Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — JP Morgan Healthcare Conference 2017
41 slides from Indivior Pharmaceuticals's conference presentation, Jan 9, 2017
Slide 1: Strengthening our global leadership in treatment of addiction
Strengthening our global leadership in treatment of addiction JP Morgan Healthcare Conference 2017 January 9-11, 2017
Slide 2: Forward Looking Statements
Forward Looking Statements This announcement 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: Indivior PLC: Global Leader in Treatment of Opioid Dependence
Indivior PLC Global Leader in Treatment of Public Company since December Opioid Dependence 2014 • 2016 Sales >$1bn • UK Domiciled • Mainly SUBOXONE® brand • London Listed US Based Business Experienced management team • 80% of sales in US • Built business from c.$35m (£21m) sales in • HQ in Richmond,
Slide 4: Addiction
Addiction Scale of the problem
Slide 5: Addiction – A Global Epidemic affecting many millions
Addiction – A Global Epidemic affecting many millions • c.250m people worldwide used illicit drugs • We are global leaders in treatment of opioid use disorder: • 27m people aged 15-64 suffer from drug use disorders or drug dependence globally • We are expanding our portfolio into other substance use
Slide 6: >3 people in the US die of opioid overdose every hour
>3 people in the US die of THE DAILY RATE OF OVERDOSE DEATHS IN THE opioid overdose every hour of US IS THE EQUIVALENT OF AN 80-PASSENGER PLANE CRASHING EVERY DAY WITH NO every day1 SURVIVORS Images like this one from the shocking Ohio overdose story in September are becoming all too common 1Center
Slide 7: Our Vision
OUR VISION That all patients around the world will have unrestricted access to high quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 8: Improving treatment access
8 RBP-6000 GOALS Improving treatment access >2.5m <50% patients diagnosed with of diagnosed patients OUD in the US1 receive any MAT2 Improving treatment retention 52% 69% of BMAT patients of patients who leave leave treatment treatment are asked to within 2 months2 leave by their physician as assess
Slide 9: Opioid Dependence
Opioid Dependence Medication assisted treatment market is very US-based currently • US accounts for substantial majority (80%+) of buprenorphine based medication assisted treatment for opioid dependency by value • Approximately 2.3m potential patients, the majority of whom (1.9m) abuse or are depend
Slide 10: Ex-US markets in earlier stage of development
Ex-US markets in earlier stage of development • EU (>1m problem opioid users) differs from US as opioid- dependence mainly heroin addiction1 • Policy focused more on harm reduction for society than on patient recovery • Methadone clinics, strict supervision prevail • Volume growing slowly, value in
Slide 11: Progress in 2016
Indivior PLC Progress in 2016
Slide 12: YTD Q3 Highlights
YTD Q3 Highlights Financials Above Plan Operationally Strong Pipeline Continuing Progress • NR $799m • US market growth in mid to high • Buprenorphine Monthly Depot single digits positive Phase 3 trial efficacy top- • Op Profit* $315m line results – in line to meet both • Third consecutive quarter o
Slide 13: Guidance for 2016
Guidance for 2016 Initial Guidance Half Year Guidance New Guidance Net Revenue $945m -$975m 1,000m - $1,030m $1,060m-$1,075m Net Income (adjusted) $155m - $180m $180m - $200m $250m-$265m Guidance was based on • Reinvestment of <$35m of the gross profit above • No material change in current market or
Slide 14: Priorities for 2016
INDIVIOR PLC – PRIORITIES FOR 2016 (AS SHOWN IN FEBRUARY & JULY) Resolve litigation & investigations 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
Slide 15: Competition is intensifying, but Film share has been resilient
Competition is intensifying, but Film share has been resilient 75% 70% 65% 60.7% 60% 55% 50% 45% 40% 35% 30% 25% 19.2% 20% 14.3% 15% 10% 5.0% 5% 0.8% 0% SUBOXONE FILM SUBOXONE TABLET GENERIC BUP GENERIC BUP/NAL ZUBSOLV BUNAVAIL 15
Slide 16: ANDA litigation update
ANDA litigation update Timetable • 5 Generic companies pursuing ANDAs seeking to commercialise generic ANDA Applicant Patents asserted Trial Date 30 Month Stay versions of SUBOXONE® Film in US against Filer Expires • Indivior has asserted patents (both Actavis Par 3 Orange Book Nov/Dec 2015 28 Feb 2
Slide 17: Other Legal Proceedings
Other Legal Proceedings (see detailed disclosures in back-up) Department of Justice Federal Trade Commission A federal criminal grand jury investigation of Indivior A non-public investigation of Indivior initiated in June initiated in Dec 2013 is continuing and includes marketing 2013 is continuing
Slide 18: R&D Pipeline Delivery
R&D Pipeline Delivery Success with the major projects Scale of Market Opportunity • RBP-6000 – Phase III efficacy and as indicated on demerger 1 safety trials concluded Product Potential Peak NR • Achieved all primary and secondary endpoints RBP-6000 $400m - $700m • RBP-7000 – Phase III efficacy and
Slide 19: More on key asset – RBP-6000
More on key asset – RBP-6000 Monthly Depot Buprenorphine Objectives of development • Proven ATRIGEL® sub-cutaneous system • To enhance compliance and adherence to • Phase III efficacy and safety trial: Top Line treatment Results published August 17th, 2016. • To reduce risk of diversion & misuse • P
Slide 20: First priority is always to invest in organic growth
First priority is always to invest in organic growth Lower risk, investing in what we know. Pre-commercialisation for RBP-6000 Accelerating growth in treatment USA Medical education Significant investment in driving patients into treatment Healthcare professional & patient preparation Opportunities
Slide 21: 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 have already achieved some savi
Slide 22: Agenda for 2017 – H1
Agenda for 2017 – H1 Date Activity Event Q1 Jan 9-11 JP Morgan Conference San Francisco Feb 22 Full Year 2016 Financial Results Presentation in London (webcast live) End Q1 RBP-6000 Long-term safety extension Top Line results End Q1 RBP-7000 long-term safety extension Top Line results Q2 May 3 Q1 20
Slide 23: Summary
Summary We are making We face the progress in We look forward future with managing the to continuing our confidence risks to the progress business 23
Slide 24: 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 25: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment
Slide 26: Back Up
Back Up - Litigation update - Pipeline update (at Q3)
Slide 27: Litigation Update
LITIGATION UPDATE Our vision is that all patients around the world will have unrestricted access to high quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 28: $220m Litigation provision
$220m Litigation provision The Company has recorded a charge of $220m in the third quarter of 2016 for the investigative and antitrust litigation matters noted below. Because these matters are in various stages, the Company cannot predict with any certainty the ultimate resolution or cost of all of
Slide 29: Department of Justice Investigation, State Subpoenas
Department of Justice Investigation State Subpoenas A federal criminal grand jury investigation of Indivior On October 12, 2016, the Company was served with a subpoena initiated in December 2013 is continuing, and includes for records from the state of Connecticut Office of the Attorney marketing an
Slide 30: FTC Investigation, Antitrust Litigation
Amneal Pharmaceuticals LLC, a manufacturer of generic buprenorphine / FTC Investigation naloxone tablets, filed a complaint against the Company in December 2015. This case has been coordinated with the Class Action litigation. The Judge overseeing the legal privilege dispute in the FTC Amneal’s comp
Slide 31: ANDA Litigation
Trial against Dr. Reddy’s in the lawsuit involving the Orange Book-listed ANDA Litigation patents for SUBOXONE® Film took place on November 7th, 16th, and 21st-- 23rd, 2016, with Dr. Reddy’s 30-month stay of FDA approval on ANDA No. 20-5806 expiring April 17th, 2017. Indivior believes Dr. Reddy’s 30
Slide 32: Inter-Partes Reviews
Inter-Partes Reviews The USPTO declined to institute Teva’s petitions for inter partes review of the three Orange Book-listed patents on procedural grounds. Dr. Reddy’s has filed an inter partes review petition on each of the three Orange Book Patents. These petitions are substantively similar to th
Slide 33: The Pipeline update
The Pipeline update SZ INDIVIOR AS
Slide 34: Opioid Use Disorder
3 4 OPIOID USE DISORDER Product Geography Milestone Additional Dosage Strengths 12mg/3 mg and 16 mg/4 mg: sNDS submitted to Health Canada SUBOXONE® (HC) Dec 6th, 2016. Tablet NDA preparation: Plan to submit NDA to CFDA by end of Q4-2016 Phase 3 efficacy and safety trial (RB-US-13-0001): Positive t
Slide 35: 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 transl
Slide 36: Psychiatric Co-Morbidities
3 6 PSYCHIATRIC CO-MORBIDITIES Product Geography Milestone Phase 3 efficacy and safety trial (RB-US-09-0010): Positive top line results released May 5th, 2015. Phase 3 long-term safety extension trial (RB-US-13-0005): Database Lock achieved Oct 21st, 2016. RBP-7000 in US Health Economics &
Slide 37: Psychiatric Co-Morbidities (Schizophrenia)
3 7 PSYCHIATRIC CO-MORBIDITIES (SCHIZOPHRENIA) Product Geography Milestone Phase 3 efficacy and safety trial (RB-US-09-0010): Positive top line results released May 5th, 2015. Phase 3 long-term safety extension trial (RB-US-13-0005): Database Lock achieved Oct 21st, 2016. RBP-7000 in US He
Slide 38: 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 39: Alcohol Use Disorder
3 9 ALCOHOL USE DISORDER Product Geography Milestone RB-US-14-0001: Final Clinical Study Report Jun 29th, 2016. Arbaclofen Placarbil appears to be safe & well tolerated up to a dose of 240mg in controlled abstinence setting. However: Arbaclofen Significant inter-individual variability in pharm
Slide 40: Rescue Medications for Drug Overdose/Intoxication
4 0 RESCUE MEDICATIONS FOR DRUG OVERDOSE/INTOXICATION Product Geography Milestone Temporary Authorization for Use (ATU): Approved by French ANSM on Nov 5th, 2015. Intranasal Naloxone for ANSM approved ATU launch on Jul 26th, 2016 with NALSCUE® launch in France on Jul France Opioid 27th, 2016. Ov
Slide 41: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment