Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Investor Day (December 2013)
107 slides from Teva Pharmaceutical Industries's investor day presentation, Dec 4, 2013
Slide 1: Teva R&D in Focus: NTE
Teva R&D in Focus: NTE From process to products: Unveiling the new pipeline from the NTE program of 2013 Webinar for the investment community December 4th, 2013
Slide 2: Teva's Safe Harbor Statement
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This document contains forward-looking statements, which express the current beliefs and expectations of management. Such statements involve a number of known and unknown risks and uncertainties that could
Slide 3: Teva R&D in Focus: NTE
Teva R&D in Focus: NTE From process to products: Unveiling the new pipeline from the NTE program of 2013 Webinar for the investment community December 4th, 2013
Slide 4: Where are we today?
Where are we today? 14 new products in development: 8 will be submitted in next 3 years Bolster pipeline in Teva’s core TAs 1 product approved (Adasuve® - in-licensed) A sustainable platform in place: ~10 new product development programs each year 4
Slide 5: Where will we be in 2018 and 2020?
Where will we be in 2018 and 2020? Projected sales of new products from NTE process (Risk Adjusted) $3B $1-1.5B 2018 2020 5
Slide 6: Agenda
Agenda The strategic rationale New products from the NTE program of 2013 Where could we be in 2018 and 2020 6
Slide 7: Agenda
Agenda The strategic rationale New products from the NTE program of 2013 Where could we be in 2018 and 2020 7
Slide 8: NTE - a process to grow our pipeline
NTE - a process to grow our pipeline The NTE process generates new specialty products that: Address an unmet patient need Are based on a known molecule Are formulated, delivered, or used in a novel way NTE: New Therapeutic Entities 8
Slide 9: Products from NTE process: attractive risk/return profile
9 Products from NTE process: attractive risk/return profile Proven efficacy Lower development risk HIGH value Shorter timelines Lower costs LOW Risk Significant returns 9 9
Slide 10: NTE products have shorter development timelines and lower costs
Products from NTE process have shorter development timelines and lower costs NCE (New Chemical Entity) process = 10-15 years, $1-2B DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III SUB. NTE process = 3-6 years, $10-50M • 505(b)(2) pathway in US PRE- PHASE I PHASE SUB. • Referencing safety & FORMULA
Slide 11: Products from NTE process have higher development success rates
Products from NTE process have higher development success rates Success rates in Phase 3: NCE vs. 505(b)(2) 66% 41% Benchmark for products NCE 505(b)(2) from NTE process Source: Biomed Tracker / BIO 11
Slide 12: Products from NTE process can generate significant sales
Products from NTE process can generate significant sales Expected distribution of peak sales of our current portfolio (from NTE program of 2013): Peak Sales Share of NTE Portfolio 100-300 M$ ~ 60% 300-500 M$ ~ 30% >500 M$ ~ 10% 12
Slide 13: Market exclusivity can be secured by combining IP and regulatory protection
Market exclusivity can be secured by combining IP and regulatory protection Many patent types can be obtained: 11 new NTE Formulations / dosage / indications / patent IP technology / combinations / product / salt / polymorph / clinical end points / applications pharmacokinetic profile / etc… filed t
Slide 14: Products from NTE process target an attractive space
Products from NTE process target an attractive space 14
Slide 15: Why is Teva positioned to succeed in this space?
Why is Teva positioned to succeed in this space? 15
Slide 16: NTE process at Teva
NTE process at Teva Unprecedented scale Based on integration of established generic and specialty skills Disciplined process Dedicated resources 16
Slide 17: Teva has strong technological capabilities
Teva has strong technological capabilities > 250 formulators > 1000 product files: Analytical methods, formulation challenges, PK Profile > 15 distinct complex technologies in house: LAR, Liposomal, transdermal, thin film, patches etc. Multiple proprietary formulation technologies: Abuse deter
Slide 18: Teva has strong drug development capabilities
Teva has strong drug development capabilities Full scale pre-clinical development Highly experienced clinical development team Strong global regulatory affairs Deep medical understanding of patient needs 18
Slide 19: Unique integrated R&D organization
Combining technological and drug development capabilities in a unique integrated R&D organization 19
Slide 20: Ideas are evaluated in a disciplined multidisciplinary process
Ideas are evaluated in a disciplined multidisciplinary process Product concepts Viability assessment (Generic & Specialty R&D, Commercial) Initial commercial validation (Commercial, payer) Technical feasibility Including (Generic & Specialty R&D) in-vitro studies Building Business case Incl. physici
Slide 21: "Class of 2013" emerged following evaluation of >150 ideas
“Class of 2013” emerged following evaluation of > 150 ideas > 150 product concepts Viability assessment (Generic & Specialty R&D, Commercial) Initial commercial validation (Commercial, payer) Technical feasibility Including (Generic & Specialty R&D) in-vitro studies Building Business case Including
Slide 22: Agenda
Agenda The strategic rationale New products from the NTE program of 2013 Where could we be in 2018 and 2020 22
Slide 23: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 23
Slide 24: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 Schizophrenia Risperidone Once-a-month injection 5 Once-every-3-months injection 6 24
Slide 25: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 Schizophrenia Risperidone Once-a-month injection 5 Once-every-3-months injection 6 Schi
Slide 26: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 Schizophrenia Risperidone Once-a-month injection 5 Once-every-3-months injection 6 Schi
Slide 27: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 Schizophrenia Risperidone Once-a-month injection 5 Once-every-3-months injection 6 Schi
Slide 28: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 Schizophrenia Risperidone Once-a-month injection 5 Once-every-3-months injection 6 Schi
Slide 29: Introducing the speakers
Introducing the speakers Jon Isaacsohn, M.D. Elisabeth Kogan Mary Ogle Chief Medical Officer Sr. VP Generic R&D VP, NTE Commercial 29
Slide 30: Abuse Deterrent (AD) Opioids
Abuse Deterrent (AD) Opioids 30
Slide 31: Opioids are widely used
Opioids are widely used Most prescribed medication for acute pain (e.g. post- surgery) Most prescribed medication for cancer-related chronic pain Expanding use in chronic non-cancer pain 1999 to 2011: Opioid sales in US increased > 300% 31
Slide 32: High levels of opioids in blood creates a feeling of euphoria
High levels of opioids in blood creates a feeling of euphoria Opioid concentration in blood EUPHORIA Toxicity threshold ANALGESIA Efficacy threshold NO EFFECT Pattern of an opioid dependent patient – evolves over a period of repeat use 32
Slide 33: The Feeling of Euphoria can Lead to Addiction
The Feeling of Euphoria can Lead to Addiction Over time, patients require higher amounts of the opioid tablets to achieve euphoria and prevent withdrawal symptoms. In order to achieve high opioid levels: Multiple tablets can be taken simultaneously Tablets can be manipulated to extract the opioi
Slide 34: High levels of opioids in blood can be achieved by tampering
High levels of opioids in blood can be achieved by tampering • Opioid tablet crushed and snorted or dissolved and injected IV Opioid concentration in blood • Opioid patch manipulated for injection Opioid tablet administered orally time Pattern of an opioid dependent patient – evolves over a period o
Slide 35: Opioid abuse is an epidemic in the US
Opioid abuse is an epidemic in the US In 2011: > 1.8M people with opioid dependence problems > 400,000 Emergency Room visits for opioid misuse > 150,000 abuse treatment admissions > 17,000 deaths Prevalence quadrupled since 2009 $72.5 Billion per year in health care costs 35
Slide 36: Introduction of abuse deterrent opioids
Introduction of abuse deterrent (AD) opioids: an important approach in the war against opioid abuse FDA issued draft guidelines for approval of abuse deterrent formulations (1/2013) FDA barred generic versions of OxyContin without tamper-resistant properties (4/2013) We expect AD opioids to comprise
Slide 37: Portfolio of AD opioids based on proprietary AD technology
We are developing a portfolio of AD opioids based on a proprietary and differentiated AD technology 37
Slide 38: OraGuard effectively addresses key tampering approaches
OraGuard effectively addresses key tampering approaches Crush into a powder (then snort / swallow) Extract with water (then inject) Dose dumping with alcohol Note: first two methods are relevant for both immediate and extended release opioids, 38 third method is relevant for extended release only
Slide 39: OraGuard creates a multi-layer gel-forming polymer coating
OraGuard technology creates a multi-layer gel-forming polymer coating of the opioid particles Polymers Polymers Polymers Polymers Polymers Polymers Polymers Polymers Polymers Opioid Opioid Opioid Opioid Opioid polymer polymer polymer polymer polymer Polymers Polymers Polymers Polymers Polymers Polym
Slide 40: OraGuard tablet forms a gel in small volume of fluid
OraGuard tablet forms a gel in small volume of fluid that prevents easy manipulation 40
Slide 41: OraGuard protects against dose dumping with alcohol
OraGuard protects against dose dumping when ingested with alcohol Simulated alcohol dose dumping in vitro Conventional Extended Release (pulled from the market) 65% % of opioid OraGuard AD3 released (Extended Release) within 2 hours 18% 17% 15% In absence In presence In absence In presence of alcoho
Slide 42: When an OraGuard tablet is crushed, polymer remains bound
When an OraGuard tablet is crushed, polymer remains bound to opioid… polymers Opioid particle 42
Slide 43: Oraguard protects against crushing and snorting
Oraguard protects against crushing and snorting In-vitro crushing and snorting experiment (Immediate Release tablet crushed and dissolved in nasal fluid at body Temperature) 89% % of opioid released within 10 minutes 26% Conventional Immediate OraGuard AD1 Release Product (Immediate Release) 43 Sour
Slide 44: OraGuard is a unique abuse deterrent technology
OraGuard is a unique abuse deterrent technology Provides the highest number of overlapping barriers to tampering Abuse deterrent properties of OraGuard technology validated in a clinical trial in patients with opioid dependence: Successful “liking” study with OraGuard extended-release hydrocodone
Slide 45: We have a broad abuse deterrent opioid portfolio
We have a broad abuse deterrent opioid portfolio AD1 Tablet (immediate release opioid 1 + acetaminophen) NTE in Development AD2 Tablet (immediate release opioid 2 + acetaminophen) Tablet AD3 (extended release opioid 3) Patch (not OraGuard) AD4 In Phase 3 Tablet CEP-33237 (extended release hydrocodon
Slide 46: Regulatory path to approval of AD opioids
Regulatory path to approval of AD opiods In Jan 2013, FDA issued Draft Guidance on the Regulatory path to approval of AD Opioids In vitro PK “Liking” Laboratory- Intact AD Studies in based in-vitro formulation vs. patients with manipulation manipulated opioid and extraction AD formulation dependence
Slide 47: We expect to submit three AD opioids in 2015
We expect to submit three AD opioids in 2015 In vitro PK “Liking” Phase3 Sub- mission AD1 ongoing 2014 2014 - 2015 AD2 ongoing 2014 2014 - 2015 AD3 ongoing 2014 2014 - 2015 2014 2015 2016 2016- 2018 AD4 2017 47
Slide 48: The Commercial Perspective
The Commercial Perspective 48
Slide 49: Physicians interviewed: very receptive to AD solutions
Physicians interviewed: very receptive to AD solutions Based on 67 in-depth interviews, 320 responses to quantitative survey “I am very concerned about opioid abuse - every time I prescribe, it’s the first thing on my mind.” (Pain care specialist) “[AD] is another layer of protection between me and
Slide 50: Payers expected to grant access to AD drugs
Payers expected to grant access to AD drugs Based on 37 in-depth interviews with US Payers • Recognize the prevalence of opioid abuse and corresponding economic burden • “Brand” prices are acceptable ($10-20 per day) • Reimbursement will be approved with standard T2/T3 co-pay to patient ($20-50 per
Slide 51: Expected shift of opioid market to AD
Expected shift of opioid market to AD US Sales of the Opioid Market ($B) 11.3 7.3 9.8 8.2 5.0 32% 2.6 51% 65% AD 5.6 4.8 AD 4.0 Non-AD 2012 2018 2023 51 Source: IMS MIDAS MAT Sep-2013, Company Market Projections
Slide 52: We have a strong competitive position
We have a strong competitive position Multiple AD products in 4 segments covering over 70% of the opioid market (in volume). In each segment we expect to encounter 1-3 competing products We expect to be 1st / 2nd to market in key segments OraGuard - a competitive advantage 3 step barrier process
Slide 53: Existing and Experienced Sales Team
Existing and Experienced Sales Team AD opioid will be marketed by our CNS sales and marketing organization (>500 reps): 70 sales reps are currently dedicated to pain: Actiq, Fentora, Amrix Dedicated pain team to expand as products are launched 53
Slide 54: Long Acting Risperidone for Schizophrenia
Long Acting Risperidone for Schizophrenia 54
Slide 55: Schizophrenia is a serious and relatively prevalent disease
Schizophrenia is a serious and relatively prevalent disease A severely disabling psychiatric disorder Chronic course associated with relapses: psychosis, ER visits and hospitalizations Affecting 2.2 million in US alone Total cost of schizophrenia in the US: $63B* 55 * Wu EQ, Birnbaum HG, Shi L, et a
Slide 56: Standard of care: long term administration of atypical antipsychotics
Standard of care: long term administration of atypical antipsychotic drugs Risperidone: most prescribed atypical antipsychotic Available in two dose forms Oral (Daily) Injectable (once-every-2-weeks) High rates of non-adherence to treatment 40% within one year, 75% within 2 years* Relapse rate
Slide 57: LAIs are superior to oral antipsychotics in addressing adherence
Long Acting Injection (LAI) are superior to oral antipsychotics in addressing adherence LAIs superior to orals in preventing relapse 60% reduction in hospitalizations* LAI have better safety profile: Significantly less extrapyramidal (Parkinson’s like) symptoms ** Accumulating evidence that LAI
Slide 58: Currently available LAI products have significant limitations
The currently available LAI products have significant limitations Most widely prescribed LAI is Risperdal Consta: Molecule: Risperidone Current dosage form has significant limitations: Every two weeks (frequent visit to the clinic) Intramuscular injection to buttock (unpleasant) 17 reconstit
Slide 59: Our solution
Our solution Risperidone LAI given once a month or every 3 months Subcutaneous injection: Less painful, does not require patient to undress Minimal reconstitution steps Minimal preparation time in office Addresses the needs of both: • Patients currently on LAI treatment • Patients on oral treatm
Slide 60: The Challenge: significantly modify the PK profile of an existing LAI
The Challenge: significantly modify the PK profile of an existing LAI product Approved risperidone LAI (Risperdal Consta 25mg): • Delayed onset • Once every 2 weeks Our Objective (illustrative): 14 • Intramuscular • Early onset 12 • Once every 3 months • Subcutaneous 10 Concentration of active 8 moi
Slide 61: Our solution
Our solution Based on cutting edge proprietary technology Two parallel development programs: Once a month (subcutaneous) Once every 3 months (subcutaneous) Once a month release achieved in-vitro and in-vivo* Early data from in-vitro studies with once every 3 month product is promising 61 * Rat s
Slide 62: Status and next steps
Status and next steps Formulation prototype and pre-clinical PK proof of concept: ongoing Pre-clinical studies: 2014-2015 PK experiments in humans: late 2014 - 2015 Clinical program: 2016 - 2018 Time to submission: 2018 62
Slide 63: The Commercial Perspective
The Commercial Perspective 63
Slide 64: Physicians find 3-month Risperidone highly attractive
Physicians find 3-month Risperidone highly attractive Based on 45 in-depth interviews and 319 quantitative survey “a game changer… probably switch all Risperdal Consta patients to this” (Psychiatrist, US) “it would take a lot away from the other IM applications… It would be a little revolution” (Psy
Slide 65: Payer would reimburse, potentially at a premium
Payer would reimburse, potentially at a premium Based on 20 in-depth interviews (US, EU) “[The product] provides differentiation… could be a 15-20% premium…” (Medical Director, US) “We would reimburse… this may even warrant a premium” (Payer, UK) Payors confirmed a 10-20% premium over the total cost
Slide 66: LAR Injectable segment will exceed $3B by 2017
LAR Injectable segment will exceed $3B by 2017 Sales of antipsychotics in US, 5EU, and Japan 10.7 1.8 9.0 8.6 3.2 8.9 3.6 LAI 5.8 5.0 Oral 2012 2017 2022 66 1 US. Germany,Spain,Italy,France,UK, Japan 2 Source: 2012 based on IMS Midas, DR Pharmacor; 2017 & 2022 based on Teva Analysis and DR Pharmacor
Slide 67: Competitive situation at launch
Competitive situation at launch Competing products in market in 2019: 1 once every-two-weeks (Consta) 3 once-a-month (IM) 1 once-every-3-month (IM, Paliperidone) Our product will be highly differentiated: Vs once-a-month IM : lower frequency, SC Vs once-every-3-months : SC, differentiated
Slide 68: Global CNS Commercial Team
Global CNS Commercial Team Risperidone LAR products will be marketed by our CNS sales and marketing organization: 500+ sales reps in US 400+ sales reps in EU Extensive experience in neuropsychiatry space (Nuvigil, Provigil, Clozapine) 68
Slide 69: Fixed dose combination for Glaucoma
Fixed dose combination of prostaglandin agonist and beta-blocker for Glaucoma 69
Slide 70: Glaucoma
Glaucoma Glaucoma - Progressive optic neuropathy strongly associated with ↑ intraocular pressure (IOP) Highly prevalent in the elderly population: 2.7M in US in 2010 (3.6M by 2020) Glaucoma results in progressive loss of vision: 2nd largest reason for blindness in Western World* 70 *Thylefors B,
Slide 71: Glaucoma results from imbalance between inflow / outflow of fluids
Glaucoma results from imbalance between inflow / outflow of fluids in the eye inflow inflow outflow outflow 71 71
Slide 72: 90% of patients initially prescribed a Prostaglandin Agonist
90% of patients are initially prescribed with a Prostaglandin Agonists inflow Prostaglandin Agonist outflow (Eye drops that increase outflow) 72
Slide 73: As Glaucoma advances, a beta blocker is commonly added
As Glaucoma advances, a beta blocker is commonly added Beta Blockers inflow (Eye drops that reduce inflow) + Prostaglandin Agonist outflow (Eye drops that increase outflow) 73
Slide 74: Problem #1: adherence to treatment declines over time
Problem #1: adherence to treatment declines over time Over a 1-year period, patients with Glaucoma miss ~30% of the prescribed doses* Non-adherence increases in correlation with number of drug administrations per day* In the US, prostaglandin agonists and beta blockers are prescribed separately, req
Slide 75: Problem #2: beta blocker eye drops have systemic side effects
Problem #2: beta blocker eye drops are associated with systemic side effects Cardiovascular: Bradyarrhythmias Reduction in cardiovascular performance during exercise Respiratory: Reduced pulmonary function (FEV1) in elderly patients treated with beta blocker eye drops 75 Source: Graefe’s Arch
Slide 76: Our solution
Our solution Once-a-day fixed-dose combination of: Standard dose of a prostaglandin agonist Low dose of beta blockers Innovative formulation that is expected to achieve: Similar efficacy to standard doses Significantly lower systemic exposure to beta blocker Less side effects associated wi
Slide 77: Teva has significant experience in ophthalmic formulation
Teva has significant experience in ophthalmic formulation 20 ophthalmic products developed by Generic R&D: Solutions, complex emulsions and suspensions Containing preservative and preservative free Manufacturing capabilities provide a range of fill/finish options: Standard multi-dose bottle, b
Slide 78: Status and path forward
Status and path forward Formulation development ongoing Preclinical development: 2014 Clinical development program: 2015-2017 Submission: 2018 in the US Additional product concepts utilizing complex ophthalmic formulations are under evaluation Goal: a basket of products in ophthalmology 78
Slide 79: The Commercial Perspective
The Commercial Perspective 79
Slide 80: Fixed dose combination market in US will reach $500M by 2018
Fixed dose combination market in US will reach $500M by 2018, $750M by 2023 Projected US Glaucoma Market ($B) 2.75 2.5 2.0 0.75 Fixed Dose 0.26 0.5 Combinations 1.7 2.0 2.0 Single Agents 2012 2018 2023 80 Source: IMS Therapy Forecaster; Teva analysis
Slide 81: Physicians are very positive about our product profile
Physicians are very positive about our product profile Based on 15 in-depth interviews and 150 quantitative surveys 75% will “definitely” or “probably” prescribe it Reasons for switching patients: More convenient dosing schedule Potential for improved compliance Improved systemic side effects
Slide 82: Payers will provide open tier-3 access
Payers will provide open tier-3 access at price levels equivalent to other brand fixed dose combination Based on 13 in-depth interviews “I have no funding concerns here. I think that [this combination] is quite a logical step. This combination makes sense regarding the current market situation.” (US
Slide 83: We will commercialize into this market ourselves
We will commercialize into this market ourselves Ophthalmology is a highly accessible space: ~22K physicians Requires ~60 sales representatives We will initially leverage Teva Select Brands: A diversified and experienced specialty sales force Focuses on products outside our core TAs Curren
Slide 84: Direct Release 6MP
Direct Release 6MP 84
Slide 85: Crohn's Disease
Crohn’s Disease An autoimmune disorder Inflammation of the intestine Symptoms: abdominal pain, diarrhea and bleeding, nutritional deficiencies 85
Slide 86: Therapeutic approach is based on disease severity
Therapeutic approach is based on disease severity Surgery Surgery Cyclosporine Moderate to Severe Remicade Disease Humira Anti-TNF Methotrexate Azathioprine/6-MP Corticosteroids Mild Immunosuppressants Mild to Moderate Budesonide Disease 5-ASA 86
Slide 87: 6-MP is the most commonly used drug for moderate CD
6-MP is the most commonly used drug for moderate CD 6-mercaptopurine (6-MP), Purinethol®, an immunosuppressive drug, is an effective treatment for moderate Crohn’s Disease: 54% of patients respond Indicated for Acute Lymphocytic Leukemia but used off-label in moderate Crohn’s Adverse effects Myelo
Slide 88: Our solution - Direct Release 6-MP
Our solution - Direct Release 6-MP Novel formulation for targeted release of 6-MP in the intestine Incorporates 2 formulation technologies: Technology 1: delays the release until drug is in intestine Technology 2: rapid release once drug is in intestine 88
Slide 89: Product progress to date
Product progress to date Exploratory phase I PK: Direct release 6-MP vs. “regular” 6-MP 11 patients, single dose 89
Slide 90: Direct Release 6-MP has minimal systemic exposure
Direct Release 6-MP has minimal systemic exposure Phase 1 Pharmacokinetic study (Single dose, n=11) 100 Systemic exposure 80 Conc. (ng/ml) “Regular” 6MP 60 40 20 Direct Release 6MP 0 0 5 10 15 20 25 Time (hr) 90 Source: Internally generated data
Slide 91: Product progress to date
Product progress to date Exploratory Phase II in patients with Crohn’s disease: Direct release 6-MP vs. “regular” 6-MP 24 patients, daily for 12 weeks Endpoint: Crohn’s Disease Activity Index (CDAI) 91
Slide 92: Encouraging efficacy data: similar improvement in Crohn's at week 12
Encouraging efficacy data: Similar improvement in Crohn’s disease at week 12 Change in CDAI score from baseline “Regular” 6MP Reduction in symptoms Direct release 6-MP 92
Slide 93: Development plan
Development plan Phase I and II to identify dose: 2014-2016 Phase III Crohn’s and ulcerative colitis: 2017-2018 Submission: 2019 93
Slide 94: Commercial perspective
Commercial perspective Global market for Crohn’s and Ulcerative Colitis: $7B (2014) Non-TNF segment of these markets: $2B Strong value proposition for Direct Release-6MP Efficacy with improved safety profile Expect to capture a meaningful share of non-TNF segment 94
Slide 95: Agenda
Agenda The strategic rationale New products from the NTE program of 2013 Where could we be in 2018 and 2020 95
Slide 96: New products from NTE process in 2013
New products from NTE process in 2013 Disease Area Compound Solution Pain Various opioids Abuse Deterrent tablet (AD1) 1 Abuse Deterrent tablet (AD2) 2 Abuse Deterrent tablet (AD3) 3 Abuse Deterrent patch (AD4) 4 Schizophrenia Risperidone Once-a-month injection 5 Once-every-3-months injection 6 Schi
Slide 97: New products bolster our CNS pipeline
New products bolster our CNS pipeline 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Laquinimod MS EU Copaxone – 40mg 3X w MS Laquinimod MS US Laquinimod in progressive MS Adasuve – Schizophrenia (in-licensed) Neuro Undisclosed - Dependence psychiatry Risperidone QM - Schizophrenia Risperido
Slide 98: New products bolster our pain pipeline
New products bolster our pain pipeline 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 AD Extended Release Hydrocodone AD 1 (tablet) Opioid AD 2 (tablet) AD 3 (tablet) AD 4 (patch) TV-45070 (erythromelalgyia) Non-Opioid TV-45070 (Osteoarthritis) 98 Products on market, assuming approval 1 year
Slide 99: Class of 2013: 14 submissions, 8 in next 3 years
Class of 2013: 14 submissions, 8 in next 3 years Class of 2013 submissions 5 3 2 2 1 1 2014 2015 2016 2017 2018 2019 99 Not adjusted for risk
Slide 100: Beyond 2013: we will initiate ~10 new programs each year
Beyond 2013: we will initiate ~10 new programs each year Class of 2014 submissions Class of 2013 submissions 8 2 3 5 4 2 2 3 3 2 1 1 1 2014 2015 2016 2017 2018 2019 100 Not adjusted for risk
Slide 101: ~50 submissions from products initiated between 2013-2017
~ 50 submissions from products initiated between 2013-2017 Class of 2015-2017 submissions 12 Class of 2014 submissions Class of 2013 submissions 7 2 9 8 8 7 5 6 3 5 1 1 2014 2015 2016 2017 2018 2019 101 Not adjusted for risk
Slide 102: Revenue projection (classes of 2013-2017)
Revenue projection (classes of 2013-2017) Not adjusted for risk $5B $2B 2018 2020 102
Slide 103: Risks
Risks Technology Clinical development Regulatory Blocking IP Exclusivity Competition 103
Slide 104: NTE Process can be a source of significant revenue
NTE Process can be a source of significant revenue: Classes of 2013-2017 can generate $1-1.5B by 2018 and $3B by 2020 Risk adjusted ~$3B $1-1.5B 2018 2020 104
Slide 105: NTE is a process to generate new specialty products
NTE is a process to generate new specialty products that: Provide benefit to patients: Improved efficacy Less side effects Better quality of life Provide benefit to clinicians: Improve compliance Reduce risk of misuse Provides benefit to payers : Reduces overall cost of treatment
Slide 106: NTE at Teva
NTE at Teva Unique model with an attractive risk / return profile Built on established expertise integrated in a novel way 2013: a year of significant progress Platform in place to sustain the model into the future 106
Slide 107: Thank You !
Thank You !
Teva Pharmaceutical Industries — Investor Day (December 2013) on 6ix