Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Non-Deal Roadshow (September 2016)
41 slides from Indivior Pharmaceuticals's roadshow presentation, September 2016
Slide 1: Strengthening our global leadership in treatment of addiction
Strengthening our global leadership in treatment of addiction US Roadshow 2016 September 2016
Slide 2: 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 3: Half Year Highlights
Half Year Highlights Financials Above Plan Operationally Strong Pipeline Continuing Progress • NR $531m • US market growth in mid to high • Buprenorphine Monthly Depot single digits positive Phase 3 trial efficacy top- • Op Profit $198m line results – meeting both • Second consecutive quarter of • N
Slide 4: What we said in February… What we are saying now
What we said in February… What we are saying now Basis for Guidance for 2016 Current Assumptions for 2016 • No material change in current market conditions; At the moment, the market trends continue ü no deterioration in generic tablet pricing; • Some slight deterioration in Generic tablet pricing ü
Slide 5: Guidance for 2016
Guidance for 2016 Previous Guidance Delta New Guidance Net Revenue $945m -$975m $25m - $55m $1,000m-$1,030m Net Income (adjusted) $155m - $180m $20m-$25m $180m-$200m Guidance is based on • Reinvestment of >$35m of the gross profit above • No material change in current market original assumptions in
Slide 6: So has anything changed?
So has anything changed? Generic Bup/Nal Tablet : Market Share No major shift in discounts since Q1 2016 70.0% 60.0% • Teva continue to build up their share of the generic market 50.0% 33.6% • Akorn/Hi-tech making relatively 40.0% little impact so far 30.0% 28.2% • Other generic company shares 27.1%
Slide 7: Competition is intensifying, but Film share has been resilient
Competition is intensifying, but Film share has been resilient 75% 70% 65% 60.6% 60% 55% 50% 45% 40% 35% 30% 25% 19.0% 20% 15% 14.9% 10% 4.8% 5% 0% 0.7% SUBOXONE FILM SUBOXONE TABLET GENERIC BUP GENERIC BUP/NAL ZUBSOLV BUNAVAIL 7
Slide 8: Europe
Europe 90.0% European share performance continues to be 80.0% extremely resilient 70.0% 60.0% 50.0% Market growth – austerity measures a drag 40.0% • Price gaps versus generics are a challenge in some 30.0% markets 20.0% 10.0% Opioid Painkiller Dependence market 0.0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 9: Indivior PLC – Priorities for 2016
Indivior PLC – Priorities for 2016 Resolve ANDA litigation and secure long-term certainty for Company 1.Suboxone Film 2. Develop the 3. Finance ready for 4. Expand Global Resilience pipeline BD / M&A treatment Preserve leadership • Transformational • Expand business • New treatment areas of position
Slide 10: Separation almost complete
Separation almost complete SAP Implemented Manufacturing and Capabilities 57 entities/countries Supply Chain • On time (2 to go) Operating Fine Chemical Fully staffed for standalone • On budget plant from 4/2015 PLC life • No disruption Company trading name Appropriate compliance and changes for 36
Slide 11: Cost Saving Initiative 2016
Cost Saving Initiative 2016 2014-2016 Building fit-for-purpose as PLC 2016 forward: Optimizing the Organisation First priority was to get it right Now optimising what we have • separation from RB • We have initiated a project in H2 2016 • standalone PLC functions • We are benchmarking costs against
Slide 12: Market Growth assisted by government focus & legislation
Market Growth assisted by government focus & legislation Patient Cap Nurse Practitioners / Assistants Directly Administered Drugs Patient Cap raised to 275 Nurse Practitioners & - Secretary given power to - but with ability for states to enact lower Physician Assistants to be exclude directly cap al
Slide 13: Agenda for 2016
Agenda for 2016 – 2 Date Activity Event Q3 Q3 Arbaclofen Placarbil for Alcohol use disorder Final CSR phase 2A study (RB-US-14-0001) July 29 Half Year Results Presentation in London Aug RBP 7000 Risperidone Depot Pre-NDA meeting Aug RBP 6000 Buprenorphine Depot Topline results of Phase 3 efficacy cl
Slide 14: Summary
Summary We face the We are making future with progress in We look forward managing the to continuing our renewed risks to the progress confidence business 14
Slide 15: Indication and 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 initiated under the direction o
Slide 16: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment
Slide 17: Back Up
Back Up - Litigation update - Pipeline update - Financial Results – Half Year
Slide 18: Litigation Update
Litigation Update “ZINDIVIOR AS
Slide 19: ANDA Litigation
Trial against Alvogen in the lawsuit involving the Orange Book-listed ANDA Litigation patents and the ‘497 process patent for Suboxone® Film scheduled for April 2017, with Alvogen’s 30-month stay of FDA approval expiring The ruling after trial against Actavis and Par in the lawsuit involving the Oct
Slide 20: FTC Investigation and Class Action Antitrust Litigation
FTC Investigation Class Action Antitrust Litigation • Fact discovery is continuing in the Class Action litigation. The Judge overseeing the legal privilege dispute in the FTC investigation has appointed a Special Master (an • In August 2015, the Company was informed that a contingent of independent
Slide 21: Department of Justice Investigation and BDSI Litigation
Department of Justice Investigation BDSI Litigation A federal criminal grand jury investigation of Indivior In October 2014, BDSI sought an inter partes initiated in December 2013 is continuing, and review by the U.S. Patent Office of claims 15-19 includes marketing and promotion practices, pediatri
Slide 22: The Pipeline update
The Pipeline update “ZINDIVIOR AS
Slide 23: SUBOXONE Tablet
SUBOXONE® Tablet Canada: Additional Dosage Strengths § Meeting with Health Canada (HC): Confirmation that bioequivalence criteria were met for the proposed 12mg/3 mg and 16 mg/4 mg dosage strengths. § NDS submission plans ongoing. China: NDA preparation & submission § Efficacy Study (RB-CN-10-0013):
Slide 24: Opioid Use Disorder: RBP-6000 (Phase III)
OPIOID USE DISORDER: RBP-6000 (PHASE III) Clinical § Phase III Efficacy & Safety trial (RB-US-13-0001): positive topline results announced August 17th, 2016 showing RBP-6000 meets both primary and secondary endpoints vs. placebo (p<0.0001) § Phase III Long-Term Safety trial (RB-US-13-0003): Last Pat
Slide 25: 2016 Peer-Reviewed Scientific Publications: RBP-6000
2016 PEER-REVIEWED SCIENTIFIC PUBLICATIONS: RBP-6000 J Clin Psychopharmacol, 36(1):18-26. http://dx.doi.org/10.1097/JCP.0000000000000434 §Monthly injections of RBP-6000 produced clinically relevant plasma levels of buprenorphine (and predicted μ-opioid receptor occupancy in the brain), which transla
Slide 26: Rescue Medication for Drug Overdose/Intoxication
RESCUE MEDICATION FOR DRUG OVERDOSE/INTOXICATION Intranasal Naloxone for Opioid Overdose § Temporary Authorization for Use (ATU): Approved by French ANSM on Nov 5th, 2015. ATU launch approval Jul 26th, 2016 with NALSCUE® launch in France on Jul 27th, 2016. RBP-8000: Cocaine Esterase for Cocaine Into
Slide 27: Alcohol Use Disorder: Arbaclofen Placarbil (Phase IIA)
ALCOHOL USE DISORDER: ARBACLOFEN PLACARBIL (PHASE IIA) § Phase IIA trial (RB-US-14-0001): ü Arbaclofen Placarbil found to be safe & well tolerated to doses up to 240mg (cap) in controlled abstinence setting. ü High inter-individual PK variability with increased doses. § New formulation development a
Slide 28: Schizophrenia: RBP-7000 (Phase III)
SCHIZOPHRENIA: RBP-7000 (PHASE III) Clinical § Long Term Safety trial (RB-US-13-0005): On track with Last Patient Last Visit expected by Q4-2016. Regulatory § Pre-NDA Meeting with FDA: Held successfully in August 2016. § Planned NDA submission by Q4-2017. 28
Slide 29: 2016 Peer-Reviewed Scientific Publications: RBP-7000
2016 PEER-REVIEWED SCIENTIFIC PUBLICATIONS: RBP-7000 J. Clin. Psychopharmacology 36(2):130-140. http://dx.doi.org/10.1097/JCP.0000000000000479 § Phase III efficacy trial (RB-US-09-0010): RBP-7000 (90 mg & 120 mg) significantly reduced Positive and Negative Syndrome Scale (PANSS) total scores (primar
Slide 30: Indivior R&D Day – December 9th, 2016
INDIVIOR R&D DAY – DECEMBER 9TH, 2016 § New York – Jefferies Offices § Invitations to be sent out in October § We aim to live webcast for those who cannot travel to New York. 30
Slide 31: Financial Back-Up
Financial Back-Up Half Year Financial Results to June 30th, 2016
Slide 32: P&L Reported Adjusted
32 P&L 2015 2015 2016 % 2016 % Half Year Ended 30th June: Unaudited Reported Adjusted Reported change Adjusted change $m Net Revenues 517 517 531 +3 531 +3 Cost of Sales (48) (48) (43) (43) Exceptional items - - (10) Gross Profit 469 469 478 +2 488 +4 Gross Margin 91% 91% 90% 92% Selling, Distributi
Slide 33: Q1 & Q2 Trend – Adjusted
33 Q1 & Q2 Trend – Adjusted (excludes exceptionals) (%Δ at constant exchange: *numbers may not aggregate due to rounding) $m Q1* % Δ Q2* % Δ HY % Δ Net Revenue 258 +4 274 +3 531 +3 Gross Profit (% margin) 237 (92%) 251 (92%) 488 (92%) SD&A (105) (112) (217) R&D (31) (28) (59) Exceptional Costs - Ope
Slide 34: Net Revenue – By Region
34 Net Revenue – By Region Net Revenue Commentary % Half Half % change USA $m Year Year 2015 2016 Change Const • Market growth mid-to-high single digits FX • Share gain from 60% to 61% • Price increase offset by annualising of USA 412 433 +5% +5% rebate increases from last year. Rest of World Rest o
Slide 35: Operating Expenses
35 Operating Expenses Margins Operating Costs H1 2016 H1 2015 Adjusted 2016 Adjusted 2016 Reported 2015 2016 % ch SD&A 180 217 +21 Gross margin 91% 92% 90% R&D 54 59 +9 Exceptional item 5 4 - Operating margin 44% 40% 37% Depreciation & Amortisation 12 12 - (included in SD&A) • SD&A increase driven b
Slide 36: Tax Rate
36 Tax Rate Guidance for rate of Working progressively Continue to guide 25% in 2016 towards that guidance towards full year rate of Plus one-off exceptional Q1 rate 36% 25% tax charge of $14m Plus $5m exceptional plus exceptional tax - $5m in Q1 Q2 rate 20% charges - $14m in Q2 less $5m tax Plus Ne
Slide 37: Cash flows
37 Cash flows Six months ended 30 th June Unaudited $m 2015 2016 Cash Flows from Operating Profit 230 198 Operating Activities Reversal of non-cash items (4) 7 Depreciation and amortisation 12 12 Changes in assets and liabilities 82 13 Cash generated from Operations 320 230 Taxes and interest paid (
Slide 38: Cash Conversion
38 Cash Conversion Six months ended 30th June: $m 2015 2016 Cash Flows from Operating Profit 230 198 Operating Activities Reversal of other non-cash items (4) 7 Depreciation and amortisation 12 12 Changes in assets and liabilities 82 13 Cash generated from Operations 320 230 Loan expenses and taxes
Slide 39: Balance Sheet
39 Balance Sheet Unaudited 2015 2016 $m Full Year Half Year Intangible Assets 62 49 Other non-current Assets 154 153 Total Non-Current Assets 216 202 Cash and Cash Equivalents 467 577 Other current assets 254 294 Total Current Assets 721 871 Total Assets 937 1,073 Short-term Borrowings (34) (47) Oth
Slide 40: Cash & Borrowing Position at Half Year
40 Cash & Borrowing Position at Half Year Full Year Half Year 2015 2016 Cash & Cash Equivalents 467 577 Net Debt of $5m at half year, improvement of $169m in the period due to strong cash in-flow.* Current Borrowings (34) (47) After repurchase of additional $46m of debt in the Long-term Borrowings (
Slide 41: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment