Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — H1 2016 Earnings Presentation
44 slides from Indivior Pharmaceuticals's earnings presentation, Jul 29, 2016
Slide 1: Strengthening our global leadership in treatment of addiction
Strengthening our global leadership in treatment of addiction Half Year Results 2016 July 29th 2016
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 Cary Claiborne Financial Review - Profit & Loss Account - Cash Flow - Balance Sheet Revised Guidance for 2016 Javier Rodriguez Litigation Update Christian Heidbreder Pipeline Update Shaun Thaxter The future Question & Answers
Slide 5: 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 Phase 3 trial efficacy top-line • Op Profit $198m results due Q3 • Second consecutive quarter of • Net Income $107m ne
Slide 6: 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 no deterioration in generic tablet pricing; • Some slight deterioration in Generic tablet pricing
Slide 7: 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% 40.0% 33.6% • Akorn/Hi-tech making relatively little impact so far 30.0% • 28.2% Other generic company shares 27.1%
Slide 8: 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
Slide 9: 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 markets 30.0% 20.0% 10.0% Opioid Painkiller Dependence market 0.0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 10: Cary Claiborne, Chief Financial Officer
Cary Claiborne Chief Financial Officer
Slide 11: P&L
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, Distribution
Slide 12: Q1 & Q2 Trend – Adjusted
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 - Operat
Slide 13: Net Revenue – By Region
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 of W
Slide 14: Operating Expenses
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 by o
Slide 15: Tax Rate
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 Net $
Slide 16: Cash flows
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 (100
Slide 17: Cash Conversion
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 pai
Slide 18: Balance Sheet
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) Other
Slide 19: Cash & Borrowing Position at Half Year
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 (571
Slide 20: 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 21: Javier Rodriguez, Chief Legal Officer
Javier Rodriguez Chief Legal Officer
Slide 22: ANDA Litigation
ANDA Litigation • Trial against Alvogen in the lawsuit involving the Orange Book- listed patents and the ‘497 process patent for Suboxone® Film scheduled for April 2017, with Alvogen’s 30-month stay of FDA • The ruling after trial against Actavis and Par in the lawsuit involving approval expiring Oc
Slide 23: FTC Investigation 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 24: Department of Justice Investigation BDSI Litigation
Department of Justice Investigation BDSI Litigation A federal criminal grand jury investigation of Indivior Briefing is complete in Indivior’s appeal of the Patent Trial initiated in December 2013 is continuing, and and Appeal Board‘s (PTAB) decision in the Inter Partes includes marketing and promot
Slide 25: Christian Heidbreder, Chief Scientific Officer
Christian Heidbreder Chief Scientific Officer
Slide 26: The Pipeline update
The Pipeline update SZ INDIVIOR AS
Slide 27: 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 28: Opioid Use Disorder: RBP-6000 (Phase III)
OPIOID USE DISORDER: RBP-6000 (PHASE III) Clinical Phase III Efficacy & Safety trial (RB-US-13-0001): Database locked July 13th, 2016. On track to deliver topline results before end of Q3-2016. Phase III Long-Term Safety trial (RB-US-13-0003): Last Patient First Visit April 2016. On track to del
Slide 29: 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. Live July 26th, 2016. RBP-8000: Cocaine Esterase for Cocaine Intoxication (Phase II) Breakthrough Therapy Designation: Granted
Slide 30: Alcohol Use Disorder: Arbaclofen Placarbil (Phase IIA)
ALCOHOL USE DISORDER: ARBACLOFEN PLACARBIL (PHASE IIA) Phase IIA trial (RB-US-14-0001): Arbaclofen Placarbil found to be safe & well tolerated to doses up to 240mg (cap) in controlled abstinence setting. High inter-individual PK variability with increased doses. New formulation development a
Slide 31: Schizophrenia: RBP-7000 (Phase III)
SCHIZOPHRENIA: RBP-7000 (PHASE III) J. Clin. Psychopharmacology 36(2):130-140. http://dx.doi.org/10.1097/JCP.0000000000000479 Phase III efficacy trial (RB-US-09-0010): Efficacy, safety, and tolerability of RBP-7000 (90, 120 mg) compared to placebo in subjects with acute exacerbation of schizophren
Slide 32: 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 in August 2016. Regulatory Pre-NDA Meeting with FDA: August 2016. Planned NDA submission (pending outcome of pre-NDA meeting): Q4-2017.
Slide 33: New R&D Centre of Excellence (Hull, UK)
NEW R&D CENTRE OF EXCELLENCE (HULL, UK) New cross-functional R&D facility that will support Indivior’s Vision and Mission Building is expected to be water tight by early October 2016, and anticipated to be handed over to Indivior within Q2-2017, ahead of schedule, to allow exit of RB TSA by end of Q
Slide 34: Indivior R&D Day - December 2016
INDIVIOR R&D DAY - DECEMBER 2016 New York – venue to be announced Invitations to be sent out in September/October We aim to live webcast for those who cannot travel to New York.
Slide 35: Shaun Thaxter, Chief Executive Officer
Shaun Thaxter Chief Executive Officer
Slide 36: The Future
The Future “2 INDIVIOR ASN
Slide 37: Indivior PLC – Priorities for 2016
37 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 posit
Slide 38: 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 39: 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 40: 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 Sept 12 Morgan Stanley Conference Presentation in New York Q3 RBP 7000 Risperidone Depot Pre-NDA meeting Q3 RBP 6000 B
Slide 41: 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 41
Slide 42: 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 43: Thank You
THANK YOU! SE INDIVIOR
Slide 44: Strengthening our global leadership in Addiction Treatment
Strengthening our global leadership in Addiction Treatment