A Q2 rate 30% Ex.-exceptional Reflects mix of profits between UK a
Slide 11: Cash & Borrowing Position at Half Year
Cash & Borrowing Position at Half Year Half Year Full Year • Net cash of $295m at half year, ($ in mil.) 2017 2016 improvement of $164m in the period Cash & Cash due to strong cash inflow 792 692 Equivalents • Retaining cash on balance sheet at Current Borrowings (129) (101) present: ✓ Flexibility u
Slide 12: Cash Conversion
Cash Conversion Six months ended 30th June: 2017 2016 Cash Flows from Operating Profit 244 198 Reversal of other non-cash items 7 7 Operating Activities Depreciation and amortization 4 12 ($ in mil.) Changes in assets and liabilities (50) 13 Cash generated from Operations 205 230 Loan expenses and t
Slide 13: Revised Guidance for 2017
Revised Guidance for 2017 ($ in mil.) Previous Guidance New Guidance Net Revenue $1,050m -$1,080m $1,090m-$1,120m Net Income (adjusted) $200m - $220m $265m-$285m New guidance is based on no material change in market conditions: Top-line Expenses • Strong US market conditions in H1 2017 continue • Lo
Slide 14: Javier Rodriguez, Chief Legal Officer
Javier Rodriguez Chief Legal Officer
Slide 15: Major Litigation
Major Litigation The Group carries a provision of $242m for the investigative and antitrust litigation matters noted below. The provision increased by $25m compared to Q1 2017, reflecting the distinct and conclusive settlement of antitrust litigation with Amneal Pharmaceuticals LLC (Amneal). Other t
Slide 16: Christian Heidbreder, Chief Scientific Officer
Christian Heidbreder Chief Scientific Officer
Slide 17: Key Pipeline Assets: >$2 Billion of Combined Peak Sales Potential
Key Pipeline Assets: >$2 Billion of Combined Peak Sales Potential Stage of Development Status(1) Buprenorphine Lifecycle Phase 1 Phase II Phase III NDA Efficacy Safety Launch Peak Net Rev. Forecast (2) Fast Track Designation 5/23/16 ✓ Ph. III ✓ Ph. III Submitted RBP-6000 5/30/17 Achieved primary & Q
Slide 18: Arbaclofen Placarbil
Arbaclofen Placarbil ▪ Reformulation and clinical pharmacology assessment ongoing: ✓ Study Part 1: Test 2 new formulations + original formulation (PK in Healthy Volunteers [HV]) and alcohol test of all formulations ✓ ✓ Study Part 2: Optimize chosen formulation and determine food interaction (PK in H
Slide 19: Overdose Rescue Technologies & Canada
Overdose Rescue Technologies & Canada Overdose Rescue Technologies CANADA SUBOXONE® Tablet & Film ▪ RBP-8000 (Cocaine Esterase for Cocaine ▪ Approval of additional SUBOXONE® tablet dosage Intoxication): Termination agreement has been strengths (12mg/3mg and 16mg/4mg) (On track for Q4- finalized and
Slide 20: RBP-7000 Monthly Risperidone Depot
RBP-7000 Monthly Risperidone Depot ▪ Topline data from pivotal Phase III Efficacy Study published on May 5th, 2015 ▪ Phase III Long-term Safety Study (RB-US-13-0005) completed in September 2016 with database lock achieved October 2016; Final CSR signed off Q1-2017 ▪ Pre-NDA meeting held August 2016
Slide 21: RBP-6000 Monthly Buprenorphine Depot
RBP-6000 Monthly Buprenorphine Depot ▪ NDA submission May 30th, 2017 ▪ FDA will inform of review designation (i.e. priority or standard) and will communicate PDUFA date by July 29th, 2017 ▪ All ongoing clinical studies in the US on track: ✓ Phase 3 long-term safety extension 12-month trial (0003): F
Slide 22: RBP-6000 data dissemination 2017
RBP-6000 data dissemination 2017 Q2 Q3 Q4 Data/Topic Status APR MAY JUN JUL AUG SEP OCT NOV DEC College on Problems of Drug Dependence · Phase III Efficacy, Safety, PK Topline Results - 0001 Presented (CPDD) · Understanding Use of Buprenorphine without an Rx Presented 17-22 Montreal, Canada American
Slide 23: Outlook
Outlook “2 INDIVIOR ASN
Slide 24: Priorities for 2017
Priorities for 2017 Resolve legal risks and secure long-term certainty for Company 1.Suboxone® Film 2. Ensure Successful 3. Expand Global 4. Position for BD Resilience launch for Pipeline Treatment • Continue to repay Maintain leadership products filing NDAs • Expand treatment debt and strengthen po
Slide 25: Agenda for 2017
Agenda for 2017 Q3 Ending Sept. 30th Date Event July 29th FDA acceptance of RBP-6000 submission; “Priority” or “regular” review determined Sept. 11th to Morgan Stanley Healthcare Conf.; Presentation in NYC 12th Sept. 25th to ANDA trial for Alvogen and Mylan; Asserting the Suboxone® Film patents 27th
Slide 26: Summary
Summary We are making We face the progress in Continued focus future with managing the on creating confidence risks to the shareholder value business 26
Slide 27: Appendix
Appendix “2 INDIVIOR ASN
Slide 28: Q2 Profit & Loss Account Reconciliation
Q2 Profit & Loss Account Reconciliation Q2 2017 Q2 2016 2017 2017 2016 2016 Adjustments Adjustments Actual Adjusted Actual Adjusted ($ in mil.) Net Revenues 288 288 274 274 Cost of Sales (25) (25) (33) (10) (2) (23) Gross Profit 263 263 241 251 Gross Margin (%) 91% 91% 88% 92% Selling, Distribution
Slide 29: H1 Profit & Loss Account Reconciliation
H1 Profit & Loss Account Reconciliation H1 2017 H1 2016 2017 2017 2016 2016 Adjustments Adjustments Actual Adjusted Actual Adjusted ($ in mil.) Net Revenues 553 553 531 531 Cost of Sales (45) (45) (53) (10) (2) (43) Gross Profit 508 508 478 488 Gross Margin (%) 92% 92% 90% 92% Selling, Distribution
Slide 30: Important Safety Information
IMPORTANT SAFETY INFORMATION Indication SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be in
Slide 31: Thank You
THANK YOU. hn INDIVIOR
Slide 32: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment