Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — Corporate Update (November 2010)
38 slides from Teva Pharmaceutical Industries's corporate update, Nov 4, 2010
Slide 1: Teva Respiratory Opportunity Business Update Meeting
Teva Respiratory Opportunity Business Update Meeting November 4, 2010
Slide 2: Forward Looking Statement
Forward Looking Statement This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause
Slide 3: Teva Respiratory Opportunity
Teva Respiratory Opportunity Shlomo Yanai, President & CEO Teva Pharmaceutical Industries Ltd. November 4, 2010
Slide 4: Targets for 2015
Targets for 2015 Revenues $31B Net income $6.8B Net profitability 22% r y 2010 r Ja nua ou iew From ategy Rev Str 4
Slide 5: Where Are We Now? Interim Update
Where Are We Now? Interim Update $31B CAGR = 14% $16.4B $15.8 B $13.9B International Europe US USD Billion 2009 2010E 2015E Source: Company filings and analysts’ reports We make better healthcare accessible around the world 5
Slide 6: Teva Branded – Multifaceted Approach
Teva Branded – Multifaceted Approach 6
Slide 7: Teva Branded – From $4.2 Billion to $9.2 Billion
Teva Branded – Multifaceted Approach From $4.2 Billion to $9.2 Billion 7
Slide 8: Teva Branded – Multifaceted Approach
Teva Branded – Multifaceted Approach How will we get there? 1. Organic growth 2. Pipeline 3. Acquisitions/licensing BioS 9% Women’s Health BioS 17% Innovative Women’s Health 2% 48% 12% Respiratory 26% Respiratory 22% Innovative 64% 8
Slide 9: Loaded Branded Pipeline
Loaded Branded Pipeline Marketed Products End Phase III 2010-2012 End Phase III 2013-2015 TV-1101 (OGX-011) 3 oncological projects (Phase III) Laquinimod DiaPep-277 Oral Multiple Sclerosis (Phase III) Type I Diabetes (Phase III) Copaxone® StemEx® Laquinimod Multiple Sclerosis & CIS Hemato-oncologica
Slide 10: Teva Branded – Multifaceted Approach
Teva Branded – Multifaceted Approach BioS 9% Women’s Health 17% Innovative 48% Respiratory 26% 10
Slide 11: Respiratory Opportunity
Respiratory Opportunity Dynamic market with great potential ‐ $34 Billion sales in 2010 High barriers to entry Robust pipeline targeting $25 Billion opportunity ‐ 10 submissions by 2015 Unique combination of talent, technology and financial resources Proven respiratory commercial platform
Slide 12: Global Respiratory Market Overview
Global Respiratory Market Overview Frank Pieters - Senior Vice President, Global Respiratory Global Branded Products
Slide 13: Global Respiratory Sales Concentrated in Seven Core Markets
Global Respiratory Sales Concentrated in Seven Core Markets Key Markets 2005 % Share 2010 % Share CAGR $Billion $Billion Worldwide 20 34 12% Top 7 Markets 17 28 13% US 9.8 59% 18.3 66% 17% Japan 1.7 10% 2.4 9% 9% Germany 1.1 7% 1.7 6% 10% UK 1.5 9% 1.7 6% 2% France 1.2 7% 1.6 6% 7% Spain 0.7 4% 1.1
Slide 14: Teva Ranked #5 in Global Respiratory Market
Teva Ranked #5 in Global Respiratory Market Global Market: $34 billion US +13.3% EU +7.0% #5 RoW +11.1% ($billions) Teva’s pipeline targets $25 billion of the total $34 billion Source: IMS MAT 2Q10 14
Slide 15: QVAR – Building a Global Brand
QVAR – Building a Global Brand QVAR has 20% market share in ICS segment in the U.S. and UK QVAR currently grows above 30% in U.S., UK, France and the Netherlands QVAR treats the total lung ‐ Continuous flow of studies bring new evidence ‐ QVAR beats fluticasone on treatment outcome ‐ Publicati
Slide 16: Teva's Robust Pipeline Targets $25 Billion
Teva’s Robust Pipeline Targets $25 Billion 2008 2010 2015* Worldwide (Q3MAT) (Q2MAT) (Worldwide) $Billion $Billion $Billion Total Respiratory Market R3 $29.6 $34 $38 ICS $4.2 $4.4 $5.3 $2.7 $3.2 SABA $4.1 (US $1.9) (US $2.3) Combination ICS/LABA $9.8 $11.7 $11.5 Anticholinergic $3.2 $4.2 $4.5 Nasal
Slide 17: Branded Focus: Easy to Use Devices
Branded Focus for the Immediate and Long-Term Future: Easy to Use Devices 17
Slide 18: Branded Respiratory Revenue Growth 2010-2015
Branded Respiratory Revenue Growth 2010 - 2015 . 5% 20 US R: EU AG 14% RoW C 36% 5% (in billions) 30% 50% 65% 2010 2015 18
Slide 19: U.S. Respiratory Market Overview
U.S. Respiratory Market Overview Mark Salyer - Executive Vice President General Manager Teva Respiratory, LLC
Slide 20: Teva Respiratory Division Vision
Teva Respiratory Division Vision To be recognized as a leader in the fight against respiratory disease in the United States through our people, our products, and our educational services 20
Slide 21: Teva Respiratory Brand Performance: 2006-2010
Teva Respiratory Brand Performance: 2006-2010 TRx Share % TRx Share % 21
Slide 22: Teva Respiratory Net Sales: 2006–2010
Teva Respiratory Net Sales: 2006 – 2010 3 0% GR: CA (in millions) * Total 2006 Jan-Dec: IVAX + Teva 22
Slide 23: Asthma and Allergic Rhinitis in the US: Room for Improvement
Asthma and Allergic Rhinitis in the US: Room for Improvement! Heavy Burden of Disease Congress Agrees! 20 million asthma patients 50 million allergy patients Congressional Asthma and Allergy Caucus Formed $27B healthcare costs April 2010 4,000 asthma deaths annually Despite many therapeuti
Slide 24: EIB Growth Opportunity for ProAir
EIB Growth Opportunity for ProAir Exercise-induced bronchospasm (EIB) is a separate disease etiology from asthma EIB affects an estimated 30 million children and adults in the U.S. EIB occurs in approximately one out of ten (10%) of individuals among the general population An estimated nine ou
Slide 25: U.S. Commercial Strategy: To Achieve $1.3 Billion by 2015
U.S. Commercial Strategy: To Achieve $1.3 Billion by 2015 Grow QVAR via aggressive market penetration as first line controller Maintain market leadership of ProAir HFA and introduce lifecycle improvements Launch QNAZE™ (BDP Nasal HFA) in Allergic Rhinitis Launch Combination program 25
Slide 26: Spiromax -- One Device for Three Brands
Spiromax -- One Device for Three Brands Estimated Teva Product Market Size Core Market ($B) Molecule Device 2020 ICS fluticasone propionate 3.4 fluticasone propionate, ICS-LABA salmeterol xinafoate 14.6 SABA albuterol 3.5 26
Slide 27: Powerful and Diversified Brand Portfolio
Powerful and Diversified Brand Portfolio – Today and Tomorrow Respiratory Sales in the U.S. to Achieve $1.3 Billion by 2015 27
Slide 28: Branded Products and Pipeline Review
Branded Products and Pipeline Review Tushar Shah, MD Senior Vice President, Teva Global Respiratory R&D
Slide 29: Strategies for Building Respiratory Portfolio
Strategies for Building Respiratory Portfolio Enhance and grow Develop new products existing brands which complement our current portfolio Target high value opportunities leveraging ProAir our technology Dose counter ‐ Combinations Spiromax Fluticasone Salmeterol Budesonide Formoterol ‐ IC
Slide 30: Complex and Lengthy Development Pathway
Complex and Lengthy Development Pathway: Representing High Entry Barrier Scale up to Pilot Scale Early Development: Identify robust formulation and generate early stability data Scale up to commercial size: Late Development: Produce clinical Fine tune formulation and supplies and final stability bat
Slide 31: Spiromax: A Novel Multi-dose DPI
Spiromax: A Novel Multi-dose DPI Uses a proprietary technology known as the X-ACT™ system - Active-metering, Cyclone-separator technology Provides accurate and consistent dosing and excellent lung deposition – even at low inspiratory flow rates Easy to teach and use: Open-Inhale-Close (breath-
Slide 32: EU Guidelines – Development of Orally Inhaled Products
EU Guidelines* – Development of Orally Inhaled Products (OIPs) MARKETING – AUTHORIZATION – APPROVAL In-vitro Comparative Data Conclusive (criteria met) Inconclusive or different (criteria not met) Pulmonary Deposition Deposition: 95% CI 0.80- (PK or Imaging Studies) 1.25 PK Safety: 90% CI 0.80-1.25
Slide 33: Implications of EU Guidance
Implications of EU Guidance Development of OIPs is more feasible Our approach is to target the large products in the EU market with similar performance Product Submission BFC Spiromax 2011 FSC Spiromax 2012 FSC HFA MDI 2012 FP HFA MDI 2011 33
Slide 34: FDA Expectations – Development of Orally Inhaled Products
FDA Expectations – Development of Orally Inhaled Products In vitro: Basically needs to be a “direct copy” of the reference ‐ Same ingredients and all within 5% of the reference ‐ Equal performance on in-vitro parameters ‐ Similar instructions for use Safety: Equivalent systemic effect (PK) at re
Slide 35: Implications of FDA Expectations for Orally Inhaled Products
Implications of FDA Expectations for Development of Orally Inhaled Products Development of generic orally inhaled products containing an ICS is unlikely at this time Market will remain branded for the foreseeable future Teva’s approach is to target the two leading products using our Spiromax dev
Slide 36: Teva Respiratory Pipeline – $5 Billion Peak Sales Potential
Teva Respiratory Pipeline – $5 Billion Peak Sales Potential End Phase III End Phase III Marketed 2010‐2012 2013‐2015 QVAR® QNAZE® ProAir Spiromax® Inhaled Steroid ProAir BFC Spiromax® Inhaled short acting beta‐ FSC HFA Combination Combination mimetic Salamol® FP HFA MDI FSC Spiromax® Combination Sa
Slide 37: Teva Respiratory Pipeline – $5 Billion Peak Sales Potential
Teva Respiratory Pipeline – $5 Billion Peak Sales Potential Marketed End Phase III End Phase III 2010‐2012 2013‐2015 QVAR® Inhaled Steroid QNAZE® ProAir Spiromax® ProAir BFC Spiromax® Inhaled short acting beta‐ FSC HFA Combination mimetic Combination Salamol® Salamol EasiBreathe® FP HFA MDI FSC Spi
Slide 38: Global Respiratory R&D: Summary
Global Respiratory R&D: Summary Teva has the expertise, technology and resources to progress our respiratory portfolio We have clarity and alignment on strategy and project priorities Continuing to successfully progress projects into late stage pharmaceutical and clinical development ‐ 10 subm
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