Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — FY2017 Earnings Presentation
37 slides from Indivior Pharmaceuticals's earnings presentation, Feb 15, 2018
Slide 1: The leader in global addiction treatments
The leader in global addiction treatments Full Year Results 2017 February 15th 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 Opening Remarks Mark Crossley Financial Review Javier Rodriguez Litigation Update Christian Heidbreder R&D Update Shaun Thaxter Priorities for 2018 Q&A
Slide 5: Our Vision
OUR VISION For all patients around the world to have access to evidenced-based treatment for the chronic relapsing conditions and co- occurring disorders of addiction
Slide 6: FY 2017 Key Takeaway: Indivior Executed on its Strategic Priorities
FY 2017 Key Takeaway: Indivior Executed on its Strategic Priorities ✓ SUBOXONE® Film Resilience – Maintained leading share (avg. 57%) among daily BMAT options in US ✓ Pipeline Progress – SUBLOCADE™ approved by FDA and RBP-7000 NDA accepted by FDA ✓ Expanded Treatment Access – Record treatment provid
Slide 7: FY 2017 Snapshot & FY 2018 Guidance
FY 2017 Snapshot & FY 2018 Guidance FY 17 Performance In-line with Raised FY 17 Operating Highlights Pipeline Realization Expectations (on an adjusted basis vs. FY 2016) • US market growth accelerated • SUBLOCADE™ on track for launch and availability week of Feb. 26, • SUBOXONE® Film share averaged
Slide 8: Litigation Provision
Litigation Provision The Group increased its provision for investigative and antitrust litigation matters to $438m. Because these matters are in various stages, Indivior cannot predict with any certainty the ultimate resolutions, costs, or timing of the ultimate resolution of any of the matters. The
Slide 9: SUBLOCADE Injection – A New Treatment for Moderate-to-Severe OUD
SUBLOCADE™ (buprenorphine extended-release) Injection– A New Treatment for Moderate-to-Severe Opioid Use Disorder (OUD) What: The first once-monthly buprenorphine long-acting injection When: Launching and available week of Feb. 26th Where: US, initially; preparing ROW market filings Dosages: 100mg a
Slide 10: Expected SUBLOCADE Uptake Weighted to H2 2018
Expected SUBLOCADE™ Uptake Weighted to H2 2018 March May Initial Initial patient prescriptions feedback HI 18: Initial Prescription Phase H2 18: Expected SUBLOCADE Uptake Wk. of Feb. 26th June Key Prescribing & Adoption Metrics National launch Additional April patients First patients injected w/ inj
Slide 11: Working Alongside Payers to Provide Access to Treatment
Working Alongside Payers to Provide Access to Treatment Payer Coverage Patient Access • Consulting with Payer Groups • $5 Copay Program for eligible ✓ Aligned on burden of disease patients ✓ Firm understanding of unmet needs • Targeting robust formulary coverage in 2018 • Primarily a medical benefit
Slide 12: Mark Crossley, Chief Financial Officer
Mark Crossley Chief Financial Officer
Slide 13: Income Statement
Income Statement* FY Q4 2017 2016 % 2017 2016 % Adjusted Adjusted change Adjusted Adjusted change ($ in mil.) Net Revenues 1,093 1,058 +3 265 259 +2 Cost of Sales (104) (96) (32) (29) Gross Profit 989 962 +3 233 230 +1 Gross Margin (%) 90% 91% -44 bps 88% 89% -88 bps Selling, Distribution and Admini
Slide 14: Net Revenue – By Region
Net Revenue – By Region Net Revenue Key Points USA FY 2017 FY 2016 % ch. % ch. • Market growth continued in low double digits on ($ in mil.) (Const. FX) expansion of treatment capacity • SUBOXONE® Film remained resilient, but ongoing USA 877 857 +2% NA share erosion in price sensitive accounts (Mana
Slide 15: FY 2017 Margins & Operating Costs
FY 2017 Margins & Operating Costs FY 2017 Margins FY 2017 Operating Costs FY 17 FY 16 FY 17 FY 16 ($ in mil.) FY 17 FY 16 % ch. Reported Reported Adjusted Adjusted SD&A (adjusted) (497) (456) +9 R&D (89) (119) -25 Gross margin 90% 90% 90% 91% Exceptional items (210) (227) - Operating margin 17% 14%
Slide 16: Net Income & Tax
Net Income & Tax FY 2017 Adjusted Net Income Adj. FY 2017 rate of 25% FY 2018 tax rate guidance ($ in mil.) FY 17 FY 16 slightly higher than 24% of high-teens, excluding Op. Profit (adj.) 403 387 expected exceptional tax charges Reflects mix of profits Due to new US tax law Net Interest (adj.) (42)
Slide 17: Cash & Borrowing Position at End of 2017
Cash & Borrowing Position at End of 2017 • Net cash of $376m at end of FY 17, FY FY improvement of $245m in the period ($ in mil.) 2017 2016 Cash & Cash • Retaining cash on balance sheet at 863 692 Equivalents present: Current Borrowings (5) (101) ✓ Protect against potential ‘at-risk’ generic bupren
Slide 18: US and EURO Denominated Term Loan B Replacements
US and EURO Denominated Term Loan B Replacements Debt maturity extension to Dec. 2022 Balloon payment deferred from Dec. 2019 More economical debt service: interest and principal Lower annual mandatory principal prepayments (1% vs. 10%) Interest cost saving (pro forma 2018) Leverage covenant thresho
Slide 19: Cash Conversion
Cash Conversion Twelve months ended December 31st: FY 17 FY 16 Cash Flows from Operating Profit 193 149 Operating Activities Depreciation and amortization 13 14 ($ in mil.) Reversal of other non-cash items 22 11 Changes in assets and liabilities (60) 119 Provisions 201 219 Cash generated from Operat
Slide 20: Guidance for 2018
Guidance for 2018 ($ in mil.) Guidance % change v. FY 17 (at mid-point) Net Revenue $1,130m -$1,170m +5% Net Income $290m - $320m +13% Top-line: Expenses: • No material change in US market conditions • Launch investments for SUBLOCADE and RBP-7000 ✓ No ‘at-risk’ generic film entry in 2018 • Lower fi
Slide 21: Javier Rodriguez, Chief Legal Officer
Javier Rodriguez Chief Legal Officer
Slide 22: Major Litigation
Major Litigation The Group increased its provision for investigative and antitrust litigation matters to $438m during the quarter. Because these matters are in various stages, Indivior cannot predict with any certainty the ultimate resolutions, costs or timing of the resolutions of any of the matter
Slide 23: Christian Heidbreder, Chief Scientific Officer
Christian Heidbreder Chief Scientific Officer
Slide 24: Postmarketing Requirements (PMR) & Postmarketing Commitments (PMC)
POSTMARKETING REQUIREMENTS (PMR) & POSTMARKETING COMMITMENTS (PMC) PMR Studies: ▪ 4 nonclinical studies to assess the effects of NMP (co-polymer in SUBLOCADE™ formulation) on embryofetal, pre-and post-natal development. ▪ 2 clinical studies: ✓ Identification of the patient population that will benef
Slide 25: Health Economics & Outcomes Research (HEOR) Studies
HEALTH ECONOMICS & OUTCOMES RESEARCH (HEOR) STUDIES STEP #1 STEP #2 STEP #3 STEP #4 RECOVER® Study SUBLOCADE™ (RB-US- Characterize the periods 13-0001) Pivotal Trial SUBLOCADE™ (RB-US- of abstinence over a 12- SUBLOCADE™ Targeted Analysis 13-0003) Long-Term month observational HEOR Trial Analysis of
Slide 26: Lifecycle Evidence Generation & Optimization (LEGO)
LIFECYCLE EVIDENCE GENERATION & OPTIMIZATION (LEGO) Study Objective Start End Buprenorphine Abuse, Deep understanding of root causes of abuse, diversion Misuse, Diversion (AMD) Q4-2017 Q3-2019 & misuse Epidemiology Explore how craving VAS and other craving SUBLOCADE™ VAS craving measurement tools mi
Slide 27: Pipeline Update
PIPELINE UPDATE SUBOXONE® Tablet & Film (OUD) RBP-7000 (Schizophrenia) ▪ Submission of SUBOXONE® Tablet NDA to Chinese FDA (CFDA) on Dec 27th, ▪ NDA submitted Sep 28th, 2017 2016. Priority Review granted by CFDA Jun 6th, 2017. ▪ NDA filing accepted by FDA Dec 12th, 2017 ▪ SUBOXONE® Film addition to
Slide 28: Planned Conferences / Events 2018
PLANNED CONFERENCES / EVENTS 2018* Conference Where? When? American Association for the Treatment of Opioid Dependence (AATOD) New York, NY Mar 10th – 14th American Society for Clinical Pharmacology and Therapeutics (ASCPT) Orlando, FL Mar 21st – 24th American Society of Addiction Medicine (ASAM) Sa
Slide 29: Shaun Thaxter, Chief Executive Officer
Shaun Thaxter Chief Executive Officer
Slide 30: 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 Launch for Pipeline Treatment Allocation Preserve leading Products • Expand treatment • Continue to manage position
Slide 31: Summary
Summary We are making We look forward We face the progress in managing the to continuing our future with progress to create confidence risks to the shareholder value business 31
Slide 32: Appendix
Appendix So INDIVIOR
Slide 33: Income Statement: FY2017 vs. FY2016
Income Statement: FY2017 vs. FY2016 FY2017 FY2016 Δ 2017 2017 Y-o-Y 2016 2016 Adjustments Adjustments Actual Adjusted (adjusted) Actual Adjusted ($ in mil. at Actual FX) Net Revenues 1,093 1,093 +3% 1,058 1,058 Cost of Sales (104) (104) (107) (11) (1) (96) Gross Profit 989 989 +3% 951 962 Gross Marg
Slide 34: Income Statement: Q4 17 vs. Q4 16
Income Statement: Q4 17 vs. Q4 16 Q4 2017 Q4 2016 Δ Q4 2017 2017 Y-o-Y 2016 2016 Adjustments Adjustments Actual Adjusted (adjusted) Actual Adjusted ($ in mil. at Actual FX ) Net Revenues 265 265 +2% 259 259 Cost of Sales (32) (32) (29) (29) Gross Profit 233 233 230 230 Gross Margin (%) 88% 88% 88% 8
Slide 35: Capital Markets Agenda 2018
Capital Markets Agenda 2018* Date Event Feb. 15th FY 2017 Results (London Presentation) Feb 27th & 28th CSFB One-on-one Conference (London) March 12th to 14th Stifel-sponsored NDR (US) March 19th Bank of America Merrill Lynch “Bus Tour” (London) May 2nd Q1 2018 Results (Conference Call) May 8th & 9t
Slide 36: 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 37: Indication and Usage
INDICATION AND USAGE SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by a dose adjustment period for a minimum of seven days. SUBLOCADE should be used as part of