Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Investor Day (December 2012)
122 slides from Teva Pharmaceutical Industries's investor day presentation, Dec 11, 2012
Slide 1: Teva Investor Day
Teva Investor Day December 11, 2012 1
Slide 2: R&D - a growth engine for Teva
2 R&D ‐ a growth engine for Teva Dr. Michael Hayden 11 December 2012
Slide 3: Why did I join Teva?
Why did I join Teva?
Slide 4: Career in science and medicine, committed to improving health
4 Career in science and medicine, committed to improving health
Slide 5: Impacting millions
5 Impacting millions
Slide 6: What did I find?
What did I find?
Slide 7: Our mission
7 Our mission Develop the most competitive and focused pipeline to address unmet patient needs in a highly differentiated way to drive the growth of Teva Life and science intimately connected … that’s uniquely Teva
Slide 8: The future of Teva R&D
8 The future of Teva R&D High Focused value NTEs specialty generics portfolio
Slide 9: The essential elements
The essential elements
Slide 10: On the patient's journey
10 Unmet needs On the patient’s journey
Slide 11: Clear prioritization
11 Unmet needs Focus Clear prioritization
Slide 12: Build where Teva is differentiated
12 Unmet needs Focus Differentiation Build where Teva is differentiated
Slide 13: The unique strengths of Teva
13 Unmet needs Focus Differentiation Leverage The unique strengths of Teva
Slide 14: Combine generic and specialty capabilities
14 Unmet needs Focus Differentiation Leverage Integrate Combine generic and specialty capabilities
Slide 15: Access external innovation
15 Unmet needs Focus Differentiation Leverage Integrate Partnership Access external innovation
Slide 16: Nurture a science culture
16 Unmet needs Focus Differentiation Leverage Integrate Partnership Science culture Nurture a science culture
Slide 17: Areas of focus
17 Areas of focus
Slide 18: A focused R&D strategy
18 A focused R&D strategy Establish leadership in High‐value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 19: A focused R&D strategy
19 A focused R&D strategy Establish leadership in High‐value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 20: High value in Gx: First-to-Market, Complex Gx
20 High value in Gx First‐to‐Market Complex Gx
Slide 21: Complex Gx: patient need, technology, affordable price
21 PATIENT NEED ‐ Compliance ‐ Efficacy ‐ Safety Complex Gx COMPLEX AFFORDABLE TECHNOLOGY PRICE
Slide 22: Focus for complex Gx technology
22 Focus for complex Gx technology capabilities in complex Sustain oral delivery (modified release, combinations) capabilities in complex Grow e.g. injectable, liposomal, LAR, nasal, patches, devices
Slide 23: No access to Liraglutide for Gabriella
23 No access to Diabetic patient on metformin, Liraglutide for but her weight loss, diabetes not under control Gabriella Doctor wants to add liraglutide, but insurance denies coverage No generic ‐ Complex API ‐ Drug + device ‐ Complex formulation ‐ Complex IP landscape Not an actual patient
Slide 24: Addressing challenges of developing generic liraglutide
24 Addressing challenges of developing generic liraglutide Access to Characte‐ Drug‐ Formulation Complex complex rization of device challenges IP API complex combo landscape API API Analytical Device Formulation Patent sourcing strategy Teva Teva Teva Teva Teva Specialty API Specialty Generic Generi
Slide 25: A focused R&D strategy
25 A focused R&D strategy Establish leadership in High‐value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 26: New Therapeutic Entity
26 NEW THERAPEUTIC ENTITY Known molecule that is formulated, delivered, or used in a novel way to address specific patient needs
Slide 27: NTE
27 NOVEL Formulation or combo’s KNOWN Molecules UNMET Need (branded / generic) NOVEL Delivery NTE NOVEL Indication
Slide 28: A strong rationale for NTEs
28 A strong rationale for NTEs Formulation and analytical Understanding medical needs Special Technologies Clinical development Strengths in Gx regulatory Strengths in generics specialty Specialty regulatory Generic IP mindset Specialty IP mindset Products already in portfolio Presence in several TA
Slide 29: NTE: patient benefits
29 NTE: patient benefits Convenience Adherence Efficacy Safety Reduced Dosing Frequency
Slide 30: NTE: patient benefits
30 NTE: patient benefits Convenience Adherence Efficacy Safety Reduced Dosing Modified PK Frequency Profile
Slide 31: NTE: patient benefits
31 NTE: patient benefits Fixed Dose Combination Convenience Adherence Efficacy Safety Reduced Dosing Modified PK Frequency Profile
Slide 32: NTE: patient benefits
32 NTE: patient benefits Convenience New Adherence populations Efficacy (elderly / Safety pediatric) New Modified routesPKof Delivery Profile
Slide 33: NTE: patient benefits
33 NTE: patient benefits Convenience New Adherence populations New Efficacy (elderly / indications Safety pediatric)
Slide 34: NTEs: attractive risk/return profile
34 NTEs: attractive risk/return HIGH profile value Validated targets Proven efficacy Low development risk LOW Low regulatory risk Risk Shorter timelines Lower costs
Slide 35: NTEs: new way, distinct space
35 NTEs : new way ‐ distinct space Higher NCE risk (NDA) Lower NTE NTE Gx risk (ANDA) Lower Higher return return
Slide 36: Duragesic, OxyContin, Namenda NTE examples
36 Duragesic® OxyContin® Namenda® (fentanyl patch) (oxycodone ER) (memantine for Alzheimer’s) $2.5b $3.6b $2.3b
Slide 37: Scaling and industrializing NTEs
37 Scaling and industrializing NTEs
Slide 38: The NTE process
38 The NTE process Product Unmet External Customer/ Technology need Payor GENERIC R&D SPECIALTY R&D BUSINESS COMMERCIAL DEVELOPMENT Global idea bank Evaluation Approval
Slide 39: NTE funnel: approved for development in 2013
39 In 2013 Medical rationale, ~120 advantage to patient 100 Commercial feasibility 60 Technical feasibility 30 Integrated business case 20 Go‐no‐go 10‐15 Approved for development
Slide 40: Gary misses 5 of his 90 monthly pills
40 Gary misses 5 of his 90 monthly pills Diagnosed with HIV 12 years ago Needs to take 30x3 pills per month Non‐adherence increases risk of resistance and recurrence Not an actual patient
Slide 41: Non-adherence is costly
41 Non‐adherence is costly 50% Not adherent 33% Don’t fill prescription 25% Under dose Cost of non‐adherence 30% Stop early $300B in US
Slide 42: NTE idea: multi drug combination in HIV
42 NTE idea: multi drug combination in HIV Convenience 90 pills per 30 pills per Adherence month month Efficacy Not an actual patient
Slide 43: Ellen's schizophrenia drug makes her gain weight
43 Ellen’s Schizophrenia drug makes her gain weight Takes olanzapine antipsychotic Side effect: weight gain (12kg) NTE idea: combine antipsychotic with weight loss drug Safety / Side Effects Not an actual patien
Slide 44: A new Lupus treatment for Elisabeth
44 A new Lupus treatment for Elisabeth CellCept, gold standard in transplantation, modifies pathways crucial in the develop‐ ment of Lupus The idea: New indication CellCept for Lupus New population Not an actual patient
Slide 45: Unique opportunities for IP protection
45 Unique opportunities for IP protection 20 years from filing Potential coverage: Formulations Indications Combinations Pharmacokinetics Clinical endpoints
Slide 46: We are uniquely positioned to become the best NTE company
46 We are uniquely positioned to become the best NTE company in the industry and turn it into a major growth engine for Teva
Slide 47: A focused R&D strategy
47 A focused R&D strategy Establish leadership in High‐value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 48: CNS: transform, adjacent, core
48 TRANSFORM Explore other CNS ADJACENT disorders Expand into neuro‐ degenerative diseases CORE Sustain MS franchise Enhance presence in pain
Slide 49: Sustain the MS franchise
49 Sustain the MS franchise
Slide 50: MS treatment trends = opportunity
50 MS treatment trends = opportunity FROM TO Relapse rate Additional endpoints RRMS only RRMS + progressive Monotherapy Combinations
Slide 51: Assets in MS: Copaxone
51 Assets in MS COPAXONE®: uniquely Decreases inflammation differentiated
Slide 52: Copaxone uniquely differentiated based on real-life experience
52 Uniquely Est. 1.3m patient years since 1996 differentiated based on Proven efficacy real‐life experience Established safety profile
Slide 53: Recent data from an independent, NIH-funded study
53 Recent data from an independent, NIH‐funded study
Slide 54: ~90% adherence after 3 years
54 ~ 90% adherence after 3 yrs % completing visit Copaxone ~90% IFN + COP IFN COP Courtesy of Dr. Fred Lublin, unpublished data
Slide 55: Low Relapse Rate
55 Low Relapse Rate Annualized relapse rate COP Courtesy of Dr. Fred Lublin, unpublished data
Slide 56: Less frequent injections of COPAXONE
56 Less frequent injections of COPAXONE® Dose 20mg 40mg daily 3 times Frequency per week Efficacy / safety demonstrated in GALA study Submission: 2013
Slide 57: Less frequent injections of COPAXONE
57 Less frequent injections of COPAXONE® Dose 20mg 40mg daily 3 times Frequency per week Assures patent coverage until 2030 (issued in US, pending in EU)
Slide 58: Differentiated properties from generics
58 Differentiated properties from generics with potential clinical implications COPAXONE® Purported Drug Product Generic upregulation downregulation
Slide 59: The Wall Street Journal: MS pills debut
59 The Wall Street Journal As MS Pills Debut, Doctors Prescribe a Dose of Caution Jonathan D. Rockoff Nov. 20, 2012 “Multiple‐sclerosis patients have waited years for the first generation of treatments in pill form. Now that they're becoming available, however, doctors are warning: not so fast. The
Slide 60: Assets in MS: Laquinimod
60 Assets in MS Laquinimod: Protects neurons novel mechanism (in preclinical models) of action
Slide 61: A unique asset in MS
61 A unique asset in MS Unique mechanism Impact of action Direct effect on central Prevents neuronal nervous system damage (in animal models) Impacts a central Decreases progression pathway of of disability neurodegeneration (in clinical trials)
Slide 62: Brain of patient with MS at onset
62 Brain of Patient with MS ‐ at onset
Slide 63: Brain of patient with MS years later
63 Brain of Patient with MS – 2 yrs later
Slide 64: Reducing brain atrophy
64 Reducing brain atrophy Drug P Brain value volume (vs placebo) Allegro* Laquinimod <0.0001 +33% N=1106 0.6 mg 24 months Laquinimod 0.0001 +27% 0.6 mg Bravo** N=1331 24 months Avonex 0.1392 ‐9% * Comi, G., et al, N.Engl.J.Med. 366;11.2012 ** Volmer, T., American Academy of Neurology 2012, Comi, G.,
Slide 65: Impact on quality of life
65 Impact on quality of life MS‐Placebo MS‐Laquinimod Change in SF‐36 subscale scores from baseline to month 24 p = 0.006 p = 0.006 p = 0.001 p = 0.076 p = 0.016 p = 0.121 1.0 0.5 0.0 ‐0.5 ‐1.0 ‐1.5 ‐2.0 Vitality Social Emotional Mental Physical General function health health function health Jeffery
Slide 66: Laquinimod: the path forward
66 Laquinimod: the path forward Q3 2012 Q1 2013 2013 EU Additional Clinical trial in submission confirmatory study Primary Progressive 2 phase II studies Initiation of phase III (Allegro, Bravo) (Concerto) Placebo, 0.6mg Placebo, 0.6mg, 1.2mg RRMS indication Results: 2016
Slide 67: Copaxone Laquinimod combination
67 Copaxone Laquinimod combination: potential to modify the course of MS Combination Copaxone Laquinimod anti‐inflammatory neuroprotective
Slide 68: Laquinimod: backbone for combination with other drugs
68 Laquinimod: backbone for combination with other drugs Oral Drug B Oral Drug A Combination Oral Drug C Laquinimod
Slide 69: We will initiate combination studies in 2013
69 We will initiate combination studies in 2013
Slide 70: Unique opportunities in neurodegenerative disorders
70 Unique opportunities in neurodegenerative disorders
Slide 71: Neurodegenerative disorders
71 Neurodegenerative disorders MS Multiple sclerosis AD Alzheimer disease PD Parkinson disease HD Huntington disease ALS Amyotrophic lateral sclerosis
Slide 72: Why expand into neurodegeneration?
72 Why expand into neurodegeneration? Increasing prevalence Huge disease burden Common pathways Better scientific understanding Unique opportunity for Teva medicines
Slide 73: Increasing prevalence
73 Increasing prevalence million MS AD and other PD HD dementias 3.3 44 7 90k 2.8 6 75k 2.5 31 5 60k 24 2005 2015 2030 2005 2015 2030 2005 2015 2030 2005 2015 2030 Note: World‐wide prevalence, Huntington is US + EU only
Slide 74: Normal brain tissue: minimal astrocytic activation
74 Normal brain tissue: minimal astrocytic activation Courtesy of Prof. W. Brueck. Neuropathology dept. Gottingen university. Germany
Slide 75: Similar pathways of astrocytic activation
75 Similar pathways of astrocytic activation MS HD AD PD
Slide 76: Laquinimod decreases astrocytic activation
76 Laquinimod decreases astrocytic activation Control Laquinimod GFAP Corpus callosum Cortex 500 µm Brueck et al., Acta Neuropathologica 2012
Slide 77: 4 medicines with potential to treat neurodegenerative disorders
77 4 medicines with potential to treat neurodegenerative disorders COPAXONE®+ Laquinimod Laquinimod Azilect® Huntexil® (pridopidine)
Slide 78: Neurodegenerative disorders: first steps
78 Neurodegenerative disorders: first steps HD HD Laquinimod Huntexil® (pridopidine) 2013: Initiate Phase II 2013: Initiate Phase II or III 2016: submission
Slide 79: Pain
79 Pain
Slide 80: Pain: transform, adjacent, core
80 TRANSFORM Non‐opioid ADJACENT alternatives New opioid‐based assets CORE Expand current opioid‐based assets
Slide 81: Opioid-based pain products
Opioid‐based pain products Marketed Phase III Extended Release Hydrocodone
Slide 82: The New York Times Magazine
82 The New York Times Magazine “The Hazards of Growing Up Painlessly” Nov. 18, 2012 Story of a young woman’s life with congenital indifference to pain http://www.nytimes.com/2012/11/18/magazine/ashlyn-blocker-feels-no- pain.html?ref=magazine
Slide 83: Nav1.7 blockade: a novel non-opioid target in pain
83 Nav1.7 blockade: a novel non‐opioid target in pain Congenital indifference to pain (CIP) Mutations in gene encoding sodium channel protein Nav1.7 in CIP pts 5‐10% gain of function mutations in Nav1.7 in erythromelalgia
Slide 84: An exclusive license to XEN402
84 An exclusive license to XEN402 A novel non‐opioid Nav1.7 inhibitor 2 products: oral, topical Multiple indications Orphan designation ‐ Erythromelalgia
Slide 85: Reduction in pain in Erythromelalgia with oral XEN402
Reduction in pain in Erythromelalgia with oral XEN402 Subject 1004: “Took first ever hot shower in my life and was thrilled” Active is reduced 88% vs Placebo p=0.031
Slide 86: Greater response with topical XEN402 in PHN pain
Greater response with topical XEN402 in PHN Pain p=0.049 p=0.0078 45 Proportion of Responders (%) 40 35 30 25 20 15 10 5 0 Improved >30% Improved >50% Placebo 21.4 9.5 Drug 42.9 28.6 N=42 Confidential Information 86
Slide 87: A focused R&D strategy
87 A focused R&D strategy Establish leadership in High‐value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 88: Respiratory: transform, adjacent, core
88 TRANSFORM New Technological ADJACENT Platforms Develop existing molecules on Spiromax ‐ BAI New disease CORE areas Optimize Reslizumab life cycle current products
Slide 89: Teva focus in Asthma
89 Teva focus in Asthma Inhaled therapy Novel mechanism of action Major classes: Novel biologics for ICS, SABA, LABA, severe asthma possibly LAMA Innovative platforms Reslizumab (Spiromax)
Slide 90: One family, three asthma patients
90 One family Three asthma patients
Slide 91: Rescue and Maintenance
Rescue Maintenance 91
Slide 92: Complex inhaler use
92 Complex Multiple technologies Dosing variability Hand‐breath coordination Requires training
Slide 93: Poor asthma control
93 Dosing Incorrect Rescue variability use medication overuse Poor asthma control
Slide 94: There must be a smarter way to do this
94 There must be a smarter way to do this
Slide 95: Maintenance: open, inhale, close
95 Maintenance 1 Open 2 Inhale Rescue 3 Close
Slide 96: The Spiromax platform
96 The Spiromax platform easy to use, easy to educate one device, all molecules the correct dose, every time
Slide 97: Spiromax: it is a validated platform
97 Spiromax: it is a validated platform Most advanced spiromax product (budesonide / formoterol) completed clinical development Bioequivalence to originator brand (Symbicort) achieved in all parameters Submission in EU in 2013
Slide 98: Reslizumab
98 Reslizumab MAb against IL‐5 Novel and validated mechanism of action Phase III in moderate‐severe allergic asthma Shown to prevent exacerbations/hospitalization IV and SC formulations development in parallel
Slide 99: COPD: A global unmet need
99 COPD: A global unmet need 210M patients #4 leading cause of death #1 cause of death in rural China $12B drug sales Class ICS/LABA and LAMA
Slide 100: COPD: the first steps of a major commitment
100 st COPD: the 1 steps of a major commitment 1 Key Spiromax products (fluticasone/salmeterol & budesonide/formeterol) 2 LAMA product in a novel proprietary device is in development
Slide 101: A focused R&D strategy
101 A focused R&D strategy Establish leadership in High‐value Gx Build a unique platform for NTEs Sustain and leverage strengths in CNS Achieve leading presence in Respiratory
Slide 102: Engines to enrich our pipeline
Engines to enrich our pipeline
Slide 103: Our discovery pipeline: internal
103 Our discovery pipeline Highly differentiated programs Small‐molecule INTERNAL and biologics
Slide 104: Differentiated biologics program
104 Differentiated biologics program Novel Bio Bio biologics betters similars Proprietary, novel Multiple Selective approach antibody arming technologies to technology enable differentiation Validated targets (Enhanced antibodies, half‐life extension)
Slide 105: Recent progress
105 Recent progress Bio Bio betters similars Glyco‐pegylated GCSF: GCSF: approved in US (8/2012) submitted in US (12/2012) and EU (11/2011) GCSF: approved in EU Albumin‐fused GCSF: FSH: submitted in EU (2/2012) ready for submission in US EPO: approved in EU Long‐acting HGH: completed phase I
Slide 106: Our discovery pipeline: external
106 Our discovery pipeline EXTERNAL Target identification Highly and differentiated validation, programs pathways, mechanisms Small‐molecule INTERNAL of action, etc. and biologics External compounds
Slide 107: Israel is world-leading in R&D investment
107 Israel is world‐leading in R&D investment R&D expenditure as % of GDP, 2008
Slide 108: Israeli academia is among the most productive in neuroscience
108 Israeli academia is among the most productive in neuroscience Neuroscience publications per capita
Slide 109: National center of excellence in neuroscience
109 National center of excellence in neuroscience Weizmann Select Medical Institute Centers University of Tel Aviv Haifa University Select Biotech Hebrew Technion University External collaborators Ben Gurion Bar Ilan University University
Slide 110: Teva and the Gates Foundation
110 Teva and the Gates Foundation NTEs for developing countries Women’s health
Slide 111: Teva and the Gates Foundation
111 Teva and the Gates Foundation NTEs for developing countries Women’s health Infectious diseases
Slide 112: Recruitment of global leaders
Recruitment of global leaders
Slide 113: Dr. Jon Isaacsohn and Dr. Volker Knappertz
113 Dr. Jon Isaacsohn Dr. Volker Knappertz Chief Medical Officer VP of MS Clinical Former EVP, head of Medical & US Board certified neurologist Regulatory Neurology residence at Medpace Yale Medical School Training in Internal 15 years of pharma experience Medicine and Cardiology Bayer, Medimmune/AZ
Slide 114: Pipeline
Pipeline
Slide 115: May 2012: 59 programs
115 May 2012: 59 programs Pre‐clinical Phase I Phase II Phase III Sub/reg 26
Slide 116: 12 programs discontinued
116 12 programs discontinued Pre‐clinical Phase I Phase II Phase III Sub/reg 21 13 13 6 8 7
Slide 117: Phase II and III programs discontinued
117 Phase II and III programs discontinued COPAXONE® 20mg/0.5mL daily III StemEx: Cord Blood* III MultiGeneAngio: Peripheral Arterial Disease* III Obatoclax: Lung Cancer III Placulumab: Sciatica II * Relationship with partner under discussion
Slide 118: 2013: 62 programs (18 programs added)
118 2013: 62 programs (18 programs added) Pre‐clinical Phase I Phase II Phase III Sub/reg 28 16 15 13 10 5 3 4 8 6
Slide 119: Increased focus: CNS, Respiratory, NTE
119 Increased focus: CNS, Respiratory, NTE 2012 2013 CNS 50% 30% Respiratory CNS NTE CNS 19% Women’s 11% Resp 27% Oncology 19% Resp Immunology 7% NTE Biologics* Other * Biosimilars and biobetters
Slide 120: 2013: Programs in CNS and Pain
120 2013: Programs in CNS and Pain Phase II Phase III Registration Laquinimod combination: MS Laquinimod High Dose: MS Copaxone® 40mg: MS Laquinimod: HD Laquinimod : Progressive MS Laquinimod: MS (EU) CNS XEN402 (oral): Pain Huntexil® (pridopidine): HD XEN402 (topical): Pain ER hydrocodone: Pain Alb
Slide 121: R&D - a growth engine for Teva
R&D ‐ a growth engine for Teva High value generics Industrialized NTEs Focused and reshaped pipeline Initial steps toward a CNS constellation Novel partnerships
Slide 122: Impacting billions
122 Impacting billions
Teva Pharmaceutical Industries — Investor Day (December 2012) on 6ix